The substandard drugs

The drug that claimed the lives of over one hundred heart patients receiving treatment at the Punjab Institute of Cardiology (PIC) has finally been tracked down to a Karachi-based pharmaceutical firm on the basis of samples flown to London in tandem with a case study of 30 patients carried out by Medicines and Healthcare Products Regulatory Agency (MHRA) and London's School of Pharmacy. Two samples - from the same batch - of Isotab tablets given out by the hospital tested positive for a lethal overdose of pyrimethamine, an anti-malarial drug that caused bone marrow suppression and drop in platelets and white blood cell counts, leading to death. FIA has restrained the factory from manufacturing activity for 14 days, telling it not to dispose of any of the relevant material or data as further investigations go on. The said company has nearly a two-decade long unblemished record of production. Still, the possibility of negligence is there. It has claimed that some of the said drug in its stock was stolen from its premises a few months ago, suggesting thereby that somebody else might have produced Isotab using its label. Which cannot be ruled out considering that production and sale of spurious and substandard drugs is a well-known menace in the country. A thorough probe is in order to determine the facts, pin responsibility and bring the culprits, whosoever they might be, to justice. Unfortunately, those in authority are using this human tragedy to play politics. The Opposition in the province as well as its colleagues in the federal government has been using the issue to point fingers at Chief Minister Shahbaz Sharif's style of governance. He in turn lashed out at the federal government, throwing hints about a dark conspiracy to undermine his government even if that meant prolonging public suffering during last year's dengue outbreak. The fact of the matter is that fake and substandard drugs are a countrywide problem. Even life-saving drugs are not spared. The present case came to public attention because of the scale of casualties caused by medicines that could be traced to a single source, PIC. But medical practitioners have long been pointing out that some of life-saving medicines contain materials such as gram powder and chalk. These things may not cause easily identifiable symptoms; yet taken in place of prescribed life-savers they can kill. The tragedy has triggered a blame game between the centre and the province, with the former arguing that post-18th Amendment health is a provincial subject and hence it is the Punjab government's responsibility to ensure quality control whereas the latter says the devolution process remains to be completed. The controversy is irrelevant to the issue at hand. In developed countries, such as Britain where the Punjab government sent samples for testing, and in the US, a single federal authority manages all matters pertaining to certification and registration of drugs. We need to follow suit. The government must do all that is necessary to make our Drug Control Administration an efficient and effective drug regulatory authority. Copyright Business Recorder, 2012