Centre amends drug rules to ensure uniform regulations, Pg16

Key Highlights:

• The Central government amended the Drugs Rules, 1945 on Thursday, July 2, 2026.
• The amendment brings stem cell derived products, gene therapeutic products, and xenografts under the Centrally License Approving Authority (CLAA) framework.
• This move aims to strengthen regulatory oversight of advanced and emerging medical technologies.
• The CLAA framework already covers critical biological products such as vaccines, large volume parenterals, and r-DNA based medicines.

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Detailed Insights:

• The amendment ensures uniform regulatory standards across India for rapidly evolving medical technologies.
• It facilitates a system of joint oversight by the Central and State Licensing Authorities.
• This increased regulatory rigor is crucial for emerging technologies due to their complex and specialized nature, ensuring patient safety.
• Stem cell derived products include regenerative treatments and CAR-T cell therapies used for blood cancers like leukemias and lymphomas.
• Gene therapeutic products encompass gene replacement and gene editing therapies for genetic disorders and various cancers.
• Xenografts are animal tissue-derived products, such as heart valves, utilized in cardiology and orthopedics.

Scientific/Technical Concepts Involved:

• Stem Cell Derived Products: Therapies using undifferentiated cells capable of self-renewal and differentiation into specialized cell types.
• Gene Therapeutic Products: Medical techniques that modify an individual's genes to treat or prevent diseases by altering genetic material.
• Xenografts: The transplantation of cells, tissues, or organs from one species to another.
• r-DNA based medicines: Pharmaceutical products developed using recombinant DNA technology, which combines genetic material from different organisms.