Government plans to make quality accreditation mandatory
The clause is expected to be included for the new clinical trials.
New Delhi, December 3, 2014: The Government of India plans to make quality accreditation mandatory for the new clinical trials taking place in the country by early next year. According to the recent reports, pharma companies or sponsors planning to conduct new clinical trials in India would require accreditation from the Quality Council of India for their sites, ethics committee and investigators before applying for a clearance from the drug regulator.
The proposal has been initiated by the Ministry of Health and is expected to be implemented by early next month. It is important to note here that the requirement may not be made mandatory immediately for the ongoing trials but these will also be brought under the accreditation fold eventually.