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Drug Regulator to Monitor Side Effects (India)

This article was originally published in PharmAsia News

Executive Summary

The Central Drugs Standard Control Organisation (CDSCO), the Indian drug regulator, is planning a major overhaul in the country's drug adverse reaction monitoring system. A team of approximately 100 clinical pharmacologists across the country will be appointed to collect adverse drug reaction reports and patient complaints from hospitals, clinics, and practicing clinicians. The drug review system typically works through collecting adverse reaction reports and analyzing them in the context of safety, efficacy, and dosage compliance. It is now being proposed as a regular procedure to keep a close watch on all approved drugs in the post-marketing phase. "Though US FDA frequently publishes drug reviews and follow-up actions (recalls or restricted-use notifications) on its website, such moves are still unheard of in India," says C.J. Shishoo, trustee, Consumer Education and Research Centre, a consumer action group. According to Dr Shishoo, at least half a dozen drugs with questionable safety profiles are still being marketed in India as there were no adverse reports available with the regulator. According to a senior official from the CDSCO, "currently our mechanism is grossly inadequate to tackle the issues related to pharmacovigilance as there are no public interaction systems wherein the doctors or patients can (share) their experiences with drugs that they use (with) the regulator directly. Since the department is also facing severe people crunch, it is not able to dedicate special cells or people with the task of collecting patient responses." (Click here for more

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