eoi for supply of anti cancer and other restricted medicines under cghs
TRANSCRIPT
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F. No. 30-01/2013-14/CGHS/MSD/EOI Govt. of India, Ministry of Health & Family Welfare
Dte. General of CGHS, Medical Store Depot DIZ Area, Sec-II, Udyan Marg, Gole Market, New Delhi-110001
Tel: 011-23365219, Fax: 011-23342124
TENDER NO.-04/2014-15
NOTICE INVITING EXPRESSION OF INTEREST CUM REGISTRATION OF SUPPLIERS
Central Government Health Scheme (CGHS) procures restricted drugs for treatment in Cancers & other life threatening conditions for its beneficiaries on case to case basis. A list of such drugs can be obtained from the Office of the Medical Store Depot (hereinafter referred to as MSD) at the address mentioned above and are also available on the CGHS webpage at cghs.nic.in.
CGHS invites expression of interest from manufacturers of above mentioned restricted drugs (as per list available on the webpage or in the office of the MSD) or importers (in case of imported drugs), as the case may be, expressing their willingness for Registration to supply such drugs to the Medical Store Depot in Delhi and in 24 outside CGHS cities. They are also to provide other details in the format attached within three weeks of publication of this expression of interest in the office of the MSD by 3.00 pm on 02/06/2014.
1. SCOPE OF EXPRESSION OF INTEREST CUM REGISTRATION
The scope of this exercise is to identify & shortlist Manufacturers/Importers of high value Drugs used in treatment of Cancers & other life threatening conditions; and, Importers of such drugs not manufactured in India with the purpose to invite Bids from Registered Vendors at the next stage. Such manufacturers / importers will need to provide information on drugs in the attached list, manufactured or marketed by them (as the case may be) in all forms, specifications, strengths & packing units as per format at Annexure-B.
2. ELIGIBILITY:
Companies intending to participate in the EOI (hereafter called bidders) should first ensure that they fulfill all the eligible criteria as prescribed in the EOI. The main eligibility criteria are:-
2.1 Should be a licensed Indian drug manufacturer or importer having valid licenses.
2.2 Should have been manufacturing the drugs in own facility and market standing of last three financial years. Drugs manufactured on Loan License or manufactured by third party will not be eligible for participation.
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This would not apply to drugs, which were introduced in India less than 3 years ago. A certificate from the concerned Drug Controller shall be required for all new drug formulations to this effect.
2.3 Should have an average annual turnover of Rupees 50 Crores per year during last five financial years, with duly certified statement of Statutory Auditors to be enclosed with the EOI.
2.4 Should have GMP/WHO-GMP certificate as per Schedule 'M (as applicable) for items under Drugs & Cosmetic act.
2.5 Should not have been convicted for manufacturing/supplying sub-standard drugs or on any other grounds under Drugs & Cosmetics Act or rules framed there under.
2.6 Should not be currently blacklisted or deregistered by any Govt /Autonomous body/ institution, hospital in India.
2.7 Should have been filing VAT return regularly; an undertaking to this effect in prescribed proforma is to be submitted along with last VAT Challan / STCC.
2.8 Should submit PAN details along with last Income tax return acknowledgement.
3. Preparation of Expression of Interest (EOI)
Details of the EOI can be seen on the CGHS Webpage and on Central Public Procurement Portal at eprocure.gov.in/epublish/app and the forms can be downloaded free of charge.
All documents required in the EOI should be serially numbered and duly signed by the bidder, with the rubber stamp of the Company on each page before uploading.
The EOI prepared by the Manufacturer/Importer and correspondence and documents relating to the EOI exchanged between the Manufacturer/Importer and the Addl. Director CGHS (Medical Store Depot), New Delhi shall be in English language only, provided that in respect of some supporting documents in other language, certified copies of English version of such documents by authorized agents, should be submitted.
3.1 No additional document shall be accepted after last date of submission of the EOI but the Addl. Director CGHS (Medical Store Depot), New Delhi may demand to see the original document or submission of attested /certified copy of any document which has been submitted online or other document(s) requiring clarification.
3.2 The information shall be submitted as per the given format and should be devoid of any cutting, alteration and ambiguity. The Forms and undertakings should be filled and signed properly. It should be neatly typed without the use of erasure/white fluid etc. The documents /
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certificates should be under the name and premises where items quoted are actually manufactured.
3.3 Submission of the EOI is deemed to be agreeing to the terms and conditions of this Expression of Interest.
3.4 If the last day for receiving EOIs is declared a holiday, the next working day at the same time will be the last date & time for the receipt of EOIs in physical form in the prescribed envelop.
3.5 Each Manufacturer/Importer shall submit only one EOI.
3.6 The Manufacturer/Importer shall bear all costs associated with the preparation and submission of his documents and the Department will in no case shall be responsible or liable for those costs, regardless of the conduct or outcome of the EOI process.
3.7 The Manufacturer/Importer are advised to acquaint himself with the operational system. It shall be deemed that the Manufacturer/Importer is aware of the operational requirements prior to the submission of the EOI documents.
3.8 The Manufacturer/Importer are expected to examine all instructions, Forms, Terms and Conditions in the EOI document. Failure to furnish all information required by the EOI document or submission of a EOI not substantially responsive to the EOI document in every respect will be at the Manufacturer/Importer’s risk and may result in rejection of his documents.
3.9 The Manufacturer/Importer can seek clarification or submit suggestions by sending an email to [email protected] during the first 5 days of the publication of the EOI. All such queries shall be responded to by the 8th day on the CGHS webpage and at eprocure.gov.in/epublish/app. Manufacturer/Importers are thus advised to remain in touch with the sites. All communications between the Manufacturer/Importer and the Department shall be carried out in writing in English. Except for any such clarification by the Office of the Addl. Director CGHS (Medical Store Depot), no written or oral communication, presentation or explanation by any other employee of the Department shall be taken to bind or fetter the Department.
3.10 The Manufacturer/Importers should submit the correct email ID. All the correspondence shall be made directly with the Manufacturer/Importers through email ID provided.
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4. DOCUMENTS TO BE SUBMITTED:
The Manufacturers/Importers would be required to submit documents to qualify for the EOI. These should include the following:
(a) A valid Drug License (wherever applicable) issued by the Licensing authority concerned for the items conforming to the relevant Pharmacopeia/ specification for the item, valid on the date of EOI opening.
(b) A valid WHO GMP/GMP certificate as per Schedule 'M’ and as per requirement of the
Drugs and cosmetic act and rules of Govt. of India from Competent Authority.
(c) A certificate issued by the drug controller or the statutory auditor (chartered accountant) stating the market standing of the product for last three financial years.
(d) Companies may also provide Label/ literature on the products offered.
(e) A certificate issued by the Licensing Authority that the Manufacturers/Importers is not convicted under the Drugs & Cosmetics Act for manufacturing/supplying sub-standard drugs or on any other grounds. The certificate should not be more than six month old on the day of the Expression of Interest.
(f) An undertaking by the Manufacturers/Importers that it has not been deregistered, debarred or black listed by any Govt /autonomous body or institution/ hospital in India.
(g) Proof of Average annual turnover during last three financial years as mentioned in the Eligibility criteria. Statements of statutory auditors regarding Audit Certificates, Balance Sheets & Profit & Loss Accounts for last three financial years are to be submitted.
(h) Proof of Manufacturing and marketing experience for each item on due date of EOI as mentioned in the Eligibility criteria.
(i) VAT/TIN undertaking along with last VAT challan / STCC
(j) Acknowledgement of income tax return of last three financial years. (k) Annexure A, B, C & D - to be submitted with Expression of Interest. (l) EOI form - Part B duly filled in.
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PART-B
FORMAT FOR EXPRESSION OF INTEREST
(To be furnished on the Pad of the Company/Firm)
(Please attach copies of the documents where indicated, duly self attested)
1. Name of the Firm/Company:
2. Registered Address of the Firm/Company:
3. Address of the Company:
4. Name of the Director or his authorized representative of the company with contact details (Landline, Mobile & Fax Nos.) & email:
5. Copy of the Registration Certificate of the Company:
Yes/ No Page No
6. Copy of Ownership documents with copy of the Directors on Board:
Yes/ No Page No
7. PAN No. with copy of the PAN Card : Yes/ No Page No
8. Copies of VAT/TIN details (Please attach copy of the latest VAT paid Challan) (Annexure-C) Yes/ No Page No
9. Turnover of the company in last three financial years 2010-11, 2011-12 & 2012-13 (Copy of the Audit Certificate from the Chartered Accountants to be attached): Yes/ No Page No
10. Copies of the Income tax Returns of the entity for last three financial years 2010-11, 2011-12 & 2012-13 to be attached. Yes/ No Page No
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11. Copy of the Manufacturing Drug License for each item in which expressed interest to be attached:
Yes/ No Page No
12. Copies of the Approval of the DCGI in case of new or Imported Drugs, as applicable, for each item in which expressed interest to be attached. Yes/ No Page No
13. Copy of the WHO GMP/GMP certification:
Yes/ No Page No
14. Certificate issued by the Licensing Authority that the Manufacturer/Importer is not convicted under the Drugs & Cosmetics Act for manufacturing/supplying sub-standard drugs or on any other grounds(from all concerned Licensing authorities) Yes/ No , Page No:
15. Undertaking as per Annexure-D to be attached:
Yes/ No , Page No:
Certified & verified the information provided.
Signature:___________________ Name of the Director or his authorized representative of the company with Designation in the entity
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ANNEXURE ‘A’
MANUFACTURING & MARKETING CERTIFICATE This is to certify that M/s ______________________________________ are holding valid Manufacturing license No. ______________________________date ___________ of the State and they are manufacturing the following drugs for at least last three years. It is further certified that the following products are being marketed by them for last three years. The Products are as follows:
Sl. No.
Name of the drug Strength Period
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Signature and seal Date
NOTE: a. The certificate is to be signed by the Drug Controller of State or his authorized
representative. Certificate issued by Inspector of Drugs / Drugs Inspector will not be accepted unless their authorization by the State Drug Controller to this effect is supported by documentary proof.
b. This is to be submitted in the format given above or any similar formats of respective Drug
Controller
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Annexure ‘B’
Details of item quoted in the EOI
Drug Code
Drug name
Form (Cap/Tab/ Inj, etc)
Specific ation & strength, Packing Units
License No. at pg no.
GMP/WHO GMP Certificate at pg no
Manufacturing & Marketing cert. at pg no.
Manufacture of 2 batches /yr cert at pg no.
Other
Signature of applicant
Name Address
VAT/TIN No: Seal Date: (Instructions: 1. Please leave the col. on drug code vacant.
2. Please provide information on different forms & strengths of a drug in separate rows. )
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Annexure C
VAT Clearance Certificate
1. Name or style in which the applicant is assessed or assessable to Value Added Tax:
2. The district, Taluks and divisions in which the applicant is assessed to VAT:
3. This is to certify that we are registered with the Value Added Tax department vide TIN
No :............. and no penal action or proceeding for recovery of tax is pending against me. Certified that up to date VAT returns have been filed with the VAT department; last VAT challan/STCC is enclosed. I declare that the above information is correct and complete to the best of my knowledge and belief.
Signature of applicant / Authorized representative of applicant
Name
Address VAT/TIN No:
Seal Date:
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Annexure D
UNDERTAKING
I,_____________________________________________________________________________ Prop/Partner/Director of M/s___________________________________________________ ______________________________________________________________________________ do hereby declare that: I have read the terms and conditions of the Expression of Interest document and I agree to abide by these terms and conditions and other guidelines issued in this regard. I have enclosed all additional undertakings and / or certificates as required. The information given by me in this form is true and correct to the best of my knowledge and belief. Our company/Firm has not been deregistered or black listed by any Govt /autonomous institution, hospital or body in India for an item which is being quoted here by me in this Expression of Interest. Our company/Firm has own testing laboratories and in built quality assurance facilities and carry out batch-wise pre-inspection of the items and submit such reports along with the supplies to each user department. I understand that it is my duty to inform the Addl. Director (MSD) immediately if any of the item presented by the Firm / Company ever becomes ineligible as per the given eligibility criteria. Non submission of such information may lead to cancellation of the contract and/or debarring of the bidder from future bids for one or more items as deemed fit by the competent authority. Date: Name:
Designation:
Seal
Note: To be signed only by the person authorized to sign the tender document.
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LIST OF AUTHORITIES WITH ADDRESSES (CGHS OUTSIDE CITIES)
Sl.
No.
CITY NAME OF THE
ADDL.
DIRECTOR/JT.
DIRECTOR
DESIGN
ATION
MOBILE PHONE
OFFICE
(landline)
OFFICE POSTAL
ADDRESS
EMAIL ID
1 AHMEDAB
AD
Dr. M.L. Verma Addl.Dir. 09727757756 079-26587798
079-26587265
The Additional Director, CGHS, 2nd Floor, S.R House, Opp.Mount Carmel School, Ashram Road, Ahmedabad-3800 09.
adcghsahmedabad@
yahoo.co.in
2 ALLAHABA
D
Dr. Rastogi Addl.Dir. 09935778831 0532-2560578
0532-2561309
The Additional Director,
CGHS 2nd Floor Sangam Place
Civil Lines Allahabad.
om
3 BANGALO
RE
Dr. U.S. Biradar Addl.Dir. 09986961473
080-25500899 The Additional Director
Central Govt. Health Scheme
3rd, Floor ‘E’ Wing Kendriya
Sadan Koramangala
Bangalore-34.
4 BHOPAL Dr. A C Morey Addl. Dir. 09459877884 0755-2550265 O/o the Additional Director
Central Govt. Health Scheme,
Police I.TI. Building
Jahangirabad, Bhopal (M.P)
adcghs_bhopal@yah
oo.co.in
5 BHUBANE
SWAR
Dr. M.M. Dash Addl.Dir. 09437052633 0674-2500127 Office of The Joint Director
Central Govt. Health Scheme
Old A.G. Colony, Unit-IV,
Bhubneswar-751001.
om
6 CHANDIG
ARH
Dr. S.C. Anand Addl. Dir 09417603552 0172-
2740555(F)
2740716
Office of the Additional
Director, 4th Floor, Kendirya
Sadan, Sec-9A, Chandigarh-
160009
Cghs_chandigarh@yah
oo.in
7 CHENNAI Dr. S. Geetha Addl.Dir 09444992541 044-23458400
044-23458432
The Additional Director
CGHS, E-II C Rajaji Bhawan
Besant Nagar Chennai-90.
m
8 Dehradun Dr.Pradeep
Kumar
Addl.
Director
0983707291
8
0135-
2521235
19-Navyug Enclave,
Indirapuram, Phase-3,
Milan Vihar, GMS Road,
Dehradun, Uttarakhand-
248001
cghsdehradun@rediff
mail.com
9 GUWAHA
TI
Dr.
Mrs.K.M.Patir
Sr.CMO(S
AG)
09435107826 0361-2471214
0361-2492712
A.K.AZAD ROAD, GOPINATH
NAGAR, GUWAHATI-781016.
12
10 HYDERAB
AD
Dr. C N Prasad Addl.Dir 09948985185 040-27902316
The joint Director, CGHS,
kendriya Swasthya Bhawan,
Begumpet, Hyderabad-
500016
11 JABALPUR Dr. M.S. Nety. Addl Dir. 09755952428 0761-2405205
Fax-2411890
The Joint Director, Central
Govt. Health Scheme, 1544-
A, Nepier Town, Opp. Ashish
Hospital. Jabalpur-482001.
12 JAIPUR Dr. D.K.Gupta Addl.
Director
09887017525 0141-
2235110,22351
17, 2235119
Kendriya Sadan, Block-B,
Sector.-10, Vidhyadhar
Nagar, Jaipur-302023
addcghsjaipur@yaho
o.in
13 JAMMU Dr. S.C. Anand Addl. Dir 9417603552 0172-
2740555(F)
0191-
2520777(Jamm
u)
Office of the Additional
Director, 4th Floor, Kendirya
Sadan, Sec-9A, Chandigarh-
160009
cghs_chandigrah@yaho
o.in
14 KANPUR Dr. Ashok Kumar Addl. Dir. 09839909262 0512-2283499 The Additional Director CGHS
Plot No.8-11, Ratan Lal
Nagar, Kanpur-208022.
15 KOLKATA Dr. Anuran
Goldar,
Addl.Dir. 09433135847 033-22103921 The Additional Director,
Central Govt. Health Scheme,
4th Floor,8 Esplanade East,
Kolkata- 700069.
addl.directorkol@yah
oo.in
16 LUCKNOW Dr. A Sood Addl. Dir 09415010946 0522-2728989
0522-2728878
CGHS B-114-115, Vibhuti
Gomti Nagar Khand,
Lucknow
17 MEERUT Dr. C.M Kohli Addl.Dir. 09411618288 0121-2601426
0121-2601319
The Additional Director,
Central Govt. Health Scheme,
Swasthya Bhawan, S.K.Road,
Meerut(U.P.)-250003.
admeerut-
18 MUMBAI Dr. Singham Addl.Dir. 09969007770
09821554685
0222-2018600 The Additional Director,
Central Govt. Health Scheme,
Pratishtha Bhawan, Old CGO
Building, South Wing, Ground
floor, 101, M.K.Road, New
Marine Lines, Mumbai-
400020.
adcghsmum@yahoo.
com
19 NAGPUR Dr. W. Kale Addl.Dir. 09422104000 0712-2513723 The Additional Director,
Central Govt. Health Scheme,
Near TV Tower, Seminary
Hills, Nagpur-440006
20 PATNA Dr. Pandey Addl.Dir. 09473199300
09334310226
0612-2221819
0612-2207209
The Additional Director,Central
Govt. Health Scheme, 54-South
Chhajjubagh, Patna-800 001.
adcghspatna@yahoo.
co.in
13
21 PUNE Dr. R.S. Katke, Addl.Dir. 9422031946 020-24262961 The Additional Director,,
Central Govt. Health Scheme,
2nd Floor, Swasthya Sadan,
Pune-411037
22 RANCHI Dr. (Mrs)
Pushplata Aind
Addl Dir. 09431358080 0651-24262961 The Joint Director, CGHS,
New A.G. Colony.Doranda,
Ranchi-834002.
23 SHILLONG Dr.
S.D.Mazumder
Addl.Dir 09436164227 364-2520652 TheAdditional Director,
P.O.laitomkhrah, Nongrim
Hills. Shillong-793003
m
24 TRIVANDR
UM
Dr.Vinod Kumar Addl.Dir. 09446574447 0471-2449760 The Joint Director. CGHS
3445, Sesavdasapuram.
Trivendrum-695004.
Cghs.trivandrum@gmai
l.com
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LIST OF DRUGS
1 ABATACEPT
2 ABIRATERONE ACETATE 3 ALBUMIN
4 ALBUMIN BOUND PACLITAXEL
5 ALTEREATAMINE
6 AMIFOSTINE
7 ANASTRAZOL
8 ANTI HEAMOPHILIC FACTOR VIII
9 ANTI HEAMOPHILLIC FACTOR IX
10 ANTITHYMOSYTE GLOBULIN
11 BASILIXIMAB
12 BEBACIZUMAB
13 BENDAMUSTINE HYDOCLORIDE
14 BORTEZOMIB
15 CAPECITABINE
16 CETUXIMAB
17 CHLORAMBUCL
18 CRIZOTINIB 19 CYCLOSPORINE
20 DACLUZIMAB
21 DARBIPOITIN ALFA
22 DASATINIB
23 DECITABINE
24 DEGARELIX
25 DENOSUMAB
26 DESFERIOXAMINE MESYLATE
27 DEXAMETHASONE IMPLANT 28 DOCETAXEL
29 DOXORUBICIN HCL
30 DOXORUBICIN HCL LIPOSOMAL
31 DOXORUBICIN HCL LIPOSOMAL (PEGYLATED)
32 ELTROMBOPAG OLAMINE
33 ENTECAVIR
34 EPIRUBICIN HCL
35 ERIBULIN MESYLATE
36 ERLOTINIB
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37 ERYTHROPOITEIN
38 ESTRAMUSTINE
39 ETANERCEPT
40 EVEROLIMUS
41 EXEMESTANE
42 FACTOR-VIII INHIBITING AGENT
43 FENTANYL TRANS PATCH
44 FILGRASTIM
45 FLUDARABINE PHOSPHATE
46 FULBEXTERANT
47 GANCICLOVIR
48 GEFITINIB
49 GEMCITABINE
50 GLARGIN INSULIN 51 GOSERELIN ACETATE
52 HYLAN G - F 20
53 HYALURONIC ACID INJ.
54 IBANDORNIC ACID
55 IMATINIB MESYLATE
56 INFLIXIMAB RECOMBINANT
57 INTERFERON ALFA 2 A
58 INTERFERON ALFA 2 B
59 INTERFERON ALFA 2B
60 INTERFERON BETA - 1 B
61 INTERFERON BETA 1 ALFA
62 INTERFERON BETA-1 ALPHA
63 IRINOTECAN HYDROCHLORIDE
64 IVIG
65 IXABEPILONE
66 LENALIDOMIDE
67 LENNPRORELIN ACETATE
68 LENOGRASTIN
69 LEPATINIB
70 LETROZOLE
71 LEUPROLIDE ACETATE
72 LIPOSOMAL AMPHOYTERICIN B
73 LYMPHOCYTE IMMUNE GLOBULIN
74 MEGESTROL ACETATE
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75 METHOXY POLYETHYLENE GLYCOL
76 MYCOPHENOLATE MOFETIL
77 NATALIZUMAB
78 NILOTINIB
79 NILUTAMIDE 80 NIMOTUZUMAB
81 OCTREOLIDE
82 OMALIZUMAB
83 OXALIPATIN
84 PACLITAXEL
85 PAZOPANIB HYDROCHLORIDE
86 PEGAPTANIB SODIUM
87 PEGFILGRASTIM
88 PEGINTERFERON ALFA 2 A
89 PEGINTERFERON ALFA 2 B
90 PEMETREXED DISODIUM
91 PIMECROLIMUS 1%
92 PURIFIED BOTULINUM TOXIN TYPE A
93 RANIBIZUMAB
94 RECOMBINANT ANTI HEMOPHILIC FACTOR VIII
95 RITUXIMAB
96 RIVASTIGMIN
97 RUXOLITINIB 98 SIROLIMUS
99 SODIUM HYLURONATE
100 SOMATROPIN
101 SUNITINIB MALATE
102 TACROLIMUS
103 TELBIVUDINE
104 TEMOZOLOMIDE
105 TEMSIROLIMUS & DILUENT
106 TERIPARATIDIE (R- HUMAN PARATHYROID HARMONE (1-34)
107 THALIODOMIDE
108 THYROTROPIN ALFA
109 TOCILIZUMAB
110 TOPITECAM HYDROCHLORIDE 111 TRABECTEDIN
112 TRIPTORELIN ACETATE
17
113 TRIPTORELIN PAMOATE 114 VALGONCILOVIR
115 VINORLEBINE
116 VORICONAZOLE
117 ZOLEDRONIC ACID