The executive order aims to eliminate delays in the availability of critical treatments to Indian patients. Credit: Gorodenkoff / Shutterstock.

India’s Central Drugs Standard Control Organization (CDSCO) has waived the requirement for local clinical trials for drugs and vaccines approved by stringent regulatory agencies in select international markets.

This decision is poised to fast-track the introduction of advanced medical treatments into the Indian healthcare system.

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The apex drug regulatory authority will now have the discretion to approve these therapies for the Indian market.

This executive order aims to eliminate delays in the availability of critical treatments to Indian patients.

An official was quoted by Times of India as saying: “For that, we did not want to deprive the rest of the patients/population who may be needing those medicines, hence this decision.

“There have been multiple instances in the past when reputed firms postponed or faced delays in the launch of a new drug that had been already approved in major markets such as the EU because they couldn’t undertake or complete local trials. Govt order will do away with this need.”

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A senior health ministry official highlighted that genetic differences, which could necessitate local trials, are minimal, affecting only approximately 0.1% to 0.2% of the population.

This rationale underpins the government’s decision to streamline the approval process for foreign-approved drugs and vaccines.

The policy change is set to benefit patients by providing quicker access to cutting-edge therapies.

Treatments such as chimeric antigen receptor (CAR) T-cell therapy, used in leukaemia treatment in the US, and Sacituzumab govitecan for advanced breast cancer, which is not yet available in India, could now be approved more swiftly.