The Government has constituted committees of experts for giving their opinions/ recommendations to the Central Drugs Standard Control Organisation (CDSCO) in respect of investigational new drugs/ new drug proposals.
In response to the 59th Report of the Parliamentary Standing Committee on the functioning of the CDSCO which raised various issues pertaining to the functioning of the organisation, including alleged approval of drugs without clinical trials, the CDSCO had constituted a three-member expert committee consisting of Dr VM Katoch, Secretary (Department of Health Research) and Director General, ICMR; Dr PN Tandon, President, National Brain Research Centre, Department of Biotechnology, Manesar and Dr SS Aggarwal, Former Director, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow. The committee is yet to release its report.
The committee is also examining the validity of the scientific and statutory basis adopted for approval of new drugs without phase-III clinical trials on the Indian population. This information was recently shared by Ghulam Nabi Azad, Union Minister of Health and Family Welfare in a written reply in the Rajya Sabha.
The Government has meanwhile constituted the following committees of experts for giving their opinions/ recommendations to the CDSCO in respect of Investigational New Drugs/ New Drug proposals:
- A Committee/ Core Panel of experts to advise on matters relating to regulatory approval of clinical trials for Investigational New Drugs (IND)
- A Core Investigational New Drugs (IND) panel of experts, namely, the Cellular Biology Bases Therapeutic Drugs Evaluation Committee (CBTDEC) to advise on matters pertaining to regulatory pathways leading to the approval of clinical trials and merket authorisation for the “therapeutic products derived from Stem Cell, Human Gene Manipulations and Xenotransplant Technology”
- 12 New Drugs Advisory Committees (NDACs) to advise on matters related to review and regulatory approval of clinical trials and new drugs (except for Investigational New Drugs)
- Six Medical Device Advisory Committees (MDACs) to advise on matters related to review and regulatory approval of new medical devices and clinical trials (except for Investigational New Medical Devices)
- A General Experts Pool for Medical device Advisory Committees on matters related to review and regulatory approval of new medical devices and clinical trials (except for Investigational New Medical Devices)
The members of these Committees are eminent doctors/ experts from different hospitals/ medical/ scientific institutions in the country and whose credibility are known to the Government. Most of them belong to the Government / Government-aided autonomous institutions. But eminent experts from non-government institutions are also sometimes selected based on their scientific calibre, knowledge and eminence, according to a press note.
EP News Bureau
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