THIS is apropos of the news item ‘Spurious drugs: ministry eased rules for firms’ (Jan 26). The reporter has made some observations on an action taken by the ministry of health some three years back.

As chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA) I would like to refute the report and present some facts in this context.

Members of the apex court have rightly taken up the issue of spurious drugs in the interest of the public and advised the ministry of health to take appropriate measures against the culprits, but I fail to understand how an inference is made that spurious medicines are being produced by bona fide pharmaceutical manufacturers.

In general, spurious drugs are produced by unlawful manufacturers who are making these products in violation of the Drugs Act 1976 and the rules framed therein.

Hence, effective measures should be taken against unregistered manufacturers and bring them to justice. Non-compliance by bona fide manufacturers is being dealt with under the Drugs Act 1976 and since then several updates have been issued in the form of SROs and the ministry of health’s directives.

As far as issuing and updating the SROs is concerned, it happens as a routine that the ministry of health issues SROs from time to time to improve the overall working of the pharmaceutical sector, and at the same time updates their previous directives if it finds that these are not in public interest.

The SROs in question were updated on similar grounds. The clauses omitted from the SRO of Sept 13, 2007 (in fact Sept 14, 2007) were already there in similar form in clauses 13, 14, 15, 16, 17 and 18 under rule 8, under the heading: Central Licensing Board.

Perhaps the correspondent missed that part of the SRO. Referring to the claim that dubious drugs registration process had been adopted due to the omission of these sub-clauses over the last three years, I would like to make a correction. Most of the omitted clauses related to the already registered drugs, except for the inspection of manufacturing plants for local as well as for imported medicines, which has been done for several years on a regular basis under previous directives of the ministry of health.

Similarly the submission of stability studies and scientific and clinical data at the time of registration is the requirement of the Drugs Act 1976 and is mandatory for getting registration (refer Form 5A, Enclosure 27, 29 and Form 5D, Enclosure 23, 25).

Further, rules related to expiry, recall and import of products were already there under separate directives and has been in practice for years. Rules related to distribution and retail sales are dominantly provincial subjects and several SROs have been issued on this subject in the recent past by provincial governments to exercise better controls on the sale and distribution of medicines.

M. HAROON QASSIM Chairman, Pakistan Pharmaceutical Manufacturers’ Association Islamabad