India Proposes Regulatory Framework for Cell and Gene Therapy Manufacturing Licenses
核心洞察
The Indian Ministry of Health and Family Welfare has published draft amendments to the Drugs Rules, 1945, to formally include cell and stem cell derived products (搜索), gene therapeutic products, and xenografts (搜索) under regulatory oversight.
The proposed changes will expand existing manufacturing license forms (27D, 27DA, 28D, 28DA) currently used for recombinant DNA products to encompass these advanced biological therapies.
The amendments received approval from the Drugs Consultative Committee (搜索) in June 2025 and the Drugs Technical Advisory Board (搜索) in August 2024, following stakeholder consultations where all parties agreed with the proposed changes.
The Indian Ministry of Health and Family Welfare has published draft amendments to the Drugs Rules, 1945, proposing to formally incorporate regulatory oversight of advanced biological therapies including cell and stem cell derived products (搜索), gene therapeutic products, and xenografts (搜索). The proposed amendment, titled the Drugs (… Amendment) Rules, 2025, integrates these cutting-edge therapy categories into the established regulatory framework currently governing recombinant DNA (r-DNA) derived drugs.
Regulatory Framework Expansion
The draft rules seek to ensure that products related to modern biological therapies are subjected to the same manufacturing and distribution standards as other high-risk biological drugs. The amendments will enable industry to apply for manufacturing licenses of stem cell derived products (搜索) and gene therapeutic products through existing State Licensing Authorities (搜索) (SLA) and Central Licences Approval Authority (搜索) (CLAA).
Currently, provisions exist under the Drugs & Cosmetics Act for granting manufacturing permission for vaccines, large volume parenterals (LVPs), and r-DNA products under Form 28D and Form 28DA with CLAA endorsement. However, there is no provision for grant of manufacturing license by the SLA and CLAA in Form 28D for approval of cell and stem cell derived products (搜索), gene therapy (搜索) products, modified release dosage forms, and such other new drugs.
Key Regulatory Changes
The core changes involve updating existing rules and associated licensing forms to include the new therapeutic categories:
Rule 75 (3) and 75A (1A): These rules covering manufacturing and testing of specified biological products will be amended to include the new categories. The original text referring only to "Recombinant DNA (r-DNA) derived drugs" will be expanded to encompass "Cell or Stem Cell derived products (搜索), Gene therapeutic products or Xenografts (搜索), etc."
Rules 76 and 76A: These rules dealing with the grant of manufacturing licenses will see the same substitution, bringing the new therapy classes under their direct purview.
Licensing Forms (27D, 27DA, 28D, 28DA): The titles and content of all forms related to applications for manufacture, sale, and distribution of these specialized drugs will be amended. The title currently referencing "Recombinant DNA (r-DNA) derived drugs" will be substituted with a combined title: "RECOMBINANT DNA (R-DNA) DERIVED DRUGS/ CELL OR STEM CELL DERIVED PRODUCTS (搜索)/ GENE THERAPEUTIC PRODUCTS OR XENOGRAFTS (搜索), ETC."
Regulatory Approval Process
The proposed amendments have undergone extensive review through India's drug regulatory committees. The Drugs Consultative Committee (搜索) (DCC) gave its approval for the central government to proceed with the amendment in its meeting on June 17, 2025. The matter was initially discussed in the 63rd meeting of the DCC in January 2024, where the Committee agreed with the proposal.
The proposal was subsequently deliberated in the 91st Drugs Technical Advisory Board (搜索) (DTAB) meeting in August 2024, where the Board agreed for the proposed amendment. Following stakeholder consultation where all stakeholders agreed with the proposed amendment, the DCC proceeded with the current draft notification.
According to the DTAB meeting minutes, "DTAB deliberated the matter and agreed for proposed amendment under Form 27D, 27DA and Form 28D and Form 28DA of Drugs Rules, 1945 for inclusion of the words 'cell or stem cell derived products (搜索), gene therapeutic products or xenografts (搜索), etc.'"
Public Consultation Period
The draft rules are now open for public feedback, with the Central Government soliciting objections and suggestions from all affected persons. The draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date the official Gazette copies, published on October 16, 2025, are made available to the public.
Objections and suggestions may be addressed to the Director (Drugs regulation), Ministry of Health and Family Welfare, or emailed to drugsdiv-mohfw@gov.in.
This regulatory update reflects the need to adapt the 1945 rules to the rapid advancement of modern medicine, ensuring patient safety and quality control for these complex biological products as India positions itself to accommodate the growing cell and gene therapy (搜索) sector.