DCC Approves Amendments to Stem Cell & Gene Therapy Licensing Rules

Drugs Consultative Committee (DCC) has sanctioned the modification of the Drugs Rules, 1945, so that products derived from stem cells and gene therapy products can be encompassed in securing a manufacturing license. This action will facilitate the industry in applying for State Licensing Authorities (SLA) and Central Licences Approval Authority (CLAA) licenses to manufacture.

The amendments are to revise Forms 27D, 27DA, 28D, and 28DA, relating to vaccines and r-DNA drugs, to embrace also "Cell or Stem Cell derived products, Gene therapeutic products or Xenografts." This will make the regulatory process simpler and cater to the increasing need for such new-era drugs.

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The decision follows extensive consultations and deliberations. The issue was initially raised in the 63rd DCC meeting in January 2024 and subsequently revisited by the 91st Drugs Technical Advisory Board (DTAB) in August 2024, both proposing the changes. A draft notification was finalized, followed by stakeholder consultations, where there was a convergence of views.

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Now, provisions in the Drugs & Cosmetics Act offer manufacture licenses for vaccines, large volume parenterals (LVPs), and r-DNA products, but not for cell and stem cell therapy, gene therapy, and modified release dosage forms. These amendments will plug this regulatory gap, and that will enable quicker approvals from the industry.

Form 27D is used by manufacturers to seek vaccine and r-DNA drug licenses or renewal licenses, and 27DA for loan licenses. Forms 28D and 28DA are used by licensing authorities for issuing manufacturing and loan licenses. The addition of stem cell and gene therapy products on these forms represents a regulatory milestone, which is a witness to India's expanding biopharma and advanced therapy industry.