Pakistan drug regulatory body “a complete failure” according to officials

pharmafile | February 2, 2017 | News story | Sales and Marketing Drug Regulatory Authority of Pakistan, Pakistan, Sania Nishtar 

Key figures in the Pakistani pharmaceutical industry are calling for review of the Drug Regulatory Authority of Pakistan (DRAP) over concerns it is not fit to streamline healthcare issues in the country.

Despite guidance from Dr Sania Nishtar (pictured), former health minister and World Health Organization (WHO) as nominated by the Pakistani government, the authority has been unable to resolve the multitude of issues outlined in her 2013 report Towards Improving Governance, in part because it is fundamentally no different from previous iterations of the government’s regulatory bodies.  

“The DRAP is no different from previous regulatory arrangements of the health ministry… serious issues are emerging as a result of this,” Nishtar said in her report.

She also called for review of the body’s pricing policy to move towards greater predictability and transparency, in part to reverse the current trend of multinational pharma firms pulling their manufacturing operations form the country: “Lessons can be learnt from innovative pricing policy approaches currently being adopted internationally as well as in the region; some of these are relevant in Pakistan’s domestic policy context. In certain cases, price increase has to be allowed to create incentives for manufacturing…several essential life-saving medicines are perpetually short as a result of a price moratorium.”

Another key issue, highlighted by a top pharma official, is that the body cannot function autonomously and is subject to frequent governmental and Health Ministry intervention which often negates any legislation it enacts, rendering it little more than a dummy institution.

“Just when the DRAP issued SRO 1002 to break freeze on pharma prices, the prime minister ordered to take back the decision, resulting in collapse of the DRAP’s spirit, destruction of industry, shortage of drugs, flight of capital and ultimately misery for patients,” he explained. “This is a big concern for the industry and future investment in the pharmaceutical sector.

“Today, the authority is a complete failure. It has failed to address many serious issues, which include acute shortage of medicines, substandard/counterfeit medicines, no policy making, ill-planning, poor enforcement of even distorted laws, toll manufacturing issues and most importantly pricing issues.”

Both Nishtar and the official also note the toxic presence of a booming black market, causing significant issues for the country’s market due to an influx of counterfeit drugs.

“This needs to be curbed. Transparency and accountability will have to be paramount in the policy formulation process in this regard,” Nishtar noted.

“The industry is struggling to stay afloat. This can be very dangerous for the millions of patients in the country,” added the official. “The government needs to consider the ground realities and extend support to the pharmaceutical industry in the best interest of poor patients.”

Matt Fellows

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