Indian Drug Regulator to get serious about Pharmacovigilance

The Indian drug regulator is planning a major overhaul in the country’s drug adverse reaction monitoring system.

The Central Drugs Standard Control Organisation is now planning to appoint a team of about 100 clinical pharmacologists across the country, on a contract basis, to collect adverse drug reaction reports and patient complaints from hospitals, clinics and practising clinicians.

“We are not taking any chances now, because the domestic pharma market is growing and a host of new drugs are being launched by domestic as well as foreign companies,” said M. Venkateswarlu, India’s drug controller general. “Though the new drugs are approved after verifying the clinical trial data, this will not be enough to establish the absolute safety of a drug as these are conducted in limited number of volunteers or patients, which are only indicative. So a regular post-marketing study will only provide the actual response (effects and side effects) of the drug as it has been practically used in a wider patient pool.”

Though it is the responsibility of drug manufacturers to do these studies on newly marketed drugs and submit the data to the regulator, the system has been a failure in India as most companies flout the law.

As a result, the country had hardly any drug recalls, even though several drugs marketed here are alleged to have a doubtful safety profile. The system could also be an early-warning system unlike recent cases, including recall controversies over GlaxoSmithKline Plc.’s Avandia diabetes drug and the voluntary recall of cardiac stents by Johnson & Johnson, where Indian authorities are still seeking information from their Western counterparts and the multinational drug companies.

Source and detailed report: http://www.livemint.com/2007/08/27004814/Drug-regulator-to-monitor-side.html