The Central Government amended the Drugs Rules, 1945, establishing centralized licensing for stem cell therapies, gene therapies, and xenografts under the CLAA framework. This reform ensures uniform oversight, promotes clinical safety, and targets unproven, exploitative medical practices across India.
Click to View MoreIndia is debating the introduction of data exclusivity in pharmaceuticals, a regulatory protection that can delay the entry of generic drugs even after patent expiry. While the move is projected as a way to attract investment and support innovation, it raises serious concerns for India’s generics-driven pharmaceutical industry and access to affordable medicines. In the absence of any international obligation under WTO-TRIPS, the policy choice involves balancing innovation incentives with public health priorities and preserving India’s role as the pharmacy of the developing world.
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