Dragging on the DRAP

Moved perhaps by the media blitz over the spate of deaths at the Pakistan Institute of Cardiology (PIC) and other hospitals, or under pressure from the legal system, the government scurried to hammer out the Drug Regulatory Agency of Pakistan (DRAP) ordinance. In the aftermath of the 18th Amendment, the Cabinet Division was temporarily tasked with the responsibility of drug oversight in the country until the establishment of the DRAP. When the President signed the DRAP draft on February 16, 2012 it appears that officials at the Cabinet Division breathed a collective sigh of relief and put down their pens. Unfortunately for the countrys pharmaceuticals industry, while the ordinance has been issued, rules for its implementation are yet to be devised. The staff for DRAP has also not been enlisted yet. In effect, all imports and exports of pharmaceutical products and raw materials must be accompanied by a no objection certificate (NOC) issued by the DRAP. But this body does not have the manpower or the procedures in place to issue the same. As a result, consignments of pharmaceutical companies are facing delays at the port for the past 12 days. Besides straining the ability of local drug manufacturers to meet their orders in the local market and abroad, this delay may also jeopardize the quality of all consignments that are currently being kept in less than ideal conditions. The PIC tragedy has laid bare the shortcomings of regulations affecting the manufacture and distribution of drugs in the country. It has also impacted the consumer confidence associated with this industry. Given these conditions, the government has two important roles to play. Firstly, the authorities have to ensure that they carry out thorough and comprehensive investigations with the help of competent experts, in order to facilitate the courts. Secondly, they must work with the pharmaceutical industry to develop a transparent and effective mechanism for oversight and regulation, and to restore the confidence of the general public in the industry. Some recent news reports have asserted that as many as four African countries have suspended pharmaceutical imports from Pakistan. Industry sources also reveal that the Uzbek government has also initiated testing of each batch of medicines arriving in that country from Pakistan in the aftermath of this tragedy. The local pharmaceutical industry contributes prominently to the countrys exports, besides providing medicines and jobs to the nation, both of which it direly needs. Federal and provincial governments must quickly realize that they too have major stakes in ensuring that this industry is not vilified and isolated.