India to Establish Committees to Help Regulate Trials and Drug Approvals

By Zachary Brennan

- Last updated on GMT

India to Set Up Committees to Help Regulate Trials and Drug Approvals
India’s Ministry of Health & Family Welfare will create two new independent committees to oversee policy, guidelines and SOPs (standard operating procedures) for clinical trials, drug approvals and FDCs (fixed-dose combinations). 

The announcement on Wednesday for the new committees does not lay out the specifics of how the committees will operate but it does request comment from CROs, pharmaceutical companies, non-governmental organizations and others on their creation by April 7.

The first committee - headed by Ranjit Roy Chaundry, head of the India-WHO programme in rational drug use – will focus on formulating policy, guidelines and SOPs for approving clinical trials and new drugs. The other committee – led by C.K. Kokate, a professor and author – will formulate policy, guidance and SOPs on FDCs.

In August, CDSCO (Central Drugs Standard Control Organization) announced plans for adding new medical experts​ for drug and trial reviews. The push for more oversight, faster drug recalls​ and other new measures seem to directly reflect concerns from a Parliamentary report released last spring that found the country needs more support to govern its drug supply and clinical trials.

Chinu Srinivasan of the All India Drug Action Network told Outsourcing-pharma.com that both committees “will be pursuant to the comments of the [Parliamentary] Standing Committee Report​,” and the report of the three member committee appointed thereafter.

"These are temporary committees appointed to feed into decision making for the CDSCO​," Srinivasan said. "After they make their recommendations, they will fold up​."

He added that he and some of his colleagues will be providing views to the newly formed committees.

CDSCO also has given drug manufacturers 18 months​ to test unapproved drugs before they are pulled from the market. That deadline came just days before India’s Supreme Court called on the agency​ to provide a more thorough description of how it would handle the overhaul of clinical trial approvals in India. 

Related topics: Clinical Development, Regulatory affairs

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