THIS refers to the news item ‘Pakistan’s drug regulatory authority not recognised by WHO’ (July 10). The Drug Regulatory Authority of Pakistan (DRAP) has a testing laboratory — Federal Drug Surveillance Laboratory (FDSL) — to check the quality of drugs randomly.

This is done when there are doubts about the quality or authenticity of the documentation data in registration files of a particular drug submitted by manufacturer to the DRAP for drug registration. It is also for the surveillance of drugs after registration in post-marketing studies or for testing the quality of the samples sent by drug inspectors in course of their controlling activities.

The National Health Services Minister, Saira Tarar, has rightly demanded a properly installed building with equipment for the laboratory. WHO is not a regulatory authority. It is an advisory organisation which strongly recommends an official drug testing laboratory.

The perception that the exports of pharmaceuticals to developed countries would increase after the DRAP is approved by WHO is erroneous. The developed and other countries importing Pakistani drug products would check the quality of the products by a thorough scrutiny of the quality documentation and by sending their inspectors for auditing the drugs manufacturing plants in Pakistan for conformance to GMP standards.

The recognition of the DRAP by WHO has nothing to do with this. In the long run, the quality of drug products manufactured in Pakistan would increase if their products are checked by FDSL.

WHO inspectors pre-qualify mainly three types of drug products — anti-malarial, anti-viral (AIDS) and anti-TB products — after thoroughly auditing the factories manufacturing these drugs in a country. After passing these audits, WHO puts these drugs as pre-qualified on its website. The pharmaceutical manufacturers should improve the drugs quality and strive for the increase in exports.

I know at least one pharmaceutical company in Karachi which was inspected by the inspectors of an Ethiopian authority and after passing this inspection the drugs products of this company are allowed to be exported.

Dr S.L. Ali

Germany

Published in Dawn, August 4th, 2015

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