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Page 1 of 116
MINUTES OF 257th
MEETING OF CENTRAL LICENSING BOARD HELD ON
JANUARY 24-25, 2018 *=*=*=*=*
257th
meeting of the Central Licensing Board (CLB) was held on January 24-25, 2018 in the
Committee Room, Drug Regulatory Authority of Pakistan, 4th
Floor, T.F. Complex, G-9/4, Islamabad
under the Chairmanship of Mr. Ghulam Rasool Dutani, Director Drug Licensing, Drug Regulatory
Authority of Pakistan, Islamabad.
Following members attended the meeting: -
S. No. Name & Designation Status
1. Dr. Sheikh Akhter Hussain.
Director (QA/LT), DRAP, Islamabad
Member
2. Mr. Munawar Hayat,
Chief Drug Controller, Primary and Secondary Health Care
Department, Govt. of Punjab, Lahore
Member
3. Syed Welayat Shah,
Chief Drug Inspector, Department of Health, Govt. of Khyber
Pakhtunkhwa, Peshawar
Member
4. Syed Saleem Shah,
Chief Drug Inspector, Department of Health, Govt. of Balochistan,
Quetta
Member
5. Syed Muied Ahmed, Expert in manufacturing of drugs. Member
6. Dr.Ikram-ul-Haque , Expert inQC/QA of drugs. Member
7. Prof. Dr. Abdullah Dayo, Dean, Faculty of Pharmacy, University of
Sindh, Jamshoro
Member
8. Prof. Dr. Mohammad Usman, Expert in manufacturing of drugs Member
9. Prof Dr. Jamshaid Ali Khan, Department of Pharmacy, University of
Peshawar, Peshawar
Member
10. Mr. KhurramShahzad Mughal,
Consultant M/o Law, Justice and Human Rights, as representative of
M/o Law and Justice, Islamabad.
Member
11. Mr. Manzoor Ali Bozdar, Additional Director (Lic.), DRAP,
Islamabad.
Secretary/Member
12. Mr Sabooor Ahmed Sheikh and Mr. Arshad Mehmood as
Representatives of PPMA
Observer
13. Mr. Nadeem Alamgir, Representative of Pharma Bureau. Observer
14. Mr. Kamran Anwar, Representative of PCDA. Observer
The meeting started with the recitation of verses from the Holy Qura’an. The Chairman Central
Licensing Board welcomed the honorable members and participants of the meeting. He stated that all
the legal and codal formalities would be taken into account for disposal of cases and respective
Divisions shall be responsible for the contents, errors and omissions of agenda and minutes. Mr.
Zeeshan Nazir, Deputy Director (QA/QC), Mr. Abdul Sattar Sohrani, Deputy Director (QC) Dr.
Muhammad Usman AD (Lic.), Dr. Muhammad Ashfaq AD (Lic) and Dr. Zunaira Farayad, AD (Lic)
DRAP Islamabad assisted the Secretary Central Licensing Board in presenting the agenda.
Page 2 of 116
The Board also appreciated the services of Mr. Faqeer Muhammad Shaikh, ex-Chairman, Central
Licensing Board for his inclusive approach of conduct of the business of the Board.
Item-I CONFIRMATION OF THE MINUTES OF 256th
MEETING
The Central Licensing Board (CLB) formally confirmed the minutes of its 256th
meeting held on
November 9-10, 2017. The Board also approved the corrections of the following items which were
decided in previous meetings.
Page 3 of 116
Case NO. 1 RESTRUCTURING OF LICENSED PREMISES WITHOUT PRIOR
APPROVAL FROM DRAP OF M/S LISKO PAKISTAN (PVT) LTD, KARACHI
A copy of letter is received from Mr. Kirshan, Assistant Director / Federal Inspector of
Drugs, Karachi addressed to the Director M/s Lisko Pakistan (Pvt) Ltd, Karachi, wherein he has stated
that as follow:-
“I am directed to inform you that the undersigned visited the premises (Lisko Pakistan
(Private) Limited, L-10/D, Block-21, Federal "B" Industrial Area) on dated 26-10-2017
regarding the subject matter and as per telephonic discussion with you that the construction
work for bottle store was undergoing on the first floor of the building without approval
intimation to Area FID.
2. As per your statement, during the course of construction work, the roof of the floor
fallen down due to overload on dated 24-10-2017 and eventually one of the labors died and the
four injured.
3. During the visit the undersigned found the factory premises were sealed by Sindh
Building Control Authority (SBCA) (annexure attached).
4. You are hereby directed to explain that why the permission was not taken from
DRAP.
5. You are further directed that explain your position within 7 days of receipt of this
office letter and intimate the DRAP for approval before resuming the activities in factory
premises”.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 19 and
Rule 20 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their Drug
Manufacturing Licence No. 000520 of M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small
Industrial Estate, Lahore Road, Sargodha by way of formulation may not be suspended or cancelled
by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board:
In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as
M/s Qintar Pharmaceuticals (Pvt) Ltd, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha
under Drug Manufacturing Licence No. 000520 by way of formulation Instead of M/s Lisko Pakistan
(Pvt) Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi under Drug Manufacturing Licence
No. 000110 by way of formulation.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board approved the correction in decision of the 256th
meeting of the Central Licensing Board
and decision may be read as under:
“The Board considering the facts on the record and after thread bare deliberation decided to
serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule,
12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the
provision of Rule, 19 and Rule 20 of the Drugs (Licensing, Registering and Advertising)
Rules, 1976 as to why their Drug Manufacturing Licence No. 000110, M/s Lisko Pakistan (Pvt)
Ltd, L-10/D, Block-21, Federal "B" Industrial Area, Karachi by way of formulation may not
be suspended or cancelled by Central Licensing Board.”
Page 4 of 116
Case NO. 2 GRANT OF ADDITIONAL SECTIONS OF M/S THERAMED
PHARMACEUTICAL (PVT) LTD, 45-KM, MULTAN ROAD, LAHORE .
M/s Theramed Pharmaceutical
(Pvt) Ltd, 45-Km, Multan Road,
Lahore
DML No. 000696
(Formulation)
10-10-2017 The Board approved the grant of following
additional sections /amendment as under:-
Section (06)
1. Oral Liquid (General) Section.
2. Dry Powder Suspension (General)
Section.
3. Capsule (General) Section.
4. Tablet (General) Section.
5. Tablet (Psychotropic) Section
(New).
6. Capsule (Psychotropic) Section
(New).
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board:
The following sections were mistakenly written in Minutes of 256th
meeting of Central Licensing
Board of the firm M/s Theramed Pharmaceutical (Pvt) Ltd, Lahore regarding grant of additional
sections.
1. Oral Liquid (General) Section.
2. Dry Powder Suspension (General) Section.
3. Capsule (General) Section.
4. Tablet (General) Section.
However, the firm already possess the aforesaid sections and Tablet (Psychotropic) Section (New) &
Capsule (Psychotropic) Section (New) are new sections.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board approved the correction in decision of the 256th
meeting of the Central Licensing Board
and decision may be read as under:
“The Board approved the grant of following additional sections /amendment as under:-
Section (02)
1. Tablet (Psychotropic) Section (New).
2. Capsule (Psychotropic) Section (New).”
Case No. 3 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE M/S AIMS
PHARMACEUTICALS, PLOT NO. 291, INDUSTRIAL TRIANGLE KAHUTA
ROAD, ISLAMABAD.
Case Background
The Case for grant of renewal of DML of M/s Aims Pharmaceuticals, Plot No. 291, Industrial Triangle
Kahuta Road, Islamabad for the period of 21-03-2017 to 20-03-2020 was placed in 256th
meeting of
Central Licensing Board held on 9th
and 10th
November, 2017 and board decided as under:-
“The Board approved the renewal of Drug Manufacturing License for the further period
w.e.f 21-03-2017 to 20-03-2022.
It is submitted that the recommendations of the panel were as under:-
“Keeping in view the above said observations, people met on site, documents reviewed;
the panel unanimously recommended not to grant renewal of DML to M/s Aims
Page 5 of 116
Pharmaceuticals till the rectification of the shortcomings pointed out by the panel and
verification of compliance of these by the same panel.”
Due to typographical mistake the words board approved the renewal were inadvertently mentioned
in minutes.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board approved the correction in decision of the 256th
meeting of the Central Licensing Board
and decision may be read as under:
“The Board considered the case and did not approve the renewal of Drug Manufacturing Licence. The
Board further decided that the licensee shall rectify the shortcomings noted by the panel within a
period not less than one month under Rule, 13 of the Drugs (Licensing, Registering and Advertising)
Rules, 1976 from the date of issuance of decision of the Board. The licensee shall inform regarding
rectifications made and accordingly panel would be constituted to verify the improvements made.
Manufacturing in the premises shall remain suspended till decision by the Board. The Central
Licening Board will take a decision on the recommendations of the panel either to grant renewal of
licence or reject the application and inform the licencee accordingly.”
Case No.4 CHANGE OF MANAGEMENT OF M/S MARTIN DOW LTD, KARACHI
M/s Martin Dow Ltd, Karachi License No. 000267 by way of formulation has submitted request for
change in management of the firm as per Form -29 with prescribed Fee Challan of 50,000/- as under;
Previous Management Interim Management New Management
1. Mr. Muhammad Jawed Akhai
S/o A. Sattar Akhai CNIC
No.42000-1658201-1.
2. Mr. Muqtadir M.A Jawad S/o
Shafiq Ahmed CNIC
No.42201-5392112-5,
3. Mr. Muhammad Hanif S/o
Abdul Sattar CNIC No.
42006-8272276-9.
4. Mr. Ali Akhai S/o
Muhammad Jawed Akhai
CNIC No. 42006-3326327-5.
5. Mr. Jawed Ghulam
Mohammad S/o Ghulam
Mohammad CNIC No.
42201-0556944-9.
1. Mr. Muhammad
Jawed Akhai S/o A.
Sattar Akhai CNIC
No.42000-1658201-1.
2. Mr. Muqtadir M.A
Jawad S/o Shafiq
Ahmed CNIC
No.42201-5392112-5.
3. Rizwan Omar S/o
Omar A Muhamamd
CNIC No. 42201-
3609527-7.
1. Mr. Muhammad Jawed
Akhai S/o A. Sattar Akhai
CNIC No.42000-1658201-1
2. Mr. Muqtadir M.A Jawad S/o
Shafiq Ahmed CNIC
No.42201-5392112-5.
3. Syed Dawood S/o Syed
Fasih Uddin Ahmed, LB-
0060600
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Inshal Pharmaceuticals Industries, Rawat, Islamabad by way of formulation as per partnership deed as
under:
Previous Management / as per
Form-29
Interim Management as
per Form-29
New Management as per
Form-29
1. Mr. Muhammad Jawed
Akhai S/o A. Sattar Akhai
CNIC No.42000-1658201-1.
2. Mr. Muqtadir M.A Jawad
S/o Shafiq Ahmed CNIC
No.42201-5392112-5,
3. Mr. Muhammad Hanif S/o
1. Mr. Muhammad
Jawed Akhai S/o A.
Sattar Akhai CNIC
No.42000-1658201-1.
2. Mr. Muqtadir M.A
Jawad S/o Shafiq
Ahmed CNIC
1. Mr. Muhammad Jawed
Akhai S/o A. Sattar Akhai
CNIC No.42000-1658201-1
2. Mr. Muqtadir M.A Jawad
S/o Shafiq Ahmed CNIC
No.42201-5392112-5.
3. Mr. Syed Dawood S/o Mr.
Page 6 of 116
Abdul Sattar CNIC No.
42006-8272276-9.
4. Mr. Ali Akhai S/o
Muhammad Jawed Akhai
CNIC No. 42006-3326327-
5.
5. Mr. Jawed Ghulam
Mohammad S/o Ghulam
Mohammad CNIC No.
42201-0556944-9.
No.42201-5392112-5.
3. Rizwan Omar S/o
Omar A Muhamamd
CNIC No. 42201-
3609527-7.
Syed Fasih Uddin Ahmed,
LB-0060600
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board:
In the aforesaid minutes of Central Licensing Board the name of the firm was inadvertently typed as
M/s Inshal Pharmaceuticals Industries, Rawat, Islamabad Instead of M/s Martin Dow Ltd, Plot No. 37,
Sector 19, Korangi Industrial Area, Karachi under Drug Manufacturing Licence No. 000267 by way of
formulation.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board approved the correction in decision of the 256th
meeting of the Central Licensing Board
and decision may be read as under:
“The Board considered and endorsed the change of management from old to new management of M/s
Martin Dow Ltd, Plot No. 37, Sector 19, Korangi Industrial Area, Karachi by way of formulation as
per Form-29 as under:
Previous Management / as per
Form-29
Interim Management as
per Form-29
New Management as per
Form-29
1. Mr. Muhammad Jawed Akhai
S/o A. Sattar Akhai CNIC
No.42000-1658201-1.
2. Mr. Muqtadir M.A Jawad S/o
Shafiq Ahmed CNIC No.42201-
5392112-5,
3. Mr. Muhammad Hanif S/o
Abdul Sattar CNIC No. 42006-
8272276-9.
4. Mr. Ali Akhai S/o Muhammad
Jawed Akhai CNIC No. 42006-
3326327-5.
5. Mr. Jawed Ghulam
Mohammad S/o Ghulam
Mohammad CNIC No. 42201-
0556944-9.
1. Mr. Muhammad
Jawed Akhai S/o A.
Sattar Akhai CNIC
No.42000-1658201-1.
2. Mr. Muqtadir M.A
Jawad S/o Shafiq
Ahmed CNIC
No.42201-5392112-5.
3. Rizwan Omar S/o
Omar A Muhamamd
CNIC No. 42201-
3609527-7.
1. Mr. Muhammad Jawed
Akhai S/o A. Sattar Akhai
CNIC No.42000-1658201-1,
CEO.
2. Mr. Muqtadir M.A Jawad
S/o Shafiq Ahmed CNIC
No.42201-5392112-5.
3. Mr. Syed Dawood S/o Mr.
Syed Fasih Uddin Ahmed,
LB-0060600, Director
Case No. 05 CHANGE OF MANAGEMENT OF M/S CKD PHARMACEUTICALS
PAKISTAN (PVT) LTD, 50/28, KORANGI INDUSTRIAL AREA, KARACHI.
M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No.
000144 by way of formulation has submitted request for change in management of the firm as per
Form-29 from S.E.C.P along with prescribed Fee Challan of 50,000/- as under:-
Existing Management as per sale
deed and Form-29
Retiring Management Proposed Management as
per Form-29
Page 7 of 116
1. Mr. Ahsan Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-3110080-9.
2. Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC
No. 42301-0887778-3.
3. Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
1. Mr. Ahsan Sultan Ahmed
S/o Sultan Ahmed CNIC
No. 42201-3110080-9.
2. Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC
No. 42301-0887778-3.
3. Mr. Anas Sultan Ahmed
S/o Sultan Ahmed CNIC
No. 42201-0775491-9.
1. Mr. Syed Mustafa
Hussain Kazmi S/o
Syed Abrar Hussain
Kazmi CNIC No.
42201-0716021-7.
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi, DML No. 000144
by way of formulation as per Form 29 of SECPas under;
Existing Management as per sale
deed and Form-29
Retiring Management New Management as per
Form-29
1. Mr. Ahsan Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-3110080-9.
2. Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC No.
42301-0887778-3.
3. Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
1.Mr. Ahsan Sultan Ahmed
S/o Sultan Ahmed CNIC
No. 42201-3110080-9.
2.Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC
No. 42301-0887778-3.
3.Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
1. Mr. Syed Mustafa
Hussain Kazmi S/o Syed
Abrar Hussain Kazmi
CNIC No. 42201-
0716021-7.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board:
In the aforesaid minutes of Central Licensing Board the name of one director i.e. Mrs. Naureen Liaqat
W/o Liaqat Ali CNIC No. 42000-0451927-2 was inadvertently not mentioned while preparation of
agenda and accordingly minutes were approved. Now M/s CKD Pharmaceutical Pakistan (Pvt) Ltd.,
Karachi has intimated in writing that the correction may be made as per Form-29 and name of the said
director may be included. Accordingly, following proposal is made;
Existing Management as per sale
deed and Form-29
Retiring Management Proposed Management as
per Form-29
Page 8 of 116
1. Mr. Ahsan Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-3110080-9.
2. Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC No.
42301-0887778-3.
3. Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
1.Mr. Ahsan Sultan Ahmed
S/o Sultan Ahmed CNIC
No. 42201-3110080-9.
2.Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC
No. 42301-0887778-3.
3.Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
1. Mr. Syed Mustafa Hussain
Kazmi S/o Syed Abrar
Hussain Kazmi CNIC No.
42201-0716021-7.
2. Mrs. Naureen Liaqat W/o
Liaqat Ali CNIC No.
42000-0451927-2
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board approved the correction in decision of the 255th
meeting of the Central Licensing Board
and decision may be read as under:
“The Board considered and endorsed the change of management from old to new management
of M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd, 50/28, Korangi Industrial Area, Karachi,
DML No. 000144 by way of formulation as per Form 29 of SECPas under
Existing Management as per sale
deed and Form-29
Retiring Management Proposed Management as per
Form-29
4. Mr. Ahsan Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-3110080-9.
5. Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC No.
42301-0887778-3.
6. Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
4.Mr. Ahsan Sultan Ahmed
S/o Sultan Ahmed CNIC No.
42201-3110080-9.
5.Mr. Shahab Ahmed S/o
Muhammad Ahmed CNIC
No. 42301-0887778-3.
6.Mr. Anas Sultan Ahmed S/o
Sultan Ahmed CNIC No.
42201-0775491-9.
3. Mr. Syed Mustafa Hussain
Kazmi S/o Syed Abrar
Hussain Kazmi CNIC No.
42201-0716021-7.
4. Mrs. Naureen Liaqat W/o
Liaqat Ali CNIC No.
42000-0451927-2
.”
Case No. 06 GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S
ROGEN PHARMACEUTICALS, PLOT NO. 30-, S-4, NATIONAL
INDUSTRIAL ZONE, RAWAT, ISLAMABAD.
Case Background
The Case for grant of renewal of DML of M/s Rogen Pharmaceuticals, Plot No. 30-, S-4, National
Industrial Zone, Rawat, Islamabad was placed in 256th
meeting of Central Licensing Board held on
9th
and 10th
November, 2017 and board decided as under:-
“The Board approved the renewal of Drug Manufacturing License for the further period w.e.f
02-04-2014 to 01-04-2019”.
It is submitted that the period of DML Renewal was inadvertently mentioned as 02-04-2014 to 01-04-
2019 instead of the correct period i.e 19-07-2015 to 18-07-2020.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Page 9 of 116
The Board approved the correction in decision of the 256th
meeting of the Central Licensing Board
and decision may be read as under:
“The Board approved the renewal of Drug Manufacturing License for the further period w.e.f 19-07-
2015 to 18-07-2020”
Page 10 of 116
LICENSING DIVISION
Item-II: GRANT OF NEW DRUG MANUFACTURING LICENSES.
The Board considered the following cases of grant of new drug manufacturing licenses in the light of
recommendations of respective panel of experts/inspectors and decided as under:
S# Name of the firm Date of Inspection
/ Type of License Decision of CLB
1. M/s Winlet Pharmaceuticals
(Pvt) Ltd, 30-Km, Sargodha
Lahore Road, Sargodha.
12-10-2017 &
12-12-2017
(Formulation)
The Board approved the grant of Drug
Manufacturing Licence by way of
formulation with following sections:
Sections 04:
1. Tablet (General) Section
2. Capsule (General) Section
3. Oral Dry Powder Suspension
(General) Section.
4. Liquid Syrup (General) Section.
2. M/s Relizon
Pharmaceuticals, Plot No.
118, Sunder Industrial
Estate, Raiwind Road,
Lahore
05-12-2017
Formulation
The Board approved the grant of Drug
Manufacturing Licence by way of
formulation with following sections:
Sections (03):
1. Tablet (General) Section
2. Capsule (General) Section
3. Dry Powder Suspension (General)
Section.
3. M/s Multicaps, Plot No. A-
92, S.I.T.E, Super Highway
Industrial Area, Karachi.
13-01-2018
Semi-Basic
The Board approved the grant of Drug
Manufacturing Licence by way of Semi-
Basic Manufacture with following
sections:
Section (01):
1. Empty Hard Gelatin Capsules for the
sizes including (00, 0, 1, 2, 3 & 4).
4. M/s Neutro Pharma (Pvt)
Ltd., 9.5-Km, Sheikhupura
Road, Lahore.
02-01-2018
Semi-Basic
The Board approved the grant of Drug
Manufacturing Licence by way of Semi-
Basic Manufacture for the pellatization
only for the following Active
Pharmaceutical Ingredients;
1. Duloxetine
2. Dexlansoperazole
3. Esomeprazole Magnesium
Dihydrate
4. Fluconazole
5. Orlistat
6. Pantoprazole
7. Ciprofloxacin
8. Lansoperazole+Domperidone
9. Itraconazole
10. Indomethacin
11. Diclofenac Potassium
Page 11 of 116
12. Esomeprazole
13. Galanthamine Hydrobromide
14. Ferrous Fumarate
15. Folic Acid
16. Clarithromycin
17. Azithromycin
18. Diclofenac Sodium
19. Tizanidine
20. Omeprazole
21. Theophylline
22. Flurbiprofen
23. Tamsulin
24. Esomeprazole Magnesium Hydrate
5 M/s MeDPharm Research
Lab, 28-Km, Ferozepur
Road, Lahore
12-01-2018
Formulation
The Board approved the grant of Drug
Manufacturing Licence by way of
formulation with following sections:
Sections (07):
1. Tablet (General) Section
2. Capsule (General) Section
3. Dry Powder for Suspension
(General) Section.
4. Sachet (General) Section.
5. Capsule (Cephalosporin) Section.
6. Dry Power for Suspension
(Cephalosporin) Section.
7. Dry Powder for Injection
(Cephalosporin) Section.
Page 12 of 116
Item-III: GRANT OF ADDITIONAL SECTIONS/ EXPANSION/ AMENDMENTS ETC.
The Board considered following cases of Grant of Additional Sections & Expansion/Amendments of
already licensed units in the light of recommendations by respective panel of experts/inspectors and
decided as under: -
S# Name of the firm / DML No. Date of
Inspection Decision of CLB
1 M/s Novartana
Pharmaceuticals, 87-B, Sunder
Industrial Estate, Lahore.
DML No. 000738
(Formulation)
21-11-2017 The Board did not approve the grant of
following additional section and as and
when the section will be ready for
inspection, the firm may apply for
constitution of panel:-
Section (01)
1. Liquid Injectable Ampoule / Vial
(General) Section.
2 M/s GlaxoSmithKline Pakistan
Ltd, Plot No. 5, Sector 21,
Korangi Industrial Area,
Karachi
DML No. 000248
(Formulation)
31-10-2017
&
21-12-2017
The Board approved the grant of
following additional sections
/amendment:-
Section (03)
1. Liquid Injection Section (Revised).
2. Tablet (General) Section (Revised).
3. Eye Drop Section (New).
3 M/s Citi Pharma (Pvt) Ltd, 3.5-
Km, Head Balloki Road, Phool
Nagar, District Kasur.
DML No. 000429
(Semi Basic)
4-12-2017 The Board did not approve the grant of
following Additional APIs and as and
when the area will be ready for
inspection, the firm may apply for
constitution of panel:-:-
APIs (03)
1. Cephradin.
2. Cephalexin.
3. Cefixime.
4 M/s Pacific Pharmaceuticals,
Ltd, 30-Km, Multan Road,
Lahore.
DML No. 000295
(Formulation)
16-08-2017
06-11-2017
07-11-2017
The Board approved the grant of
following additional sections:-
Sections (03)
1. Tablet (Psychotropic / Narcotic)
(New)
2. Capsule (Psychotropic /
Narcotic) (New)
3. Tablet (Hormone) (New)
However, Board did not approve
Section for Anti T.B drugs till
improvements are made.
Moreover, the area FID will werify the
working of HVAC system befor the firm
starts the production activity.
Page 13 of 116
5 M/s PharmEvo (Pvt) Ltd, Plot
No. A-29, North Western
Industrial Zone, Port Qasim,
Karachi.
DML No. 000504
(Formulation)
02-01-2018 The Board approved the grant of
amendments in following sections
except packaging warehouse:-
Amendments in Sections (06)
1. Tablet (General) Section (Revised)
2. Capsule (General) Section (Revised)
3. Ointment / Cream (General) Section
(Revised)
4. Sachet (General) Section (Revised)
5. Oral Liquid (General) Section
(Revised)
6. Relocation of in process lab.
(Revised)
The Board advised the firm to submit
Layout plan for approval where
changes are reported by the panel being
made.
6 M/s Kanel Pharma, Plot No. 6,
Street No. SS-3, National
Industrial Zone, Rawat.
DML No. 000758
(Formulation).
20-12-2017 The Board approved the grant of
following additional sections:-
Sections (05).
1. Cream / Ointment Section (General)
(New).
2. Topical Lotion Section (General)
(New).
3. Capsule Section (Ceph).
4. Dry Suspension Section (Ceph)
(New).
5. Dry Vial Injection (Ceph) (New).
7 M/s Pharmagen Ltd, Kot Nabi
Wala, 34-Km, Ferozepur
Road, Lahore
DML No. 000325
(Semi Basic)
08-12-2017 The Board approved the grant of
following APIs:-
Through Semi Basic Manufacture
(Alternate Method in addition to
existing Method)
1. Amoxycillin Trihydrate
2. Ampicillin Trihydrate
3. Cephalexin Hydrate
4. Cefaclor
5. Cefadroxil
Through Semi Basic Manufacture
1. Ledipasvir
2. Daclatasvir Dihydrochloride
3. Velpatasvir
Page 14 of 116
4. Vildagliptin
8 M/s Honig Pharmaceutical
Laboratories, 14 KM Adyala
Road, Rawalpindi
DML No. 000550
(Formulation).
21-12-2017 The Board approved the grant of
following additional sections:-
Sections (02).
1. Oral Dry Powder Suspension
(General).
2. Capsule (General).
9 M/s Innvotek Pharmaceutical,
Plot No. 35, Industrial
Triangle, Kahuta Road,
Islamabad.
DML No. 000487
(Formulation).
30-11-2017 The Board approved the grant of
following additional sections
/amendment:-
Section (02).
1. Tablet Section General
(Revised).
2. Capsule Section General
(Revised)
10 M/s Sayyed Pharmaceutical
Industries (Pvt) Ltd, Plot No.
67/2, Phase-3, Industrial
Estate, Hattar
DML No. 000697
(Formulation).
05-01-2018 The Board approved the grant of
following additional sections:-
Sections (03).
1. Dry Powder Injection
(Cephalosporin) Section.
2. Sachet (General) Section.
3. Stores (Finished Goods, Packing
material, Liquid and Product
recall)
11 M/s Tas Pharmaceuticals (Pvt)
Ltd., Plot No. 209, Industrial
Triangle, Kahuta Road,
Islamabad
DML No. 000375
(Formulation).
03-01-2018 The Board did not approve the grant of
following additional section
/amendment and as and when the
sections will be ready for inspection, the
firm may apply for constitution of
panel:-
Sections (04).
1. Tablet Section (Psychotropic) –
Page 15 of 116
New.
2. Tablet General – Amended /
Revised.
3. Packing Hall in place of Syrup
Section.
4. Regularization of Cream /
Ointment Section General.
12 M/s Skims Pharmaceuticals,
10-B, Value Addition City
Khurrianwala, Faisalabad.
DML No. 000830
(Formulation).
19-01-2018 The Board approved the grant of
following additional sections:-
Sections (04).
1. Tablet Section (General).
2. Capsule (General) Section.
3. Oral Dry Powder Suspension
(General) Section.
4. Oral Dry Powder Sachet
(General) Section.
13 M/s Grand Pharma (Pvt) Ltd.,
Plot No. 5-A, Street No. N-5,
National Industrial Zone,
Rawat, Rawalpindi
DML No. 000680
(Formulation).
09-01-2018 The Board approved the grant of
following additional sections:-
Section (01).
1. New Ware House for storage of
eggs at Veterinary Biological
Facility.
14 M/s Hudson Pharma (Pvt)
Ltd., Plot No. D-93, North
Western Industrial Zone, Port
Qasim, Karachi.
DML No. 000842
(Formulation).
19-01-2018 The Board approved the grant of
following additional sections:-
Sections (02).
1. Ointment/Cream/Lotion/Gel
(General) Section.
2. Capsule (General) Section.
The Board did not approve the grant of
following additional section and as and
when the section will be ready for
inspection, the firm may apply for
constitution of panel:-
1. Eye/Ear & Nasal Drops (General)
Section
15 M/s Chemiworld (Pvt) Ltd.,
Plot No.97-J, Industrial Estate,
Hayatabad, Peshawar.
DML No. 000579 (Basic
Manufacture)
18-01-2018 The Board approved the grant of
following additional API:-
API (01). 1. Iron Polysaccharide Complex
The Board did not approve the grant of
following additional APIs and as and
when the area will be ready for
inspection, the firm may apply for
constitution of panel:-
APIs (02). 1. Iron Sucrose Complex
2. Iron Protein Succinylate
16 M/s Saakh Pharma (Pvt) Ltd.,
C-7/1, North Western
Insustrial Zone,
16-10-2017 The Board did not approve the grant of
following additional API and as and
Page 16 of 116
Karachi
DML No. 000588 (Semi
Basic)
when the section will be ready for
insection, the firm may apply for
constitution of panel:-
Additional APIs (03):
1. Paracetamol
2. Ciprofloxacin HCL
3. Sulphamethoxazole
Page 17 of 116
Item-IV: GRANT OF RENEWAL OF DRUG MANUFACTURING LICENSE.
The Board considered the following cases of grant of Renewal of Drug Manufacturing Licenses in the
light of recommendations by panel of experts/inspectors subject to confirmation of deposition of CRF
as admissible under the rules and decided as under: -
S.
No
Name of the firm/
Type of License
Date of
Inspection Decision of CLB
1. M/s General Pharma, Farm
Road, 03-Km, G.T. Road,
Manhes (Kotli Wagha)
Komoke.
DML No. 000689
(Formulation)
04-10-2017
The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 20-07-2015 to
19-07-2020.
2. M/s Healthtek (Pvt) Ltd, Plot
No. 14, Sector 19, Korangi
Industrial Area, Karachi.
DML No. 000618
(Formulation)
02-11-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 18-07-2017 to
17-07-2022
3. M/s Safe Pharmaceuticals
(Pvt), Ltd, Plot No. C-1-20,
Sector 6-B,North Karachi
Industrial Area, Karachi
06-02-2015 to 05-02-2020.
DML No. 000349
(Formulation)
05-10-2017 The Board considered the case and did
not approve the renewal of Drug
Manufacturing Licence on
recommendations of the panel. The
Board further decided that the licensee
shall rectify the shortcomings noted by
the panel within a period not less than
one month under Rule, 13 of the Drugs
(Licensing, Registering and
Advertising) Rules, 1976 from the date
of issuance of decision of the Board.
The licensee shall inform regarding
rectifications made and accordingly
panel would be constituted to verify the
improvements made. Manufacturing in
the premises shall remain suspended till
decision by the Board. The Central
Licening Board will take a decision on
the recommendations of the panel either
to grant renewal of licence or reject the
application and inform the licencee
accordingly.
4. M/s Albro Pharmaceuticals
(Pvt) Ltd, 340-S, Quaid-e-
Azam Industrial Estate, Kot
Lakhpat, Lahore.
14-06-2015 to 13-06-2020.
DML No. 000175
(Formulation)
25-09-2017 The Board considered the case and
decided to defer the case till next
meeting of the Board for want of
personal hearing regarding update from
the licensee on the decision of the
Central Licencing Board for purchase of
plot and completion of facility.
Page 18 of 116
5. M/s GlaxoSmithKline Pakistan
Ltd, Plot No. 5, Sector 21,
Korangi Industrial Area,
Karachi
DML No. 000248
(Formulation)
31-10-2017
&
21-12-2017
The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 12-08-2015 to
11-08-2020
6. M/s PharmEvo (Pvt) Ltd, Plot
No. A-29, North Western
Industrial Zone, Port Qasim,
Karachi.
DML No. 000504
(Formulation)
02-01-2018 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 05-10-2017 to
04-10-2022.
7. M/s Innvotek Pharmaceutical,
Plot No. 35, Industrial
Triangle, Kahuta Road,
Islamabad.
DML No. 000487
(Formulation).
30-11-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 05-05-2016 to
04-05-2021.
8. M/s Pfizer Pakistan Ltd, B-2,
S.I.T.E, Karachi
DML No. 000025
(Formulation)
30-10-2017
The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 22-06-2015 to
21-06-2020. However it was advised the
firm must have separate facility for
manufacturing of their only registered
corticosteroid product while they have
already allocated dedicated compression
Cubical and packing line. The matter
may also be referred to Drug
Registeration Board for their
consideration. It was also decided that
the firm may be advised to file
application for regularization of capsule
(General) section which is already
mentioned in the their layout.
9. M/s Kanel Pharma, Plot No. 6,
Street No. SS-3, National
Industrial Zone, Rawat.
DML No. 000758
(Formulation).
20-12-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 04-10-2017 to
03-10-2022.
Page 19 of 116
10. M/s Ethical Laboratories (Pvt)
Ltd, 14-Km, Link Katar Bund
Road, Thokar Niaz Baig,
Lahore.
DML No. 000100
(Formulation)
21-11-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 14-05-2014 to
13-05-2019 for following sections.
1. Tablet (General) Section.
2. Eye Drops (Non-Steroidal)
Section.
3. Eye Drops (Steroidal) Section.
The Board considered the case and did
not approve the renewal of Oral
Liquid Section (General) and Capsule
Section (General). The Board further
decided that the licensee shall rectify the
shortcomings noted by the panel within
a period not less than one month under
Rule, 13 of the Drugs (Licensing,
Registering and Advertising) Rules,
1976 from the date of issuance of
decision of the Board. The licensee shall
inform regarding rectifications made in
Oral Liquid Section (General) and
Capsule Section (General) and
accordingly panel would be constituted
to verify the improvements made.
Manufacturing in the premises shall
remain suspended till decision by the
Board. The Central Licening Board will
take a decision on the recommendations
of the panel either to grant renewal of
Oral Liquid Section (General) and
Capsule Section (General) or reject the
application and inform the licencee
accordingly.
11. M/s Medisynth
Pharmaceuticals, Plot No. 55,
Street No. S-5, National
Industrial Zone, Rawat.
DML No. 000718
(Formulation).
05-10-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 14-06-2016 to
13-06-2021
Page 20 of 116
12. M/s Honig Pharmaceutical
Laboratories, 14 KM Adyala
Road, Rawalpindi
DML No. 000550
(Formulation)
21-12-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 28-08-2014 to
27-08-2019
13. M/s Tas Pharmaceuticals (Pvt)
Ltd., Plot No. 209, Industrial
Triangle, Kahuta Road,
Islamabad
DML No. 000375
(Formulation).
16-11-2015 to 15-11-2020.
03-01-2018 The Board considered the case and did
not approve the renewal of Drug
Manufacturing Licence. The Board
further decided that the licensee shall
rectify the shortcomings noted by the
panel within a period not less than one
month under Rule, 13 of the Drugs
(Licensing, Registering and
Advertising) Rules, 1976 from the date
of issuance of decision of the Board.
The licensee shall inform regarding
rectifications made and accordingly
panel would be constituted to verify the
improvements made. Manufacturing in
the premises shall remain suspended till
decision by the Board. The Central
Licening Board will take a decision on
the recommendations of the panel either
to grant renewal of licence or reject the
application and inform the licencee
accordingly.
14. M/s Aptcure (Pvt) Ltd.,8-
Pharmacity, 30-Km, Multan
Road, Lahore
DML No. 000648
(Formulation).
24-11-2017 The Board approved the renewal of
Drug Manufacturing Licence w.e.f
24-10-2013 to 23-10-2018
1
1
15.
M/s Munawar Pharma (Pvt)
Ltd., 31-Km, Ferozpur Road,
Lahore.
DML No. 000379
(Formulation).
07-11-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 12-01-2014 to
11-01-2019.
Page 21 of 116
16. M/s SPL Pharmaceuticals,
Phase-III, Industrial Estate,
Hattar.
DML No. 000605
(Formulation)
04-01-2018 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 19-02-2017 to
18-02-2022
17. M/s Ottoman Pharma, 10-Km,
Raiwind Road, Lahore.
DML No. 000502
(Formulation)
19-12-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 05-08-2017 to
04-08-2022
18. M/s Werrick Pharmaceuticals,
216-217, I-10/3, Industrial
Area, Islamabad
DML No. 000489 (Semi
Basic).
19-01-2018 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 31-10-2016 to
30-10- 2021
19. M/s Medipharm (Pvt) Ltd.,
108, Kot Lakhpat, Industrial
Estate, Lahore.
DML No. 000243
(Formulation).
07-12-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 18-11-2014 to
17-11-2019 The Board considered the case and did
not approve the renewal of
Psychotropic section. The Board
further decided that the licensee shall
rectify the shortcomings noted by the
panel within a period not less than one
month under Rule, 13 of the Drugs
(Licensing, Registering and
Advertising) Rules, 1976 from the date
of issuance of decision of the Board.
The licensee shall inform regarding
rectifications made and accordingly
panel would be constituted to verify the
improvements made. Manufacturing in
the Psychotropic section shall remain
suspended till decision by the Board.
The Central Licening Board will take a
decision on the recommendations of the
panel either to grant renewal of
Psychotropic section or reject the
application and inform the licencee
accordingly.
20. M/s Medisave
Pharmaceuticals, Plot No. 578-
579,Sunder Industrial Estate,
Lahore
DML No. 000681
(Formulation).
11-12-2017
&
10-01-2018
The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 26-01-2015 to
25-01-2020.
Page 22 of 116
21. M/s Medicraft Pharmaceuticals
(Pvt) Ltd., 126-B, Industrial
Estate, Hayatabad, Peshawar.
DML No. 000390
(Formulation).
22-01-2018 The Board approved the renewal of the
following previously defferd section;
Section (01):
1. Syrup Section (General)
22. M/s Saakh Pharma (Pvt) Ltd.,
C-7/1, North Western
Insustrial Zone,
Karachi
DML No. 000588 (Semi
Basic)
16-10-2017 The Board approved the renewal of
Drug Manufacturing Licence for the
further period w.e.f 29-03-2016 to
28-03-2021.
Page 23 of 116
Item No. V MISCELLANEOUS CASES.
Case No. 1 CHANGE OF MANAGEMENT OF M/S HONIG PHARMACEUTICAL
LABORATORIES, 14 KM, ADYALA ROAD, RAWALPINDI.
M/s Honig Pharmaceutical Laboratories, 14 KM, Adyala Road, Rawalpindi, DML No. 000550 by way
of (Formulation)has submitted request for change in management of the firm as per partnership deed
along with prescribed Fee Challan of 50,000/- as under:-
Previous Management Retiring Management New Management
1. Muhammad Maskeen Bhatti S/o
Haji Khuda Buksh
CNIC # 37405-5553312-3.
2. Muhammad Rizwan Baig S/o
Muhammad Yaqoob Baig
CNIC # 37405-2183954-1.
3. Muhammad Saleem Bhatti S/o
Nuhammad Maskeen Bhatti
CNIC # 37405-5961906-9.
4. Tanveer Akhtar Bhatti S/o
Muhammad Maskeen Bhatti
CNIC # 37405-6851774-7.
5. Tahir Mehmood S/o Ch.
Muhammad Yousaf
CNIC # 37405-0330867-1.
6. Abu Bakkar S/o Abdul Rasheed
CNIC # 35202-2206953-5.
1. Muhammad Maskeen Bhatti
S/o Haji Khuda Buksh CNIC #
37405-5553312-3.
2. Muhammad Rizwan Baig S/o
Muhammad Yaqoob Baig
CNIC # 37405-2183954-1.
3. Muhammad Saleem Bhatti S/o
Nuhammad Maskeen Bhatti
CNIC # 37405-5961906-9.
4. Tanveer Akhtar Bhatti S/o
Muhammad Maskeen Bhatti
CNIC # 37405-6851774-7.
5. Tahir Mehmood S/o Ch.
Muhammad Yousaf
CNIC # 37405-0330867-
6. Abu Bakkar S/o Abdul
Rasheed
CNIC # 35202-2206953-5.
1. Iftkhar Ahmed S/o Imtiaz
Ahmad
CNIC # 37405-6039992-3.
2. Muhammad Faisal Latif S/o
Ch. Muhammad Latif
CNIC # 37405-5664181-3.
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Honig Pharmaceutical Laboratories, 14 KM, Adyala Road, Rawalpindi, DML No. 000550 by way of
(Formulation) as per partnership deed as under ;
Previous Management Retiring Management New Management
1. Muhammad Maskeen Bhatti S/o
Haji Khuda Buksh
CNIC # 37405-5553312-3.
2. Muhammad Rizwan Baig S/o
Muhammad Yaqoob Baig
CNIC # 37405-2183954-1.
3. Muhammad Saleem Bhatti S/o
Nuhammad Maskeen Bhatti
CNIC # 37405-5961906-9.
4. Tanveer Akhtar Bhatti S/o
Muhammad Maskeen Bhatti
CNIC # 37405-6851774-7.
5. Tahir Mehmood S/o Ch.
Muhammad Yousaf
CNIC # 37405-0330867-1.
6. Abu Bakkar S/o Abdul Rasheed
CNIC # 35202-2206953-5.
1. Muhammad Maskeen Bhatti
S/o Haji Khuda Buksh
CNIC # 37405-5553312-3.
2. Muhammad Rizwan Baig S/o
Muhammad Yaqoob Baig
CNIC # 37405-2183954-1.
3. Muhammad Saleem Bhatti S/o
Nuhammad Maskeen Bhatti
CNIC # 37405-5961906-9.
4. Tanveer Akhtar Bhatti S/o
Muhammad Maskeen Bhatti
CNIC # 37405-6851774-7.
5. Tahir Mehmood S/o Ch.
Muhammad Yousaf
CNIC # 37405-0330867-
6. Abu Bakkar S/o Abdul
Rasheed
CNIC # 35202-2206953-5.
1. Iftkhar Ahmed S/o Imtiaz
Ahmad
CNIC # 37405-6039992-3.
2. Muhammad Faisal Latif S/o
Ch. Muhammad Latif
CNIC # 37405-5664181-3.
Page 24 of 116
Case No. 2. CHANGE OF MANAGEMENT OF M/S SHAIGAN PHARMACEUTICALS
(PVT) LTD, ISLAMABAD.
M/s Shaigan Pharmaceuticals (Pvt) Ltd, Islamabad, DML No. 000333 by way of (Formulation) has
submitted request for change in management of the firm as per Form 29 along with prescribed Fee
Challan of 50,000/- as under:-
Previous Management Retiring Management New Management
1. Mr. Waheed Ahmed S/o Rashid Ahmed
CNIC # 37405-4456480-7.
2. Mrs. Mahrukh Waheed D/o Waheed
Ahmed
CNIC # 37405-1101276-6.
3. Mrs. Qamar-un-Nisa W/o Rashid
Ahmed
CNIC # 210-36-056283.
1. Mrs. Qamar-un-Nisa W/o
Rashid Ahmed
CNIC # 210-36-056283.
1. Mr. Waheed Ahmed S/o
Rashid Ahmed
CNIC # 37405-4456480-7.
2. Mrs. Mahrukh Waheed D/o
Waheed Ahmed
CNIC # 37405-1101276-6.
3. Mr. Basil Ahmed S/o
Washeed Ahamed
CNIC # 37405-6039509-3.
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Shaigan Pharmaceuticals (Pvt) Ltd, Islamabad, DML No. 000333 by way of (Formulation) as per
Form 29 as under:
Previous Management Retiring Management New Management
1. Mr. Waheed Ahmed S/o Rashid
Ahmed
CNIC # 37405-4456480-7.
2. Mrs. Mahrukh Waheed D/o Waheed
Ahmed
CNIC # 37405-1101276-6.
3. Mrs. Qamar-un-Nisa W/o Rashid
Ahmed
CNIC # 210-36-056283.
1. Mrs. Qamar-un-Nisa W/o
Rashid Ahmed
CNIC # 210-36-056283.
1. Mr. Waheed Ahmed S/o
Rashid Ahmed
CNIC # 37405-4456480-7.
2. Mrs. Mahrukh Waheed
D/o Waheed Ahmed
CNIC # 37405-1101276-6.
3. Mr. Basil Ahmed S/o
Washeed Ahamed
CNIC # 37405-6039509-3.
Case No. 3. CHANGE OF MANAGEMENT OF M/S GULF PHARMACEUTICALS, PLOT
NO. 49, STREET NO. S-5, RAWALPINDI INDUSTRIAL ZONE (RIZ),
ISLAMABAD.
M/s Gulf Pharmaceuticals, Plot No. 49, Street No. S-5, Rawalpindi Industrial Zone (RIZ), Islamabad,
DML No. 750 by way of (Formulation) has submitted request for change in management of the firm
as per partnership deed along with prescribed Fee Challan of 50,000/- as under:-
Previous Management Incoming Management New Management
1. Mr. Muhammad Munawar Khan S/o
Muhammad Ashfaq
CNIC No. 37405-5834516-9.
1. Mr. Muhammad Wassi Shan S/o
Muhammad Inyat Ullah
CNIC No. 37405-2288811-1.
1. Mr. Muhammad Munawar
Khan S/o Muhammad Ashfaq
CNIC No. 37405-5834516-9.
2. Mr. Muhammad Wassi Shan
S/o Muhammad Inyat Ullah
CNIC No. 37405-2288811-1.
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s Gulf Pharmaceuticals,
Plot No. 49, Street No. S-5, Rawalpindi Industrial Zone (RIZ), Islamabad, DML No. 750 by way of (Formulation) as per
partnership deed as under:
Previous Management Incoming Management New Management
1. Mr. Muhammad Munawar Khan S/o
Muhammad Ashfaq
CNIC No. 37405-5834516-9.
1. Mr. Muhammad Wassi Shan S/o
Muhammad Inyat Ullah
CNIC No. 37405-2288811-1.
1. Mr. Muhammad Munawar
Khan S/o Muhammad Ashfaq
CNIC No. 37405-5834516-9.
2. Mr. Muhammad Wassi Shan
S/o Muhammad Inyat Ullah
CNIC No. 37405-2288811-1.
Page 25 of 116
Case No. 4. CHANGE OF MANAGEMENT OF M/S UNIMARK PHARMACEUTICALS,
PLOT NO. 7-A, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.
M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad DML No.
000557 by way of (Formulation) has submitted request for change in management of the firm as per
Form 29 along with prescribed Fee Challan of 50,000/- as under:-
Previous Management
(Sole Proprietor).
Incoming Management New Management
1. Talat Munir Baig S/o Sadiq Hussain
Baig
CNIC # 37405-1017139-3.
1. Zarqa W/o Riaz Ahmed
CNIC # 16202-5656628-0.
1. Talat Munir Baig S/o Sadiq
Hussain Baig
CNIC # 37405-1017139-3.
2. Zarqa W/o Riaz Ahmed
CNIC # 16202-5656628-0.
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad DML No.
000557 by way of (Formulation) as per Form-29 as under:
Previous Management
(Sole Proprietor).
Incoming Management New Management
1. Talat Munir Baig S/o Sadiq Hussain
Baig
CNIC # 37405-1017139-3.
1. Zarqa W/o Riaz Ahmed
CNIC # 16202-5656628-0.
1. Talat Munir Baig S/o Sadiq
Hussain Baig
CNIC # 37405-1017139-3.
2. Zarqa W/o Riaz Ahmed
CNIC # 16202-5656628-0.
Case No. 5. CHANGE OF TITLE OF M/S UNIMARK PHARMACEUTICALS, PLOT NO. 7-
A, NATIONAL INDUSTRIAL ZONE, RAWAT, ISLAMABAD.
M/s UniMark Pharmaceuticals, Plot No. 7-A, National Industrial Zone, Rawat, Islamabad, has
submitted request for change of Title of the firm along with prescribed Fee Challan of 50,000/- as
under:-
Previous Title of the firm
(Sole Proprietor).
Current Title of the firm as per Form 29
UniMark Pharmaceuticals, Plot No. 7-A, National
Industrial Zone, Rawat, Islamabad.
UniMark Pharmaceuticals (Pvt) Ltd, Plot No. 7-
A, National Industrial Zone, Rawat, Islamabad.
Decision of CLB:
The Board considered and approved the change of title of M/s UniMark Pharmaceuticals, Plot No. 7-
A, National Industrial Zone, Rawat, Islamabad DML No. 000557 by way of (Formulation) as per
Form-29 as under:
Previous Title of the firm
(Sole Proprietor).
Current Title of the firm as per Form 29
UniMark Pharmaceuticals, Plot No. 7-A, National
Industrial Zone, Rawat, Islamabad.
UniMark Pharmaceuticals (Pvt) Ltd, Plot No. 7-
A, National Industrial Zone, Rawat, Islamabad.
Page 26 of 116
Case No. 6 CHANGE OF MANAGEMENT OF M/S CALIPH PHARMACEUTICALS
(PVT) LTD., PLOT NO.17, SPECIAL INDUSTRIAL ZONE (EPZ), RISALPUR.
M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur No. 000748 by way of formulation has submitted
request for change in management of the firm as per Form-A of SECP alongwith prescribed Fee
Challan of Rs.50,000/- as under;
Previous management Retiring management New management
1. Mr. Mumtaz Ali S/o Naeem
Shah
CNIC. No. 16101-3653393-9
2. Mr. Hameed ur Rehman
CNIC. No. 16101-5527602-9
3. Mr. Muhammad Saleem S/o
Feroz Bakht,
CNIC. No. 21103-4249119-3
4. Mr. Abdul Haq S/o Rehmat
Khan,
CNIC. No. 15303-1202154-1
1. Mr. Mumtaz Ali S/o Naeem
Shah
CNIC. No. 16101-3653393-9
2. Mr. Hameed ur Rehman
CNIC. No. 16101-5527602-9
3. Mr. Muhammad Saleem S/o
Feroz Bakht,
CNIC. No. 21103-4249119-3
4. Mr. Abdul Haq S/o Rehmat
Khan,
CNIC. No. 15303-1202154-1
1. Mr. Muhammad Azmat
Ali S/o Fazal Mannan
CNIC No. 17301-
3861340-1
2. Mr. Amjad Ali Zeb S/o
Muhammad Aurangzeb
CNIC No. 42201-
3056252-3
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Caliph Pharmaceuticals (Pvt) Ltd. Risalpur DML No. 000748 by way of (Formulation) as per Form-A
of SECP as under:
Previous management Retiring management New management
1. Mr. Mumtaz Ali S/o
Naeem Shah
CNIC. No. 16101-
3653393-9
2. Mr. Hameed ur Rehman
CNIC. No. 16101-
5527602-9
3. Mr. Muhammad Saleem
S/o Feroz Bakht,
CNIC. No. 21103-
4249119-3
4. Mr. Abdul Haq S/o
Rehmat Khan,
CNIC. No. 15303-
1202154-1
1. Mr. Mumtaz Ali S/o
Naeem Shah
CNIC. No. 16101-
3653393-9
2. Mr. Hameed ur Rehman
CNIC. No. 16101-
5527602-9
3. Mr. Muhammad Saleem
S/o Feroz Bakht,
CNIC. No. 21103-
4249119-3
4. Mr. Abdul Haq S/o Rehmat
Khan,
CNIC. No. 15303-
1202154-1
1. Mr. Muhammad Azmat Ali
S/o Fazal Mannan
CNIC No. 17301-3861340-1
2. Mr. Amjad Ali Zeb S/o
Muhammad Aurangzeb
CNIC No. 42201-3056252-3
Page 27 of 116
Case No. 7 CHANGE OF MANAGEMENT OF M/S MED ASIA PHARMACEUTICALS
(PVT) LTD., PLOT NO.7, NOWSHERA INDUSTRIAL ESTATE, RISALPUR.
M/s Med Asia Pharmaceuticals (Pvt) Ltd. Risalpur has submitted request for change in management of
the firm as per Form-A of SECP alongwith prescribed Fee Challan of Rs.50,000/- as under;
Previous management Retiring management New management
1. Mr. Sher Muhammad S/o
Muhammad Akram,
CNIC No.17301-3889455-1
2. Mr. Muhammad Yousaf
Khalil S/o Malik Nusa Khan,
CNIC No.17301-1490031-5
3. Mr. Kashif Khan S/o
Muhammad Hayat,
CNIC No.17301-1347227-1
4. Mr. Muhammad Tahir S/o
Sahib Gul, CNIIC No.16101-
9356882-3
5. Mr. Muhammad Fayaz S/o
Kachkol, CNIC No.17101-
7193842-7
1. Mr. Sher Muhammad S/o
Muhammad Akram,
CNIC No.17301-3889455-1
2. Mr. Muhammad Yousaf
Khalil S/o Malik Nusa Khan,
CNIC No.17301-1490031-5
3. Mr. Kashif Khan S/o
Muhammad Hayat,
CNIC No.17301-1347227-1
4. Mr. Muhammad Tahir S/o
Sahib Gul, CNIIC No.16101-
9356882-3
5. Mr. Muhammad Fayaz S/o
Kachkol, CNIC No.17101-
7193842-7
1. Col. (R) Anwar Ul Haq
S/o Ch. Muhammad Shafi
CNIC No. 61101-
1920315-5
2. Mr. Mujeeb Alam S/o
Shah Jehan, CNIC
No. 17301-1457033-9
3. Mr. Shabeer Ahmad S/o
Faraz Ullah, CNIC
No. 17101-0277504-1
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Med Asia Pharmaceuticals (Pvt) Ltd. Risalpur by way of (Formulation) as per Form-A of SECP as
under:
Previous management Retiring management New management
1. Mr. Sher Muhammad S/o
Muhammad Akram,
CNIC No.17301-3889455-1
2. Mr. Muhammad Yousaf
Khalil S/o Malik Nusa
Khan,
CNIC No.17301-1490031-5
3. Mr. Kashif Khan S/o
Muhammad Hayat,
CNIC No.17301-1347227-1
4. Mr. Muhammad Tahir S/o
Sahib Gul, CNIIC
No.16101-9356882-3
5. Mr. Muhammad Fayaz S/o
Kachkol, CNIC No.17101-
7193842-7
1. Mr. Sher Muhammad S/o
Muhammad Akram,
CNIC No.17301-3889455-1
2. Mr. Muhammad Yousaf
Khalil S/o Malik Nusa
Khan,
CNIC No.17301-1490031-5
3. Mr. Kashif Khan S/o
Muhammad Hayat,
CNIC No.17301-1347227-1
4. Mr. Muhammad Tahir S/o
Sahib Gul, CNIC
No.16101-9356882-3
5. Mr. Muhammad Fayaz S/o
Kachkol, CNIC No.17101-
7193842-7
1. Col. (R) Anwar Ul Haq S/o
Ch. Muhammad Shafi
CNIC No. 61101-1920315-5
2. Mr. Mujeeb Alam S/o Shah
Jehan,
CNIC No. 17301-1457033-9
3. Mr. Shabeer Ahmad S/o
Faraz Ullah,
CNIC No. 17101-0277504-1
Page 28 of 116
Case No. 8 CHANGE OF MANAGEMENT OF M/S POPULAR CHEMICAL WORKS
(PVT) LTD, LAHORE UNDER DML NO. 000076 (FORMULATION)
M/s Popular Chemical Works (Pvt) Ltd, 9-Km, Lahore Sheikhupura Road, Lahore, License No.
000076 by way of formulation has submitted request for change in management of the firm as per
Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as
under;
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Popular Chemical Works (Pvt) Ltd, 9-Km, Lahore Sheikhupura Road, Lahore License No. 000076
by way of (Formulation) as per Form-A of SECP as under:
Previous Management as
per Form-1A
Retiring Management
Current Management as per
Form-29 from SECP
1. Mr. Mian Asad Shuja-ur-
Rehman S/o Shuja-Ur-
Rehman CNIC No. 35201-
0587490-1.
2. Mr. Mian Tariq Rehman.
1. Mr. Mian Tariq Rehman.
1. Mr. Mian Misbah-Ur-Rehman
S/o Mian Ghulam Qadir
CNIC No. 35202-2773300-3.
2. Mr. Abdul Hameed Piracha
S/o Mian Abdul Raheem
Piracha
CNIC No. 35202-2910398-7.
3. Mr. Mian Omer Rehman S/o
Mian Misbah-Ur-Rehman
CNIC No. 35202-7045808-3.
4. Mr. Mian Asad Shuja-ur-
Rehman S/o Shuja-Ur-
Rehman
CNIC No. 35201-0587490-1.
Previous Management as
per Form-1A
Retiring Management
Current Management as per
Form-29 from SECP
1. Mr. Mian Asad Shuja-ur-
Rehman S/o Shuja-Ur-
Rehman CNIC No. 35201-
0587490-1.
2. Mr. Mian Tariq Rehman.
1. Mr. Mian Tariq Rehman.
1. Mr. Mian Misbah-Ur-Rehman
S/o Mian Ghulam Qadir
CNIC No. 35202-2773300-3.
2. Mr. Abdul Hameed Piracha
S/o Mian Abdul Raheem
Piracha CNIC No. 35202-
2910398-7.
3. Mr. Mian Omer Rehman S/o
Mian Misbah-Ur-Rehman
CNIC No. 35202-7045808-3.
4. Mr. Mian Asad Shuja-ur-
Rehman S/o Shuja-Ur-
Rehman CNIC No. 35201-
0587490-1.
Page 29 of 116
Case No. 9 CHANGE OF MANAGEMENT OF M/S ZAKFAS PHARMACEUTICALS
(PVT) LTD, MULTAN
M/s Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of formulation
hasSubmitted request for change in management of the firm as per Form-29 with prescribed Fee
Challan of Rs.50, 000/-. The detail of management of the firm is as under;
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Zakfas Pharmaceuticals (Pvt) Ltd, Multan, License No. 000603 by way of (Formulation) as per Form-
29 of SECP as under:
Previous Management as per
Form-1A
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Malik Noor Samad
Awan S/o Malik Ghulam
Hyder Awan CNIC
No.36302-8840665-3.
2. Mr. Malik Kashif Kamran
Awan S/o Malik Noor Samad
Awan CNIC No. 36302-
8850165-3.
3. Mr. Malik Atif Adnan Awan
S/o Malik Noor Samad Awan
CNIC No. 36302-5044246-9.
4. 4. Mr. Faisal Faizan Awan
S/o Malik Noor Samad Awan
CNIC No. 36302-5301868-7.
1.Mr. Malik Noor Samad
Awan S/o Malik
Ghulam Hyder Awan
CNIC No.36302-
8840665-3.
1.Mr. Malik Kashif Kamran
Awan S/o Malik Noor Samad
Awan CNIC No. 36302-
8850165-3.
2.Mr. Malik Atif Adnan Awan
S/o Malik Noor Samad Awan
CNIC No. 36302-5044246-9.
3.Mr. Faisal Faizan Awan S/o
Malik Noor Samad Awan
CNIC No. 36302-5301868-7.
Previous Management as per
Form-1A
Retiring Management Current Management as per
Form-29 from SECP
1.Mr. Malik Noor Samad Awan
S/o Malik Ghulam Hyder
Awan CNIC No.36302-
8840665-3.
2.Mr. Malik Kashif Kamran
Awan S/o Malik Noor Samad
Awan CNIC No. 36302-
8850165-3.
3.Mr. Malik Atif Adnan Awan
S/o Malik Noor Samad Awan
CNIC No. 36302-5044246-9.
4.4. Mr. Faisal Faizan Awan
S/o Malik Noor Samad Awan
CNIC No. 36302-5301868-7.
1.Mr. Malik Noor Samad
Awan S/o Malik
Ghulam Hyder Awan
CNIC No.36302-
8840665-3.
1. Mr. Malik Kashif Kamran
Awan S/o Malik Noor Samad
Awan CNIC No. 36302-
8850165-3.
2. Mr. Malik Atif Adnan Awan
S/o Malik Noor Samad Awan
CNIC No. 36302-5044246-9.
3. Mr. Faisal Faizan Awan S/o
Malik Noor Samad Awan
CNIC No. 36302-5301868-7.
Page 30 of 116
Case No. 10 CHANGE OF TITLE OF M/S PAKHEIM INT’L (PVT) LTD, 28-KM,
FEROZEPUR ROAD, LAHORE
M/s Pakheim Int’l (Pvt) Ltd, 28-Km, Ferozepur Road, Lahore under DML No. 000492 by way of
formulation has submitted request for change of title of the firm as per Form-29 with prescribed Fee
Challan of Rs.50,000/- as under;
Title and legal status of the firm at previous
renewal of DML as per Form-1A
Title and legal status of the firm at
Current renewal of DML
as per Form-1A & Form-29
M/s Pakheim Pharma, 28-Km, Ferozepur Road,
Lahore. (Partnership firm)
M/s Pakheim International Pharma (Pvt) Ltd,
28-Km, Ferozepur Road, Lahore. (Private
Limited firm)
Decision of CLB:
The Board considered and approved the change of title of M/s Zakfas Pharmaceuticals (Pvt) Ltd,
Multan, License No. 000603 by way of (Formulation) as per Form-29 of SECP as under:
Title and legal status of the firm at previous
renewal of DML as per Form-1A
Title and legal status of the firm at Current
renewal of DML
as per Form-1A & Form-29
M/s Pakheim Pharma, 28-Km, Ferozepur Road,
Lahore. (Partnership firm)
M/s Pakheim International Pharma (Pvt) Ltd,
28-Km, Ferozepur Road, Lahore. (Private
Limited firm)
Case No. 11. CHANGE OF MANAGEMENT OF M/S CURATECH PHARMA (PVT) LTD, 35-
KM, MULTAN ROAD, LAHORE
M/s Curatech Pharma (Pvt) Ltd, 35-Km, Multan Road, Lahore under DML No. 000619 by way of
formulation has submitted request for change of management of the firm as per Form-29 with
prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;
Previous Management as per
Form-1A & Form-29 from
SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Sajid Ijaz Shah
S/o Ijaz Hussain
CNIC No. 33104-8350132-9
2. Mr. Iftikhar Ahmad
Siddiqui S/o Abdul Rasheed
CNIC No. 61101-3310031-7
3. Mr. Bashir Ahmad Qureshi
S/o Ijaz Ahmad
CNIC No. 35202-7995621-1
1. Mr. Sajid Ijaz Shah
S/o Ijaz Hussain
CNIC No. 33104-8350132-9
2. Mr. Iftikhar Ahmad
Siddiqui S/o Abdul Rasheed
CNIC No. 61101-3310031-7
3. Mr. Bashir Ahmad Qureshi
S/o Ijaz Ahmad
CNIC No. 35202-7995621-1
1. Mr. Muhammad Asher
Khurram S/o M.I. Iftikhar
CNIC No.35202-1650603-9
2. Mr. Muhammad Imran
Khurram S/o M.I. Iftikhar
CNIC No 35202-5323653-1
3. Mr. M.I. Khurram S/o Haji
BArkat Ali
CNIC No. 35202-2013319-7
Page 31 of 116
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Curatech Pharma (Pvt) Ltd, 35-Km, Multan Road, Lahore under DML No. 000619 by way of
(Formulation) as per Form-29 of SECP as under:
Previous Management as per
Form-1A & Form-29 from
SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Sajid Ijaz Shah
S/o Ijaz Hussain
CNIC No. 33104-8350132-9
2. Mr. Iftikhar Ahmad Siddiqui
S/o Abdul Rasheed
CNIC No. 61101-3310031-7
3. Mr. Bashir Ahmad Qureshi
S/o Ijaz Ahmad
CNIC No. 35202-7995621-1
1. Mr. Sajid Ijaz Shah
S/o Ijaz Hussain
CNIC No. 33104-8350132-9
2. Mr. Iftikhar Ahmad
Siddiqui S/o Abdul Rasheed
CNIC No. 61101-3310031-7
3. Mr. Bashir Ahmad Qureshi
S/o Ijaz Ahmad
CNIC No. 35202-7995621-1
1. Mr. Muhammad Asher
Khurram S/o M.I. Khurram
CNIC No.35202-1650603-9
2. Mr. Muhammad Imran
Khurram S/o M.I. Khurram
CNIC No 35202-5323653-1
3. Mr. M.I. Khurram S/o Haji
Barkat Ali CNIC No.
35202-2013319-7
Case No.12 CHANGE OF TITLE OF M/S WINTHROX LABORATORIES,
K-129-A, PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI.
M/s Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E, Super Highway, Karachi under DML No.
000807 by way of formulation has submitted request for change of title of the firm as per Form-29
with prescribed Fee Challan of Rs.50,000/- as under;
Previous Legal Status and Title as per
Partnership Deed of The Firm
Proposed Legal Status and Title as per
Form-29 of The Firm
Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E,
Super Highway, Karachi.
1. Rizwan Umer Sheikh, Partner.
2. Tabassum Tariq, Partner.
Winthrox Laboratories (Pvt) Ltd, K-129-A,
Phase-II, S.I.T.E, Super Highway, Karachi.
1. Rizwan Umer Sheikh, Director.
2. Tabassum Tariq, Director.
Decision of CLB:
The Board considered and approved the change of title of M/s Winthrox Laboratories, K-129-A,
Phase-II, S.I.T.E, Super Highway, Karachi under DML No. 000807 by way of (Formulation) as per
Form-29 of SECP as under:
Previous Legal Status and Title as per
Partnership Deed of The Firm
Proposed Legal Status and Title as per
Form-29 of The Firm
Winthrox Laboratories, K-129-A, Phase-II, S.I.T.E,
Super Highway, Karachi.
3. Rizwan Umer Sheikh, Partner.
4. Tabassum Tariq, Partner.
Winthrox Laboratories (Pvt) Ltd, K-129-A,
Phase-II, S.I.T.E, Super Highway, Karachi.
3. Rizwan Umer Sheikh, Director.
4. Tabassum Tariq, Director.
Page 32 of 116
Case No. 13 CHANGE OF MANAGEMENT OF M/S SAMI PHARMACEUTICALS (PVT)
LTD, F-95, OFF HUB RIVER ROAD, S.I.T.E, KARACHI
M/s Sami Pharmaceuticals (Pvt) Ltd, F-95, Off Hub River Road, S.I.T.E, Karachi under DML No.
000072 by way of formulation has submitted request for change of management of the firm as per
Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as
under;
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Sami Pharmaceuticals (Pvt) Ltd, F-95, Off Hub River Road, S.I.T.E, Karachi under DML No. 000072
by way of (Formulation) as per Form-29 of SECP as under:
Previous Management as per
Form-29 from SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Shamim Ahmed S/o
S.M. Rafi CNIC No.
42201-0709868-7.
2. Ms. Nafees Yasin W/o
Muhamamd Yasin CNIC
No. 42301-4246934-6.
3. Ovais Shamim S/o Shamim
Ahmed CNIC No. 42201-
0709876-5.
4. Mr. Zubair Shamim S/o
Shamim Ahmed CNIC No.
42201-0709872-3.
5. Mr. Shoaib Shamim S/o
Shamim Ahmed CNIC No.
42201-0709871-7.
6. Mr. Junaid Shamim S/o
Shamim Ahmed CNIC No.
42201-0709876-3.
7. Mr. Abdul Salam S/o Zik-
ur-Rehman CNIC No.
42201-6555398-5.
1. Ms. Nafees Yasin
W/o Muhamamd
Yasin CNIC No.
42301-4246934-6.
1. Mr. Shamim Ahmed S/o S.M.
Rafi CNIC No. 42201-0709868-
7.
2. Mr. Muhammad Yasin Malik S/o
Hameed Eid Muhammad CNIC
No. 42301-0668555-7.
3. Ovais Shamim S/o Shamim
Ahmed CNIC No. 42201-
0709876-5.
4. Mr. Zubair Shamim S/o
Shamim Ahmed CNIC No.
42201-0709872-3.
5. Mr. Shoaib Shamim S/o
Shamim Ahmed CNIC No.
42201-0709871-7.
6. Mr. Junaid Shamim S/o Shamim
Ahmed CNIC No. 42201-
0709876-3.
7. Mr. Abdul Salam S/o Zik-ur-
Rehman CNIC No. 42201-
6555398-5.
Previous Management as per
Form-29 from SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Shamim Ahmed S/o
S.M. Rafi CNIC No. 42201-
0709868-7.
2. Ms. Nafees Yasin W/o
Muhamamd Yasin CNIC No.
42301-4246934-6.
3. Ovais Shamim S/o Shamim
Ahmed CNIC No. 42201-
0709876-5.
4. Mr. Zubair Shamim S/o
Shamim Ahmed CNIC No.
1. Ms. Nafees Yasin
W/o Muhamamd
Yasin CNIC No.
42301-4246934-6.
1. Mr. Shamim Ahmed S/o S.M.
Rafi CNIC No. 42201-0709868-
7.
2. Mr. Muhammad Yasin Malik S/o
Hameed Eid Muhammad CNIC
No. 42301-0668555-7.
3. Mr. Ovais Shamim S/o Shamim
Ahmed CNIC No. 42201-
0709876-5.
4. Mr. Zubair Shamim S/o
Shamim Ahmed CNIC No.
Page 33 of 116
Case No. 14 CHANGE OF MANAGEMENT OF M/S MAPLE PHARMACEUTICALS (PVT)
LTD, PLOT NO. 147, SECTOR 23, KORANGI INDUSTRIAL AREA, KARACHI
M/S Maple Pharmaceuticals (Pvt) Ltd, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi under DML
No. 000620 by way of formulation has submitted request for change of management of the firm as per
Form-29 with prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as
under;
Previous Management as per
Form-29 from SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Mehtabuddin Feroz S/o
Ferozuddin CNIC No. 42201-
1613369-5.
2. Mr. Shafiuddin Feroz S/o
Ferozuddin CNIC No. 42201-
2816202-7.
3. Mr. Taufiq Feroz S/o
Ferozuddin CNIC No. 42201-
3557318-9.
4. Mr. Sohail Feroze S/o
Ferozuddin CNIC No. 42201-
0841143-9.
5. Mr. Mohsin Shafi Feroz S/o
Shafiuddin Feroze CNIC
No. 42201-1967477-1.
6. Mr. Ahsan Feroz S/o
Shafiuddin Feroze CNIC No.
42201-7653450-7.
7. Mr. Tehsin Feroz S/o
Shafiuddin Feroze CNIC No.
42201-0721036-1.
8. Mr. Raheel Shafi S/o
Shafiuddin Feroz CNIC No.
42201-9232879-3.
1.Mr. Mehtabuddin Feroz
S/o Ferozuddin CNIC No.
42201-1613369-5.
2.Mr. Taufiq Feroz S/o
Ferozuddin CNIC No.
42201-3557318-9.
3.Mr. Sohail Feroz S/o
Ferozuddin CNIC No.
42201-0841143-9.
1. Mr. Shafiuddin Feroz S/o
Ferozuddin CNIC No.
42201-2816202-7.
2. Mr. Mohsin Shafi Feroz
S/o Shafiuddin Feroze
CNIC No. 42201-
1967477-1.
3. Mr. Ahsan Feroz S/o
Shafiuddin Feroze CNIC
No. 42201-7653450-7.
4. Mr. Tehseen Feroz S/o
Shafiuddin Feroze CNIC
No. 42201-0721036-1.
5. 5. Mr. Raheel Shafi S/o
Shafiuddin Feroz CNIC
No. 42201-9232879-3.
42201-0709872-3.
5. Mr. Shoaib Shamim S/o
Shamim Ahmed CNIC No.
42201-0709871-7.
6. Mr. Junaid Shamim S/o
Shamim Ahmed CNIC No.
42201-0709876-3.
7. Mr. Abdul Salam S/o Zik-ur-
Rehman CNIC No. 42201-
6555398-5.
42201-0709872-3.
5. Mr. Shoaib Shamim S/o
Shamim Ahmed CNIC No.
42201-0709871-7.
6. Mr. Junaid Shamim S/o Shamim
Ahmed CNIC No. 42201-
0709876-3.
7. Mr. Abdul Salam S/o Zik-ur-
Rehman CNIC No. 42201-
6555398-5.
Page 34 of 116
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/S
Maple Pharmaceuticals (Pvt) Ltd, Plot No. 147, Sector 23, Korangi Industrial Area, Karachi under DML No.
000620 by way of (Formulation) as per Form-29 of SECP as under:
Previous Management as per
Form-29 from SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Mehtabuddin Feroz S/o
Ferozuddin CNIC No. 42201-
1613369-5.
2. Mr. Shafiuddin Feroz S/o
Ferozuddin CNIC No. 42201-
2816202-7.
3. Mr. Taufiq Feroz S/o Ferozuddin
CNIC No. 42201-3557318-9.
4. Mr. Sohail Feroz S/o Ferozuddin
CNIC No. 42201-0841143-9.
5. Mr. Mohsin Shafi Feroz S/o
Shafiuddin Feroze CNIC No.
42201-1967477-1.
6. Mr. Ahsan Feroz S/o Shafiuddin
Feroze CNIC No. 42201-
7653450-7.
7. Mr. Tehsin Feroz S/o Shafiuddin
Feroze CNIC No. 42201-
0721036-1.
8. Mr. Raheel Shafi S/o Shafiuddin
Feroze CNIC No. 42201-
9232879-3.
1. Mr. Mehtabuddin Feroz S/o
Ferozuddin CNIC No.
42201-1613369-5.
2. Mr. Taufiq Feroz S/o
Ferozuddin CNIC No.
42201-3557318-9.
3. Mr. Sohail Feroz S/o
Ferozuddin CNIC No.
42201-0841143-9.
1. Mr. Shafiuddin Feroz S/o
Ferozuddin CNIC No. 42201-
2816202-7.
2. Mr. Mohsin Shafi Feroz S/o
Shafiuddin Feroze CNIC No.
42201-1967477-1.
3. Mr. Ahsan Feroz S/o
Shafiuddin Feroze CNIC No.
42201-7653450-7.
4. Mr. Tehseen Feroz S/o
Shafiuddin Feroze CNIC No.
42201-0721036-1.
5. Mr. Raheel Shafi S/o
Shafiuddin Feroze CNIC No.
42201-9232879-3.
Case No. 15 CHANGE OF MANAGEMENT OF M/S HUMAYUN INTERNATIONAL PHARMA
(PVT) LTD, 20-KM, SATIANA ROAD, FAISALABAD
M/s Humayun International Pharma (Pvt) Ltd, 20-Km, Satiana Road, Faisalabad under DML No. 000443 by
way of formulation has submitted request for change of management of the firm as per Form-29 with
prescribed Fee Challan of Rs.50,000/-. The detail of management of the firm is as under;
Previous Management as per
Form-29 from SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Humayun Chaudhry S/o
Chaudhry Imam-udDin C.E.O /
Director.
2. Mr. Tahir Humayun S/o Humayun
Chaudhry Director CNIC No.
33100-4362414-1.
3. Ms. Saima Tahir W/o Tahir
Humayun Director CNIC No.
33100-8987772-6
1. Mr. Humayun
Chaudhry S/o
Chaudhry Imam-ud-
Din C.E.O / Director
1. Mr. Tahir Humayun
S/o Humayun Chaudhry
Director CNIC No. 33100-
4362414-1
2. Ms. Saima Tahir
W/o Tahir Humayun
Director
CNIC No. 33100- 8987772-6.
Page 35 of 116
Decision of CLB:
The Board considered and endorsed the change of management from old to new management of M/s
Humayun International Pharma (Pvt) Ltd, 20-Km, Satiana Road, Faisalabad under DML No. 000443 by
way of (Formulation) as per Form-29 of SECP as under:
Previous Management as per
Form-29 from SECP
Retiring Management Current Management as per
Form-29 from SECP
1. Mr. Humayun Chaudhry S/o
Chaudhry Imam-udDin C.E.O /
Director.
2. Mr. Tahir Humayun S/o Humayun
Chaudhry Director CNIC No.
33100-4362414-1.
3. Ms. Saima Tahir W/o Tahir
Humayun Director CNIC No.
33100-8987772-6
1.Mr. Humayun Chaudhry
S/o Chaudhry Imam-ud-
Din C.E.O / Director
1. Mr. Tahir Humayun
S/o Humayun Chaudhry
Director CNIC No. 33100-
4362414-1
2. Ms. Saima Tahir W/o Tahir
Humayun Director
CNIC No. 33100- 8987772-6.
Case No.16 M/S MEDLEY PHARMACEUTICALS (DML NO. 000237) PLOT NO. 41/A,
PUNJAB SMALL INDUSTRIES ESTATE, JHANG BAHTAR ROAD, WAH
CANTT.
Case Background.
M/s Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries Estate, Jhang
Bahtar Road, Wah Cantt., submitted the application for renewal of DML No. 000675 by way of
formulation on 30-06-2014 for the period of 30-06-2014 to 01-07-2019, as due date of renewal of said
DML was 30-06-2014.
After evaluation of the renewal application of the firm, a letter for completion of application for
renewal of DML was issued for following shortcomings: -
i. Appointment letter, Job acceptance letter, resignation of proposed production
Incharge from previous firm, resignation of Production Incharge previously
working in your firm, undertaking on letter head of the firm that proposed
Production Incharge is whole time employee of the firm.
ii. Appointment letter, Job acceptance letter, resignation of proposed Quality
Control Incharge from previous firm, resignation of Quality Control Incharge
previously working in your firm, undertaking on letter head of the firm that
proposed Quality Control Incharge is whole time employee of the firm.
iii. Nothing Due Certificate issued by Statistical Officer, DRAP, Islamabad
regarding deposition of Central Research Fund up 31-12-2014.
With reference to above letter, the firm submitted following documents;
i. Appointment letter, Job acceptance letter, resignation of proposed production
Incharge from previous firm, resignation of Production Incharge previously
working in your firm, undertaking on letter head of the firm that proposed
Production Incharge is whole time employee of the firm.
ii. Appointment letter, Job acceptance letter, resignation of proposed Quality
Control Incharge from previous firm, resignation of Quality Control Incharge
previously working in your firm, undertaking on letter head of the firm that
proposed Quality Control Incharge is whole time employee of the firm.
Upon evaluation of firm’s reply, a shortcoming still deficient regarding technical persons. A letter was
issued to the firm with following shortcomings:-
i. Attested documents of technical staff (Production & Quality Control Incharge)
as per check list.
Page 36 of 116
In response to letter, the firm has submitted for the approval of new technical staff and upon
evaluation of documents following shortcomings have still been observed:
For Quality Control Incharge Miss. Nabeela Noor.
i. Attested copy of Appointment letter.
ii. Attested Copy of CNIC.
iii. Attested copy of Job acceptance letter.
iv. Attested copy of Experience Certificate (s) covering the period of not less than 10
years.
v. Attested copy of Resignation / retirement of earlier Quality Control Manager.
vi. Attested copy of Resignation or termination letter of appointee from the previous
firm / promotion letter / transfer letter from the same firm (QC Incharge).
For Production Mr. Mohammad Imran.
i. Attested copy of Appointment letter.
ii. Attested copy of Job acceptance letter.
iii. Attested copy of Experience Certificate (s) covering the period of not less than 10
years.
iv. Attested copy of Resignation / retirement of earlier Production Manager.
v. Attested copy of Resignation or termination letter of appointee from the previous
firm / promotion letter / transfer letter from the same firm (Production Incharge).
A file is received from B&A relating to CRF issue of the M/s Medley Pharmaceuticals with following
observations:-
Extract at place below taken from File No.2-282/STO(R&D) Para 7-10/N).
“For issuance of NDC, required documents have been submitted by the licensee M/s
Medley Pharmaceuticals (DML No. 000237) Plot No. 41/A, Punjab Small Industries
Estate, Jhang Bahtar Road, Wah Cantt., i.e audited financial statements and income tax
returns, for F.Y 2015 & 2016 alongwith original bank receipts on account of CRF. The
same were checked as per SOP’s / procedure in vogue, IFRS and IAS, but found basic
accounting mistakes in preparation of financial statements, that made financial
statements suspicious. Therefore for M/s Medley was asked to submit duly
authenticated / attested aforesaid documents in order to proceed further (Page 81/Corr).
But the firm taken it leniently and again submitted the same documents by affixing
attested rubber stamp page 91-106/Corr).
Accordingly to establish authenticity of relevant documents, it was decided to approach
concerned audit firm M/s Nasir Absar & Co. to get verify the above said financial
statements. Therefore, telephonically contacted to Mr. Rizwan Chartered Accountant
on behalf of M/s Nasir Absar & Co. and then he came to this office on 14-05-17 and
shown their strong concerns about using their letter head and name were forged as the
firm is only dealing with tax matters. Hence, the above financial statements are of
fraud. As this office required some written evidence from their side, then M/s Nasir
Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to
auditor were issued on 24-05-17 at page (110/Corr).
In reply, M/s Nasir Absar & Co. vide letter No.NCAL/DRAP/002 dated 13-0717 at
page (112)/Corr). has recommended to this office (“to take strict action as allowed
under the Drugs Act, 1976 and its ancillary rules for forging, falsifying and
misleading to this office in this regard)” against M/s Medley Pharmaceuticals.
In the light above it is emerged that M/s Medley is not contributing towards CRF since
2014 (July 2014) as per rules and also submitted forged, falsified and misleading
annual audited financial statements of outstanding periods i.e July, 2014 to June 2016.
This is clear violation of rule 19 sub rule (14), Chapter II of “The Drugs (Licensing,
Registration and Advertising) Rules, 1976”. The same also attracts necessary action as
mentioned in rule 12 of aforesaid rules because it seems that the licensee is managing
to avoid the actual amount of CRF.
Page 37 of 116
In the light of para 7-11/N, Licensing Division may proceed to take necessary action
under relevant rules and regulation, please”.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries
Estate, Jhang Bahtar Road, Wah Cantt Drug Manufacturing Licence No. 000237 by way of
formulation may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled
by Central Licensing Board.
Accordingly, show cause notice dated 05-01-2018 and letter of personal hearing dated 17-01-2018 has
been issued to the firm.
Reply of the Show Cause Notice.
With this letter we are enclosing our shortcomings for Renewal of License No. 000237
i.e Documents for Production Incharge and Quality Control Incharge. All the necessary
documents are attached hereby.
As for the matter of CRF issue as stated in Show Cause Notice, it is stated that our
representative person for auditing and CRF of firm Mr. Anwar and CEO Mr. Javied
Iqbal Chishti of the firm passed away in 2016 because of which the matter could not be
handled properly and lead to some misconceptions. It is humbly requested to you that
kindly give us time to dig out the matter more efficiently and come out with authentic
audit reports so as to prove ourselves clean in the matter as firm has receive NOC of
year 2014 and duly submitted all CRF in time.
Current Status.
The firm has submitted documents of new Production & Quality Control Incharge which are complete
and only shortcoming remaining is up- to-date Nothing Due Certificate.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Zia , Director of the firm appeared before the Board. He contested that CEO of the firm is died
and they have taken up the matter with the concerned firm for audit of the accounts. He was of the
view that matter would be resolved very soon. The Board apprised him that secretariat for the Central
Licening Board only accepts the nothing due certificate issued from the Division of the Budget and
Accounts. The Board considering the facts on the record and after thread bare deliberation decided to
suspend the Drug Manufacturing Licence No. 000237 by way of formulation issued in the name of
M/s Medley Pharmaceuticals Plot No. 41/A, Punjab Small Industries Estate, Jhang Bahtar Road, Wah
Cantt till settelemnt of Central Research Fund under Section 41 of the Drugs Act, 1976 read with
Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the
provision of Rule, 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976.
Page 38 of 116
Case No. 17 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S ZEB
LABORATOIRES (PVT) LTD, LAHORE
M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital,
Lahore had applied for renewal of DML No. 000122 by way of formulation for the period of 22-09-13
to 21-09-2018 on 20-09-2013.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 21st July, 2017 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Attested Detail of management at the time of previous renewal of DML and latest
management at renewal of DML along with CNIC copies of all Director / Partners.
2. Attested Nothing due certificate regarding CRF from STO (updated).
3. Approval letter of Production Incharge and Quality Control Incharge, if any change
then provide set of documents for proposed Production Incharge and Quality Control
(as per check list) along with prescribe fee of Rs. 10,000/-.
4. Approved Master Layout Plan / Proof of licensed section from CLB.
5. All documents should be duly attested.
The firm submitted their reply on 21st
August, 2017 After evaluation of the submitted documents, final
reminder was issued on 15th
September, 2017 to the firm with following shortcomings: -
1. Form 29 for year 2016-17 duly attested by S.E.C.P.
2. Nothing due certificate regarding CRF from STO (Valid upto 31-12-2017).
3. Detail of premises including approved sections from CLB.
4. Section wise detail of machinery for manufacture.
5. Detail of machinery for Quality Control Lab.
6. Copy of CNIC of appointee (Production Incharge and Quality Control Incharge).
7. Registration certificate from Pharmacy Council (Production Incharge).
8. Experience Certificate of Production Incharge as under Drugs (Licensing, Registering and
Advertising) Rules, 1976 (Not less than 10 years in relevant field of Production).
9. Resignation / retirement of earlier Production Incharge and Quality Control Incharge.
10. Resignation or termination letter of appointee from the previous firm / promotion letter /
transfer letter from the same firm (Production Incharge and Quality Control Incharge).
11. Undertaking as whole time employee (Production Incharge and Quality Control Incharge).
12. All Documents should be duly attested.
Firm submitted documents on 29th
September, 2017in reply to Final Reminder but following
documents are still deficient /short and application for renewal of DML is still incomplete.
i. Nothing due certificate regarding CRF from STO.
ii. Form 29 for year 2016-2017 duly attested from S.E.C.P.
iii. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules,
1976 for proposed Production Incharge (Not less than 10 years).
iv. Resignation or termination letter of Quality Control Incharge from the previous firm /
promotion letter / transfer letter from the same firm.
Page 39 of 116
As per available record, there seems to be change of management of the firm. The detail of which is as
under:
Change of management from last renewal
Previous Management as
per Form-1A
(Page-21/Corr)
Retiring
Management
Current Management
as per Form-29 (Page-
400-401/Corr)
1. Mr. Fateh-Ullah Khan
S/o Zafar-Ullah Khan.
2. Mr. Asad-Ullah Khan S/o
Zafar-Ullah Khan.
3. Mr. Khair- Ullah Khan
S/o Zafar-Ullah Khan.
4. Mr. Kaleem-Ullah Khan
S/o Fateh-Ullah Khan.
5. Mr. Saif-Ullah Khan S/o
Fateh-Ullah Khan.
1. Mr. Asad-Ullah
Khan S/o Zafar-
Ullah Khan.
2. Mr. Khair- Ullah
Khan S/o Zafar-
Ullah Khan.
1. Mr. Fateh-Ullah Khan
S/o Zafar-Ullah
Khan.
2. Mr. Kaleem-Ullah
Khan S/o Fateh-Ullah
Khan.
3. Mr. Saif-Ullah Khan
S/o Fateh-Ullah
Khan.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Zeb Laboratories (Pvt) Ltd,
Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore.
A letter of Personal hearing has been issued on 17th January, 2018.
Meanwhile a letter is receive from the firm, wherein the firm has stated that they had stopped
production of common generic drugs due to some business decisions. The firm is, therefore,
surrendering their Drug Manufacturing License No. 000122 (Formulation) in the name of M/s
Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad near Shoukat Khanum Hospital, Lahore
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Fatehullah Khan, Chief Executive of the firm appeared before the Board. He apprised the Board
that they intend to surrender the Drug Manufacturing Licence by way of formulation for the purpose
of utilizing the premises for HOTC products. The Board considering the facts on the record and after
thread bare deliberation decided to cancel the Drug Manufacturing Licence No. 000122 by way of
formulation issued in the name of M/s Zeb Laboratories (Pvt) Ltd, Link Raiwind Road, Nasirabad
near Shoukat Khanum Hospital, Lahore on the request of the firm under Section 41 of the Drugs Act,
1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976
Page 40 of 116
Case No. 18 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S DR. SETHI
PHARMA INDUSTRIES, CHICHAWATNI.
M/s Dr. Sethi Pharma Industries, 3-Burewala Road, Chichawatni had applied for renewal of DML No.
000293 by way of formulation for the period of 22-07-2015 to 21-07-2020 on 10-07-2015
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 1st November, 2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Details of management / proprietor / director alone with copies of CNIC attested.
2. Legal status of firm, Partnership deed, Form”C”, which one is applicable.
3. Affidavit that whether there is any change in management and provided information
is correct.
4. L.O.P of firm.
5. Proof of approval of licensed sections from CLB.
6. Registration of earlier Q.C Incharge
7. Complete experience certificates dully attested for 10 years.
8. Registration of appointee from previous firm.
9. Fee challan for approval.
The firm submitted their reply on 23th
November, 2016 After evaluation of the submitted documents,
Final Reminder was issued on 11th
July, 2017 to the firm with following shortcomings: -
1. Approved copy of L.O.P and Section approval letters for section from Licensing
Board.
2. Attested copies of experience letter for 10 years for proposed Q.C Incharge.
3. Resignation of earlier Q.C Incharge and present nominee.
Page 41 of 116
The firm submitted their reply on 25th
July, 2017 to Final Reminder and following documents are still
deficient /short and application for renewal of DML is still incomplete.
1. Approved copy of L.O.P and Section approval letters for section from Licensing
Board.
2. Attested copies of experience letter for 10 years for proposed Q.C Incharge.
3. Resignation of earlier Q.C Incharge and present nominee.
4. Affidavit as sole proprietor on stamp paper.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Dr. Sethi Pharma Industries, 3-Burewala Road, Chichawatni Drug
Manufacturing Licence No000293 by way of formulation may not be rejected or Drug Manufacturing
Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Dr. Sethi Pharma Industries, 3-
Burewala Road, Chichawatni
Reply of the show cause is received from the firm and documents were evaluated. Firm has submitted
all the required documents for renewal of DML No. 000293 (Formulation) and application for renewal
of DML is complete.
The firm has been called for personal hearing vide Licensing Division letter dated 17th January, 2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Mehmood Durrani , Production Manager of the firm appeared before the Central Licensing Board
and contented that requirements has been completed by him and showcuase issued to him may be
recalled. The Borad after hearing the representative of the firm advised him to comply the legal
requirements in time in future and decided to cease the operation of the showcause notice issued to the
firm with immediate effect.
Case No. 19 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S PULSE
PHARMACEUTICALS (PVT) LTD, LAHORE.
M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore had
applied for renewal of DML No. 000564 by way of formulation for the period of 31-12-2014 to 30-12-
2019 on 15-12-2014.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 30th
March, 2015 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. To provide approval letters of Capsule (Antibiotic) and Oral Dry Powder suspension
(Antibiotic) which are mentioned in last inspection report of renewal of DML but in
licensing Division, there is no proof for grant of these sections.
Page 42 of 116
2. To furnish latest Form-29 issued by Security Exchange Commission of Pakistan
(S.E.C.P) and CNIC photocopies of all Directors.
3. To furnish documents / information of proposed Technical Expert with respect to Rule
16 of the Drug (L, R & A) Rules 1976 after promulgation of SRO 1134(1)/2014. The
technical experts shall possess minimum 10 years experience after academic
qualification.
The firm submitted their reply on 04th
May, 2015.After evaluation of the submitted documents, Final
Reminder was issued on 17th
September, 2016 to the firm with following shortcomings: -
1. As per Form-29, there seems change in management, if change then the requisite
fee.
2. Job acceptance letter of Q.C Incharge.
3. Resignation letter of earlier Q.C Incharge.
4. Prescribe fee of Rs. 5000/ for approval of technical staff.
Firm did not submit their reply to Final Reminder and following documents are still deficient /short
and application for renewal of DML was incomplete.
i. As per Form 29, there seems change in management, if change then the prescribe fee
alongwith CNIC copies of all Directors.
ii. Form-29 duly attested from S.E.C.P.
iii. Nothing due certificate regarding CRF from STO (Updated).
iv. Duly attested Appointment letter (Q.C Incharge).
v. Duly attested Copy of academic degrees (Q.C Incharge).
vi. Duly attested copy of experience certificates (Q.C Incharge).
vii. Undertaking as whole time employee on stamp paper.
viii. Duly attested resignation letter of appointee from previous firm (Q.C Incharge).
ix. Job acceptance letter of Q.C Incharge.
x. Resignation letter of earlier Q.C Incharge.
xi. Prescribe fee of Rs. 10.000/ for approval of technical staff.
xii. Duly attested copy of experience certificates (Production Incharge).
Accordingly, case was placed before the Board in its 256th
meeting held on 9-10th
November, 2017.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Pulse Pharmaceuticals (Pvt) Ltd, Mozay Badoke, Raiwind Road(Sua
Aasil Road), Lahore Drug Manufacturing Licence No000564 by way of formulation may not be
rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing
Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Pulse Pharmaceuticals (Pvt)
Ltd, Mozay Badoke, Raiwind Road(Sua Aasil Road), Lahore
A letter of Personal hearing has been issued on 17th
January, 2018.
Page 43 of 116
Firm has replied to show cause notice on 22-01-2018. Application for renewal of DML is still short of
following documents;
1. Form-29 duly attested from SECP.
2. Up-to-date Nothing Due Certificate (CRF) from STO, DRAP.
3. Resignation/retirement of earlier Production Incharge duly attested.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Umar Mehmood, Executive of the firm appeared before the Central Licensing Board and
presented documents which were considered and found complete. He also contended that that
requirements has been completed and showcuase issued to him may be recalled. The Borad after
hearing the representative of the firm advised him to comply the legal requirements in time in future
and decided to cease the operation of the showcause notice issued to the firm with immediate effect.
Case No. 20 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S DRUGPHARM
(PVT) LTD, LAHORE
M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore had applied for renewal of
DML No. 000366 by way of formulation for the period of 24-04-2016 to 23-04-2021 on 15-04-2016.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 23th
August, 2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Classes of Drugs.
2. Dosage forms of drugs.
3. Change (s) in name of proprietor / directors / partners.
4. Detail of premises including approved layout plan of the factory / proof of section
from CLB.
5. Copy of approval production and QC Incharge
6. Noting due certificate regarding CRF from STO.
7. Form-29 from S.E.C.P and CNIC of partners
The firm submitted their reply on 8th
September, 2016 After evaluation of the submitted documents, a
letter was issued on 30th
January, 2017 to the firm with following shortcomings: -
1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors.
2. Any change in directors from last renewal along with Form-29 at previous renewal.
3. N.O.C for C.R.F (attested up to 2015).
4. Approved copy of Layout Plan.
5. Approved of technical staff or application / documents.
6. All documents should be duly attested.
The firm submitted their reply on 23th
February, 2017 After evaluation of the submitted documents,
Final Reminder was issued on 19th
June, 2017 to the firm with following shortcomings: -
1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors.
2. Any change in directors from last renewal along with Form-29 at previous renewal.
3. N.O.C for C.R.F (attested up to 2016).
4. Approved copy of Layout Plan.
5. Approved of technical staff or application / documents.
6. All documents should be duly attested.
Page 44 of 116
Firm did not submit their reply to Final Reminder and following documents are still deficient /short
and application for renewal of DML is still incomplete.
1. Attested Form-29 from S.E.C.P along with copies of CNIC of all directors.
2. Any change in directors from last renewal along with Form-29 at previous renewal.
3. N.O.C for C.R.F (attested up to 2016).
4. Approved copy of Layout Plan.
5. Approved of technical staff or application / documents.
6. All documents should be duly attested.
Moreover, The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is
stated that a case No. 37/17 is filed before Hon’ble Drug Court, Quetta in respect of M/s DrugPharm
(Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore. Accused are not appearing before the Court
despite issuance of Non bailable warrants repeatedly. Therefore, Chairman Drug Court, Balochistan,
Quetta has ordered to cancel the Drug Manufacturing Licence of said firm and report in this regard
may be forwarded to Chairman Drug Court, Balochistan, Quetta.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Drug Pharm (Pvt) Ltd, 28-Km, Lahore Sheikhupura Road, Lahore
Drug Manufacturing Licence No. 000366 by way of formulation may not be rejected or Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Drug Pharm (Pvt) Ltd, 28-Km,
Lahore Sheikhupura Road, Lahore
A letter of Personal hearing has been issued on 17th
January,2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting
No representative of the of the firm appeared before the Board. The Board considering the facts on
the record and after thread bare deliberation decided to cancel Drug Manufacturing Licence No.
000366 by way of formulation issued in the name of M/s Drugpharm (Pvt) Ltd, 28-Km, Lahore
Sheikhupura Road, Lahore on the orders of the Court under Section 41 of the Drugs Act, 1976 read
with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying
the provision of Rule, 5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising)
Rules, 1976.
Case No. 21 CANCELLATION OF DRUG MANUFACTURING LICNCE OF M/S FRIENDS
PHARMA (PVT) LTD, 31-KM, FEROZEPUR ROAD, LAHORE
The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a
case No. 42/16 is filed before Hon’ble Drug Court, Quetta in respect of M/s Friends Pharma (Pvt) Ltd,
31-Km, Ferozepur Road, Lahore. Accused are not appearing before the Court despite issuance of Non
Page 45 of 116
bailable warrants repeatedly. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to
cancel the Drug Manufacturing Licence of said firm and report in this regard may be forwarded to
Chairman Drug Court, Balochistan, Quetta.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for cancellation of Drug Manufacturing
Licence.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Friends Pharma (Pvt) Ltd, 31-
Km, Ferozepur Road, Lahore.
A letter of Personal hearing has been issued on 17th
January, 2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Nadeem Zafar, chief Executive of the company appeared before the Board and submitted orders
of the Honourbale High Court, Balochistan, Quetta. Honourbale High Court, Balochistan, Quetta has
suspended the ordes of the Drug Court, Balochistan, Quetta, dated 10th
November, 2017 and 30th
December, 2017 to the extent of the issuance of warrant of arrest and for initiating proceedings against
the company. Keeping in view the facts and verbal assurance by the chief Executive of the company
for appearance before the Drug Court, Balochistan, the Board decided to cease the operation of
showcause notice and report shall be submitted to the Drug Court, Balochistan, Quetta.
Case NO. 22 M/S HELICON PHARMACEUTEK PAKISTAN (PVT) LTD., MODEL TOWN
ROAD, FAISALABAD – VIOLATION OF RULE 5(2A) OF DRUGS (L,R&A)
RULES, 1976.
M/s Helicon Pharmaceutek Pakistan (Pvt) Ltd, Faisalabad had submitted application
dated 06-11-2015 for the renewal of DML No. 000117. After evaluation of the renewal application of
the firm, a letter for completion of application for renewal of DML was issued for following
shortcomings/attested documents dated 28-12-2016: -
i. Details of management/Form-29 from S.E.C.P. Previous Form-29 and any change in
management, CNIC copies of all Directors.
ii. Details of premises including approved L.O.P
iii. Approval of technical staff or proposed documents for technical staff as per check list
iv. Proof of all licensed sections.
v. N.O.C for C.R.F
2. Firm did not submit the reply of the above shortcoming letter; accordingly a final reminder was
issued by Secretary CLB dated 17-02-2017.Firm submitted reply alongwith deficient documents
against the final reminder for the completion of their DML renewal application as under:
i. Unattested form-29 from SECP
ii. Copy of L.O.P
iii. Nothing Due certificate UPTO 31-12-2005
iv. Mr. Rafaqat Ali , production Incharge
v. Miss ZahidaMaqsood, Q.C Incharge
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3. Following documents /information is still deficient /short;
i. Firm submitted the name of Miss ZahidaMaqsood as Q.C. Incharge, However it is
revealed from record that she had resigned from her post on 2-1-2009 and her
resignation was accepted by the management of firm. According Mr. Muhammad
Rafiq Khan S/o Sultan Jan Khan was approved as Q.C. Incharge vide this office
letter of even Number dated 21-07-2009 Firm did not reply for approval of
approved of Q.C. Incharge Miss ZahidaMaqsood to this office was submitted
resignation of Mr. Muhammad Rafiq Khan till to date as per available record of
licensing Division.
ii. Firm submitted form-29 (un-attested) and seems change in management, however
fee Challan for change of management is not provided
iii. Letter of approved Section from CCB is not provided.
iv. Latest nothing due certificate for C.R.F from S.T.) is not provided. Firm submitted
certificate up to 2015.
Proceedings and Decision of Central Licensing Board in 254th
meeting.
4. The Board considering the facts on the record and after thread bare deliberation decided to
serve Show Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of
the Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of
Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why
the application for renewal of DML No. 000117 by way of formulation ofM/s Helicon Pharmaceutek
Pakistan (Pvt.) Ltd, Faisalabad may not be rejected by Central Licensing Board or their Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
5. The Show Cause notice dated 21st July, 2017 was issued to the M/s Helicon Pharmaceutek
Pakistan (Pvt.) Ltd, Faisalabad.Reply of the show cause is received from the firm which is as under:-
“This show cause notice is seem to be a result of misreading/ non reading of our reply
received on dated 20.03.2017 and reply to your letter dated 28.12.2016 and 17.02.2017.We were
required to provide following five information's/ queries
i. Detail of management form-29 duly attested from S.E.C.P. previous Form-29
and any change in management. CNIC copies of all direction.
ii. Detail of premises including approved layout plan.
iii. Proof of all licensed sections.
iv. Approval of technical staff or proposed documents for technical person as per
check list.
v. Nothing due Certificate for CR.F.
We have already thoroughly replied all these queries/ observations by providing all
requisite information and by attaching the requisite documents. We reproduce for your kind
information along with the extract of requisite reply para wise as below. Which proves that this
show cause/notice is unwarranted and liable to withdrawn forth with
Query 1. Detail of management form-29 duly attested previous Form-29 and from S.E.C.P.
any change in management. CNIC copies of all directors.
Page 47 of 116
Reply: Form 29 duly certified on 06 August 2016 diary no. 918622 from joint registrar S.
E.C.P. Faisalabad elaborating he following information of all the directors.
Query 2. Detail of premises including approved layout plan.
Reply: The detail of premises including layout plan is attached here with again. This factory
was licensed in 1962 and then under Drug Act 1976 and since then continuing at this premises
duly inspected and approved and renewed as per layout plan.
Query 3.Proof of all licensed sections.
Reply: The license sections have been duly inspected while granting the registrations and
while renewing the drug manufacturing license. This is the sufficient proof of licensed section.
More over all our registrations are current and renewed.
Query 4. Approval of technical staff proposed documents for technical person as per check list.
Reply: The following approved technical staff is working continuously without any
interruptions
After fulfillment of all requisite qualifications. As under
Sr. No Name Job assigned Qualification
1. Mr. Rafaqat Ali Production Manager B. Pharmacy
2. Ms. ZahidaMaqsood Quality Control Manager B. Pharmacy
copy of approval letter of Ministry of Health is attached for ready reference.
Query 5. Nothing due certificate for C.R.F,
Reply: Letter dated 20th March 2015 issued by the statistical officer DRAP Islamabad
narrating this "Nothing due certificate is valid up to 31.12.2015" copy attached.
We are amongst the pioneer manufacturing units serving the country. In the recent past
we have donated 50% of our registered drugs to a charity. Thus we are not working for profit.
it is not out of place to mention that in line with the suggestions of the inspection
panels, we have closed down few sections and are intending to shift the production to a third
party arrangement till such time that we have alternative manufacturing facility to under take
these by our self for which we have made positive arrangements. We have sufficiently replied
to your queries on the basis of which we were issued this un warranted show cause notice. We
therefore request personal hearing to clarify our stance for ends of justice as poor patients are
likely to suffer incase of any adverse consequences arising out of misreading's
We may be accorded some convenient date with sufficient lead time for personal
hearing as well”.
Observations of the Licensing Division
6. Observations of the Licensing Division are as under:
Query 1. Detail of management form-29 duly attested previous Form-29 and from S.E.C.P.
any change in management. CNIC copies of all directors.
Page 48 of 116
Observation: The firm has submitted copy of form-29 which is not duly attested from
S.E.C.P. and not provided CNIC copies of all directors.
Query 2. Detail of premises including approved layout plan.
Observation: The firm did not submit approved layout plan.
Query 3.Proof of all licensed sections.
Observation: Not provided by the firm
Query 4. Approval of technical staff proposed documents for technical person as per check
list.
Observation: It is revealed from the record that Ms. ZahidaMaqsood (approved Quality
Control Incharge) had resigned from her post on 02-01-2009 and her resignation was accepted
by the management of firm (page 56/Corr). Accordingly Mr. Muhammad Rafiq Khan S/o
Sultan Jan Khan was approved as Quality Control Incharge vide this office letter of even
number date 21-07-2009 (page 69/Corr). Afterwards, the firm neither applied for approval of
Ms. Zahida Maqsood as Quality Control Incharge nor submitted resignation of Mr.
Muhammad Rafiq Khan till date to Licensing Division.
Query 5. Nothing due certificate for C.R.F,
Observation: The Nothing due certificate for C.R.F. is valid upto 31-12-2015.
The firm has been called for personal hearing
Proceedings and Decision of Central Licensing Board in 255th
meeting
No person appeared before the Board. Letter issued to the firm for personal hearing is received
undelivered. The Board therefore, decided to defer the case till next meeting of the Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
A letter of Personal hearing has been issued on 1st November, 2017. The firm has replied in the
response of Personal hearing letter and informed that due to paucity of time, they could not properly
prepared for the personal hearing and their technical person is on leave for medical reasons. The firm,
therefore, requested that the personal hearing may kindly be adjourned to the forthcoming meeting of
Central Licensing Board.
Proceedings and Decision of Central Licensing Board in 256th
meeting.
Mr. Tariq Mahmood Accounts Manager appeared on behalf of the firm the Board. He contended that
their technical person is on leave for medical reasons therefore, time may be granted for next hearing
to defend the case. The Board, therefore, decided to provided one opportunity for personal appearance
before the Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
A letter of Personal hearing has been issued on 17th
January,2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting.
Mr. Tariq Mahmood, Accounts Manager appeared on behalf of the firm before the Board. He
contended that he may be given time of two weeks to complete the application. The Board considering
Page 49 of 116
the facts on the record and after thread bare deliberation decided to suspend Drug Manufacturing
Licence No. 000117 by way of formulation in the name of M/s Helicon Pharmaceutek Pakistan (Pvt.)
Ltd, Faisalabad till completion of requirements as per Schedule B and codal formalities under Section
41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising)
Rules, 1976 for not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing,
Registering and Advertising) Rules, 1976.
Page 50 of 116
Case No. 23. INSPECTION REPORT OF M/S HIMONT PHARMACEUTUCALS, LAHORE.
A panel inspection report pertaining to M/s Himont Pharmaceuticals (Pvt) Ltd, 17-Km,
Ferozepur Road, Lahore forwarded vide letter No. F. No. 1-59/2017-FID IV dated 21st
June, 2017, on
the subject cited above. The panel observed that in Cephalosporin Section approved change room was
not being used and it has been converted into washing area. The firm was using another room for
entrance which was not provided with proper change over facility for workers. It was observed that the
workers in the section were just wearing a coat over their street cloths. The panel was of the opinion
that in this sensitive area of manufacturing the workers should wear proper uniform to avoid any
chance of cross contamination, additionally it may pose a greater risk on workers and others safety due
to exposure to the Cephalosporin powders sticking on the cloths. The panel advised the firm to provide
proper change over facility for the workers. In the Capsule (General) Section, the firm has provided
only manual Capsule filling machines, which seems not to be appropriate to meet the latest GMP
requirements. The Panel recommended the renewal Drug Manufacturing License to all approved
sections except Capsule (General) and Cephalosporin (injectable, oral dry powder suspension &
capsule) section. The case was accordingly placed before the Central Licensing Board in its 255th
meeting held on 16-17th
August, 2017.
The Central Licensing Board considered the facts of the case, legal provisions and decided as
under;
“The Board decided to issue Show Cause Notice to the firm under Section 41
of the Drugs Act, 1976 read with Rule 12 of the Drugs (Licensing, Registering and
Advertising) Rules, 1976 for suspension or cancellation for Capsule (General) and
Cephalosporin (injectable, oral dry powder suspension & capsule) section on the
recommendations of the panel of experts”.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board:
The Show Cause notice dated 12th
January, 2018 was issued to the M/s Himont
Pharmaceuticals (Pvt) Ltd, 17-Km, Ferozepur Road, Lahore.
Reply of the show cause is received from the firm which is as under:-
Sr.
No
Observations Status
1 General Capsule Area
It was noted that in the general capsule section the firm
has provided only manual capsule filling machine which
seemed not to be appropriate to meet
The latest GMP requirement Capsule polisher and
metal detector to be installed.
Complied semi-
automatic machine
installed
Complied. Capsule
polisher and metal
detector installed.
2 Capsule Area (Cephalosporin)
Capsule was neat and clean provided with the required
machine and equipment. HVAC system was installed and
functional. It was note provided with proper change over just
wearing a coat over their street cloths addition to cross
Complied. Change over
facility provided
Complied, Capsule
polisher and metal
detector installed.
Page 51 of 116
contamination may also pose a greater risk on workers own
and others safety due to exposure to the Cephalosporin
powders sticking on the cloths. The firm was also advised to
provide capsule polisher and metal detector in the section.
3 Oral Dry Powder Suspension(Cephalosporin )
Metal was neat and clean provide with the require machine and
equipment. HVAC system was installed and functional. It was
not provided with proper change over facility for workers. The
workers in the section were just wearing a coat over their street
cloths which in addition to cross contamination may also pose
a greater risk on workers and others safety due to exposure
Cephalosporin powders sticking on the cloths.
Complied, Change
over facility provided
4 Dry Powder Injectable (Cephalosporin)
Section was neat and clean provided with the require machine
and equipment. HVAC system was installed and functional. It
was noted that entrance to this section was not provided with
proper change over facility for workers. The workers in section
were just wearing a coat over their street cloths which in
addition to cross contamination may also pose a greater risk on
workers own and others safety due to exposure to the
Cephalosporin powders sticking on the cloths.
Complied, Change
over facility provided
5 Quality Control
In quality department the firm possesses necessary equipment
to carry out the testing / analysis for the products being
manufactured quality control equipment were installed and
calibrated. Among the major instruments the firm possesses
the HPLC, UV spectrophotometer. Karl Fisher, TOC, and
liquid particle analyzer etc. The microbiology lab was also
equipped. However, it was noted that FTIR was out of order;
the firm was advised to make it functional at earliest.
FTIR has been sent for
diagnosis and
rectification of problem
to Perkin Elmer
Company.
The firm has been called for personal hearing vide Licensing Division letter dated 17th January, 2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting.
Dr. Maqsood Ahmed, Head Quality Operations appeared before the Board and contended that all
rectifications have been made as per advice of the panel of experts. He further requested that panel of
experts may be constituted for verification of the improvemengts made in Capsule (General) and
Cephalosporin (injectable, oral dry powder suspension & capsule) section. The Board after hearing the
represenetative of the firm decided to constitute same panel for verification of improvements made.
The Board also authorized that Chief Drug Controller may be replaced with Mr. Anjum Pervaiz in the
panel.
Page 52 of 116
Case No. 24. INSPECTION REPORT OF M/S REKO PHARMACAL, LAHORE.
A panel inspection report pertaining to M/s M/s Reko Pharmacal (Pvt) Ltd., 13-KM,
Multan Road, Lahore forwarded vide letter No. F. No. 1-21/2012-FID (F) dated 12th
June, 2017, on the
subject cited above. The panel observed that Liquid Injectable (General) Section was neat and clean.
HVAC system was installed and functional. However, it was noted that firm has not provided
appropriate vial filling machine and hence did not possess proper vial manufacturing facility. The firm
has provided the necessary equipment and instrument for test / analysis of products except the liquid
injectable dosage forms. It was noted the firm has not provided TOC and liquid particle analyzer,
required for conducting test / analysis of liquid injectable dosage forms. Hence the firm did not
possess the Quality Control facility for liquid injectable. The case was accordingly placed before the
Central Licensing Board in its 254th
meeting held on 15th
June, 2017.
The Central Licensing Board considered the facts of the case, legal provisions and decided as
under; “The Board decided to issue Show Cause Notice to the firm under Section 41 of the
Drugs Act, 1976 read with Rule 12 of the Drugs (Licensing, Registering and
Advertising) Rules, 1976 for suspension / cancellation of Liquid Injectable Section on
the recommendations of the Panel of Inspectors till the provision of proper
manufacturing and testing facilities”.
The Show Cause notice dated 26th
October, 2017 was issued to the M/s Reko Pharmacal (Pvt)
Ltd., 13 KM, Multan Road, Lahore.
Now the firm has replied to Show Cause notice the observations of panel and reply of
the firm is as under:
Observations of panel Reply of the firm
Liquid Injectable (General) Section was neat
and clean. HVAC system was installed and
functional. However, it was noted that firm
has not provided appropriate vial filling
machine and hence did not possess proper
vial manufacturing facility
In respect to the specific observation of the panel
regarding manual vial machine in the vial filling
section, we are in the process of upgrading the
vial section and have ordered the new automatic
vial filling machine (quotation is attached) which
will replace the manual vial filling machine.
The firm has provided the necessary equipment
and instrument for test / analysis of products
except the liquid injectable dosage forms. It
was noted the firm has not provided TOC
and liquid particle analyzer, required for
conducting test / analysis of liquid injectable
dosage forms. Hence the firm did not possess
the Quality Control facility for liquid
injectable.
As per instruction / observations of panel
inspection report pertaining to M/s Reko
Pharmacal (Pvt) Ltd, we have upgraded our
testing facilities of liquid injectable dosage
forms. We have purchased and installed the TOC
analyzer and liquid particle counter and all tests
for injectable dosage form are being conducted
on these instruments (copies of invoices of TOC
analyzer and liquid particle counter attached )
Furthermore, the firm has requested that they would highly appreciate if the CLB note the
required change and withdraw the whole cause and renew their injectable section.
The firm has been called for personal hearing vide Licensing Division letter dated 17th January, 2018.
Page 53 of 116
Proceedings and Decision of Central Licensing Board in 257th
meeting.
Ms. Seemal Khalid, Director and Mr. Sameer Iftikhar appeared before the Board and contended that
all rectifications have been made as per advice of the panel of experts. She further requested that panel
of experts may be constituted for verification of the improvemengts made in Liquid Injectable Section.
The Board after hearing the represenetative of the firm decided to constitute same panel for
verification of improvements made and installation of liquid injectable filling machine..
Case No. 25 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SATURN
PHARMACEUTICALS (PVT) LTD, LAHORE
M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore had applied for renewal
of DML No. 000734 by way of formulation for the period of 15-06-2016 to 14-06-2021 on 9-05-2016.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 16th
June, 2017 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Duly signed and stamped Form-1A.
2. Detail of management Previous at the time of grant of DML and latest management
present renewal of DML along with CNIC copies of directors.
3. Nothing due certificate regarding CRF from STO (Updated).
4. Approval letter / proof of proposed Production Incharge and Quality Control Incharge
if any change then provide complete set of documents for proposed Production
Incharge and Quality Control Incharge (as per check list) along with prescribe fee.
5. Documents should be duly attested.
The firm submitted their reply on 31st
July, 2017 After evaluation of the submitted documents, final
reminder was issued on 15th
August, 2017 to the firm with following shortcomings: -
1. Duly signed and stamped Form-1A.
2. Detail of management Previous at the time of grant of DML and latest management
present renewal of DML along with CNIC copies of directors.
3. Nothing due certificate regarding CRF from STO (Updated).
4. Approval letter / proof of proposed Production Incharge and Quality Control Incharge
if any change then provide complete set of documents for proposed Production
Incharge and Quality Control Incharge (as per check list) along with prescribe fee.
5. All Documents should be duly attested.
Firm replied on 13-09-2017 to Final Reminder by stating that they have already submitted documents
but unfortunately these documents were not duly attested. Now it is our humble request in your honor
that duly attested copies will be provided in your office within few days. Following documents are
still deficient /short and application for renewal of DML is incomplete.
Page 54 of 116
1. Duly signed and stamped Form-1A.
2. Detail of management Previous at the time of grant of DML and latest management
present renewal of DML along with CNIC copies of directors.
3. Nothing due certificate regarding CRF from STO (Updated).
4. Approval letter / proof of proposed Production Incharge and Quality Control Incharge
if any change then provide complete set of documents for proposed Production
Incharge and Quality Control Incharge (as per check list) along with prescribe fee.
5. All Documents should be duly attested.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road,
Lahore Drug Manufacturing Licence No. 000734 by way of formulation may not be rejected or Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Saturn Pharmaceuticals (Pvt)
Ltd, 25-Km, Thokar Raiwind Road, Lahore
Reply of show cause notice
The firm has submitted the documents in reply of the show cause notice. Upon evaluation following
documents are found to be deficient;
1. Duly attested resignation/retirement of earlier Production and Quality Control Incharge.
2. Nothing Due Certificate regarding CRF.
3. Duly attested appointment and job acceptance letter of QC Incharge.
A letter of Personal hearing has been issued on 17th
January, 2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Ghulam Yasin Paracha , Chief Executive of the firm appeared before the Board and contended
that they have applied for nothing due certificate on 12-01-2018 and no production is being carried out
in the premises. The Board considering the facts on the record and after thread bare deliberation
decided to suspend the Drug Manufacturing Licence No. 000734 by way of formulation issued in the
name of M/s Saturn Pharmaceuticals (Pvt) Ltd, 25-Km, Thokar Raiwind Road, Lahore till settlement
of CRF and other codal formalities under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the
Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule,
5(2A) and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976
Page 55 of 116
Case No. 26 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S CHISHTI
PHARMACEUTICAL INDUSTRIES, CHICHAWATNI
M/s Chishti Pharmaceutical Industries, Chichawatni had applied for renewal of DML No. 000483 by
way of formulation for the period of 19-12-2015 to 18-12-2020 on 15-12-2015
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 1st November, 2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Details of management at the time grant of DML and previous renewal of DML
and present renewal of DML.
2. Details of premises including layout plan / proof of section from Central
Licensing Board.
3. All documents should be duly attested.
The firm submitted their reply on 26th
December, 2016 After evaluation of the submitted documents,
Final Reminder was issued on 19th
August, 2017 to the firm with following shortcomings: -
1. Proposed Change in management agreement i.e revised deed from previous to
present management alongwith attested copies of CNIC’s.
2. Requisite fee Rs. 50,000/- for change of management.
3. Form-D from registrar of firms.
4. Complete set of documents for QC Incharge (as per check list) along with prescribe
fee Rs. 5,000/-.
5. Nothing due certificate regarding CRF from STO (Updated).
6. All documents should be duly attested.
Firm submitted documents on 25th
September, 2017 in reply to Final Reminder but following
documents are still deficient /short and application for renewal of DML is still incomplete.
1. There seems to be Change in management, revised Partnership deed alongwith
attested copies of CNIC’s of partners.
2. Requisite fee Rs. 50,000/- for change of management.
3. Form-D from registrar of firms.
4. Complete set of documents for QC Incharge (as per check list) along with prescribe
fee Rs. 5,000/-.
5. Nothing due certificate regarding CRF from STO (Updated).
6. All documents should be duly attested.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
Page 56 of 116
application for renewal of M/s Chishti Pharmaceutical Industries, Chichawatni Drug Manufacturing
Licence No000483 by way of formulation may not be rejected or Drug Manufacturing Licence may
not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Chishti Pharmaceutical
Industries, Chichawatni
A letter of Personal hearing has been issued on 17th
January, 2018.
The firm has replied to show cause notice and documents submitted by the firm are evaluated and
application is found to be deficient of following documents;
1. Complete set of duly attested documents for approval of Quality Control Incharge
alongwith requisite fee of Rs. 5000/-.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Muhammad Arshad Chisti, Chief Executive of the firm appeared before the Central Licensing
Board and submitted documents which have been perused found as per requirement. The Borad after
hearing the representative of the firm advised him to comply the legal requirements in time in future
and decided to cease the operation of the showcause notice issued to the firm with immediate effect.
Case No.27 HIRRA PHARMACEUTICAL LABORATORIES (PVT) LTD, LAHORE
M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt
had applied for renewal of DML No. 000449 by way of formulation for the period of 1-08-2015 to 31-
07-2020 on 30-07-2015.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 20th
October, 2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Form 29 from S.E.C.P. newly details of management along with CNIC copies &
any change in management
2. Section wise details of machinery
3. Name & qualification along with documents for QC Incharge & Production
Incharge
4. Noting due certificate regarding CRF from STO.
5. Proof of all licensed Sections.
The firm did not submit their reply and Final Reminder was issued on 19th
June, 2017 to the firm with
following shortcomings: -
1. Form 29 from S.E.C.P. newly details of management along with CNIC copies & any
change in management
2. Section wise details of machinery
3. Name & qualification along with documents for QC Incharge & Production Incharge
4. Noting due certificate regarding CRF from STO.
5. Proof of all licensed Sections.
Page 57 of 116
Firm submitted documents on 13th
July, 2017 in reply to Final Reminder but following documents are
still deficient /short and application for renewal of DML is still incomplete.
1. Form-29 duly attested from S.E.C.P alongwith CNIC copies of all directors.
2. Duly attested document for approval of proposed QC Incharge & Production Incharge
alongwith prescribe fee.
3. Proof of all licensed Sections approved by Central Licensing Board.
4. Prescribe fee of 50,000/- for change of management.
5. Prescribe fee of 50,000/- for change of Legal Status from M/s Hirra Pharmaceutical
Laboratories to Hirra Pharmaceutical Laboratories (Pvt) Ltd.
6. All document should be duly attested.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Hirra Pharmaceutical Laboratories, 1.3-Km, Asli Raiwind Road
(Ladhaky Bhula). Lahore-Cantt Drug Manufacturing Licence No. 000449 by way of formulation may
not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central
Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Hirra Pharmaceutical
Laboratories, 1.3-Km, Asli Raiwind Road (Ladhaky Bhula). Lahore-Cantt
A letter of Personal hearing has been issued on 17th
January,2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Dr. Kamran Ahmed, Director of the firm appeared before the Central Licensing Board and submitted
documents which have been perused found as per requirement. The Borad after hearing the
representative of the firm advised him to comply the legal requirements in time in future and decided
to cease the operation of the showcause notice issued to the firm with immediate effect.
Case No. 28 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S QINTAR
PHARMACEUTICALS, SARGODHA
M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha, had
applied for renewal of DML No. 000520 by way of formulation for the period of 19-06-2013 to 18-06-
2018 on 13-06-2013.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 22-10-2013 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
Page 58 of 116
1. Copy of new partnership deed duly attested by office of Registrar of firm as the name of
partners as mentioned in your above said application are different than mention in
previous application dated 10-06-2008 for the same purpose i.e. grant of renewal of Drug
Manufacturing License at that time.
2. Attested copy of Certificate of Registrar of firm duly issued by the office of Registrar of
firm’s alongwith attested copies of CNIC of all the present Directors / Partner.
3. No Objection Certificate for Central Research Fund (CRF) by Statistical Officer DRAP,
Islamabad till to date.
Firm submitted documents on 10th
February, 2017 and a letter was issued on 8th
August, 2017 under
Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following shortcomings.
1. Prescribe fee of Rs. 50,000/- for change of management and original challan retained
by STO (R&D), DRAP, Islamabad.
2. Attested Nothing due certificate regarding CRF from STO (Updated).
Firm submitted documents on 5th
September, 2017 in reply to letter issued on 8th
August, 2017 and a
letter for following shortcomings / deficiencies was issued to the firm on 18th
October, 2017 under
Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
1. Form-D from Registrar of firms.
2. Copy of previous partnership deed.
3. NOC from previous partners on stamp paper.
4. All documents should be duly attested.
File is received from Budget & Account Division related to CRF issue of M/s Qintar Pharmaceuticals,
14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha with following observations.
Extract taken from 2-194/2008-STO (R&D)
13. For issuance of NDC, required documents have been submitted by the licensee M/s Qintar
Pharmaceuticals (DML No. 000520 11-A Punjab Small Industrial Estate Lahore), i.e. audited financial
statements and income tax returns, for FY 2014, 2015 & 2016 along with original bank receipts on
account of CRE. The same were checked as per SOP procedure in vogue, IFRS and IAS, but found
basic accounting mistakes in preparation financial statements, that made financial statements
suspicious. Therefore, for M/s Qintar was asked to submit duly authenticated attested aforesaid
documents in order to proceed further (page 109 /Corr.). But the firm taken it leniently and again
submitted the same documents by affixing at rubber stamp.
14. Accordingly to establish authenticity of relevant documents it was decided to approach concerned
audit firm M/s. Nasir Absar & Co. to get verify the above said financial statements. Therefore,
telephonically contacted to Mr. Rizwan Chartered Accountant on behalf of M/s Nasir Absar & Co. and
then he came to this office on 14-05-17 and shown their strong concerns about using their letter head
and name were forged as the firm is only dealing with tax matters. Hence, the above financial
statements are of fraud. As this office required some written evidence from their side, then M/s Nasir
Absar & Co. asked for a letter, therefore with approval of Director (B&A) letter to auditor were issued
on 24-05-17
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15. In reply, M/s Nasir Absar & Co. vide letter No NCAI/DRAP/001 dated 13-07-17 at page
(180/Corr.) has requested to this office ("to take strict action as allowed under the Drugs Act, 1976
and its ancillary rules for forging, falsifying and misleading to this office in this regard)", against
M/s Qintar Pharmaceuticals.
16. In the light above it is emerged that M/s Qintar is not contributing towards CRF since 2013 (July
2013) as per rules and also submitted forged, falsified and misleading annual audited financial
statements of outstanding periods i.e. July 2013 to June 2016. This is clear violation of rule 19 sub rule
(14), Chapter II of “The Drugs (Licensing, Registration and Advertising) Rules 1976". The same also
attracts necessary action as mentioned in rule 12 of aforesaid rules because it seems that the licensee is
managing to avoid actual amount of CRF.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Qintar Pharmaceuticals, 14-A, Punjab Small Industrial Estate, Lahore
Road, Sargodha, Drug Manufacturing Licence No. 000520 by way of formulation may not be
rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing
Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s Qintar Pharmaceuticals, 14-A,
Punjab Small Industrial Estate, Lahore Road, Sargodha
A letter of Personal hearing has been issued on 17th January, 2018.
Firm has replied to Show Cause Notice and application of renewal of DML is complete except
following documents:
1. Updated Noting due certificate regarding CRF from STO.
Moreover, firm has stated that in case of CRF, we recruited authorized person Mr. Anwar Ahmed
(Late) for dealing all matters of DRAP including CRF on behalf of Qintar Pharmaceutical.
Unfortunately, he died few months ago, therefore, we could not communicate properly with Budget
and Accounts Department to resolve matters about audited financial statements. We are requesting to
CLB to please give us some time for issuance of NDC from Budget & Accounts Department. We also
make sure that this kind of negligence will not happen again.
Proceedings and Decision of Central Licensing Board in 257th
meeting
Mr. Zeeshan Masood, Managing Director of the firm appeared before the Board. He contested that
representative of the firm is died who used to deal with the subject matter and they have taken up the
matter with the concerned firm for audit of the accounts. He was of the view that matter would be
resolved very soon. The Board apprised him that secretariat for the Central Licening Board only
Page 60 of 116
accepts the nothing due certificate issued from the Division of the Budget and Accounts. The Board
considering the facts on the record and after thread bare deliberation decided to suspend the Drug
Manufacturing Licence No. 000520 by way of formulation issued in the name of M/s Qintar
Pharmaceuticals 14-A, Punjab Small Industrial Estate, Lahore Road, Sargodha till settlement of
Central Research Fund under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5 (2A)
of the Drugs (Licensing, Registering and Advertising) Rules, 1976.
Case No. 29 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S T.G PHARMA,
KARACHI
M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi had applied for renewal of DML
No. 000547 by way of formulation for the period of 24-07-2014 to 23-07-2019 on 23-07-2014.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 23rd
February, 2016 and 2nd
March, 2017 under
Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
i) Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of
firm.
ii) No Objection Certificate for Central Research Fund (CRF) (updated) issued by
Statistical Officer DRAP, Islamabad
iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s.
iv) List of total section of the firm and their letters of approval which were issued by
Central Licensing Board.
v) Approval letter of QC Incharge and Production Incharge if (not available) then
provide complete documents of technical persons i.e QC Incharge and Production
Incharge according to checklist (enclosed).
Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 10th
July,
2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following
shortcomings.
i) Proper application on Form-IA on firm’s letter head dully signed / stamp by CEO of
firm.
ii) Nothing due certificate regarding CRF from STO (Updated).
iii) Legal status of the firm along with details of ownership, attested copies of CNIC’s. .
iv) Approval letters of sections issued by the Central Licensing Board
v) Approval letter of proposed Quality Control Incharge and Production Incharge, if any
change then provide set of duly attested documents for Proposed Quality Control
Incharge and Production Incharge (as per check list) along with prescribe fee.
vi) Documents should be duly attested.
Page 61 of 116
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s T.G Pharma, E-30, Sector 15, Korangi Industrial Area, Karachi Drug
Manufacturing Licence No. 000547 by way of formulation may not be rejected or Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 05th
January, 2018 was issued to the M/s T.G Pharma, E-30, Sector 15,
Korangi Industrial Area, Karachi.
No reply of the show cause notice is received from the firm.
A letter of Personal hearing has been issued on 17th
January, 2018
Proceedings and Decision of Central Licensing Board in 257th
meeting
No person appeared on behalf of the firm. The Board decided to defer the case for giving one more
opportunity and service of notice through Federal Inspector of Drugs.
Case No. 30 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SULTAN
COTTON & BANDAGES, MIRPURKHAS.
M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial Estate, Mirwah Road,
Mirpurkhas Karachi, had applied for renewal of DML No. 000585 by way of formulation for the
period of 08-11-2015 to 07-11-2020 on 27-10-2015.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 07-11-2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
i. Latest Form-29 from S.E.C.P. dully attested alongwith CNIC copies of
management at the time of previous renewal and now at present renewal.
ii. Latest N.O.C. of CRF.
iii. Detail of Premises with Proof of approved sections.
iv. Job Acceptance letter of QC incharge/Production incharge.
v. Required Fee for change of QC incharge/Production incharge.
vi. Experience certificates of at least 10 years of proposed Production Incharge/QC
Incharge.
vii. Resignation letter of proposed Production Incharge/QC Incharge from previous
firm.
viii. Registration certificate from Pharmacy Council of proposed Production
Incharge dully attested.
Page 62 of 116
Firm did not submit the shortcoming documents and a Final Reminder letter was issued on 26th
July,
2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following
shortcomings.
1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of management at
the time of previous renewal and now at present renewal.
2. Nothing due certificate regarding CRF from STO (Updated).
3. Detail of Premises with Proof of approved sections.
4. Job Acceptance letter of QC Incharge and Production Incharge.
5. Required Fee of Rs 10,000/- for change of QC Incharge and Production Incharge.
6. Experience certificates of at least 10 years of proposed Production Incharge and QC
Incharge.
7. Resignation letter of proposed Production Incharge and QC Incharge from previous
firm.
8. Registration certificate from Pharmacy Council of proposed Production Incharge dully
attested.
9. Documents should be duly attested.
Firm submitted documents on 7th
August, 2017in reply to Final Reminder but following documents are
still deficient /short and application for renewal of DML is still incomplete.
1. Attested Photocopy of Partnership deed (Latest) and CNIC copies of Both Partners.
2. Attested Approval letters of all sections issued by the Central Licensing Board.
3. Copy of academic degrees, as under Drugs (Licensing, Registering and Advertising) Rules,
1976 (Production Incharge and Quality Control Incharge).
4. Attested Experience Certificate of Production Incharge and Quality Control Incharge as
under Drugs (Licensing, Registering and Advertising) Rules, 1976 (Not less than 10 years
in relent field).
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Sultan Cotton & Bandages, Plot No. 145-146, Sindh Small Industrial
Estate, Mirwah Road, Mirpurkhas Drug Manufacturing Licence No. 000585 by way of formulation
may not be rejected or Drug Manufacturing Licence may not be suspended or cancelled by Central
Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 5th
January, 2018 was issued to the M/s Sultan Cotton & Bandages, Plot
No. 145-146, Sindh Small Industrial Estate, Mirwah Road, Mirpurkhas .
Reply of the show cause notice is received from the firm on 19th
January, 2018 which is evaluated and
application for renewal of DML of firm is now found to be complete.
A letter of Personal hearing has been issued on 17th
January, 2018
Page 63 of 116
Proceedings and Decision of Central Licensing Board in 257th
meeting
Dr. Muhammad Saleem apeared before the Central Licensing Board and contented that requirements
has been completed by him and showcuase issued to him may be recalled. The Borad after hearing the
representative of the firm advised him to comply the legal requirements in time in future and decided
to cease the operation of the showcause notice issued to the firm with immediate effect.
Case No. 31 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S KAILGON
AGRO INDUSTRIES (Pvt) Ltd, HUB.
M/s Kailgon Agro Industries (Pvt) Ltd , Hub, Balochistan had submitted application
dated 10-02-2016 for the renewal of DML No. 000277 for the tenure 11-02-2016 to 10-02-2021 .
After evaluation of the renewal application of the firm, a letter for completion of application for
renewal of DML was issued for following shortcomings/attested documents dated 09-09-2016: -
i. Fee for change of management/Directors.
ii. Proof of all licensed sections issued from Central Licensing Board.
iii. N.O.C for C.R.F.
2. Firm did not submit the reply of the above shortcoming letter; accordingly a reminder was
issued by Secretary CLB dated 09-03-2017 to submit documents for renewal of DML .Firm did not
submit reply along with deficient documents against the reminder for the completion of their DML
renewal application. In the meanwhile firm also applied for change of both technical personsand letter
dated: 27-03-2017of shortcomings was issued to the firm to submitdocuments for approval of
Production Incharge & Q.C. incharge.
3. A Final Reminder dated 16-06-2017 was issued to the firm to submit following documents for
renewal of DML& for approval of technical staff(Production Incharge & Q.C. Incharge):
i. Attested form-29 along with Form -A from SECP(Updated).
ii. Approval letters of sections issued from CLB.
iii. Nothing Due certificate(Updated)
iv. Prescribed fee of Rs.50,000 for change of management.
v. N.O.C from previous management to new management.
vi. Prescribed fee of Rs.5000 for change of Q.C. Incharge
vii. Attested academic certificates of Q.C. Incharge.
viii. Resignation of Production Incharge & QC incharge from previous firm.
ix. Attested CNIC copy of QC incharge.
x. Resignation of earlier appointed Production Inchage.
4. Firm submitted documents on 29-06-2017 in reply to Final Reminder but following documents
are still deficient /short;
i. Attested form-29 along with Form -A from SECP(Updated).
ii. Prescribed fee of Rs.50,000 for change of management.
iii. Resignation of earlier appointed Production Incharge.
iv. Relevant Experience certificates of Production Incharge & QC Incharge.
Page 64 of 116
v. Prescribed fee of Rs.5000 for change of Q.C. Incharge
vi. Attested academic certificates of Q.C. Incharge.
vii. Resignation of Production Incharge & QC incharge from previous firm.
viii. Attested CNIC copy of QC incharge.
Proceedings and Decision of Central Licensing Board in 255th
meeting.
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000277 by way of formulation of M/s Kailgon agro
industries(Pvt) Ltd , Hub, Balochistan may not be rejected by Central Licensing Board or the Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 26th
September, 2017 was issued to the M/s Kailgon Agro
Industries(Pvt) Ltd , Hub, Balochistan
In reply to show cause notice firm has submitted the required documents for renewal of DML but
upon evaluation following documents are still found deficient.
i. Proposed Quality Control Incharge does not fulfill the requirement of Rule 16 (e) of
(L,R&A) Rules 1976 in term of Qualification.
ii. Attested Form-29 for year 2017 from S.E.C.P.
iii. Resignation of earlier appointed Production Incharge.
iv. Resignation or termination letter of appointee from the previous firm / promotion
letter / transfer letter from the same firm (Production Incharge).
v. Experience Certificate as under Drugs (Licensing, Registering and Advertising)
Rules, 1976 (Not less than 10 years in relevant field) of proposed Production
Incharge Mr. Muhammad Akhtar.
The firm has been called for personal hearing vide Licensing Division letter date 1st November, 2017.
Proceedings and Decision of Central Licensing Board in 256th
meeting.
No person appeared on behalf of the firm the Board, therefore, decided to provide one opportunity for
personal appearance before the Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
A letter of Personal hearing has been issued on 17th
January,2018.
Proceedings and Decision of Central Licensing Board in 257th
meeting.
Mr. Shahab Hashmi, Director of the firm appeared before the Board and contended that mail at
company address is not reaching in time and therefore they are facing difficulty for submitting reply in
time. He further contended that they have applied for change in management at SECP office Quetta
but due to law and order situation he is unable to travel to Quetta as soon as he get certificate
regarding updated management he would submit accordingly. The Board considering the facts on the
record and after thread bare deliberation decided to suspend Drug Manufacturing Licence No. 000277
Page 65 of 116
by way of formulation in the name of M/s Kailgon Agro Industries (Pvt) Ltd , Hub, Balochistan till
completion of codal formalities under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the
Drugs (Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule,
16 and Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976.
Case No. 32 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S
WYETH PAKISTAN LTD, KARACHI.
M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi, had applied for renewal of DML
No. 000006 by way of formulation for the period of 31-03-2015 to 30-03-2020 on 02-03-2015.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 23-02-2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
i) Detail management on firm letter head, Form-29, attested copies of CNIC’s.
ii) Approval letter of QC Incharge and Production Incharge if not then provide
complete documents of technical persons i.e QC Incharge and Production Incharge
as per checklist (enclosed).
iii) List of total section of the firm and their letters of grant which were approved in
meetings of Central Licensing Board.
iv) No Objection Certificate for Central Research Fund (CRF) by Statistical Officer
DRAP, Islamabad
Firm did not submit the shortcoming documents and a Reminder-I letter was issued on 15th
February,
2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of following
shortcomings.
i) Detail management on firm letter head, Form-29, attested copies of CNIC’s.
ii) Approval letter of QC Incharge and Production Incharge if not then provide
complete documents of technical persons i.e QC Incharge and Production Incharge
as per checklist (enclosed).
iii) List of total section of the firm and their letters of grant which were approved in
meetings of Central Licensing Board.
iv) No Objection Certificate for Central Research Fund (CRF) by Statistical Officer
DRAP, Islamabad
Firm submitted documents on 27th
February, 2017 and a Final Reminder letter was issued on 29th
March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering & Advertising) Rules, 1976 of
following shortcomings.
1. Detail of premises including approved layout plan / Proof of Sections from CLB.
2. Prescribed fee of Rs. 50,000/- for change of management / directors as it seems like
management is changed from last renewal till at present renewal.
3. Set of documents for Proposed Quality Control Incharge and Production Incharge as
per check list.
Page 66 of 116
4. Experience Certificate as under Drugs (Licensing, Registering and Advertising) Rules,
1976 (Not less than 10 years for proposed Quality Control Incharge and Production
Incharge).
5. All documents should be duly attested.
Firm submitted documents on 28th
April, 2017 in reply to Final Reminder but following documents are
still deficient /short and application for renewal of DML is still incomplete.
1. Updated Form-29 and Form-A duly attested from S.E.C.P alongwith CNIC copies of
all Director.
2. Set of documents for Proposed Production Incharge as per check list with relevant
Qualification and Experience.
3. Appointment letter (Quality Control Incharge).
4. Job acceptance letter by the appointee (Quality Control Incharge).
5. Resignation or termination letter of appointee from the previous firm / promotion letter
/ transfer letter from the same firm (Quality Control Incharge).
6. All documents should be duly attested.
Proceedings and Decision of Central Licensing Board in 256th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5(2A)
and Rule 16 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why their
application for renewal of M/s Wyeth Pakistan Ltd, S-33, Hawkes Bay Road, SITE, Karachi, Drug
Manufacturing Licence No. 000006 by way of formulation may not be rejected or Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 5th
January, 2018 was issued to the M/s Wyeth Pakistan Ltd, S-33,
Hawkes Bay Road, SITE, Karachi.
In reply to the showcause notice firm has submitted the shortcoming documents and application for
renewal of DML in now complete.
A letter of Personal hearing has been issued on 17th
January, 2018
Proceedings and Decision of Central Licensing Board in 257th
meeting
Dr. Sadia, Head of Regulatory Affairs and Mr. Rashid, Director Production apeared before the Central
Licensing Board and contented that requirements has been completed by him and showcuase issued to
him may be recalled. The Borad after hearing the representative of the firm advised him to comply the
legal requirements in time in future and decided to cease the operation of the showcause notice issued
to the firm with immediate effect.
Page 67 of 116
Case No. 33 RENEWAL OF DRUG MANUFACTURING LICENCE M/S GABA
PHARMACEUTICAL LABORATORIES, KARACHI.
M/s Gaba Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi, has applied for renewal
of DML No. 000168 by way of formulation for the period of 29-06-2015 to 28-06-2020 on 15th
May,
2015.
The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 9th
September, 2016 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
i. Legal status of firm i.e. sole proprietor, partnership, private limited or public limited
company.
ii. Detail of management / partners /directoralong with CNIC copies and relevant
Form i.e. Form-C,D or Form-29 (whichever is applicable).
iii. Form-1A duly signed / stamped by Authorized person.
iv. Detail of premises including layout plan.
v. NOC of CRF issued from statistical officer of DRAP (Updated).
vi. Resignation / retirement of earlier Production Incharge.
vii. Complete set of attested documents (as per check list) of proposed QC Incharge
previous approved QC Incharge in B.Sc. and Current requirement is M.Sc.
viii. Complete set of attested documents for 10 year experience.
Later on with reference to above shortcomings / deficiencies a reminder letter was issued on
7th
February, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976.
i. Complete set of attested documents of proposed QC Incharge holding degree in
M.S.C. (Chemistry) or Pharmacy and with relevant experience.
ii. Latest NOC of CRF.
iii. Approval letter of sections issued from CLB along with copy of approved L.O.P.
iv. Attested experience certificate of 10 years of proposed Production Incharge
according to Drugs (L,R&A) Rules, 1976.
v. Resignation letter of previously appointed Production Incharge.
vi. Resignation letter of Production Incharge Mr. RiazHusain from previous firm.
vii. Attested CNIC copy of proposed Production Incharge.
viii. Attested Appointment letter and Joining Report of Production Incharge.
ix. Undertaking by Production Incharge.
x. Prescribed Fee for change of Production Incharge Mr. Riaz Husain.
Later on with reference to above shortcomings / deficiencies a final reminder letter was issued on 27th
March, 2017 under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976.
i. Detail of premises including approved layout plan / Proof of Section from CLB.
ii. Nothing due certificate regarding CRF from STO (Updated).
iii. Fee of Rs. 5,000/- for proposed Quality Control Incharge.
iv. Fee challan should be retained by STO (R&D), DRAP, Islamabad (Production
Incharge).
v. Provide name of approved Quality Control Incharge and Production Incharge. In
case of new nominees, provide complete set of documents for Proposed Quality
Control Incharge and Production Incharge with names as per check list.
vi. All documents should be duly attested.
Page 68 of 116
The firm has submitted their reply on 23rd
February, 2017 and 10th
April, 2017 which is evaluated and
still found following shortcomings / deficiencies:-
i. Detail of premises including approved layout plan / Proof of Section from CLB.
ii. Nothing due certificate regarding CRF from STO (Updated).
iii. Fee of Rs. 5,000/- for proposed Quality Control Incharge.
iv. Complete Set of documents of proposed Quality Control Incharge and production
Incharge (as per check list)
Decision of Central Licensing Board in 254th
meeting.
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000168 by way of formulation of M/s Gaba Pharmaceutical
Laboratories, S-76, S.I.T.E, Maripur Road, Karachi, may not be rejected by Central Licensing Board
or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
The Show Cause notice dated 22nd
June, 2017 was issued to the M/s Gaba Pharmaceutical
Laboratories, S-76, S.I.T.E, Maripur Road, Karachi.
A letter of Personal hearing has been issued on 17th
January, 2018.
The reply of the firm is received on 24-01-2018 which is as under;
I would like to inform you that entire business of Gaba Pharmaceuical Laboratories has been shut
down/closed completely due to certain family issues among the partners. It is not out of place to
mention here that some litigation are also pending in the courts of law. Under these circumstances, we
are unabale to attend your scheduled meeting. It is therefore requested to grant minimum three months
time for personal appearance before the central licensing board. Your cooperation in this regard is
highly appreciated.
Decision of Central Licensing Board in 257th
meeting.
The Board considering the facts on the record and after thread bare deliberation decided to suspend
Drug Manufacturing Licence No. 000168 by way of formulation in the name of M/s Gaba
Pharmaceutical Laboratories, S-76, S.I.T.E, Maripur Road, Karachi under Section 41 of the Drugs
Act, 1976 read with Rule, 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 for
not complying the provision of Rule, 16 and Rule 5(2A) of the Drugs (Licensing, Registering and
Advertising) Rules, 1976 till settlement of codal formalities.
Page 69 of 116
Case No. 34. M/S DANAS PHARMACEUTICALS (PVT) LTD., 312 INDUSTRIAL
TRIANGLE KAHUTA RAOD, ISLAMABAD CHANGE OF MANGEMENT –
VIOLATION OF SECTION 34 OF DRUGS ACT, 1976 THEREOF.
M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad Licence
No. 000569 by way of formulation was granted licence in 2005. The company/ firm informed for
change of Chief Executive vide letter No. Danas /L&A/2014 dated 08-07-2014. Some observations
were noted and conveyed to firm on 26th
December, 2014 and reminder to this effect was issued on
12January, 2015. The observations which were conveyed to the firm are as under:
i) It seems that management of the firm has been changed number of times without intimation
to Central Licensing Board. It is not clear that who has purchased the licensed premises of
M/S Danas Pharmaceuticals (Pvt) Ltd, DML No.000569 (Formulation) located at Plot #
312, Industrial Estate, Kahuta Triangle, Islamabad from Mr. Ansar Farooq, who was Chief
Executive Officer of the firm according to available record of Licensing Division, DRAP,
Islamabad.
ii) With respect to the deed of sale dated 09-09-2011 submitted by your firm, it has been
observed that one of the present Directors of your firm i.e Mr. Imran Khan S/o
Muhammad Khan holding CNIC # 3602-0489641-7 has purchased this licensed unit from
Mr. Rizwan Khan S/O Muhammad Khan holding CNIC # 36302-5064463-5. Mr. Rizwan
Khan was not the Director of the firm as per available record of Licensing Division DRAP
Islamabad and in any of Form 29 provided by your firm. Therefore you are required to
submit sale deed / agreement made between Mr. Ansar Farooq, previous CEO of the firm
& Mr. Rizwan Khan and to also submit copy of Form 29 issued and attested by SECP
wherein Mr. Rizwan Khan was appointed as Director of the firm and also for retirement /
resignation from directorship of the firm.
iii) You are also required to submit attested photocopy of Form-29 issued by SECP wherein
Mr. Usma Lahooti was appointed as director of the firm.
2. The firm replied that we are still waiting for the fresh Form—29 and annual return i.e Form-A
for the year 2014-15 from SECP, which is expected to receive with fortnight. Meanwhile Anti
Narcotics Force, Rawalpindi has also issued a letter on 26th
October, 2015 wherein they referred to
FIR 40/2011 ANF Police Station, Rawalpindi and directed to not to accept Form-A and 29 till
finalization of said case in Supreme Court of Pakistan.
3. Danas Pharmaceuticals, Islamabad has filled writ petition through Mr. Mohammad Mustafa
purported Chief Executive in the Islamabad High Court, Islamabad vide writ petition No. 1174/2016,
wherein above referred letter of ANF has been contested. The court has not yet granted any relief to
petitioner.Moreover, firm has been concealing information and changing their management time and
again without seeking approval from the Board as under:
Page 70 of 116
DETAILS OF THE DIRECTOR OF THE FIRM FROM THE TIME OF GRANT OF DML TO
TILL DATE
At time of grant of
first DML in year
2005. The name of
the Directors of the
firm on prescribed
Form 1 for
application for grant
of DML
(Page 87/Corr.) of
main volume
At the time of
submission of
renewal of
DML of the
firm dated 29-
03-2011
Form 29 issued
on 30-12-2012
(Page 50-
52/Corr.)
Form 29
issued on 31-
10-2013
(Page 53-
54/Corr.)
Form 29 issued
on 16-04-2014
(Page 48-
49/Corr.)
Form 29
issued on
02-07-
2014
(Page 45-
47/Corr.)
1. Mr. Ansar
Farooq
2. Mr. Muhammad
Naveed Akhtar
3. Mrs. Azra
Parveen
4. Mr. Nadeem
Ahmed Khan
5. Mrs. Mehreen
Nadeem
6. Mrs. Tahira
Tasneem
Mr. Ansar
Farooq CEO of
the firm.
1. Imran
Ahmed
Khan –
Appointed
2. Usman
Bashir -
Appointed
3. Najam-ul-
Ghafar-
Appointed
4. Tariq
Haneef Sole
proprietor
of Tariq
Hanif and
Co.
Chartered
Accountant-
Retired
Tariq Haneef
Sole
proprietor of
Tariq Hanif
and Co.
Chartered
Accountant-
re-appointed`
1. Mudasir
Farooq-
Appointed
2. Kaleem
Arshad -
Appointed
3. Usama
Lahooti -
Resigned
4. Fawad
Rasheed-
Retirement
Muhamm
ad
Mustafa
has been
appointed
by Board
of
Director
as Chief
Executiv
e Officer
upto the
conclusio
n of
AGM in
2015.
4. In the circumstance mentioned above, section 34 of the Drugs Act, 1976 and Rule 5(6)
of the Drugs (Licensing, Registering and Advertising) Rules, 1976 is not being complied. Any
contravention / illegality committed by M/s Danas Pharmaceuticals (Pvt) Ltd., 312 Industrial Triangle
Kahuta Raod, Islamabad would create trouble for the DRAP to nominate accused in the case.
DECISION.
5. The Board deliberated on the case matter in detail in the light of steps taken by the
Licensing Division and facts of the case decided to show-cause the company under Section 41 of the
Drugs Act, 1976 and Rule 12 of the Drug (Licensing, Registering and Advertising) Rules,1976 as to
why their Drug manufacturing Licence may not be cancelled or suspended for violation of Section 34
of the Drugs Act, 1976 and Rule 5 (6) of the Drug (Licensing, Registering and Advertising)
Rules,1976.
Action by Licensing Division
6. Accordingly, show cause notice was served to the firm through Chief Executive (claimant) and
Director (claimant).
Page 71 of 116
Reply by Mr. Muhammad Mustufa,
Managing Director & Chief Executive
7. Reply of Mr. Muhammad Mustufa
1. With due respects and apologies, aggrieved and resented with the observations
given and further issuance of show cause notice dt.02-03-2017 acknowledged by us dt.07-03-2017 in
the above referred meeting . In replying to show cause notice would like to bring the following points
for your kind consideration that justify if dully considered, will remove all the ambiguities and
issuance of un-warranted show-cause notice should be vacated .
i. That first of all, present management took the control of the company in 2014 by
purchasing shares at a juncture when it was at a “Crash situation”
ii. That with the restructuring, the present management team set a goal to reinvigorate
the image and business of the company which was tarnished / spoiled by the
misdeeds of erstwhile members. Through dedication and fairness the company is
gaining confidence in the business community and today IMS Data ranks it at #123
(listing of 2016). We are not just stopping here , rather we have set target to be
within top 100 companies by the end of current year.
iii. That currently, we are also proud to be one of the companies,chosen by the KPK
Government in its campaign to purchase quality drugs from the Market at
competitive prices.
iv. That with the staff strength of 50 peoples and revenue generation of forty millions,
In 2016 we are looking with 185 people and revenue generations two hundred
Eighty five Million plus per annum.
v. That is discussed earlier, In th transitional period of 2014,we took control of the
management/the undersigned being Chief Executive office of the Company
appointed in July 2014, and upon receipt of certified copy of Form-29 from SECP,
intimated the licensing Division vide letter No. Danas L/A/2014 dated 08-07-2014,
18-11-2014 and 24-11-2014 including the paid free Challan of Rs.50,000/- dt.18-
11-2014 for change of management (copy of letter enclosed herewith as Annexure-
A,B&C.)
vi. That besides, the share Holders and management Team, as mentioned in preceding
para, no change has been brought in the formation of the company , but re-elected
till 2019.Therefore, there exists no element of concealment from the licensing
Division, Whatsoever, on the part of the present Management has dully submitted
to your good office vide our letter dt.10-01-2017 dully acknowledged by you dt.10-
01-2017(Attached herewith certified copies of Form-29 and Form-A for the year
2016 for your kind perusal as Annexure-D)
vii. That the above fact clearly revealed that at the part of the present management there
is no concealment at all from the Licensing Division .
viii. That it is also pertinent to mention here that , we did queried the then Licensing
Division officer that since Januray,2014 we were continuously observing the name
of Mr. Imran Ahmed Khan the then C.E.O of the company not only signatory on all
documents related to Ministry /DRAP, but specifically with the Licensing Division
for submission of details of technical staff, layout plan, etc, for which we have seen
due acknowledgements from Licensing Division, including but not limited to
dealing with Area FID, DDG(E&M)/ Chairman QC for CGMP inspections, imports
of material (API’s) but no objection was ever raised upon the same. Therefore, we
requested the then Licensing Division to recheck/verify the record for change of
Page 72 of 116
management .However, despite assurance to do the needful, we had no reply or
response.
ix. That in view of our aforesaid observation, it is once again requested to re-check this
aspect as the same is needed to be rectified being an act done by the erstwhile
Management While dealing with the then members of Licensing Division.
x. It is also stated that if some illegality ,irregularity or concealment has been
committed by the previous Management between the period of 2011 up to july -
2014, the same is not attributable to us we have already submitted that we took
control of the affairs of the company in July 2014.
xi. That however, being the present custodian of the affairs of the company for the last
three years, we are extremely apologetic for the same and are ready to rectify any
error done / caused by the previous Management with the hope that the error
caused previously and prior to our inclusion in the Company may be condoned.
xii. That in edition to the aforesaid, through the subject Meeting, it has also been
observed by the Board that we promised to submit the certified copies of Form-29
for 2014 and 2015 but remained silent about the submission. It is submitted that the
same has been furnished to the licensing Division vide our letter
No.L&A/DANAS/SECP/01 & DANAS/L&A/2014.(copy of letters enclosed
herewith as Annexure-E)
xiii. That apart from above submission, your attention is also drawn towards our
meeting with the then Honourable Secretary Licensing Board Mr. Abdullah dt.22-
03-2016. In result of that meeting a detailed and elaborated /comprehensive
letter/reply explaining all the happenings/events and objections /observations in
chronological order since our inclusion in the affairs of the company in the year
2014 annexed with all necessary supportive documents including mentioned at
aforesaid para was re-submitted to your good office vide our letter dt.24-03-2016
duly acknowledged by the Licensing Division dt.25-03-2016 (copy of letter along
with all annexure enclosed herewith for your ready reference as Annexure-F)
xiv. That however, about the pending certified copies of Form-A (of present
management) for the year 2014 and 2015 have been dully submitted vide letter
dt.08-08-2016 acknowldged by your good office on dated 09-08-2016. (Copy of
letter enclosed herewith as Annexure-G).
xv. That regarding ANF’s letter dt. 26-10-2015 is concerned, it was about directions (in
our opinion beyond their legal scope) to our two main regulators i.e SECP and
DRAP i.e not to issue certified copies of Form-A and Form-29 for the year 2014
and 2015 for SECP and not to entertain the same by DRAP respectively.
xvi. That initially the issuance of certified copies of Forms A and 29 for the year
2014 and 2015 were g egretted by the SECP while acting upon the direction of the
ANF. That we have approached and explained our stance to SECP vide our letter
dated 19-11-2015. (Copy of letter enclosed herewith as Annexure-H).
xvii. That in this connection, we also approached and explained our stance to ANF
Authorities as well vide our letter dated 11-12-2015 and a copy of the same was
also submitted to the license Division vide our letter No.CEO/DP/01 dated 25-12-
2015. However, the ANF Authorities did not reply that letter. (Copy of letter
enclosed herewith as Annexure-I).
xviii. That to contest our statuary rights vis a vis management of the Company, we
were constrained to approach the Court of Law and filed a Constitutional Petition
bearing No. 1174/2015, titled “M/s Danas Pharmaceuticals (Pvt) Ltd. etc. Vs.
Page 73 of 116
Federation of Pakistan etc”, pending adjudication before the Honourable Islamabad
High Court, Islamabad.
xix. That the above scenario has also been brought to your kind notice vide our letter
No. dated 13-04-2016 dully acknowledged by your good office dated 14-04-2016
(copy of letter enclosed herewith as Annexure-I).
xx. That after initial few hearings and arguments raised in the above refereed case, The
SECP admitted / felt their wrong footings on acting upon the directions of ANF’s
letter.
xxi. That therefore, during the pendency of the case, SECP has issued all the
pending certified copies of Form-A and Form-29 i.e for the year 2014, 2015 and
later for the year 2016.
xxii. That the same have been dully submitted to the licensing Division vide our
letter dated 08-08-2016 acknowledged by your good office dated 09-08-2016 and
for the year 2016 vide our letter dated 10-01-2017 dully acknowledged by you
dated 10-01-2017 (Attached herewith copies of letters alongwith certified copies of
Form-A and Form-29 enclosed herewith as Annexure-K and L).
xxiii. That although the same impugned letter in question contained direction for you
as well, but it is appreciated by saluting your wisdom that the Authority has not
aided any illegality on the Directions of ANF. We also appreciate this very fact that
the Authority has trusted in our words and acts and confided us. Therefore, keeping
in view of the stance, the Drug Regulatory Authority has been arrayed as Proforma
Respondent, as no relief has been sought against the Authority.
xxiv. Therefore, the undersigned while acting for and on behalf of the Company and
rest of the Sharre Holders / Management assures you that ever since our inclusion,
no illegality has ever been committed. However, the concerns raised by the Board
in the Meeting can only be attributable to the past Management.
xxv. That in the light of foregoing, we at present believe have no issues with our
main regulators i.e SECP or your good office. Further the main relief we were
looking for have already obtained.
2. That in the light of above submission, it would be crystal clealr that the present
management haven’s concealed anything from the competent authority, the main argument of
that licensing board meeting. Hence, otherwise, all other formalities are being fully complied
by us So, at this juncture, we can fairly say that there is no justification and plausible reason to
serve us a Show Cause Notice and it needs earnest reconciliation and revocation. Therefore
your early response to safeguard our valuable interests are dire needed, and the same shall also
be highly appreciated. Your precious time is also sought in furthereance of this communication
for a personal hearing and we hope to hear from you soon in this regard at your earliest
convenience.
3. He has also written an other letter where in he has made submission that we
further would like to inform you that in response to ANF’s letter No. dated 02-03-2017 a
comprehensive and well elaborated reply vide our letter dated 06-03-2017 has been dully
submitted to ANF Authorities. Acknowledgement to our above refered letter ANF authorities
is enclosed herewith for your kind perusal. We are looking forward to receive their appropriate
reply with in fortnight inshAllah. We are very much hopeful through that expected reply / letter
Page 74 of 116
our last issue pertaining to the directions given to SECP and your good office will also be
resolved amicably. You are also aware of the fact that regarding issue of management and
shares holding, we have already submitted up-to-date Form-A and Form-29 for the year 2016-
2019.
4. He has further responded through legal consel M/S AJURIS, Advocates &
Corporate Counsel, Islamabad, Where it is stated :-
i. We have been instructed by M/S Danas Pharmaceuticals (Pvt) Limited
(company ) and act for and on behalf of the Compnay and Mr.Mustafa/Chief
Exective Officer of the Company (Clients). This response is with refrence to
Show Cause Noted 02-03-2017 issued in the name of M/s Danas
Pharmaceuticals (Pvt) Limited .
ii. The Show Cause Notes alleges that the company has been concealing
information and changing their management without approval of Central
Licensing Borad in violation of section 34 of the Drugs Act,1976 read with
Rule 5(6) of the Drugs (L,R&A.) Rule,1976.Our client have been required
to show cause in writing within 15 days of issuance of the Show Cause
Notes as to why the Compnay’s Drug Manufacturing License No.000569
should not be cancelled or suspended .
iii. You will appreciate that our Clients have filed Writ Petition No.1174/2016
titled ‘M/s. Danas Pharmaceutics (Pvt.) Limited etc. vs. Federation of
Pakistan etc.’ (“Petition”) before the Honorable Islamabad High Court in
which notices have been served to the Drug Regulatory Authority of
Pakistan (“DRAP”). You will further appreciate that in the Petition our
Clients have impugned all letters of the Anti Narcotics Force that form the
foundation of the baseless allegations leveled against the Clients. Our
Clients have also filed an application for interim relief in the Petition, which
is pending adjudication before the Honorable Islamabad High Court.
iv. It is emphasized that during the pendency of the application for interim
relief, any adverse action against the Clients would be tantamount to
interference with the proceedings of the Honorable Islamabad High Court.
In this regard, reliance is placed on the case of Saifur Rehman Vs.
Muhammad Ayub and 2 others (1998 CLC 1872) which states “Needless
to point out that there is sound logic behind the proposition that a party to
the proceedings cannot, while an application for interim relief is bona fide
pending, blatantly so act as to pre-empt its lawful disposal because that, in
given set of circumstances, may amount to doing things calculated “to
interfere with or obstruct or interrupt or prejudice the process of law or the
Page 75 of 116
due course of a judicial proceeding” and thus fell within the mischief of
section 3 of the Contempt of Court Act, 1976.” Reliance is also placed on
the case of Arif Khan and 7 others Vs. Federation of Pakistan and others
(2002 CLC 601) which states that “There appears to be prima facie force in
the contention of Mr. K.M. Nadeem that while notices of a lis are issued to
the other side, the latter is expected to maintain a status guo.”
v. The basis of the SCN is a matter in dispute pending adjudication which is
ripe for final arguments and strong likelihood of success exists in favour of
the Clients. Any continuation of proceedings in pursuance of the SCN while
the Petition is pending may not only cause serious prejudice and loss to the
Clients it may also tantamount to interference with pending proceedings
before the Hononorable Islamabad High Court.
In view of the facts as stated and the law on the subject, you are requested to desist from
taking any coercive action against our Clients in relation to matters pending adjudication
before the Honorable Islamabad High Court. Your cooperation in this regard shall be highly
appreciated.
Reply by Mr. Usma Lahoti, Director.
8. Reply of Mr Usama Lahooti is as under:
1. It is submitted that I hold 66666.66 shares in Danas Pharmaceuticals (Pvt) Ltd.
Since 2012, which previously were held by Tahir-ul-Wadood Lahoti (my father) since 2007. I
alongwith shareholding was also the Director of the company, the title which I still hold as per
the record of Security Exchange commission of Pakistan (SECP), till date. Meanwhile a case
was registered against the company by ANF with regard to allotment of ephedrine to the
company. During the period 2012 to 2014 due to hectic commitment in the case and
subsequently the health issue of my father, which resulted into his CABG procedure, I
remained mostly busy there. During 2012, the then Chief Executive, illegally prepared Form
29 against me for removal from the Board of Director and submitted the same to the SECP.
The same was turned down by the SECP by declaring it as an illegal document prepared
contrary to the relevant rules spelled out in the Companies Ordinace 1984. After this I was re-
elected as director in 2013 by the company and my name was endorsed in the Form 29 of
2013.
2. During July, 2014, Mr. Imran Ahmad Khan resigned from the post of Chief
Exeuctive and Mr. Muhammad Mustafa, on the same date took over as Chief Executive. This
act was a gross irregularity of the companies Ordinance, 1984. I was neither informed nor
asked to vote, as per rights authorized to me by the Companies Ordinance, 1984.
Page 76 of 116
3. During the stay of my father in the company, he had loan an amount
approximately around 40 Million to the company at various stages, for various activities, from
his personal account. During last quarter of 2013 when the company was asked to pay back the
loan, they hesitated in one form or the other, saying that financial position of the company at
this point is not in a condition to pay back such a heavy loan. Since we were in dire need of the
money so the company was requested for grant of loan from the personal accounts of any of
the shareholder. This request was acceded to and a resolution was passed during the Board of
Director meeting held on 30th
January, 2014, wherein Mr. Muhammad Mustafa and Mr.
Mudassar Farooq agreed to give the loan amounting to 30.25 Millions against pledging of my
shares. For which as a guarantee I had given blank dated shares deed and resignation signed
and submitted the same to the company for keeping it as a pledged record. Contrary to the
agreement, Mr. Muhammad Mustafa fraudulently submitted my these documents to the SECP
for transfer of shares in his name. On getting this information about of his this malafide act I
immediately approached SECP for non transfer of my shares in anyone name without my
personal appearance.
4. Meanwhile, ANF had also frozen the shares of mine and my family through a
letter to SECP during December, 2012, February, 2015 and October, 2016. In the light of these
letters, SECP, paid no heed to fraudulently submitted documents for transfer of shares. After
having the knowledge about this act of Mr. Muhammad Mustafa, I initiated a correspondence
with the SECP mentioning about the irregularities taking place in the company, also
highlighted the illegal occupation of Mr. Muhammad Mustafa as Chief Executive of the
company. In response to my letter SECP gave me a comprehensive reply in February, 2016
mentioning therein that statutory documents of the company are frozen at the time of 2011 and
also clarified that Form 26 submitted by the company against me stands null and void after
being withdrawn by the company. Thereby confirming me back to the status of Director of the
company till date.
5. After having received detail reply from the SECP about the status of self
declared chief Executive by Mr. Muhammad Mustafa, I approached Drug Regulatory
Authority’s (DRAP), staring from Federal Inspector of Drugs, Chairman Quality Control,
Director Licensing, Director Quality Assurance and the Chief Executive Officer of the DRAP
through nth numbers of time. Similarly I had been corresponding through normal letters as
well as through legal notices with Mr. Muhammad Mustafa and Mudassar Farooq cautioning
them about all the illegalities being performed by them as per DRAP lay as well as, as per
Companies Ordinance, 1984 but unfortuneately nothing could put them right. Finally as a
result of my various personal meetings with Licensing Directorate Officials in DRAP resulted
in taking this case in the board meeting.
Page 77 of 116
6. To summarize the present management sitting in the company and
corresponding with DRAP is totally illegal and unauthorized. As per the record of SECP
according to the directions of ANF about freezing of assets. The only authorize Director is
myself which has been confirmed by the SECP through their letter of February, 2016. Since
the present management could not g et any headway from SECP through a marathon
correspondence by their counsel and even putting all kind of pressure on the Regulators of
SECP, finally they filed a writ petition No. 1174/2016 in Islamabad High Court, Islamabad. In
this petition, Mr. Muhammad Mustafa and party has made ANF, SECP and DRAP as the
respondents but have not made me or Ansar Farooq Ch. As respondents in the same petition.
The concern of the petitioners is evident from the court record that for the past more than 4
months, the petitioner’s counsel is seeking adjournment for the one reson or the other.
Moreover, the Honourable Islamabad High Court, Islamabad has not passed any restraining /
supporting order in favour of petitioner. The respondents ANF as well as SECP have submitted
their replies to the Islamabad High Court, Islamabad wherein they have clearly mentioned their
legal position about freezing of shares and making the same non transfereable in the SECP.
7. Just for record and for demand of justice, I am attaching copies of all letters sent
to SECP and their reply to me, letters / legal notices sent to Mr. Muhammad Mustafa and
Mudassar Farooq and copies of letter sent to FIDm CQC, DD Licensing, Director Licensing
and the CEO of DRAP, Going through these letters will give a clear idea that how much effort
I have put in to stand beside the law and knock each door to get the justice. The copies of reply
by ANF and SECP as respondents to the Islamabad High Court, Islamabad.
8. Keeping in view, the above brief history and seeing my efforts through
correspondence with Mr. Muhammad Mustafa, SECP and DRAP, I have no doubt in
conformingly mentoning that the management is illegal therefore, they should not be
entertained in seeking any approval, sanctions and any other facility from the DRAP. If the
company has to proceed on a legal way then all the correspondence reaching DRAP should
have my signature since I am the only legitimate director as per law. It is also submitted that as
per Drug Act relevant rules quoted in your show cause notice, I am being legitimate Director
be authorized to take on as Chief Executive of the company.
9. In response to para 3 of your show cause notice dated 02-03-2017, I hereby
confirm that Mr. Tahir-ul-Wadood Lahoti will like to be heard by the Central Licensing Board
on the date of its assembly in person. You are requested to intimate about the date and venue of
Board Meeting at Cell No. 0332-5555532 and 0316-5555532
Page 78 of 116
Proceedings Central Licensing Board in 254th
meeting
9. Mr. Osama Lahooti, Director (claimant) or his representative could not appear before the
Board.
10. Mr. Muhammad Mustafa, Chief Executive (Claimant), Mr. Muhammad Mudassir and Ahmad
Junaid Advocate appeared before the Board. They pleaded their case reiterated the facts already
submitted in reply to the Showcause Notice and set of documents presented before the Board. During
the pleadings they apprised the Board that till March, 2016 Security and Exchange Commission of
Pakistan has been issuing Form-29 and has been refusing to issue Shareholdings. They also apprised
the Board that they have signed a “Sale Deed” with Mr Osama Lahooti while “Transfer Deed” is
signed without date of execution. They also apprised the Board that they have contested against the
letter of the ANF in the Islamabad High Court, Islamabad through Constitutional Petition bearing No.
1174/2015 whereby Drug regulatory Authority of Pakistan was directed not to accept Form-A and
Form 29. A number of hearings has been held and no relief to the plaintiff has been awarded by the
Honourable Court and no restraining orders are passed by the Honourable High Court.
Decision of the Central Licensing Board in 254th
meeting
11. The Board after hearing the one party decided to defer the case for giving final opportunity of
personal hearing to the Mr. Osama Lahooti in the next meeting of the Board.
12. After 254th
meeting of the Central Licenisng Board Mr. Muhammad Mustafa through his legal
counsel M/s Ahmed Junaid Advocate addressed to Secretary Central Licensing Board has alleged as
under:
i. that he have acted on for and on behalf of M/s Danas Pharmaceuticals (Pvt)
Limited (the Company) and this refers to the hearing dated 15-06-2017, under Show Cause
Notice dated 02-03-2017. With regard to the same, you are being conveyed utmost
disappointment on behalf of the Company, as serious observations and concerns causing
grievance to the Company have been made/found during the course of the subject Meeting. It
has been explicitly observed/witnessed that, you had deliberately kept the Respectable
Members of CLB in dark, regarding certain aspects of our case, which are validly and legally
favoring the Renewal of License. Further, in a deliberate and blatant manner, you have
concealed from the minutes of CLB meeting the very aspect/fact that the present management
(those who are reflecting from the updated/later/recent Form-29 issued from the SECP) are the
legitimate sole owners of total 200,000 shares of the Company out of which 133,334 (66.67%)
shareholding (an absolute majority) in the company holds PERFECT TITLE, and only 66,666
(33.33%) shares with the freezing status by ANF Authorities. The said aspect was supported by
documentary evidences/facts as has been submitted by the Company from time to time in your
good office.You have not only deliberately concealed from the respectable members of the
CLB but also from the minutes of CLB meeting the fact that the company has been submitting
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all forms A and Forms 29 since 2014, which do not reflect Mr. Lahooti as Director of the
company.
ii. You have also deliberately concealed from the respectable members of the
CLB, but also not recorded in the minutes of CLB meeting the contents of letter dated 10-01-
2017, wherein you were informed by the company that as per relevant provisions of governing
law i.e. companies ordinance, 1984, through elections in the AGM of the company, as was due
in October, 2016, the present Management has been elected for the period of next three years
i.e. for the term 2016-2019, which do not reflect Mr. Lahooti as Director of the Company for
the said term.
iii The company and its present Management in therefore highly indignant and in
deep dejection, which further observing the unacceptable/unwarranted biasness on the part of
the Secretary Licensing Board, as it has been witnessed beyond and shadow of doubt that you
have reflected a mindset to deteriorate the very interests of the company, as you have brushed
aside the contents of reply to the show cause Notice, which was mainly rebutting the alleged
concealment of change of Management. Through the said reply it has been maintained that it
was committed/ mis-doing of the then Management, however you only discussed, to our
understanding supported mostly the allegations leveled by Mr. Usama Lahoti against the
present management of the company.
iv Therefore, being the stake holders of the situations, they therefore, hold right to
query us with expectations of an immediate/without any delay response from your side.
Needless to state that you and us are fortified by the provisions of the Drugs Act, 1976 and
Drugs (Licensing, Registration and Advertising) Rules, 1976, for the purpose of renewal of
license. Without prejudice, it seems to us that we have sat to argue/defend the so-called and
irrelevant concerns of an outgoing share holder and previous director of the company i.e. Mr.
Lahooti. Therefore, in view of the same, please clarify that haven’t you created a norm/history
that the Central Licensing Board is also authorized to turn its ears to any complaint, if raised
and agitated regarding the title of share holdings or any dispute, if raised thereon? Or you are
broadening the scope of the aforesaid legislations by acting as a Judge of your own cause?
Please, write to us that which provision of the said laws warrants you to travel beyond the
scope of your permitted authority.
v To the best of their knowledge and understanding, if you could prove otherwise,
our perusal of the aforesaid laws reveals that renewal of license of a company is only
dependent to what is required under Rule-5 thereof and also disclosure of mandatory
information i.e. name of management only, as required to be placed through Form-1-A.
Therefore, if you are privy to any other piece of legislation, which does warrant you to arbitrate
and adjudicate any correspondence/complaint as a judge, whereby a previous share holder has
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raised any objection regarding transfer of shares, or his directorship, then you are requested to
share the said law with us as well.
vi. You are also reminded that during the hearing of show Cause Notice, we have
referred to plethora of decisions given by the Central Licensing Board’s Meetings, wherein the
Board while renewing the License/Change of management has only resorted to Form-29 of the
company which the company has been dully submitting since 2014. We are also keen to know
that what made you convinced to contradict and deviate from the previous decisions
passed/taken by the Board, whereby the Licenses have been renewed on the basis of the
information available through Form-29, issued by the SECP.
vii All the aforesaid events and those out of our previous hearing, transpire beyond
any shadow of doubt that you have taken steps ahead to facilitate the concern of Mr. Lahooti
and that too in such a manner that you forget to follow the law governing your ambit and
preview/authority. This is also to state that the Show Cause Notice only levels an allegation of
concealment on our part, which we clarified and rebutted through convincing/tangible and
reliable evidence.
viii Knowingly well that you are not empowered to do so under the law, but to our
extreme astonishment, we are unable to understand as to what personal interests/fringe
benefits, or simply what urgency was existing on your part that made you to adjudicate upon.
We are also unable to understand, what exactly barred you that even you didn’t even bother to
make it part of show cause notice or call an explanation/justification/from the company prior to
discussion in the CLB, which you are under an obligation to. But rather, you seem completely
biased to the Company, whereas it should not be based on personal grievances, rather it is
about legal proceedings against a legally licensed company and the company and its present
management owe all its rights and reservations, but given your
KNOWINGLY/DELIBERATELYRENDERING AN UNJUST
JUDGMENT/FAVORITISM/NEPOTISM in favour OF AN ALIEN TO THE PRESENT
MANAGEMENT, YOU EVEN have given him another opportunity of hearing to fulfill his
suspicious plans. Although Show Cause Notice was very clear and candid that if nobody
appears, the decision with made ex-parte.
ix As matter of fact, you must understand that this is the licensed company duly licensed
under Drugs(Licensing, Registration and Advertising) Rules, 1976, in particular you are
dealing with, and not merely the Shareholder of the Company and this is THE COMPNAY
which takes full responsibility of th records and documents attached with or contents declared
thereof submitted through statuary documents/ forms from time to time dully certified by the
SECP, wherein your role is mere an employee and the law applicable on the subject make you
a PUBLIC SERVANT, who as the custodian of law, is not only required to maintain the norms
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of justice and equity, but is expected to deal with the affairs fo the Companies without any
fear, favour or nepotism.
x That although you are not in your legal capacity to play the role of an
adjudicator under various provisions and sections of the Drugs (Licensing, Registration and
Advertising) Rules, 1976 as we have every reason to believe that you have acted in excess of
your legal jurisdiction. It was your moral but definitely a legal obligation to first enquire the
stand of the Company by sharing the documents/claim submitted by Mr. Lahooti, and in the
light of that submissions you should have questioned us or ask any reply after testimonial of
the evidences, heard/seen from both end.
xi. It is also strange that you have failed to advice Mr. Usama Lahooti that SECP under the
preview of various PROVISIONS of Companies Ordinance 1984, i.e. Section-76, Section 152
and Section-290, DRAP is not the competent Authority to adjudicate such matters but only
Civil Court has jurisdiction to adjudicate thereon. Further, if any Shareholder is aggrieved of
omission of his name from the register of Share Holders, it is only for the Company Judge of
High Court to decide and adjudicate the said issue/matter under Section-152 of the Companies
Ordinance, 1984. On the contrary by agitating this matter in the CLB, you have rendered him
favour, which is highly unbecoming of a man of your stature.
xii Even worse than this, you seem to favor/show fidelity to Mr. Usama Lahooti, as
YOU deliberately concealed our letters written a year ago dated 21-03-2016 and 24-03-2016
from the CLB in the hearing, wherein we have explicitly explained/clarified/informed your
good office that Mr. Lahooti was removed from directorship of the company in year, 2012 and
was never re-instate or re-elected by the board of the company, you not only turned a deaf ear
to our aforesaid letters, but miserably failed to convey our advice to Mr. Lahooti that DRAP is
not competent forum to adjudicate upon his grievance, if any.
xiii Further, you have deliberately concealed from the Respectable Members of
CLB that the Company has submitted the dully certified Form-29 dated 04-10-2012 issued by
SECP wherein Mr. Lahooti having tendered his willful resignation from the said office on 19-
09-2012, in lieu of his forced removal from the directorship through Board Resolution passed
by the then management and by the vast majority of the shared holders on 19-09-2012 (copy of
the said resolution is re-enclosed for your kind perusal and understanding) the same was duly
acknowledged by him on 05-12-2012. Afterwards he was never restored neither re-appointed
nor elected by the company since 2012 copy of Form-29 dated 04-10-2012 (Fresh copy of the
said Form-29 dated 04-10-2012 re-attested and re-certified on dated 14-07-2017 by SECP is
enclosed herewith for your kind perusal and understanding) .
xiv We have already reached to the conclusion that having your sympathies for him,
Mr. Usama has been knitting a plan against the Company and its Management, and having got
your illegal support, while playing a dubious role, you mysteriously portrayed this whole
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matter suspicious in front of CLB, by referring to a Form-29 dated 31-10-2013, wherein Mr.
Usama is shown re-elected as Director till 2016, as becoming a part and parcel of Mr.
Lahooti’s intrigue thinking you kept a dreadful and criminal silence at your part of
justification, to the fact that the said form-29 is not issued/certified by the SECP.
xv We have strong apprehension about accepting/entertaining of the said Form,
though knowingly well that the same has no legal sanctity and is a sheer violation of your
lawful duty, rather we consider it the mischief/misconduct on your part while acting as the
Secretary Licensing Board. The said act of yours in unfathomable and incomprehensible to the
company and its management and needs immediate clarification/legal footing, if any, from
your side. At the same time, we reserve the right to question the validity of the said Form in the
court of law.
xvi Further, you have also deliberately concealed from the respectable members of CLB
that the company has been submitting all Form A and Forms 29 since 2014, which don not
reflect Mr. Lahooti as Director of Company.Let the company make it very clear that the
aforesaid on your part is your acts of duality and it further give rise to a simple question
about your conduct and your impartiality as The Secretary Licensing Board.
xvii. It is hard to understand that, what made you to sit and act as a judge and term
Mr. Usama’s so-called complaint a Dispute. This leads to the conclusion that either you are
unable to understand the scope of your duties inside the Central Licensing Board, or you
are acting in flagrant disregard of the same. Therefore, to justify your part, we shall also await
to see, when you will write a letter to Mr. Usama clearly stating therein that he should
approach the appropriate forum, if he has any objection of the transactions inside the Company
OR OTHERWISE WE SHOULD BE CALLED UPON WHEN HE WILL BE HEARD IN
THE UP COMING MEETING OF CLB TO COUNTER HIS CLAIMS/DOCUMENTS. And
in case, you fail to do so, it will lead to the conclusion, as drawn aforesaid, that you are acting
hands in gloves with Mr. Usama under the garb of his evil designs coupled with your personal
interests.
xviii You must be already privy to the fact that we have issued a letter dated 21-03-
2016 in the name of Mr. Usama Lahooti to withdraw from his evil designs or at-least approach
the Court of law against us to prove the same. You are also therefore, as we consider the same
malicious and unproductive attempts and futile efforts on your part, advised to forthwith
withdraw your un-lawful objection/arbitration or else, we shall be within our rights to hold you
answerable before the Courts of law to prove your legal standings and footings, and in case of
your failure to prove the same, you shall also be liable to face our claim of damages.
xix. We have also seen that during the hearing of show cause notice you told us
that letter dated 26-10-2015 written by ANF has tied your hands and you have expressed
your inability to acknowledge the change of Management due to the same, But more
Page 83 of 116
surprisingly, for un-known reason you had deliberately concealed from the minutes of
CLB in dark about ANF’s letter dated 30-05-2017 in which ANF’s Authorities have
shown their inability to respond to their earlier letter dated 26-10-2015, as the matter is
prejudice before the Honourable Islamabad High Court, which raises a very serious
question that if ANF’s Authorities couldn’t stand to their stance, how you could react to
the same? (Copy of the said letter is enclosed herewith for your kind perusal and
understanding)
xx. But even to settle this issue, when you were asked to give us the same in writing
that enable us to place the same before the Honourable Court to get directions thereof, you
simply flare up and used abusive language with Representative of the Company, who came to
your office for the letter. The company and its management reserve right to place on record of
the appropriate forum, the recorded/documented version of your conduct, as you have shown
to the company’s representative.
xxi. You are further directed, as well as required, through this communication to
forthwith and in any case within FIVE DAYS of receipt of the instant letter, do the needful
done, as required through preceding paras, failing which we reserve our rights and, therefore,
shall be at liberty to initiate legal proceedings against you. In that eventuality, this is to inform
you further, that we might feel obligated to divulge to the Court of Law or any other
competent forum to secure our rights. Looking forward to hear from you soon.
Proceedings of Licensing Division in compliance to the decision of Central Licensing Board.
13. Mr. Osama Lahooti has been called for personal hearing.
Proceedings and Decision of Central Licensing Board in 255th
meeting
14. The Secretary, Central Licensing Board separated himself from the proceedings of the case in
the light of allegations from legal counsel of Mr. Muhammad Mustafa as reproduced at para 12 above
and went out of the Committee Room. The honourbale members of the Board brought him back and
posed confidence on him being Secretary of the Central Licensing Board. The Board also condemned
in stronger terms the contents of the letter written by legal counsel of Mr. Muhammad Mustafa. The
Board also reiterated that decision taken and recorded in minutes are taken by the Board and not by
any individual and allegations leveled against the Secretary, Central Licensing Board are baseless and
of infected mind. The observers on the Board also condemned the contents of the letter written by
legal counsel of Mr. Muhammad Mustafa in stronger terms.
15. Col. (R) Tahir ul Wudood Lahooti father of Mr Osama Lahooti appeared before the Board as
representative of Mr Osama Lahooti. He contended that:
i. I, hold 33% shares of the company till date.
ii. I am the legitimate director of the company till date as clarified by the SECP during their
letters.
iii. All documents submitted by Mr. Muhammad Mustafa to your office against my share
holding and directorship are false, fabricated and have been turned down by the SECP,
being the regulator of private limited companies as per the Company Ordinance, 1984.
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iv. Since July 2014 onward, every activity took place in the company related to purchases,
obtaining sanctions from DRAP related to the active and inactive materials are illegal and
also are in total violations of Drug Act.
v. All relevant restrictions imposed by the Anti Narcotics Force (ANF) have also been
communicated to your office since October, 2015 which clearly directs that sharing
capacity of mine cannot be changed.
vi. I have been communicating with all relevant offices in the Drug Regulatory Authority,
Pakistan starting from FID, CQC, DDG Licensing, Director Licensing and the CEO of
DRAP.
vii. Mr. Mustafa and party have not been able to prove their legal position in front of all legal
Regulators.
viii. Restriction imposed by the ANF on transfer of my shares have been communicated to all
the concerned regulators since October, 2015.
ix. I definitely have apprehension about illegal activities in the company which may harm me,
being a director, and not being a part of management physically.
x. Drug Act paras quoted in the show cause notice if read and viewed, it allows the board to
handover the management to me being the legitimate director in all legal documents.
xi. If the DRAP accepts the direction of ANF conveyed then it must accept my shares holding
and directorship. Similarly if DRAP and the Licensing Board do not accept the ANF
direction then it must be conveyed to me in clear words so as enabling me to approach the
appropriate forum regarding this decision of Drugs Licensing Board.
The Board after hearing the versions of both Parties, is of the unanimous view that the dispute
between the Parties is regarding the share holding of the Company i.e M/s Danas Pharmaceuticals
(Pvt) Ltd., 312 Industrial Triangle Kahuta Raod, Islamabad which is purely of civil nature and not
within the mandate and jurisdiction of the Board. The Parties therefore, may be advised to have it
resolved from the Court of competent jurisdiction.
Meanwhile, since the important question before the Board is that who will be responsible for any
irregularity / illegality during the time the question of ownership is resolved by the Court. It was
resolved that the Secretary Licensing Board, may write a letter to Anti Narcotics Force, in reference to
their last received letter stating therein that the Board has received an application from one of the
Parties, who has allegedly acquired the major share holding in the Company and same has been
endorsed by the Securities and Exchange Commission of Pakistan (SECP), but the Board is unable to
process their application due to the impeding instructions issued by the Anti Narcotics Force vide their
letter No. F. 2 (132) Assets/ANF/IR/2011-4143 dated 26th
October, 2015, F. 2 (132)
Assets/ANF/IR/2011-4143 dated 02 March, 2017. Therefore, ANF, may advise the Board the course
of action required to be taken in this regard.
Compliance of the Licensing Division.
In the light of decision of Central Licensing Board in its 255th
meeting, a letter dated 2nd
October,
2017 was written to Anti Narcotic Force for seeking their advice that the whether the request of Mr.
Mohammad Mustafa, Chief Executive (Claimant) may be entertained for change of management.
Page 85 of 116
Reply of the ANF dated 8th
November, 2017.
1. It is intimated that quota was allocated in the name of company which is nominated through its
administration in case FIR No.40/2011 PS ANF Rawalpindi.
2. It is further intimated that the matter is sub-judice before the Honourable Islamabad High
Court and learned CNS Court, Islamabad. Moreover, proceedings for freezing the shares of
Usama Lahoti in CNS Court Islamabad have been initiated in which next date of hearing is 15-
11-2017.
3. Forgoing in view it is advised that no action regarding transfer of shares / change of
administration be taken till finalization of above said case, please.
Reply of the ANF dated 13th
December, 2017.
1. Assets inquiry of all stakeholders in case FIR No.40/2011, State Vs Ansar Farooq etc. PS
ANF Rawalpindi is under process.
2. Apropos, it is requested that any adverse order may not be passed or any such process may
not be initiated prejudiced to the right of company / persons to conduct business till
finalization of the inquiry, please.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considered the replies received from ANF Rawalpindi which is law enforcement agency.
ANF Rawalpindi has advised that no action regarding transfer of shares / change of administration be
taken till finalization of above said case and any adverse order may not be passed or any such process
may not be initiated prejudiced to the right of company / persons to conduct business till finalization
of the inquiry. The Board therefore decided to pend the case till decision by the court of the competent
jurisdiction on the subject matter.
Case No. 35. M/S CALIPH PHARMACEUTICALS (PVT) LTD., PLOT NO.17, SPECIAL
INDUSTRIAL ZONE (EPZ), RISALPUR – VIOLATION OF RULE 5(2A) OF
DRUGS (L,R&A) RULES, 1976.
Case Background
M/s Caliph Pharmaceuticals (Pvt) Ltd. Risalpur submitted the application for renewal of DML
No. 000748 by way of formulation on 17-07-2017 for the period of 13-08-2017 to 12-08-2022, which
was well on time. After evaluation of the renewal application of the firm, a letter for completion of
application for renewal of DML was issued for following shortcomings: -
i. Fee of Rs.50,000/- alongwith requisite documents for approval of change in
management, but the management seems to have been changed as under;
Previous Management as per
Memorandum and Article of
Association (Page 33/Corr –
main file)
Current Management as per
Form-1A (Page 8/Corr) dated
14-07-2017
i. Mr. Mumtaz Ali
ii. Mrs. Lal Zari
iii. Mr. Farman Ali
i. Mr. Muhammad Azmat Ali
ii. Mr. Amjad Ali Zeb
Page 86 of 116
ii. Attested copy of approval letter(s) of all the approved section(s) has not been
attached
Proposed QC Incharge (Mr. Naseer Ahmed).
iii. Complete set of attested documents as per check list.
iv. Fee challan of Rs.5,000/- for approval of change of QC Incharge.
With reference to above letter, the firm submitted some shortcoming documents. Upon
evaluation, Licensing Division issued final reminder with following shortcomings;
i. Attested copy of Form-29 and Form-A of SECP showing the detail of previous
management, has not been attached.
ii. Approval letter(s) of all licensed section(s), has not been attached.
iii. Resignation letter of previously appointed QC Incharge.
With reference to above final reminder, the firm submitted some shortcoming documents.
Upon evaluation, following shortcoming has still been observed;
i. Attested copy of section approval letter(s) has not been provided.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule 5(2A)
of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the application for
renewal of DML No. 000748 by way of formulation of M/s Caliph Pharmaceuticals (Pvt) Ltd.
Risalpur not be rejected by Central Licensing Board.
Case No.36 M/S GENERA PHARMACEUTICALS, PLOT NO. 244, STREET NO. 8, I-9/2,
INDUSTRIAL AREA, ISLAMABAD – VIOLATION OF RULE 5(2A) OF
DRUGS (L,R&A) RULES, 1976.
Case Background
M/s Genera Pharmaceuticals, Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad submitted
the application for renewal of DML No. 000448 by way of (Formulation) on 27-04-2015 for the
period of 29-04-2015 to 28-04-2020, as due date of renewal of said DML was 28-04-2015.
After evaluation of the renewal application of the firm, a letter for completion of application for
renewal of DML was issued for following shortcomings: -
i. Form “C” from registrar of firm.
ii. Partnership deed, attested copies of CNICs of all partners.
iii. Declaration regarding change of management from last renewal.
iv. Proof of sections approved by the Central Licensing Board.
v. Approved copy of layout plan.
vi. Nothing due certificate regarding CRF from STO.
With reference to above letter, the firm submitted some documents. Upon evaluation, a final reminder
with following shortcomings was issued to the firm;
i. Form “C” from registrar of firm.
ii. Partnership deed, attested copies of CNICs of all partners.
iii. Declaration regarding change of management from last renewal.
iv. Proof of sections approved by the Central Licensing Board.
v. Approved copy of layout plan.
Page 87 of 116
vi. Nothing due certificate regarding CRF from STO.
vii. Documents of proposed Quality Control Incharge (Mr. Hashim)
With reference to above letter, it is mentioned that as per available record of Licensing Division, no
correspondence received in respect to shortcomings in application for renewal of DML of the firm.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000448 by way of formulation of M/s Genera Pharmaceuticals,
Plot No. 244, Street No. 8, I-9/2, Industrial Area, Islamabad may not be rejected by Central Licensing
Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing
Board.
Case No.37 M/S EG PHARMACEUTICALS, 13-A, INDUSTRIAL TRIANGLE, KAHUTA
ROAD, ISLAMABAD – VIOLATION OF RULE 16 OF DRUGS (L,R&A)
RULES, 1976.
Case Background
M/s EG Pharmaceuticals, 13-A, Industrial Triangle, Kahuta Road, Islamabad wherein the firm has
submitted the application for change of technical staff (Production Incharge) dated 17-11-2015.
After evaluation of the change of technical staff application of the firm, a letter for completion of
application for change of technical staff was issued for following shortcomings: -
1. Clear readable and attested copy of CNIC of appointee.
2. Job acceptance letter by the appointee.
3. Approval letter of earlier approved Production Manager.
4. Resignation letter of the previous approved Production Manager.
5. Undertaking as whole time employee from the Firm’s higher authority.
6. Detail experience of 10 years for Production Manager according to the Section (16)
of Drugs Licensing Registering & Advertising Rules, 1976.
The firm submitted reply but the same was incomplete and reminder was issued to the firm with
following shortcomings:-
1. Job acceptance letter by the appointee.
2. Approval letter of earlier approved Production Manager.
3. Resignation letter of the previous approved Production Manager.
4. Undertaking as whole time employee from the Firm.
5. Detail experience certificate as under Drugs Licensing Registering & Advertising
Rules, 1976 (not less then 10 years).
6. All documents attested as per check list.
The firm submitted reply but the same was incomplete and final reminder was issued to the firm with
following shortcoming;
1. Relevant experience of proposed Production Incharge is less than 10 years.
As per record of Licensing Division, no reply has been received from the firm in response to above
mentioned final reminder. It is also submitted that the proposed Production Incharge has resigned from
the firm dated 30-11-2017 and firm has not submitted documents for approval of new Production
Incharge.
Page 88 of 116
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000752 by way of formulation of M/s EG Pharmaceuticals, 13-A,
Industrial Triangle, Kahuta Road, Islamabad may not be rejected by Central Licensing Board or their
Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Case No. 38 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S TAGMA
PHARMA (PVT) LTD, 12.5-KM, RAIWIND ROAD, LAHORE
M/s Tagma Pharma (Pvt) Ltd, 12.5-Km, Raiwind Road, Lahore had applied for renewal
of DML No. 000414 by way of formulation on 14-07-2015 for the period of 06-08-2015 to 05-08-
2020.The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 03-09-2015 under Rule 5{2A} of Drugs
(Licensing, Registering, Advertising) Rules, 1976:-
1. Duly attested details of management.
2. Form-29.
3. Proof of all sections.
4. CNIC copies of management.
5. Attested details of qualified persons.
6. Undertaking regarding correct details.
The firm submitted documents on 29-09-2015 but following documents were still
deficient /short and Final Reminder was issued on 21-07-2017 to the firm with following
shortcomings: -
1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of
management at the time of previous renewal and now at present renewal.
2. Nothing due certificate regarding CRF from STO (Updated).
3. Detail of Premises with Proof of CLB approved sections.
4. Approval letter of Production Incharge and Quality Control Incharge, if any
change then provide set of documents for proposed Production Incharge and
Quality Control (as per check list) along with prescribe fee of Rs. 10,000/-
5. All Documents should be duly attested.
The firm submitted documents on 01-08-2017 in reply to Final Reminder. Upon Evaluation
following shortcoming has been observed and application for renewal of DML is still incomplete
1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of
management at the time of previous renewal and now at present renewal.
2. Nothing due certificate regarding CRF from STO (Updated).
3. Detail of Premises with Proof of CLB approved sections.
4. All Documents should be duly attested.
Page 89 of 116
Now the Division of Budget and Account has forwarded Nothing due certificate regarding CRF from
STO (Updated) and following documents shortcomings:
1. Latest Form-29 from S.E.C.P. dully attested along with CNIC copies of
management at the time of previous renewal and now at present renewal.
2. Detail of Premises with Proof of CLB approved sections.
3. All Documents should be duly attested.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000414 by way of formulation of M/s Tagma Pharma (Pvt) Ltd,
12.5-Km, Raiwind Road, Lahore may not be rejected by Central Licensing Board or their Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Case No. 39 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S SYMANS
PHARMACEUTICALS (PVT) LTD, 10-KM, SHEIKHUPURA ROAD, LAHORE
M/s Symans Pharmaceuticals (Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore had applied
for renewal of DML No. 000323 by way of formulation on 16-09-2015 for the period of 19-10-2015 to
18-10-2020.The application for the renewal of DML of the firm was evaluated and a letter for
following shortcomings / deficiencies was issued to the firm on 26-07-2016 under Rule 5{2A} of
Drugs (Licensing, Registering, Advertising) Rules, 1976:-
1. Form 29- from S.E.C.P along with copies of CNIC and any change in management
/ Directors / Owners
2. Approval Layout plan of premises (Copy)
3. Proof of licensed sections from CLB
4. Approval letter of technical staff
5. Nothing due certificate for CRF
The firm submitted documents on 11-08-2016 but following documents were still
deficient /short and same were conveyed to the firm Reminder-I letter issued on 28-12-2016.
1. Attested documents of renewal as per form 1A.
2. Proposed technical staff documents as per check list.
3. Approval Layout plan of premises (Copy).
4. Proof of licensed sections from CLB.
5. All documents should be duly attested.
Page 90 of 116
The firm submitted documents on 30-01-2017 in reply to Reminder-I but following
documents were still deficient /short and Final Reminder was issued on 06-02-2017 to the firm with
following shortcomings: -
1. Attested documents of renewal as per form 1A.
2. Proposed technical staff documents as per check list.
3. Approval Layout plan of premises (Copy).
4. Proof of licensed sections from CLB.
5. All documents should be duly attested.
The firm submitted documents on 28-02-2017 in reply to Final Reminder. Upon Evaluation
following shortcoming has been observed and application for renewal of DML is still incomplete
1. Approval letter of proposed Quality Control Incharge, if any change then provide set of
documents for Proposed Quality Control Incharge (as per check list) along with
prescribe fee.
2. Approved master Layout plan of premises (Copy).
3. Proof of licensed sections from CLB.
4. Updated nothing due certificate regarding CRF from STO.
5. All documents should be duly attested.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000323 by way of formulation of M/s Symans Pharmaceuticals
(Pvt) Ltd, 10-Km, Sheikhupura Road, Lahore may not be rejected by Central Licensing Board or their
Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Case No. 40 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S SHAFI
TEXTILE CORPORATION, 608-B, SMALL INDUSTRIAL ESTATE,
SARGODHA ROAD, FAISALABAD
M/s Shafi Textile Corporation, 608-B, Small Industrial Estate, Sargodha Road,
Faisalabad had applied for renewal of DML No. 000436 by way of formulation on 22-10-2014 for the
period of 07-09-2014 to 06-09-2019.The application for the renewal of DML of the firm was
evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 16-02-2017
under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
1. Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule
1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- =
(45x5000).
Page 91 of 116
2. There is change in management of the firm, so proper application along with
challan fee of Rs. 50,000/-.
3. Proof of licensed section from CLB /Approved layout plan.
4. Updated nothing due certificate regarding CRF from STO.
5. All documents should be duly attested.
The firm did not submit their reply. Final Reminder was issued on 08-06-2017 to the firm
with following shortcomings: -
1. Renewal application is 45 days late according to Rule 6 of drugs (L, R&A) rule
1976 the additional surcharge 5,000/- each day, deposit fee of Rs. 225000/- =
(45x5000).
2. There is change in management of the firm, so proper application along with
challan fee of Rs. 50,000/-.
3. Proof of licensed section from CLB /Approved layout plan.
4. Updated nothing due certificate regarding CRF from STO.
5. All documents should be duly attested.
The firm has not submitted the above mentioned documents till date and application for
renewal of DML is still incomplete
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000436 by way of formulation of M/s Shafi Textile Corporation,
608-B, Small Industrial Estate, Sargodha Road, Faisalabad may not be rejected by Central Licensing
Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central Licensing
Board.
Case No. 41 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S MASFA
INDUSTRIES (PVT) LTD, 17-KM, SHEIKHUPURA ROAD, LAHORE
M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore had applied for
renewal of DML No. 000713 by way of formulation on 13-07-2016 for the period of 15-06-2016 to
14-06-2021.The application for the renewal of DML of the firm was evaluated and a letter for
following shortcomings / deficiencies was issued to the firm on 19-09-2016:-
1. The application of renewal of DML is 30 days late.
2. Detail of management ate previous renewal of DML and latest management at
present renewal of DML.
3. Proof of sections approved by CLB.
4. Approval letter of Production Incharge and Quality Control Incharge.
Page 92 of 116
5. Updated Nothing due certificate for CRF from STO (R&D) DRAP, Islamabad.
The firm submitted documents on 18-10-2016 but following documents were still
deficient /short and Final Reminder was issued to the firm on 10-07-2017 for completion of
application.
1. You were asked to submit late surcharge fee for DML renewal
i.e.30*5,000=150,000/- However Statistical Officer of DRAP endorsed for Rs.134,
970/- you are required to submit remaining Rs. 15,030/- in DRAP account.
2. Attested Form-29 from S.E.C.P. (Latest 2017 and at time of grant of DML (2011) if
any change in management then fee for change in management/Director.
3. Nothing due certificate of C.R.F. from S.T.O DRAP.
The firm submitted documents on 28-08 -2017 in reply to Final Reminder but
application for renewal of DML is short of following documents as of today:
1. Nothing due certificate of C.R.F. from S.T.O DRAP.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 as to why the DML No. 000713 by way of
formulation of M/s Masfa Industries (Pvt) Ltd, 17-km, Sheikhupura road, Lahore may not be
suspended under Rule 12 of the Drugs (Licensing, Registering and Advertising) Rules, 1976 till
settlement of Central Research Fund.
Case No. 42 RENEWAL OF DRUG MANUFACTURING LICENCE OF M/S BAXTER
PHARMACEUTICALS, KARACHI
M/s Baxter Pharmaceuticals, A-1/A, Scheme No. 33, Phase-II, S.I.T.E, Super Highway,
Karachi had applied for renewal of DML No. 000700 by way of formulation on 28-01-2016 for the
period of 25-02-2016 to 24-02-2021.The application for the renewal of DML of the firm was
evaluated and a letter for following shortcomings / deficiencies was issued to the firm on 07-11-2016
under Rule 5{2A} of Drugs (Licensing, Registering, Advertising) Rules, 1976:-
i. Form 1-A.
ii. Class(es) of Drugs.
iii. Dosage form(s) of Drugs.
iv. Name of Drug(s) registered.
v. Name of Proprietor/Director alongwith attested CNIC copies.
vi. Detail of Premises including approved L.O.P.
vii. Detail of Section-wise equipments/machinery.
viii. Detail of Technical Staff.
Page 93 of 116
ix. Latest N.O.C. of C.R.F.
The firm did not submit their reply. A Reminder-I was issued on 24-04-2017 to the firm
with following shortcomings: -
1. Form 1-A,
2. Class(es) of Drugs.
3. Dosage form(s) of Drugs.
4. Name of Drug(s) registered.
5. Name of Proprietor / Director along with CNIC copies
6. Detail of premises including approved layout plan / Proof of Sections from CLB.
7. Detail of Section-wise equipments/machinery.
8. Nothing due certificate regarding CRF from STO (Updated).
9. Provide name of approved Quality Control Incharge and Production Incharge. In case
of new nominees, provide complete set of documents for Proposed Quality Control
Incharge and Production Incharge with names as (per check list) along with prescribe
fee.
10. All documents should be duly attested.
The firm did not submit their reply. Final Reminder was issued on 19-06-2017 to the firm for
above mentioned documents.
The firm has submitted the requisite documents. Upon evaluation, following documents are
still found to be short and application for renewal of DML is still incomplete;
1. Prescribed fee for change of management.
2. NOC from previous management.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000700 by way of formulation of M/s Baxter Pharmaceuticals, A-
1/A, Scheme No. 33, Phase-II, S.I.T.E, Super Highway, Karachi may not be rejected by Central
Licensing Board or their Drug Manufacturing Licence may not be suspended or cancelled by Central
Licensing Board.
Case No. 43 CANCELLATION OF DRUG MANUFACTURING LICENSE NO. (000663)
(FORMULATION) OF M/S AL-AJU COTTON INDUSTRIES MIR PUR KHAS
SINDH.
The case was presented before the Board as under:-
The brief background of the case is as under: -
Federal Inspector of Drugs Dr. Najam-us-Saquib visited M/s Al-Aju Cotton Industries
on 28th June 2013 wherein the FID had reported that there was no production activity underway and
premises were found closed. He had further informed that letters and reminders to the firms were
issued but no reply from the firm was received. The neighboring person informed that there was no
production activity since long and said premises alongwith other surrounding land had been purchased
Page 94 of 116
by another person namely Mr. Amjad Memon. On contact to Mr. Amjad Memon he had confirmed
that he had purchased the whole land and he did not know about running a pharmaceutical unit, nor he
was interested in the same. The FID had recommended for cancellation of Drug Manufacturing
License of M/s Al-Aju Cotton Industries, Mirpur Khas, Sindh. Accordingly the case was placed in
233rd
meeting of CLB held on 30th
& 31st December 2013.
Decision of CLB taken in 233rd
meeting held on 30-31 December, 2013.
The Board in light of inspection report of area FID and after thorough discussion and
deliberations decided to issue Show Cause notice to M/s Al-Aju Cotton Industries, Mirpur Khas, Sindh
and called the firm for personal hearing in next meeting before cancellation of DML. Board further
decided to collect the DML and Inspection Book through area FID.
Accordingly, Show Cause notice was issued to the firm and the firm was also called for personal
hearing in the 234th
meeting of CLB. The firm did not respond to the show cause notice. The case was
again placed before the Board in its 234th
meeting held on 27-02-2014 however firm also failed to
appear for personal hearing despite of issuance of letter for the same.
Decision of CLB taken in 234th
meeting of CLB held on 27-02-2014
The Board after thorough discussion / deliberations and facts on grounds considered and
deferred the case for final opportunity of personal hearing and collection of DML and inspection book
through Area FID before suspension / cancellation of DML.
3. Accordingly, the decision was conveyed to the firm for final opportunity of personal
hearing and a letter was also issued to area FID to collect the DML and inspection book. But no
response received from area FID and firm. Accordingly the case was once again presented in 235th
meeting of CLB held on 15th
May 2014 for consideration/decision.
Decision of CLB
The Board after thorough discussion/deliberation and facts on ground decided to defer
the case for report of area FID.
No report from area FID. In the light of aforesaid decision is received till date.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to give final
opportunity to area Federal Inspector of Drugs for updated report for perusal of the Board.
Case No. 44 RENEWAL OF DRUG MANUFACTURING LICENSE NO. (000684)
(FORMULATION) OF M/S BRAND PHARMA INTERNATIONAL, K-105,
PHASE-II, S.I.T.E, SUPER HIGHWAY, KARACHI
M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi was issued the
License No. 000684 (Formulation) on 10-05-2010 and due date of renewal of License was 09-05-
2015. It is pertinent to mention that Rule 5 (6) of Drug (L, R & A) Rule, 1976 states “if an application
of renewal is made after the expiry of the period of validity of License but within 60 days of expiry, the
License shall continue in force on payment of additional surcharge of Rs. 5,000/- per day the
application is delayed and thereafter until orders are passed on such application”. But in this case the
Page 95 of 116
application for renewal of DML for the period 10-05-2015 to 09-05-2020 has not been received till
date. Therefore, DML No. 000684 (Formulation) M/s Brand Pharma International, K-105, Phase-II,
S.I.T.E, Super Highway, Karachi is no more valid.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 5 of the
Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why DML No. 000684 by way of
formulation of M/s Brand Pharma International, K-105, Phase-II, S.I.T.E, Super Highway, Karachi
may not be declared cancelled.
Case No. 45 RENEWAL OF DRUG MANUFACTURING LICENSE OF M/S DOSACO
LABORATORIES, 9.2-KM, SHEIKHUPURA ROAD, LAHORE.
M/s Dosaco Laboratories, 9.2-Km, Sheikhupura Road, Lahore. had applied for renewal
of DML No. 000094 by way of formulation on 12-04-2016 for the period of 19-04-2016 to 18-04-
2021.The application for the renewal of DML of the firm was evaluated and a letter for following
shortcomings / deficiencies was issued to the firm on 04-10-2016:-
1. Classes of Drugs
2. Dosage forms of drugs
3. Detail of management previous renewal of DML and lattes management present
renewal of DML.
4. Proof of Section from CLB
5. Approval letter of Production Incharge and QC Incharge
6. Noting due certificate regarding CRF from STO.
The firm submitted documents of Mr. Yasir Khan for approval as Production Incharge on 13-12-2016
but did not respond to shortcomings to Licensing Division’s letter issued on 04-10-2016. Application
for approval of Production Incharge was evaluated and firm was communicated following deficient
documents in the application vide letter issued on 28-12-2016:-
1. Job acceptance letter by the appointee
2. Experience Certificate as under Drugs (Licensing, Registering and Advertising)
Rules, 1976 (Not less than 10 year).
3. Resignation / retirement of earlier Production Incharge.
4. Resignation or termination letter of appointee from the previous firm / promotion
letter / transfer letter from the same firm.
5. Undertaking as whole time employee
6. All documents should be duly attested.
Page 96 of 116
The firm did not submitted documents and Final Reminder was issued to the firm on
19-06-2017 for completion of application.
1. Classes of Drugs
2. Dosage forms of drugs
3. Detail of management previous renewal of DML and lattes management present
renewal of DML.
4. Proof of Section from CLB
5. Approval letter of QC Incharge
6. Noting due certificate regarding CRF from STO (Updated).
7. Job acceptance letter by the appointee (Production Incharge)
8. Experience Certificate as under Drugs (Licensing, Registering and Advertising)
Rules, 1976 of Production Incharge (Not less than 10 year).
9. Resignation / retirement of earlier Production Incharge.
10. Resignation or termination letter of appointee from the previous firm / promotion
letter / transfer letter from the same firm (Production Incharge).
11. Undertaking as whole time employee on stamp paper (Production Incharge)
12. All documents should be duly attested.
The firm submitted documents on 13-09-2017 is reply to Final Reminder for renewal of
DML. Upon evaluation following shortcomings has been observed in the application for renewal of
DML is still incomplete:
i. Nothing due certificate regarding CRF form STO, DRAP, Islamabad
(Update).
ii. Proof of sections approved by Central Licensing Board.
iii. CNIC copy, academic degrees and Registration Certificate of appointee are
not duly attested.
iv. Resignation/ retirement letter of earlier Production Incharge is not
provided.
v. Experience certificates is less than 10 years as per submitted documents of
the firm. Total experience of Proposed Production Incharge is
approximately 9 years and 03 months.
vi. There is change in management of the firm. The detail of which is as
under:
Management as
per Form-1A at
the time of
renewal of DML
for tenure 19-04-
2006 to 18-04-
2011
Management as
per Form-1A at
the time of
renewal of
DML for tenure
19-04-2011 to
18-04-2016
Management as
per Form-1A at
the time of
renewal of DML
for tenure 19-04-
2016 to 18-04-
2021
Current Status
Page 97 of 116
i. Mr.
Muhammad
Firdous.
ii. Mr.
Muhammad
Yaqoob Butt
and Others.
Not Provided i. Mr. Nadeem
Firdous.
ii. Mr. Abu
Obaida Butt &
Others.
i. Mr. Nadeem
Firdous.
ii. Mr. Umar
Butt
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to serve Show
Cause Notice to the firm under Section 41 of the Drugs Act, 1976 read with Rule, 12 of the Drugs
(Licensing, Registering and Advertising) Rules, 1976 for not complying the provision of Rule, 16 and
Rule 5(2A) of the Drugs (Licensing, Registering and Advertising) Rules, 1976 as to why the
application for renewal of DML No. 000094 by way of formulation of M/s Dosaco Laboratories, 9.2-
Km, Sheikhupura Road, Lahore may not be rejected by Central Licensing Board or their Drug
Manufacturing Licence may not be suspended or cancelled by Central Licensing Board.
Case No.46 CANCELLATION OF DRUG MANUFACTURING LICNCE OF M/S
MEDIPAK LTD,132/1 INDUSTRIAL ESTATE, KOT LAKHPAT, LAHORE.
The Hon’ble Chairman, Drug Court, Balochistan Quetta has passed an order whereby it is stated that a
case No. 19/2016 is filed before Hon’ble Drug Court, Quetta in respect of M/S Medipak Ltd,132/1
Industrial Estate, Kot Lakhpat, Lahore. Accused are wasting time of Hon’ble Court by adopting
delaying tactics.. Therefore, Chairman Drug Court, Balochistan, Quetta has ordered to cancel the Drug
Manufacturing Licence of said firm.
Meanwhile, M/s Medipak Ltd, 132-Industrial Estate, Kot Lakhpat, Lahore, wherein firm has submitted
a copy of orders dated 29-11-2017 of Hon’ble High Court Balochistan, Quetta wherein The Hon’ble
High Court suspended the directions of Drug Court, Balochistan Quetta till next date of hearing i.e,
20th
December, 2017.
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board considering the facts on the record and after thread bare deliberation decided to seek
updated status from the firm regarding the case and accordingly communicated to the Honourable
Drug Court.
Case No. 47. CONSIDERATION OF BIOCHEMISTS FOR APPROVAL AS QUALITY
CONTROL INCHARGE.
Case Background
Mr. Jehangir Alam was proposed as Quality Control Incharge by the M/s Pak Risen
Pharmaceuticals, Hattar but application was rejected by the Licensing Division on the basis that he
does not fulfill the requirement of Rule 16(e) of Drugs (L,R&A) Rules, 1976 in terms of qualification
as he holds the degree of BS (Hons) in Biochemistry.
Page 98 of 116
Now, Mr. Jehangir Alam, Assistant Quality Control Manager, M/s Pak Risen
Pharmaceuticals, Hattar has requested to consider Biochemists for approval as Quality Control
Incharge as under;
“It is stated with great concern that I am a Biochemist and I am associated with
Pharmaceutical Industry for about 10 years. I have worked as Quality Control
Incharge (DRA approved) for about 04 years. Recently I have applied for the post of
Quality Control Incharge from PakRisen Pharmaceuticals but my case was declared
rejected as I was found deficient on Rule 16(e) of Drug Act 1976 (i.e degree of
Biochemistry was not considered as a branch of chemistry).
I have discussed this matter with honorable Dr. Manzoor Bozdar Sahib and Shaikh
Faqeer Muhammad Sahib and they both respectable dignities directed me to consult
HEC for a clarification note on Biochemistry as a branch of chemistry So, I did
accordingly and submitted my application to HEC.
The panel of curriculum board immediately responded in positive and declared Bio-
chemistry a one of the main five branches of chemistry and more over they (HEC)
enquired my need for this clarification so I wrote about the rules of DRAP 16(e). They
had gone through my case in detail and released a detail clarification note on
“Biochemistry as one of the main branch of chemistry”. (Copy of Declaration note
attached)
Honorable sir, I am working as assistant quality control manger despite of all my
experience of pharmaceutical laboratory. Our biochemist friends of India and
Philippines are working as quality control Incharge without any objection in their
respective authorities.
We request honorable DRAP to consider (Biochemists) for Quality Control Incharge.
The course outline of biochemistry suggests that it is the most closest and appropriate
branch of chemistry for pharmaceutical laboratory.”
CLARIFICATION BY HEC
“It is hereby to inform you that your case was forwarded to our expert for
comments/reply. The reply from expert is reproduced below;
i. Biochemistry is one of the five branches of Chemistry.
ii. Pharmacology is the branch of Biochemistry.
iii. Physical Chemistry and two subjects of organic Chemistry were taught
compulsory in BS Biochemistry and are evident from the mark sheet of applicant.
iv. Subject of analytical techniques was taught in the degree under heading
Biochemical Techniques in which Homogenization, Centrifugation,
Spectrophotometry, Chromatography, Gas Chromatography, HPLC, IR, Atomic
Absorption, Electrophoresis and other chemical techniques are extensively
studies using chemical, pharmaceutical and biological samples.
v. Other techniques like density, viscosity, pH and titrations and drug quantity
determinations are the part of studies in the degree.
vi. That BS Biochemistry fulfill the requirement of Rule 16(e) of Drugs (Licensing,
Registering and Advertising) Rules, 1976 in terms of qualification.
Therefore, based on the above observations, it is to informed that Biochemistry is a
branch of Chemistry and falls in domain of Chemistry under Drugs Rule 1976.”
Proceedings and Decision of Central Licensing Board in 257th
meeting
Deferred for detailed working regarding the subject being taught in different Universities.
Page 99 of 116
Case No.48 APPROVAL OF MASTER LAYOUT PLAN / AUTHENTICATION /
REGULARIZATION OF EXISTING FACILITY, DRUG
MANUFACTURING LICENSE NO.000379 (FORMULATION) OF M/S
MUNAWAR PHARMA (PVT) LTD, LAHORE
M/s Munawar Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore, DML No. 000379 (Formulation),
has applied for regularization of layout plan of running facility for their following existing sections
which were licensed before the promulgation of S.R.O. 470/98 dated 15th
May 1998 when approval of
layout plan was not mandatory: -
Regularization / Authentication / Amendment of Already existing Sections.
1. Tablet (General) Section. 2. Liquid (General) Section.
3. Liquid Injection (General) Section. 4. Capsule (Cephalosporin) Section
5. Oral Dry Powder Suspension
(Cephalosporin) Section
6. Capsule (Penicillin) Section
7. Oral Dry Powder Suspension
(Penicillin) Section
8. Tablet (Psychotropic) Section
9. Injection (Psychotropic) Section 10. Quality Control Laboratory
Accordingly, layout plan of firm was approved/regularized/authenticated and following panel was
constituted to verify the above sections of firm as per approved layout plan.
1. Dr. Ikrarm-ul-Haq, Member Central Licensing Board.
2. Prof. Dr. Muhammad Jamshed, Dean Faculty of Pharmacy, University of Central
Punjab, Lahore.
3. Mr. Asim Rauf, Deputy Director General (E&M), DRAP, Lahore.
4. Hafiz Muhammad Jawad Ali, Federal Inspector of Drugs, Lahore-V.
Accordingly, Panel has inspected the premises and verified the above mentioned section.
Recommendations: -
The Panel of inspectors endorsed the regularization of the above mentioned section to M/s
Munawar Pharma (Pvt) Ltd, 31-Km, Ferozepur Road, Lahore
Proceedings and Decision of Central Licensing Board in 257th
meeting
The Board approved the regularization of Layout Plan as per recommendations of the members of the
panel.
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QUALITY ASSURANCE CASES
Item No. I. Resumption of DML
Case No. i. M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad. Background of the case:
Dr. Abdur Rashid, Additional Director (QA<) along-with Syed Hakim Masood, Area FID, Karachi conducted inspection of the firm M/s Alkemy Pharmaceutical, Hyderabad on 16.11.2016 in connection to Quality Control letter dated 27.05.2016, wherein the firm was found in manufacturing and sale of sub-standard drug Azofin suspension, Kemycone suspension and to verify GMP compliance / production activities of the firm. 2. The panel noticed number of critical observations, which need urgent attention and rectification. The observations includes:-
i. No traceability of Raw Materials was available. No proper records were available. No thermometer and hygrometer were found for recording of temperature and humidity in the warehouse.
ii. Dispensing Areas needs renovation and additional calibrated weighing balance required.
iii. Old silverson mixers are rusted/old and required to be placed with new ones.
iv. Storage tanks required to be replaced with new ones.
v. Floor, walls and ceiling are cracked/old and needs overall, renovation required.
vi. The rodents and insects can enter from drainage in the production of syrup section and so requires better drainage system.
vii. Vessels need to be replaced.
viii. Liquid filling machine is old and rusty and must be replaced with semi- automatic filling machine with conveyor belt.
ix. Water System needs to be upgraded with new one.
x. Batch Manufacturing instructions were missing from batch manufacturing records.
xi. Iron racks are required to be placed in the warehouse. Iron and plastic pellets maybe further added in the warehouse and wooden pellets should be removed from the area.
xii. There are no racks in the finished goods store and medicines are placed on the floor. Few wooden pellets and plastic pellets are also seen in one room. There is a need that iron racks and plastic pellets maybe provided along with hygrometers to monitor the humidity of the finished goods store. Floor walls and ceiling needs renovation paint and up gradation.
xiii. Dust can enter from the open exhaust, therefore an exhaust is required.
xiv. There is overall need to upgrade the facility in the chemical and microbiological sections of the QC laboratory. No HPLC is available, so one HPLC may be provided.
xv. There is lacking of proper log book of the equipments, calibration, and validation of the analytical methods.
xvi. Viscometer is no more available to measure the viscosity of suspension.
xvii. In microbiological section, autoclave, colony counter and refrigerator are no more available. It is recommended to provide the same.
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xviii. The qualified person in chemical and microbiological section needs training and has lack of latest knowledge. It is recommended that the technical personnel may be sent to Karachi for proper training.
xix. Qualified persons documents were submitted in 2013, but have not been approved by the concerned division.
xx. Packaging materials and labels are not properly stored and documented.
The panel concluded that:- The observations were discussed with the management and
the management of the firm voluntarily stopped production in the liquid syrup section for maintenance and renovation. The panel recommended to issue a show cause notice for Liquid Section and personal hearing be given to the representative of the firm for cancellation and suspension of DML. Action taken by DRAP: Accordingly show cause notice / suspension of production activities in liquid syrup section was issued to the firm on 09.01.2017. Reply by the firm: The firm vide letter dated 17.01.2017 submitted reply, requested that the facility has been maintained and requested for the constitution of the panel to visit the firm and to provide opportunity for personal hearing. Proceedings of the 252nd Meeting of CLB
The Board was informed by the Deputy Director (QA) that the samples of Azofin Suspension and Kemycone Suspension were declared as of substandard quality by the Central Drugs Laboratory, Karachi. Accordingly the case was placed in 258th meeting of Registration Board held on 25th and 26th April, 2016. The Registration Board constituted panel of experts comprising of Dr. Abdur Rashid, Additional Director (QA<) and Syed Hakim Masood, Area FID to conduct PSI. The panel conducted inspection of the firm on 16.11.2016 and observed gross violations in Liquid syrup Section. Accordingly show cause notice / suspension of production activities in liquid syrup section was issued to the firm on 09.01.2017. The firm was served letter for personal hearing on 08.03.2017. Mr. Faraz Ahad Shaikh, Managing Director and Mr. Asif Najeeb Laghari, QC In-charge appeared before the Board. Managing Director inform the Board that they voluntarily stop the production in liquid section. He added that the observations noted by the panel have been rectified and they are ready for inspection. The Board inquired regarding availability of FTIR, Viscometer and Polarimeter in the Quality Control Lab. The QC In-charge replied in negative. The Board took serious notice of non-availability of most important equipments used for testing of liquid products, in QC Lab. Decision of the 252nd Meeting of CLB
After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 16.11.2016, casual attitude of the firm towards GMP compliance in liquid syrup section, the Board decided to:-
i. Suspend the Drug Manufacturing License of liquid syrup section of the firm M/s Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Karachi, for a period of 03 months under section 41 of the Drugs Act, 1976 read with Rule 12 of the Drugs (LR&A) Rules, 1976, from the date of issuance of decision of the 252nd meeting of CLB.
ii. Conduct panel cGMP inspection of the firm on approved format under
Schedule B-II of Drugs (LR&A) Rules, 1976, after submission of compliance report by the firm, by the following members:-
Syed Muid Ahmad, Member CLB Dr. Abdur Rashid, Additional Director (QA<), Islamabad.
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Syed Hakim Masood, Area FID, Hyderabad / Karachi
iii. The Board also decided to direct the panel to submit brief report in tabulated form identifying the previous observations and the current status with clear and candid recommendations.
iv. The report shall be presented in the meeting of Central Licensing Board for
perusal and approval.
Updated Status:
Decision of the 252nd meeting of CLB was conveyed to the firm M/s Alkemy Pharmaceutical, Hyderabad on 24.04.2017 after approval of the minutes of the meeting. Suspension of DML period of the firm has been expired on 23.07.2017.
In compliance to decision of 252nd Meeting of CLB the panel conducted inspection of the firm on 26.07.2017 and forward the report to Division of QA< on 14.11.2017. The panel submitted detailed inspection report as under:-
S# Observations noticed on Panel inspection conducted on 26.07.2017
1 No traceability of Raw Materials was available. No proper records were available. No thermometer and hygrometer were found for recording of temperature and humidity in the warehouse.
Firm has initiated record keeping in respective ledgers. Installed calibrated thermometer and hygrometer with available records for previous month and current month.
2 Dispensing Areas needs renovation and additional calibrated weighing balance required.
Dispensing area has been upgraded and calibrated weighing balance is now provided.
3 Old silverson mixers are rusted/old and required to be placed with new ones.
New silver sons mixer has been installed
4 Storage tanks required to be replaced with new ones.
New storage tanks have been installed
5 Floor, walls and ceiling are cracked/old and needs overall, renovation required.
Flooring has been improved with preventable backflow drainage sieve.
6 The rodents and insects can enter from drainage in the production of syrup section and so requires better drainage system.
Drainage lines have been improved with preventable backflow drainage sieve.
7 Vessels need to be replaced. Complied with replacement with new ones
8 Liquid filling machine is old and rusty and must be replaced with semi- automatic filling machine with conveyor belt.
Filling machine has been repaired and semi automatic capping machine with the conveyor belt has been installed.
9 Water System needs to be upgraded with new one.
Renovated the water system. Some new S.S. Lines has been provided where
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required.
10 Batch Manufacturing instructions were missing from batch manufacturing records.
Documentation is found improved management was further advised to adhere GDP.
11 Iron racks are required to be placed in the warehouse. Iron and plastic pellets maybe further added in the warehouse and wooden pellets should be removed from the area.
Wooden pallets have been replaced with plastic pallets. Racking system is seen in the raw material store.
12 xii. There are no racks in the finished goods store and medicines are placed on the floor. Few wooden pellets and plastic pellets are also seen in one room. There is a need that iron racks and plastic pellets maybe provided along with hygrometers to monitor the humidity of the finished goods store. Floor walls and ceiling needs renovation paint and up gradation.
Renovated the area. Plastic pallets have been provided. Racking system is still in process.
13 Dust can enter from the open exhaust, therefore an exhaust is required.
Open exhaust has been closed. HVAC system installed in liquid manufacturing area which is observed functional.
14 There is overall need to upgrade the facility in the chemical and microbiological sections of the QC laboratory. No HPLC is available, so one HPLC may be provided.
HPLC seen installed at the time of inspection. QC system seen / observed upgraded.
15 There is lacking of proper log book of the equipments, calibration, and validation of the analytical methods.
Log book / sheets seen implemented.
16 Viscometer is no more available to measure the viscosity of suspension.
Viscometer provided
17 In microbiological section, autoclave, colony counter and refrigerator are no more available. It is recommended to provide the same.
Autoclave, refrigerator have been provided. Colony counter is in purchase process.
18 The qualified person in chemical and microbiological section needs training and has lack of latest knowledge. It is recommended that the technical personnel may be sent to Karachi for proper training.
Initiated. It is suggested that training program should remain continued.
19 Qualified persons documents were submitted in 2013, but have not been approved by the concerned division.
Receiving in DRAP regarding approval of qualified personnel where presented.
20 Packaging materials and labels are not properly stored and documented.
Packing material inventory is now being managed in this area.
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Recommendations of the panel
“The panel appreciated the improvements under taken by the firm. Keeping in view the commitment for continuous improvement, people met and area visited the panel recommends resumption of production in syrup section of the firm M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad”.
Proceedings of the 257th Meeting of CLB
The Deputy Director (QA) presented panel report of the firm M/s Alkemy Pharmaceuticals Laboratories (Pvt) Ltd, Hyderabad conducted on 26.07.2017 in compliance to the decision of the 252nd Meeting of CLB. Decision of the 257th Meeting of CLB
After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 26.07.2017 decided to resume the DML of Liquid Syrup Section of the firm M/s Alkemy Pharma, Hyderabad alongwith resumption of production in the Liquid Syrup Section.
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Case No. ii. M/s Rex Pharmaceuticals, Karachi
Background of the case
Inspection of the firm M/s Rex Pharmaceutical Pakistan, Karachi was conducted on
06.03.2013 by Mr. Abdul Rasool Sheikh, FID, Karachi. During inspection the FID pointed out
a number of serious/critical shortcomings in all sections. Accordingly showcause notice/stop
production order was issued on 23.04.2013. The case was presented before CLB in its 232nd
meeting held on 29&30th July 2013. The Board had decided as under:-
i) The case was deferred by Central Licensing Board till its next meeting as per
your request that the Director of the firm had gone to Saudi Arabia for performing Umrah and requested to defer the case till next meeting of CLB.
ii) The production will remain stopped / suspended till the final approval for
resumption of production by the Central Licensing Board. 2. The case was again presented before the 233rd Meeting of CLB, wherein the CLB had
decided as under:-
“After thorough discussion and deliberations, considering the background of the case and facts on record, Board unanimously decided to suspend the DML of the firm for period of three months under Rule 13 of Drugs (Licensing, Registering and Advertising) Rules, 1976. The Board further decided to issue show cause notice and personal hearing to the firm and advised for market survey of production manufactured by firm.”
3. The decision of the CLB was conveyed to the firm on 24.02.2014.The firm vide letter No. Nil dated 02.04.2014 replied that they have removed all the shortcomings and ready for inspection. The Area FID visited the firm on 18.11.2014 and recommended for cancellation of DML. The case was placed before the CLB in its 245th Meeting held on 30.12.2015. Proceedings of the 245th Meeting of CLB:
The firm was provided opportunity of personal hearing before the Board, but no representative appeared before the CLB, on behalf of firm. The Board showed displeasure on such non serious attitude of the company. Decision of 245th Meeting of CLB:
The Board after thorough discussion, keeping in view the available record, observations of the FID in its inspection conducted on 06.03.2013, track record and non serious attitude of the firm, and report of the FID dated 18.11.2014 which categorically stated that “The DML of the firm may be cancelled in larger public interest”, has decided to suspend the DML of the firm M/s Rex Pharmaceuticals Pakistan, Karachi for a period of 06 months, under Rule 12 of the Drugs (LR&A) Rules, 1976. 4. The decision of the CLB was conveyed to the firm on 09.02.2016.
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Inspection conducted by Area FID, Karachi on 06.01.2017
Mr. Abdul Rasool Shaikh, FID, Karachi vide letter dated 24.01.2017 informed that the firm was inspected on 06.01.2017 and found non-operational, no one was there except watchman who told that factory is closed since 2011 and owners are reported to be living in USA now days. Based on the current conditions of the firm it is recommended that their DML by way of formulation may be cancelled in larger public interest. Proceedings of the 252nd Meeting of CLB
The Board was informed by the Deputy Director (QA) that the firm was served letter for personal hearing on 08.03.2017 and the area FID was also informed to send the letter to the firm. But no representative of the firm appeared before the Board for personal hearing under section 41 under the Drug Act 1976, read with rule 12 of the Drugs (L, R & A) Rules 1976.
Decision of the 252nd Meeting of CLB
After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the Federal Inspector of Drugs in its letter dated 24.01.2017, in which the FID recommended to cancel the DML of the firm in the larger public interest, casual attitude of the firm towards GMP compliance, track record of the firm and nonappearance of representatives of the firm before the Board to defend the case, the Board decided to cancel the Drug Manufacturing License of the firm M/s Rex Pharmaceutical Pakistan, Karachi, under Section 41 of the Drugs Act, 1976 read with Rule 12 of the Drugs (L,R&A) Rules, 1976, from the date of issuance of decision of the 252nd meeting of CLB. 5. Decision of the CLB was conveyed to the firm and quarter concerned on 15.03.2017. Decision of Appellate Board in its 147th Meeting
M/s Rex Pharmaceutical Pakistan, Karachi filed an appeal against the decision of the CLB regarding cancellation of DML. The case was considered in 147th meeting of the Appellate Board held on 28.08.2017, wherein the appellate board decided to suspend the operation of impugned order of CLB dated 15.03.2017 communicated on 24.04.2017 and remand the appeal back to the CLB. The appellate board constituted a panel of following panel to inspect the premises of the appellant who shall submit its report within 30 days from the date of communication:-
a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistan b. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahore c. Syed Muied Ahmed, Expert in Manufacturing, Karachi
The report of the panel will be placed before the CLB in its forthcoming meeting. Meanwhile the production of the firm will remain suspended till recommendations by the panel for the resumption of production and approval thereof by the CLB. Panel inspection on the decision of the Appellate Board:-
The panel inspected the firm on 12.12.2017 and noticed following observation which
still needs rectification:-
General:- Layout of the facility was approved by DRAP in 1997. Panel noticed number of
changes in the facility as compared to the approved layout of 1997.
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Dry Powder injectables (Cephalosporin) There was not status labeling for clean down quarantine and passed material storage
areas There was not air conditioning in cold store area. No temperature monitoring or recording in raw material stores area No designated area for material sampling. No provision of HVAC in change room and main corridor of ceph manufacturing area No HVAC in vial washing room Plain water, deionized water and distilled water lines were provided in the vial washing
room but no status labeling on these lines. No provision was seen for water for injection loop in vial washing room Dry heat sterilizer and autoclave installed in washing room were very old and no
evidence was available for their qualification / validation Magenhelic gauge outside the sterile vial filling area showed zero pressure, meaning
there was no pressure differential in the room. Dry powder vial filling line was very old and no evidence of qualification / validation. No temperature monitoring in finished goods store area.
Liquid injectables (ampoule) section
Common change room for liquid injectable and cephalosporin dry powder injectable sections. Male and female staff enter and come out of both the above sections through the same change room.
No proper change room for ampoule washing room No proper HVAC in ampoule washing room Ampoule washing machine was very old and almost manual. No clarity on quality of water used for ampoule washing. No provision was seen for
water injection loop in ampoule filling machine. No manometer installed to demonstrate air pressure differential in ampoule filling
room. No connection of water for injection loop in ampoule manufacturing area. No mixer for
making solutions. No means for pressure filtration of solutions. Autoclave for filled ampoule sterilization was very old and no evidence of qualification
/ validation. No provision for ampoule leak testing.
Veterinary injectables section
Clean down and quarantine area is common No temperature control in raw material store. No sampling and dispensing booth No status label on water lines No filter assembly was available for filtration of injectable solutions. No laminar flow on injectable filling machine No HVAC in sterile cool down area and vial washing area. No autoclave was available in veterinary injectable area
Eye drop section:
No proper change facility for sterile eye drop section No HVAC in washing area No status labeling on water lines No filter assembly for eye drop solution filtration. One old filling machine was installed in a room, without any provision for stopper
inserting and capping. No laminar flow on filling machine.
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Eye ointment section There was no equipment in ointment manufacturing No service lines or drain lines in the room There was not any room for ointment filling and no filling machine was available.
Dry powder (cephalosporin)
No status labeling in stores No HVAC in change room HVAC was not working in powder mixing room Cephalosporin powder filling room is next to non-cephalosporin tablet compression
room and non-ceph tablet coating room with a door in between. Chances of cross contamination were evident.
No provision of bottle cleaning No dust control or extraction in powder filling area. A blister cutting and a strip cutting machine were lying in a small room. Both were very
old and looking out of order. An old capsule filling machine was lying in a small room in cephalosporin area.
Oral liquids section
HVAC supply and return duct were on the same wall of the liquid filling room. Therefore chances of quality air not reaching to the other end of the room
No transfer pump or filtration assembly seen in the liquid manufacturing room. Tablet section
No positive or negative air pressure differential in tablet compression rooms. Entry to one table compression room is through another tablet compression room;
therefore chances of cross contamination. Solvent coating is carried out in open pans. No exhaust system for solvent vapors. No proper HVAC ducting. Supply and return on the same wall. Granulation area very noisy due to air coming from the air supply duct. Seems
problem in air balancing. No positive or negative air pressure differential in granulation room. Veterinary oral liquid & powder section.
No proper manufacturing vessel in liquid manufacturing area. No proper liquid filling machine. Powder blender was available in one room but not powder filling machine. No exhaust system or air pressure differential were available.
The panel further concluded and recommended that:- The panel observed a number of shortcomings in building, production machinery, HVAC system, documentation etc. Therefore, based on the areas inspected, the people met and documents reviewed and considering the findings of inspection the panel recommends that the Drug Manufacturing License may be granted to M/s Rex Pharmaceuticals Pakistan, Karachi, for two sections only namely Oral Liquids and Tablet (after addressing the observations in this report). Proceedings of the 257th Meeting of CLB
The Deputy Director (QA) presented report of the panel in compliance to decision of 147th Meeting of Appellate Board.
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Decision of the 257th Meeting of CLB
After thorough discussion/deliberations, considering all the pros and cons of the case, recommendations of the panel of experts in its report dated 12.12.2017 decided to
1. Re-inspect the firm M/s Rex Pharmaceutical Pakistan, Karachi by following panel
of experts, constituted by the Appellate Board in its 147th Meeting:-
a. Dr. Kifayat Ullah, CDC, Gilgit, Baltistan b. Prof. Dr. Maqsood Ahmed, Ripah International University, Lahore c. Syed Muied Ahmed, Expert in Manufacturing, Karachi
2. The panel shall submit the detailed report alongwith rectification status of the
observations in the Tablet Section and Liquid Syrup Section noted by the panel in its report dated 12.12.2017. Further more the panel will also submit detailed report regarding the quality control laboratory and storage facilities of the firm. The report shall be placed in the forthcoming meeting of Central Licensing Board for consideration.
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Quality Control Cases
Case No. 01:
Subject: - Manufacturing and Sale of Unregistered Drug Product-PregEase Tablets Batch
No.15021 by M/s Zestech Sciences, Karachi for ICI Pakistan, Karachi F. No. 4-
07/2015- (QC)
The FID-II, Karachi Mrs. Muneeza Khan inspected the premises of M/s ICI Pakistan Limited
5- West Wharf Road Karachi on 19-03-2015 and took the sample of Tab Preg Ease Batch No.15021
manufactured by M/s Zestech Sciences Karachi. The sample was sent to the Federal Government
Analyst, CDL Karachi for test/analysis purpose. However, the Federal Government Analyst, CDL,
Karachi vide his test report No. KQ.102/2015 dated 13-05-2015 declared the said drug product preg-
Ease tablets Batch No.15021 manufactured by M/s Zestech Sciences, Karachi for ICI Pakistan,
Karachi as Un-registered drug product under the Drug Act, 1976.
The result of CDL test Report
Remarks:-
“The label of the sample claims “Natural Nutritional Supplement to help calm nausea &
jkvomiting of pregnancy (NVP) vitamin B6 and calcium have been identified as allopathic ingredients.
Hence, the sample is declared as un Registered Drug product under the Drug Act 1976”
2 The FID-II served the explanation letter on 26th
May 2015 to the firm M/s ICI Pakistan Ltd
Karachi and M/s Zestech Sciences Karachi to explain their position. In reply to the FID explanation
M/s Zestech Sciences Karachi requested for Appellate testing of drug in question under the provision
of Drugs Act 1976 on 30th June 2015. The sample was sent to the Appellate Laboratory NIH
Islamabad. The Appellate Laboratory has also declared the sample of said drug product as of
substandard quality vide its test report No. 027-MNHRS/2015 dated 02nd
November 2015 along with
remarks mentioning the sample unregistered and unlicensed.
The result of Appellate Laboratory:-
Assay:- Stated Found Limit Percentage
Vitamin B6 2mg/tab 1.903mg/tab 90-110% 95.14%
Folic Acid 400mcg/tab 415.68mcg/tab 90-110% 103.92%
Calcium 124.1mg/tab 11.18mg/tab 90-110% 9.018%
Does not comply with manufacturer’s specification.
The FID-II Karachi furnished the names of responsible accused persons in his report are as
under:-
Mr. Ahsan Feroz Proprietor
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Mr. Mumtaz Ali Khan Production Incharge
Mr. Ejaz Ahmad Paracha QC Manager
Recommendations of FID:-
“Based on the above submission and Lab reports it can easily be concluded that the drug Preg Ease
tablets is un registered un-licensed and Sub-Standard product hence sheer violation of Section 23 &27
of Drugs Act 1976 by the manufacturer M/s Zestech Sciences Plot No. 47/23, Korangi Industrial area
Karachi based on the violations committed by the firm it is concluded that the contents of case may be
kept on the agenda of upcoming meeting of CLB for permission of prosecution against the firm or the
contents may be sent to Director OTC & Herbal for his comments in the light of the SRO 412”.
The show cause notices were issued to the above named accused persons offering them opportunity of
personal hearing before the Central Licensing Board before its 249th
meeting held on 29-08-2016. The
Firm had submitted the reply of show cause notice. The case was accordingly placed before the CLB
in its 249th
meeting held 29th
August 2016.
Decision of 249th
meeting of CLB
The Board deferred the case due to paucity of time.
The said accused persons were called for personal hearing.
Proceedings:-
Mr. Ahson Feroze appeared before the Central Licensing Board in its 250th
meeting held 27th
October
2016 and pleaded their case and informed that he is the Managing Director of M/s Zestech Sciences
Karachi and M/s Maple Pharmaceuticals Karachi. He was accompanied by Mr. Saeed Khan who
informed that he looks the matters of
Regulatory affairs of both firms M/s Maple Pharmaceuticals Karachi and M/s Zestech Sciences,
Karachi. Mr. Ahson Feroze claimed that their firm (M/s Zestech Sciences Karachi) had not received
the copy of test report of Appellate Lab NIH Islamabad and said that the FID had picked three
products out of which two were cleared by CDL, Karachi. He informed that their firm has got the
enlistment while products were applied to Division of Health & OTC, DRAP, Islamabad.
Decision:-
The Board after detailed discussion, deliberation and keeping in view the facts of the case the Board
decided as under:-
1. To direct the concerned FID Karachi, to re investigate the case by including M/s ICI,
Karachi from where the samples were picked for test/analysis as the subject drugs were
stocked for sale in the premises of M/s ICI Karachi. The Board directed the FID to
submit the complete case after fulfilling codal formalities with provisions of law and
along with clear and candid recommendations.
2. The Board directed the Quality Control Section to get the status of enlistment of the firm
M/s Zestech Science Karachi and product (Tablet Preg Ease) from the Division of Health
& OTC, DRAP, Islamabad along with the comments on both laboratories test reports.
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As per decision of the Central Licensing Board Federal Inspector of Drugs Karachi (Mrs.
Muneeza Khan) and Deputy Director Health OTC, DRAP Islamabad was requested to
implement the decision of Central Licensing Board.
In compliance of decision of Central Licensing Board:
1. The Deputy Director Health & OTC, DRAP, Islamabad replied vide letter No.F.08-24/2016-
DD (Health &OTC) dated 23rd
December 2016 wherein he informed that the said firm was
enlisted as manufacturer of Softgel capsules Hardgel capsule Tablet, Oral Liquid, Cream
Ointment and Sachet dosage forms in 7th
meeting of Enlistment Evaluation committee held on
01-02-2016. The products of M/s Zestech Sciences are under evaluation and till to date no
product have been enlisted for market authorization.
2. The area FID Karachi vide letter No.MK-33-43/2015-FID-II(K) dated 27th
April, 2017,
informed that she picked the samples from the premises of ICI Pakistan Limited 5- West
Wharf Road Karachi.
She further submitted that based on information and Laboratory reports it can easily be concluded that
the drug PregEase is un-registered and substandard drug/ product, hence M/s ICI Pakistan
violated the section 23(1)(a)(v) & 23(1)(a)(vii), which is punishable under section 27 of the
Drugs Act 1976. She recommended that M/s ICI Pakistan Ltd: may be prosecuted in the drug
Court of Sindh Karachi.
Current Status of the Case:
The case was placed before CLB in its 254th
meeting held on 15th
June 2017. The Board decided the
case as under:
Decision:
“The Board deliberated on the facts presented above and decided to defer the case till
completion of all codal formalities including the Showcause Notice is required to be served to M/s
ICI Pakistan Limited 5- West Wharf Road Karachi with clear and candid recommendations for the
consideration of the board.”
As per decision of CLB the show cause notice was issued to the M/S ICI Pakistan Ltd: Karachi dated
07-07-2017, but no response has been received till to date.
Proceedings and Decision of 257th
Meeting of CLB:
Central Licensing Board was informed that M/s. ICI Pakistan failed to respond the show cause
notice issued to them. After threadbare evaluation decided that the views/ comments of the Health &
OTC Division/ EEC shall be obtained on the subject matter before taking any decision.
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Case No. 02:
Subject: Seizure of un registered Drugs under Section 18(1) of the Drug Act 1976.
The FID Lahore Mr. Syed Zia Husnain visited the premises of M/s Mahmood
Pharmacy S-77-R/85/C, Jail Road, opposite Services Hospital Lahore on 26th
August, 2016. The FID
forwarded the case to the Director, QA<, DRAP, Islamabad vide letter No.12406/2016-DRAP (L-
V) dated 29th
August, 2016.
At the time of raid Mr. Sana ullah S/o Muhammad Suleman R/o H. No.05 St. No.05, mohallah
Amin park Ravi road Lahore who is manger was present. Mr. Atif Ejaz S/o Ejaz pervaz R/o 67/C
Punjab Co-operative housing Society, defense Lahore (Qualified person as per drug sale license ) was
gone for jumma prayer as informed by the manager Mr. Daud Tareen s/o Muhammad Aslam Tareen
R/o B-42, GOR-III Shadman, Lahore (Proprietor) was absent.
The FID Lahore seized the following drugs on form-2 under section 18 (1) (f) of Drug Act,
1976:
S. No. Name Of
Product(s)
Batch/Lot
No.
Mfg
Data
Exp.
Date
Manufactured
by
Quantity
01. Marevan
5mg
Tablets
A520518 11-15 05-18 Mfd By. GSK
(Detail address
not mentioned
in English)
(13)
Thirteen
jars
02. Marevan
5mg
Tablets
A521058 03-16 09-16 -do- (11)
Eleven
jars
03. Marevan
5mg
Tablets
A520917 02-16 08-18 -do- (04) Four
jars
04. Marevan
5mg
Tablets
A520916 02-16 08-18 -do- (15)
Fifteen
jars
05. Marevan
5mg
Tablets
A520917 02-16 08-18 -do- (03)
Three
jars
06. Centrum
Silver
M25939 - Sep-17
Marked by.
Pfizer
Madison,
NJ07940 USA
2015 Pfizer Inc
Made in
Canada
(03)
Three
Packs
07. Centrum
Silver
M87735 - Dec-17 2014 Pfizer Inc
Made in
Canada
(02) Two
Packs
08. Centrum
Silver
N43989 - 01-18 2014 Pfizer Inc
marked by M/s
Pfizer
Madison,
NJ07940
(02) Two
Jars
Page 114 of 116
09. Colomycin
Injection
11393 10-2014 10-2017 M/s Forest
Laboratories
UK, Ltd,
Whiddon
Valley,
Branstaple,
North Devon
Ex 32 8NS,
United
Kingdom.
02
Packs×10
Vials
10. Viagra
100mg
Tablets
MALL
19990544G
Dec-
2013
01-Apr-
2018
Mfd by.
Brooklyn, Ne
Packed by:
Pfizer Ply Ltd,
Australia
(03)
Three
Packs×
06
Tablets
11. Cialis
20mg
Tablets
Control No.
0674654099
-
April-
04/2018
Made in USA (02) Two
Packs×
03
Tablets
12. Centrum
Tablets
M877733 - Dec-17 Mfd. Pfizer
Inc. Canada
(02)
Packs
13. Neurobion
Injection
213371 12-2015 112017 Mfd. Merck
kGaA,
Darmstadt,
Germany
(03)
Three
Packs
14. Pirfenex
200mg
Tablets
BA60218 Dec-15 Nov-17 Mfd. Cipla
Malpur, Solan
173205 India
(01) One
Pack
The FID seized these unregistered drugs in contravention to section 23 of Drugs Act,
1976 and also contravention to DRAP Act, 2012 and the room was locked and sealed under section 18
(i) (h) of Drugs Act, 1976.
Samples of drugs which were available in sufficient quantities were also sent to Federal
Government Analyst for test/ analysis.
The details of test/analysis results of said drugs by Federal Government Analyst, Central
Drug Laboratory are as under:-
S.No. Test Report No.&
date
Name of Drug
with batch No.
Mfg by Remarks of CDL
1. Test Report No.
R.LHR.403/2016 dated
01-11-2016
Marevan 5mg
Tablets Batch
No.A521058
M/s GSK Declared
Unregistered report
no.R.LHR.403/2016
dated 01-11-2016
Page 115 of 116
2. Test Report No.
R.LHR.404/2016 dated
01-11-2016
Centrum Sliver
Batch
No.M30477
M/s Pfizer
Inch,
Canada
Declared
Unregistered report
no.R.LHR.404/2016
dated 01-11-2016
3. Test Report No.
R.LHR.405/2016 dated
02-11-2016
Cialis 20mg
Batch
No.0674654099
M/s GSK Declared
Unregistered test
report no.
R.LHR.405/2016
dated 02-11-2016
4. Test Report No.
R.LHR.406/2016 dated
02-11-2016
Pirfenex Tablets
Batch
No.BA60218
M/s Cipla
Ltd India
Drug is not included
in any
Pharmacopoeia, test
report no.
R.LHR.406/2016,
dated 02-11-2016
The FID requested to allow to keep the safe custody of the seized drugs mentioned on
Form-2 under Section 19(5) of the Drug Act 1976 as the firm is involved in illegal and unregistered
manufacturing of drugs.
Permission of safe custody of the stock was granted to the FID on 16th
September 2016.
Meanwhile M/s Mehmood Pharmacy S-77-R/85/C, Jail Road Opposite Services Hospital Lahore filed
application in the Drug Court, Lahore in connection with case under reference. On the order of Drug
Court Lahore, premises (room) under reference was de-sealed on 17-11-2016.
Recommendations of FID
Since the sale and stock of un registered drugs in prohibited under section 23 (1) and section A(1)
(a)(vii) of schedule II of Drugs Regulatory Authority of Pakistan Act 2012 which is punishable under
section 27(1) (A) of the Drug Act 1976 and schedule III of DRAP Act 2012 . sale of un registered
drug is cognizable offence under section 30(2) of the Drug Act 1976 and schedule IV(1) (a) of Drug
regulatory authority of Pakistan Act 2012. As pharmacy is not explaining their position in response to
the letters of FID. The FID further informed that all four reports of Federal Government Analyst have
also been received, therefore under the explained circumstances mentioned above case is being
forwarded under section 19(7) of Drugs Act 1976 and section 7 of schedule V of Drugs Regulatory
Authority of Pakistan Act 2012 to seek further orders of central licensing Board as to action to be
taken against the following accused persons in respect of contravention of Drug Act 1976 and Drug
Regulatory Authority of Pakistan Act 2012.
The Show cause notice was issued to the following accused persons on 25th
January 2017.
Page 116 of 116
M/s. Mehmood Pharmacy S-77-R/85/C,
Jail road, Opposite Services Hospital,
Lahore.
Mr. Sana Ullah S/O M Suleman
House No. 05, Street No.05
Mohellah Amin Park Ravi Road, Lahore
Mr. Atif Ejaz S/O Ejaz Perves R/O67/C
Punjab Co-Operative Housing Society
Defense Lahore.
Mr. Daud Tareen S/O M Aslam Tareen R/O
B-42, GOR-III, Shadman, Lahore
(Proprietor).
However, the accused persons had not submitted the reply of the show cause notice.
Current Status:
The Names of the accused persons alongwith CNIC nos., contact nos. and copy of Drug Sale
License have been received from the FID in response of the decision of 252nd
Meeting of the Central
Licensing Board.
Proceedings and Decision of 257th
Meeting of CLB:
After detailed evaluation and discussion the Central Licensing Board decided to issue show
cause notice to the following accused persons:
i. M/s. Mehmood Pharmacy
S-77-R/85/C, Jail Road,
Opposite Services Hospital, Lahore through its Proprietor
ii. Mr. Sana Ullah S/O M Suleman
House No. 05, Street No.05
Mohellah Amin Park Ravi Road, Lahore.
iii. Mr. Atif Ejaz S/O Ejaz Perves R/O67/C
Punjab Co-Operative Housing Society Defense,
Lahore.
iv. Mr. Daud Tareen S/O M Aslam Tareen R/O
B-42, GOR-III, Shadman, Lahore
(Proprietor).
and called for personal hearing in the upcoming meeting of the Central Licensing Board.
The meeting ended with the vote of thanks to and by the chair.
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