Another drug alert
A global medical product alert issued by the World Health Organisation for an allegedly contaminated cough syrup manufactured by a Punjab firm is another setback for the Indian pharmaceutical industry. The lax and fragmented drug regulatory system in the country had become the focus of attention after the death of over 66 Gambian kids was linked to a syrup made by a Sonepat-based firm last year. Stung by the prospect of the pharma sector taking a hit, the Centre has been working on an overhaul of the drug regulatory mechanisms for effective enforcement through capacity-building of state and national regulators. The aim is to build trust in the quality of India-made drugs and salvage the image of being the pharmacy of the world, delivering affordable healthcare. The latest alert is a wake-up call to hasten efforts to streamline the surveillance of the manufacture, sale and distribution of drugs.
On the cards is a centralised database of drugs that will give regulators digital access to the credentials of pharmaceutical firms and drugs. It will ensure time-bound and effective action against any firm flouting quality norms or not adhering to good manufacturing practices. A unified digital portal will bring together all stakeholders, be it the regulators, manufacturers, distributors, state-run departments or procurement agencies. Plans are afoot to strengthen inspection teams under state drugs controllers. Newly-created Central teams have been tasked with frequent inspections. Suggestions have been put forth to consolidate drug regulation at the national level, increase monitoring of repeat offenders and cancel licences.
Currently valued at $50 billion, the Indian pharmaceutical industry offers 60,000 generic brands across 60 therapeutic categories, popular even in affluent and developed countries. Quality concerns, thus, should lead to strictly regimented responses, such as a recall of the suspect product and a transparent root cause analysis. Fixing accountability is vital.
