CDSCO Waives Local Clinical Trials for Drugs Approved in Select Countries: Health Minister
New Delhi: All new drugs are approved by the Central Drugs Standard Control Organization (CDSCO) without local clinical trials on case to case basis in consultation with Subject Expert Committee, the Lok Sabha was recently informed.
The revelation came from Union Health Minister Anupriya Patel in response to a query raised by Tirupati MP Maddila Gurumoorthy on Friday. Additionally, the MP questioned the present status and the impact on drug availability and affordability in the country.
The MP asked whether the Union Health Ministry has decided to waive the requirement of clinical trials for drugs approved in countries like the US, UK, Japan, Australia, Canada, or the European Union (EU).
“What mechanisms will be put in place to monitor the safety and efficacy of drugs introduced in the Indian market without undergoing local clinical trials including any post-market surveillance or testing protocols that is likely to be followed and if so, the details thereof?,” Gurumoorthy questioned.
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