TRANSPARENCY INTERNATIONAL-PAKISTAN

24th July, 2017

Mr. Ayub Sheikh, Federal Secretary, Ministry of Health, Government of Pakistan, Block C, Pak Secretariat, Islamabad.

4-C, Mezzanine Floor, Khayaban-e-lttehad, Phase VII, Defence Housing Authority, Karachi. Tel: (92-21) 35390408, 35311897-8, Fax: (92-21)35390410 E-mail: ti.pakistan@gmail.com Website: www.transparency.org.pk

TL17/2407/5A

Sub: Violation of Rules by DRAP on Posting of Inexperience and Newly Appointed Assistant Directors as Federal Inspector Drug in MOH.

Dear Sir,

Transparency International Pakistan has received a complaint on the violation of rules by DRAP on posting of inexperience and newly appointed Assistant Directors as Federal Inspector Drug in MOH.

The complainant has made following allegations;

1. DRAP Authorities recent)~ issued an illegal office order, Reference No: F-1-112017 Addl Dir (QA & l.T) dated 1 i May 2017, issued by Hamza Zahid Malik Assistant Director Admin, about posting of6 Asst. Directors, (RO 12) as Federal Inspector Drug.

2. The Office Order is unlawful & against the DRUG ACT I 976. 3. The Office Order relates with the Assistant Director recruited last year only by DRAP,

and have been given the additional duties to act as Federal Inspector of Drug, which can not be performed by these fresh graduate with no experience at all.

4. This official orders has endangered and has put the life of innocent people at risk due to the following acquirements of DRAP Act:

Duties of Federal Inspector of Drug

• The main duties are to ensure sales & production of quality medicine in public interest at large.

• To give advice to pharmaceutical industries on technical matters pertaining to manufacturer of Drugs in accordance with GMP with a view to improve the standard of industries & quality of drugs.

• To conduct the surveillance of the marketed drugs for ensuring quality control & compliance of various provisions ofthe act and these rules &

• To assist in organizing & conducting the program for the monitoring of the adverse reactions of drugs.

5. For this reason, the following selection criteria of Federal Inspector of DRUG has is mandatory;

Qualification of Federal Inspectors: A Federal Inspector shall be a person who: }7

A NON-PARTISAN, NON-PROFIT COALITION AGAINST CORRUPTION Donations exempted from tax U/S 2 (36) (c) of I. Tax Ordinance 2001

~TRANSPARENCY .:;/INTERNATIONAL-PAKISTAN

Continuation Sheet No ......... .

1. Has a degree in Pharmacy from a Pakistani university or any other institution for this purpose by the Federal government &

ii. Has for a period of, or for periods: aggregating not less than ten years practical experience in i) the manufacture testing or ii) analysis of drug or in drug administration.

iii. Provided that condition of experience may be relaxed in exceptionally deserving cases or for persons with higher qualification or where the candidate with requisite experience is not readily available.

6. All the Six newly posted FID's neither have prescribed qualification nor any kind of relevant experience and are unable to analyse GMP compliance which may lead to serious life threats of innocent patients.

7. Moreover the nomination of Federal Inspector of DRUG is the responsibility of Federal Government and not DRAP.

8. The CEO DRAP should be asked withdraw the said notification immediately & all types of inspection such as (Grant of License, Grant of additional sections, H & OTC Manufacturing units, e.t.c.), which have been conducted by these illegal and unqualified officer may be considered Null & Void.

9. Inquiry shall be conducted for this illegal act.

TI Pakistan have examined the compliant, and feels the prima facie, DRAP has committed illegal act of posting of 6 Asst. Directors, (RO 12) as Federal Inspector Drug, against the rules and experience criteria.

The Secretary is requested examine the compliant, and ifthe allegations are correct, action shall be taken to withdraw the illegal orders and also make accountable all officers and pharmaceutical firms responsible for this act which may be cause of serious life threats of innocent patients.

Transparency International Pakistan is striving for across the board application of Rule of Law, which is the only way to stop corruption.

Copies forwarded for the information with request to take action under their mandate to:

1. Secretary to Prime Minister, Islamabad. 2. Chairman, NAB, Islamabad. 3. Registrar, Supreme Court of Pakistan, Islamabad.

Secretary

M/ONHSR&C

Subject: Appointment ofFIDs in violation of rules

Dear Sir,

Drug Act, 1976 and DRAP Act, 2012 are comprehensive legislations to cater drugs and medicines/therapeutics goods for their import, export, manufacturing, registration, pricing, testing and inspections. As per aforementioned Acts, various rules have been framed for performing these activities as per law.

Drugs (Federal Inspector, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976 are comprehensive and have provisions for appointment, duties and procedures for FIDs and government analysts. It is pertinent to mention that DRAP has recently appointed 06 FIDs at various stations but these appointments are in contravention to above mentioned rules, as follows:

• As per rule 3(a)(b ), FIDs must have a least I 0 years' experience for entitlement for appointment as FID. But to our astonishment these recently appointed persons don't possess required experiences for posting as FlO.

• The rules also explicitly said that I 0 years' experience can be relaxed in case of either higher qualification or a candidate with requisite experience is not available. Bit in DRAP's case, both conditions are not applicable as these persons are neither highly qualified nor there is dearth of experienced persons in DRAP.

• There are likely chances that mafias involved in manufacturing and sale of spurious, un-registered and il-legal drugs will get benefit like relief from drug courts due to violation ofthe law.

• There are reports that these newly appointed FIDs are so in-experienced that they hesitate to go to manufacturing units alone and in some cases industries persons also threatened them from entering their manufacturing facilities.

You being Secretary of the Ministry and Chairman, DRAP's policy Board should review above decision in best public interest.

THE DRUGS (FEDERAL INSPECTORS, FEDERAL DRUG LABORATORY AND FEDERAL GOVERNMENT ANALYSTS) RULES, 1976

S. R. 0. 793 (1 )176: In exercise of the powers conferred by Sec. 43 of the Drugs Act, 1976 (XXXI of 1976), the Federal Government is pleased to make the following rules, the same having been previously published as required by sub-section (3) of the said section, namely

1 Short title and Commencement : (I) These rules may be called 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976.

(2) They shall come into force at once. 2. Definitions: In these rules, unless there is anything repugnant in the subject or context,-­(a) "Act" means the Drugs Act, 1976 (XXX1 of 1976); (b) "Section" means a section of the Act; and {c) "form" means a form set forth in the Schedule.

3. Qualification of federal Inspectors: (1) AF:.ederallnspector shall be a person who-

(a) has a .degree in Pharmacy from a f'akistani University or any other institution recognised for this purpose by the Federal Government; and

(b) has for a period of, or for periods: aggregating, not less .than ten year~· practical experience in, (i) the manufacture, testing'or analysis ofdrugs, or (ii) in drug administration:

Provided that the condition· of ~xperienc~. may be relaxed .in exceptionally deserving cases or for persons with higher qualifications.or\vherethe candidate; with requisite experience are not readily available:

Provided further that the Federal Government may, by notification in the official Gazette, for the exercise of such powers as may be specified in such notification, appoint as ex officio Inspector any officer of medical or public health department who is a registered medical practitioner or any officer who is working in the drugs administration of a Government who has a degree in Medicine or Science or Pharmacy or any person having similar qualifications working as a teacher in any pharmaceutical or medical educational institution

(2) Th.- Federal Inspector shall be under the control of the licensing authority referred to in Section 18.

Explanation: For the purposes of this sub-rule and rule 4, "licensing authority" means the Director General Health, Government of Pakistan, or an officer authorised by him in this behalf.

4. Duties of Fec:ferallrispectC>rsi (1) Subject to the instructions of the licensing authority, it shall be the duty of an inspector, within the local limits for which he is. appointed--

(a) to inspect not less than twice a year, all premises licensed for the manufacture of drugs

including the plant and the process of manufacture, the means employed for standardising and testing the drugs, the methods and places of storage, the location, construction and administration of the establishment likely to affect the potency for purity of the product, records and registers and to satisfy himself that the conditions of the licence and the provisions of the Act and the rules made thereunder, are being observed ;

(b) to inspect from time to time establishment licensed for the import, export or sale of drugs and to satisfy himself that the conditions of the licence are being observed;

(c) to send forthwith to the licensing authority after each inspection a detailed-report indicating the conditions of the licence and provisions of the Act and the rules made thereunder which are being observed and the conditions and provisions, if any, which are not being observed;

(d) to take samples of any drug which he has reason to suspect that it is being manufactured, stocked, sold or exhibited for sale in contravention of the provisions of the Act or the rules made thereunder. and send them for test or analysis;

(e) to investigate any complaint in writing which may be made to him; L .... ]

(f) to institute, if necessary, prosecutions in respect of breaches of the Act and the rules made thereunder. §.nd

.(g) to give advice to phermaceutical industry on technical matters pertaining to the manufacture of drugs in accordance with good manufacturing practices with a view to improve the standard of industry and quality control of drugs;

(h) to conduct surveillance of the marketed drugs for ensuring quality control and compliance of the various provisions of the Act and these rules, and

(i) to assist in organizing and conducting the programme for monitoring of the adverse reactions of drugs.

(2) A Federal Inspector shall, for the purpose of clause (i) of sub-section(!) of Section 18 take the approval of, and for the purpose of clause (ii) of sub-section (3) and sub-section (5) of Section 19, send the sample to, or, as the case may be, inform. the Registration Board in the case of registered Drugs and the Central Licensing Board in all other cases.

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