Risk to public health
IT is a frightening indictment: a judicial probe into the Punjab Institute of Cardiology deaths that occurred a year ago has revealed that effectively the only protective system against substandard or incorrectly constituted drugs exists at the manufacturing stage. In other words, the state does virtually nothing to ensure that all locally manufactured drugs are safe for consumption, do not contain any surplus ingredient and have been manufactured and tested in compliance with the Current Good Manufacturing Practices; routine compliance audits of pharmaceuticals are not conducted. How serious an issue this is, is evident from the tragedy that led to the probe in the first place: towards the tail-end of 2011, mysterious deaths started being reported from Lahore hospitals, prompting an inquiry by the Punjab government and police. By the time the cause — batch J093 of the medicine Isotab distributed by the PIC through its free pharmacy — had been identified, countered with an antidote and recalled, 213 patients had died and about 1,000 others had suffered adverse symptoms.
The report, finalised by Justice Ijazul Ahsan and handed over to the Punjab home secretary last month, holds most of the parties involved responsible, foremost among them the Karachi-based pharmaceutical that got the constitution of this batch of Isotab wrong. However, it also points out that the distributing company omitted mention of batch J093 in the delivery receipt for the PIC, as a result of which the latter did not include samples from it while having suspect drugs tested. Indeed, it seems to be mere good luck that led to the identification of the cause of the deaths, for according to the judicial probe even the police inquiry and the Punjab administration’s response lacked direction or force. In terms of the PIC, the report points out that the staff of the pharmacy’s storeroom and inventory control that checked and approved the consignment also need to answer the question of why they missed the presence of batch J093.
It is to be hoped that this report will prove to be a wake-up call and that the health authorities will begin to keep a strict eye on the manufacture, distribution and sale of drugs. There was earlier some confusion after the passage of the 18th Amendment as the health sector stood devolved as a provincial subject. But now the Drug Regulatory Authority of Pakistan, signed into law last year, needs to start an immediate overhaul of the drugs sector. It must stringently apply the law where available and propose new legislation where required. Pharmaceutical products that can make people ill constitute a deadly risk.