Government Plans to do Away With Clinical Trials for Drugs With Proven Efficacy in Developed Markets

According to news reports, Government may soon do away with he clinical trials for drugs that have proven efficacy in the developed markets.

“Provisions are available under the Drugs and Cosmetics Rules, 1945 to grant permission to import/manufacture for marketing of new drugs, including certain types of anticancer drugs without local clinical trial under certain conditions in order to make such drugs available early in the country in public interest,” Minister of State (Health and Family Welfare), Anupriya Patel said in a written reply in the Rajya Sabha today.


If implemented, this rule will reduce the time to launch a drug in the market from 5-6 years to as few as 45 days. While the move is being hailed for its ability to reduce the cost of drugs owing to less expensive route to market, many feel that this move will do more harm than good.

Dr. Dhivya Ashok Kumar, Consultant, Surgeon and Head R&D, Dr. Agarwal’s Eye Hospital said, “The government’s proposal to waive off local clinical trials on proven drugs can affect the health care to certain extent. Indians are different from the westerners genetically and hence it would be ideal if the drugs are tested on Indian population as well.

In the case of eye care, especially in topical formulations wherein the effect of any drug will depend on the bioavailability of the drug on the particular ocular tissue (eg: the pigment layers in eye in Indians are highly pigmented than other races) and disease patterns of the region (eg: tuberculosis etiology is common in India), individual assessment on the local population is recommended. Further, any additional new indications or effect the drug may show can only be identified and confirmed by a proper clinical trial. Additionally, the microbial growth and drug resistance also varies from geography to geography.”


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