Setting up drug regulatory authority

It has taken a major disaster - the death of 147 people who took contaminated cardiac medicines distributed free by the Lahore-based Pakistan Institute of Cardiology - for all concerned to jump into action. This week, provincial assemblies of Khyber Pakhtunkhwa, Punjab and Sindh passed resolutions calling for the establishment of a drug regulatory authority. They urged Parliament to organise the sector's affairs. Meanwhile, a special committee of Parliament, under pressure to meet the February 17 deadline set by the Supreme Court for a report on the issue, finalised its draft proposals for the establishment of an authority to regulate and register drugs and fix their prices, and sent the same to the federal cabinet for approval. On the face of it, this should not have been a difficult task considering that there are well-established models in other countries, such as the Medicines and Healthcare Products Regulatory Agency in Britain where the Punjab government sent samples of suspected drugs for testing as well as the US' Food and Drug Administration. Nonetheless, there are problems peculiar to Pakistan, particularly the widespread marketing of spurious drugs. That perhaps is the reason why while forwarding its draft to the Cabinet the parliamentary committee insisted that bureaucracy should be directed not to add or delete even a single word from the draft, and that in the event any amendment needed to be made on the demand of the provinces, the same should be sent back to it. A bigger challenge though would be proper implementation which would require modern infrastructure facilities, especially well-equipped laboratories for carrying out research and testing work, and professional experts. Indeed, there is no dearth of eminently qualified people in this country to man the laboratories. But in order for the proposed authority to function effectively and efficiently it needs to have administrative as well as financial independence. And the provinces would need to maintain monitory mechanism to ensure that no drug manufacturing activity takes place in the unregistered sector. The regulatory authority must also cover the medicines distributed by alternative medicines sector, including homeopathy and the traditional Unani Tibb. The parliamentary committee waxed indignant that so far no responsibility has been fixed by either the Punjab or the federal government regarding the deaths of cardiac patients due to spurious drugs. That though is not an entirely fair reading of the situation. First of all, the government has to move cautiously so as not to make any mistakes in a rush to fix responsibility. The process has been in progress, and the culprit drug and its manufacturer identified. Secondly, the provincial government did suspend senior medical officials suspected of negligence, but only to see a protest strike by the said hospital's doctors, which caused a lot of unnecessary suffering to patients and their families. The episode highlights the need for the government to put in place some legislation that acts as a deterrent for hospital doctors and paramedical staff - all those dealing with matters of life and death - from resorting to strikes for one or another reason. They must always remain cognisant of the reason why their line of work is known as a 'noble profession'. Copyright Business Recorder, 2012