Faster Access to Medicines
India’s Central Licensing Authority (CLA) now allows waivers for local clinical trials for certain drugs approved in countries like the US, UK, Japan, EU, Australia, and Canada.
This aims to speed up drug approval and market access, including for orphan drugs, gene therapy, and pandemic-related treatments.
Safety Concerns
Experts warn that waiving local trials may lead to safety risks due to genetic diversity in India’s population.
Local trials are important to assess how drugs interact with different genetic profiles, reducing potential adverse effects or reduced efficacy.
Regulatory Shift
India’s approach marks a significant regulatory change to fast-track drug availability.
Countries like Japan and China require local testing or foreign data analysis due to ethnic sensitivity in drug metabolism, urging India to consider similar precautions.
Patient and Industry Perspectives
Patient groups support faster approvals for rare disease treatments, as it reduces waiting times for life-saving medicines.
The industry sees the move as beneficial for quicker responses to pandemics and facilitating new drug launches.
However, some patient advocacy groups worry that local trials offer an opportunity to access costly medicines for rare diseases.
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