India Waives Clinical Trial Requirement for Certain Drugs

On 7th August, 2024, India announced that it will now accept drug approvals from the US, UK, Japan, Australia, Canada, and the EU without requiring local clinical trials for specific categories.

Key Points

Categories Covered: The waiver applies to orphan drugs, gene and cellular therapies, pandemic-related drugs, defense-related drugs, and those with significant therapeutic advances.
Benefits for Patients: This move is expected to accelerate the availability of advanced treatments for cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions in India.
Regulatory Change: According to Rule 101 of the New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority can specify countries for waiving local trials. The order issued on August 7 includes the USA, UK, Japan, Australia, Canada, and the EU.
Impact on Availability: This waiver is anticipated to reduce the launch delay from 5-20 years, aligning India more closely with Western markets.
Cost Reduction: The waiver is expected to lower the cost of advanced medicines and public procurement costs under schemes like Ayushman Bharat.
It will also reduce the financial burden on pharmaceutical firms, potentially lowering costs for patients, especially for rare diseases.
Research and Innovation: The policy shift will foster earlier access to patient data in India, encouraging more research and innovation in the pharmaceutical sector, and supporting the government’s goal of transitioning from volume to value.