off record
Shaukat Ali Jawaid

Strengthening Drug Regulatory
Authority of Pakistan 


After the recent constitutional amendments which transferred health to the provinces, the Federal Government has established Drug Regulatory Authority of Pakistan to manage and regulate pharmaceutical trade and industry which is centrally controlled all over the world. Prior to the formation of DRAP some discussions were held by the government authorities with the representatives of the pharmaceutical trade and industry which did give some useful suggestions to ensure its efficient functioning. One of the most important suggestions put forward was that it should be headed by a qualified person fully familiar with the working of the pharmaceutical trade and industry. Not only that it was also suggested that various committees and boards constituted by DRAP should also consist of people with good track record who are not only experts in their respective fields but also devoted and dedicated, in short each and every appointment should be based on merit.

Now after so many months of its establishment, the functioning of DRAP has come under severe criticism from the pharmaceutical trade and industry and some of their concerns are genuine which needs to be looked into seriously. Chairman of the PPMA in a press statement has stated that no meeting of the registration board, licensing board, or pricing committee has taken place in the last six months with the result that decision on 16,000 products is pending at various levels. Pakistani Pharma industry had made lot of inroads in various markets to export pharmaceuticals earning precious foreign exchange for the country but due to inefficient working at the DRAP, efforts to increase drugs exports are likely to suffer. DRAP is also reported to have increased its fees and charges for various services which, it is said, will also affect drugs exports.
There is no denying the fact that some groups within the pharmaceutical trade and industry may have their own vested interests. Hence it is all the more important that DRAP should be headed by a person who cannot be befooled and misguided. Only a competent and qualified person who is fully familiar with the situation can take decisions which are in the greater national interests. A comprehensive job description of the Chief Executive of DRAP, it is learnt, was forwarded to the federal government sometime ago and if the authorities were sincere, they should have selected the right person. The position requires a post graduate degree in Pharmacy, Public Health or Medicine, with a minimum 20 years’ experience in varied positions of management dealing progressively with regulatory affairs, professional pharmacy practice, training of subordinates and mentorships, human resource management, budget and planning, information systems, supply chain management and in depth knowledge of quality system for drug manufacture and drug usage. Track record of research in pharmacovigilancve, pharmacy practice, pharmacoecnomics, pharmacoepidimiology, quality systems and drug usage evaluation would definitely be a plus.
There seems to be no justification for not holding the meetings of the Drug Registration Board, Licensing Board and Pricing Committee for so long. In fact they should be meeting quite frequently to ensure there is no inordinate delay in taking decisions. All the pending cases should also be expedited in an emergency meeting and effective measures taken so that no fresh cases get piled up for too long without any decision. All this is only possible if the authorities select the right people for this job and also give them authority removing all bureaucratic hurdles. The job of the regulators should be that of a facilitator rather than punitive and controller.
Keeping in view the current economic conditions of the country, every effort should be made to help facilitate economic revival. The PML (N) government which has recently released numerous advertisements offering coveted jobs of chief executives of various institutions and organizations in the public sector and also assured transparency, should also look into the state of affairs of Drug Regulatory Authority of Pakistan. Why not apply the same principle and advertise the post of CEO of DRAP and select the best talent.
It is heartening to note that the government is now ensuring transparency in such appointments hence it must also ensure that DRAP is also headed by an experienced competent talented individual who understands this subject. Similarly membership of various boards and pricing committee should also be looked into and if need be, appropriate steps taken which ensures efficient functioning of Drug Regulatory Authority of Pakistan. Problems and hardships faced by the Pharma trade and industry must be resolved on urgent basis and a meaningful dialogue with the representatives of pharmaceutical trade and industry will prove to be quite helpful.

Tail Piece: According to reports sometime ago a committee was interviewing people for the post of chief executive of Drug Regulatory Authority of Pakistan for which many including some people from the drug control department had applied. After giving interview when one of these government officials went out, an important member of this committee is reported to have gone after him and had some discussion with him in the corridor at which other members of the committee were quite surprised. Later when one of them asked this official as to what was discussed, he said “I was told elections are coming, help me collect about two crore rupees from the pharmaceutical trade and industry so that I can finance my election campaign”.{jcomments on}

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