India’s drug regulator asleep on the job?

Why does it take the US Food and Drug Administration (FDA) to detect quality lapses at Ranbaxy’s plant at Mohali, Punjab? The US FDA has every right to inspect plants that supply drugs to its US citizens. Don’t Indian health authorities have a similar responsibility to protect the health of Indians by ensuring that all plants that produce drugs for the Indian market consistently follow good manufacturing practices? If this is done, the likelihood of any plant that supplies drugs to an export market would be not found wanting. Globalisation calls for stricter standards at home, not just for production for export. It is time India’s drug directorate got its act together.

A weak regulatory system has failed to ensure that drugmakers comply with quality norms. The state of apathy flows from a lackadaisical government machinery and drug administration overseen by truant babus. Their track record — be it in the procurement of TB drugs or medical equipment for faster diagnosis of the disease or ensuring that laboratories carry out rigorous quality checks on drugs — has been poor. These officials should be made accountable for failure to ensure timely availability of good quality drugs for both local consumption and exports. The need is to have tighter regulation.

Systems should also be in place for quality checks on generic drugs. India must move in the direction of the US where drugmakers comply with stringent norms on quality and crackdown on unethical marketing practices. Moreover, as Indian companies globalise, they will be exposed to multiple regulations and jurisdictions. The costs of regulatory mishaps due to compromising on the quality of drugs can be crippling. This is clearly avoidable, and it’s the job of drug administrators to discover substandard drugs.