Regulatory Focus™ > News Articles > After Drug Deaths, Calls for Pakistan to Form Independent Drug Regulatory Authority

After Drug Deaths, Calls for Pakistan to Form Independent Drug Regulatory Authority

Posted 30 January 2012 | By Alexander Gaffney, RAC 

Pakistan is facing calls from industry for a drug regulatory authority to be formed after a batch of cardiac drugs given to patients at a government-run hospital has been linked to more than 100 deaths.

Patients at the Punjab Institute of Cardiology were given one or more drugs manufactured by relatively small, local companies. The drugs, given to roughly 40,000 patients, generated side effects that were initially confused with dengue fever. Almost 250 patients remain hospitalized as a result of the drugs, and the owners of the manufacturing companies responsible for making the drugs remain under arrest pending an investigation and the return of lab results.

As a result of the deaths and injuries, a Pakistani industry consortium known as Pharma Bureau is calling for the formation of an independent drug regulatory authority. According to Pakistan Today, Pharma Bureau cited the need to regain public confidence in the pharmaceutical industry after the scandal. They further noted that many companies are skirting the existing regulations entirely, while those that attempt to get their drugs and molecules through the official registration process are often subjected to a slow and arduous process.

According to the BBC, the pharmaceuticals market in Pakistan is "intensely competitive" and the calls for an independent drug regulatory authority may be partially in response to this competition.



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