In a pivotal move to accelerate access to advanced medical treatments, the Indian government has announced a significant policy change. The Centre has waived the requirement for local clinical trials for drugs and vaccines already approved by stringent regulatory agencies in the US, UK, Japan, Australia, Canada, and the EU. This new directive, issued through an executive order, will allow these advanced therapies to enter the Indian market directly, pending approval from the Central Drugs Standard Control Organization (CDSCO), India’s top drug regulatory body.
The decision was made to avoid depriving patients who urgently need these medicines. The official also noted that delays in launching new drugs, already approved in major markets like the EU, often stemmed from the inability to conduct or complete local trials. The government order aims to eliminate this barrier. A senior health ministry official highlighted that differences between populations typically affect only 0.1% to 0.2%, reducing the critical need for local trials in many cases. This policy change is expected to facilitate the faster introduction of innovative treatments in India, such as Chimeric Antigen Receptor (CAR) T-cell therapy for leukemia and Sacituzumab govitecan for advanced breast cancer. Dr. Pooja Sharma, project lead at Patient Advocates for Clinical Research (PACER), emphasized that while local trials are being waived, the CDSCO will ensure rigorous post-marketing surveillance and clinical trials to monitor the drugs’ performance and safety in the Indian context. This balanced approach aims to expedite access to essential therapies while maintaining high safety and efficacy standards.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
