In a move to bolster the biotechnology sector, the government is poised to introduce amendments to the Drugs and Cosmetics Rules, 1945. This initiative aims to streamline the process for obtaining manufacturing licenses for stem cell-based and gene therapy products by allowing applications through State Licensing Authorities (SLA) and the Central Licenses Approval Authority (CLAA).
The proposal entails revisions to specific existing forms used to issue manufacturing clearances for vaccines and recombinant DNA products. These amendments will encompass cell-based and gene therapy medications, enabling the industry to submit manufacturing license applications using these updated forms.
The discussions around this proposal were brought forward during meetings held by the Drugs Consultative Committee (DCC) and the Drugs Technical Advisory Board (DTAB) earlier in the year.
In its 63rd session in January, the DCC reviewed and endorsed the proposal for licensing of products derived from cells and stem cells, gene therapies, and xenographs, through CLAA certification.
At present, the Drugs & Cosmetics Act provisions cater to manufacturing rights for vaccines, large volume parenterals (LVPs), and recombinant DNA products under Forms 28D and 28DA with CLAA approval. However, they lack clauses enabling SLAs and CLAA to issue manufacturing licenses for cell and stem cell-derived products, gene therapies, modified release formulations, and other new pharmaceuticals within Form 28D.
The Committee deliberated on updating the relevant forms—including Forms 27D, 27DA, 28D, and 28DA—to integrate terminology for cell-based and gene therapy products, xenografts, and agreed with the modifications.
Consequently, on August 14, 2024, the DTAB analyzed and approved the proposed amendments to these forms to extend their scope to such therapies.
Within the DTAB meeting minutes, it was noted: “DTAB has evaluated the proposal and approved the suggested amendments involving Forms 27D, 27DA, 28D, and 28DA of the Drugs Rules, 1945 to include ‘cell or stem cell derived products, gene therapeutic products or xenografts.'”
Here are the specifics for the forms:
– **Form 27D** allows the industry to apply for or renew licenses for the manufacture, sale, or distribution of large volume parenterals, sera, vaccines, or recombinant DNA drugs, excluding those listed in Schedule X of the Rules.
– **Form 27DA** pertains to loan licenses serving the same purpose.
– **Form 28D and 28DA** are utilized by the licensing authority to authorize manufacturing licenses for these products and corresponding loan licenses.
Previously, the government has actively pursued developing regulations and regulatory frameworks to support stem cell and gene therapy sectors. Other initiatives include establishing dedicated divisions for stem cells and related innovations.