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Posted 10 July 2014 | By Louise Zornoza,
India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.
New policies stated in the documents include:
CDSCO is also re-organizing the structure of the committees involved in the drug approval process. The New Drug Advisory Committees will now become the Subject Expert Committees, whose recommendations will be reviewed by a newly formed Technical Review Committee (TRC). The TRC will be under the direction of the Directorate General of Health Services (DGHS), which will draw the membership of the committee from experts in such areas as clinical pharmacology, clinical toxicology/ pathology, and scientists involved in drug development.
The changes implement the recommendations of the Expert Committee chaired by Prof. Chaudhury, which was tasked with formulating policy and guidelines for the approval of new drugs, clinical trials, and the banning of drugs.
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Tags: Clinical Trials Regulation, Ethics Committees, IRBs, Clinical Investigators
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