Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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
Advertisement
Advertisement
UsernamePublicRestriction

Register

SC066463

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel