BOX 4-6
Dissolution of the Pakistani Drug Regulatory Authority

Over the course of several weeks in January 2012, more than 120 patients in Lahore, Pakistan, died of drug overdoses and hundreds more suffered adverse reactions after being treated with contaminated heart medicine at the Punjab Institute of Cardiology (Arie, 2012). The drug responsible was Isotab (isosorbide mononitrate, 20 mg), manufactured by Efroze Chemical in Karachi, Pakistan (Arie, 2012). Each Isotab tablet contained isosorbide mononitrate, as well as 14 times the normal dose of the antimalarial drug pyrimethamine. The overdose caused rapid bone marrow, white blood cell, and platelet depletion (BBC, 2012). The drug’s packaging did not contain dates of manufacture or expiration, and the drugs were given to patients for free (Arie, 2012). Drug pricing was a concern at Punjab Institute of Cardiology. Anonymous sources at the hospital reported significant pressure to buy the lowest cost drugs available. Under Pakistani law, when the lowest bidder does not win a sale, rejected firms can bring lawsuits against the hospital (BBC, 2012).

Pharmaceutical regulation in Pakistan is particularly weak. Though the government approved an independent drug regulatory authority in 2005, political tensions prevented action (Arie, 2012). In 2010, a constitutional amendment further debilitated regulation by abolishing the ministry of health. Provincial governments, many with weak infrastructures, were given sole responsibility for drug regulation. Manufacturers exploited the confused system by rapidly registering thousands of drugs (Khan, 2012).

Following the Isotab scandal, the Pakistan Supreme Court ordered action on the independent agency. Doctors have expressed doubts, fearing that insufficient regulatory expertise and ineffective execution will impede the new agency’s success (Khan, 2012). Their concerns appear to be well founded. The new agency’s board includes only one position for an expert in medicine or pharmacy (Khan, 2012).

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Protesters in Lahore, January 2012.
SOURCE: Owasis Asam Ali, Demotix News.



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