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.
In response to the query, Patel, in a statement said, “The CDSCO approves new drugs through a rigorous process of evaluation of submitted data and in consultation with Subject expert Committee for consideration of waiver of clinical trials on a case to case basis, in accordance with New Drugs and Clinical Trials Rules, 2019 to ensure the quality, safety and efficacy of such drugs.”
“As per Rule 101 of the New Drugs and Clinical Trials (NDCT) Rules, the Central Licensing Authority (CLA), with approval of Central Government, has issued an order specifying names of countries including USA, UK, Japan, Australia, Canada and EU for considering the waiver of local clinical trial for the approval of certain categories of new drugs,” the statement added.
