Reviews about the Government policy to provide fast-track drugs approvals without clinical trials

Medicare News

New Delhi : Health experts are concerned about the government decision to allowing drugs without clinical trials in India. Indian government might allow new drugs without local clinical trials if the drug is already approved for marketing in the US and European markets for four years to reduce timelines for approvals. The main reason as per government for this move is just a swift availability of drugs to benefit patients in India.

According to the health experts, this is the objective of conducting local trials in the domestic market is to reassess the safety and effectiveness of the drugs in the Indian population. The local clinical trials are necessary to help to determine efficacy and safety of the drug when administered to patients of different ethnic origins living in India.

A number of cases are found in the International market when a few of the drugs withdrawn from the markets after three to four years of their launch because of serious adverse reactions in patients. Just because of the clinical trials were done in the other developed country does not approve that the drug suits for Indian population.

Health consultants said that the government’s new policy to stop local clinical trials on proven drugs can affect health care to a certain extent. There are few drugs which need to be tested in Indian population as it has racial differences from western population.

Prof. Ranjit Roy Chaudhury suggested in his report was that waiver of clinical trials on Indian population can be considered for new drugs only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions or diseases for which there is no cure. It should be considered only in case of some cases but not for all cases.


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