Drug regulatory body: As PPMA strives to have its input included, govt considers two drafts

Committee will prepare a new draft incorporating the older versions; asks PPMA to submit its recommendations.

Sehrish Wasif July 06, 2012


The government is considering two drafts of a bill to make the Drug Regulatory Agency of Pakistan (DRAP), neither of which has had input from the Pakistan Pharmaceutical Manufacturers Association (PPMA).

The association has expressed concern over not being taken on board for the preparation of the bill. PPMA Chairman Muhammad Asad Khawaja told The Express Tribune that the government should have invited them for consultation while drafting the bill.

“It is strange that PPMA, the main stakeholder for whom this bill is being prepared, has been ignored in the process,” he said.

The draft of the bill was to be finalised in the meeting of National Assembly Standing Committee on National Regulations and Services held recently but PPMA chairman was not invited to attend the meeting.

Senator Abdul Haseeb from the Muttahida Qaumi Movement, who is also convener of the Senate Special Committee on Formation of Drug Regulatory Authority, said that “it is strange” that the PPMA was hoping that the government would invite it for consultation. Instead, he suggested, the association should present a separate draft of the bill or recommendations for the government to incorporate into its own drafts.

He said two drafts, one prepared by Nargis Sethi, the cabinet secretary and the other drafted by the Senate Special Committee on Formation of Drug Regulatory Authority, are under discussion.

“The bill prepared by Nargis Sethi will be of no benefit to the country as she wants to involve the bureaucracy in this sector. However, the committee wants to make this drug regulatory agency an autonomous authority,” he said. He added that Sethi is not authorised to formulate the draft.

However, Hasseb said, recommendations from both drafts have been incorporated in the revised bill, which will be finalised in the upcoming meeting. “The bill should be finalised, approved and implemented within 100 days, otherwise the ordinance will lapse,” he added.

Published in The Express Tribune, July 6th, 2012.


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