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DRAP seeks opinion on generic medicines registration

May 12, 2021

Islamabad : Drug Regulatory Authority of Pakistan (DRAP) Tuesday decided to take initiative on the issue of registration of a generic basis for all single-ingredient drugs in consultation with relevant stakeholders.

In this regard DRAP’s Division of Pharmaceutical Evaluation and Registration has sought an opinion from stakeholders on generic medicines, an official of DRAP said.

He said that DRAP’s initiative on this matter is in compliance with the law for generic medicines like the Drugs Act 1976 and rules framed there under which is part of the DRAP Act 2012 under Schedule -VI.

After the 18th amendment sale of therapeutic drugs is the responsibility of provincial governments and assurance of sale under the physical presence of a qualified pharmacist is also the responsibility of provincial governments, he added.

He said that DRAP has conveyed the grievance of the masses that was submitted through the Prime Minister Implementation Delivery Unit (PIMU) Portal by requesting the provincial governments to develop a mechanism for prescription of generic medicines in coordination with the Healthcare Commission, Pakistan Medical Association (PMS), Pakistan Pharmacists Association (PPA), Pakistan Chemists and Druggists Association and others deemed fit by the provincial governments.