New rules to bring stem cell, gene therapies under Central licensing net close regulatory gap
The Indian Health Ministry has amended the Drugs Rules, 1945 to bring stem cell and gene therapies under the Central licensing framework. This move aims to regulate advanced medical treatments and prevent the marketing of unproven, costly therapies.
Why it matters
This regulatory update is a critical step in protecting patients from medical fraud and ensuring that advanced biotechnological treatments meet safety and efficacy standards.
The Union Ministry of Health recently amended the Drugs Rules, 1945 to bring cell and stem cell products, gene therapies, and xenografts under the Centrally Licence Approving Authority (CLAA) framework, closing a long-standing regulatory gap in India’s oversight of advanced therapies.
The article objectively reports on a government policy change and includes expert commentary on its necessity.
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