Business
Updated : Mar 19, 2018, 05:29 AM IST
The Central Drugs Standard Control Organisation (CDSCO) will not be involved in the certifying process of the council that will be set up to oversee the accreditation of institutes, clinical investigators and institute ethics committees.
Last year, the government of India had set up an expert committee with professor Ranjit Roy Chaudhury, National Professor of Pharmacology, as chairman to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
Roy Chaudhury, also advisor to the ministry of health and family welfare, said recently, "The CDSCO will not be involved at all in the accreditation process. We want a separate assessor to accreditate it."
The key recommendations submitted by the Roy Chaudhury Committee in July 2013 were clinical trials can only be carried out at centres which have been certified for such purpose, ethics committee of the institute must also be accredited, no compensation needs to be paid for therapeutic inefficiency since the very purpose of clinical trials is to determine safety and efficacy of given drug, vaccine, or device.
The accreditation process is likely to start by January 15, 2015. "It will be a smooth transition but within 6-8 months, all clinical trials in India will be carried out in accredited centres," Roy Chaudhury said. The members of ethics committee also have to undergo training, he added.
The accreditation process would be a blind randomized system so that it offers no scope for a particular individual to evaluate.
He also said that the earlier recommended cap of only three trials per investigator should also be removed and should be offered more flexibility.
There have been a lot of debate on the way clinical trials were conducted in India. The Supreme Court in last October halted 162 clinical trials, after 254 women from the marginalised section of the society died in the course of a 15-year long US funded clinical trial for a cervical cancer screening method. The apex court had in its judgement said that "the clinical trials conducted in India must help us and not others"
Yusuf K Hamied, chairman, Cipla, said, "If a company is doing a clinical trial in India, the results of the trial should be handed over to the authority overlooking the trial. This should be in case of both successful or unsuccessful trial. Recently, a Japanese company has done clinical trials in India but has gone back without informing the Indian authority about the outcome of the trial."