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Summary:

To expedite access to modern medical treatments, the Indian government has waived local clinical trial requirements for pharmaceuticals and vaccines approved by major global organizations such as the United States, United Kingdom, and the European Union. This new policy, introduced through an executive order, allows these treatments to enter the Indian market immediately, pending CDSCO clearance.

 

The decision aims to address delays in launching these treatments by removing the barrier of local trials. As population differences typically affect only 0.1% to 0.2%, the need for local trials is reduced. This policy is expected to accelerate the introduction of advanced therapies like CAR Tcell therapy for leukemia and Sacituzumab govitecan for advanced breast cancer. Dr. Pooja Sharma noted that while local trials are waived, the CDSCO will ensure rigorous post-marketing surveillance and ongoing clinical trials to monitor the drugs' safety and efficacy in the Indian context.

 

Source: IBEF 

 

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