Regulatory Focus™ > News Articles > Two New Indian Advisory Committees to Generate New Guidelines for Clinical Trials, Drugs

Two New Indian Advisory Committees to Generate New Guidelines for Clinical Trials, Drugs

Posted 18 March 2013 | By Louise ZornozaAlexander Gaffney, RAC

The Drugs Controller General of India (DCGI) for the Central Drugs Standard Control Organization (CDSCO) has requested input from the public regarding two newly formed independent advisory committees.

The first committee, the Expert Committee to formulate policy guidelines and SOPs for approval of new drugs, clinical trials and banning of drugs, will be chaired by Prof. Ranjit Roy Chaudhury and include six other members. The committee's charge will be to formulate policy guidelines and SOPs for the approval of new drugs and biological with a particular emphasis on clinical trials.

A key part of its charge will be to formulate policy guidelines and operating procedures for trials, including the conduct of ethics committees, the accreditation of trials sites, inspections of trials sites, and the ongoing monitoring of trials.

The second committee, the Expert Committee to formulate policy guidelines and procedures for approval of fixed dose combinations, will be chaired by Prof. C K Kokate and include four other members. The committee will be charged-as with the other committee-with formulating guidelines and procedures for fixed dose combinations, including clinical requirements, recommended trial designs and controls, and post-marketing safety assessments.

Comments, which are specifically requested from the pharmaceutical and clinical trials industries and other interested parties, are due by 7 April 2013.


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