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Centre to amend Drugs Rules related to licensing of stem cell derived & gene therapy products
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Gireesh Babu, New Delhi
October 22 , 2025
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The Union ministry of health and family welfare has issued a draft amendment of Drugs Rules, 1945 to enable industry to apply for manufacturing license of stem cell derived products, gene therapeutic products, among others.
The draft amendment proposes to amend the forms, already used to grant manufacturing permission for vaccines and r-DNA products, to include these products, so that the industry can apply with the State Licensing Authorities (SLA) and Central Licences Approval Authority (CLAA) for manufacturing licenses for these products.
It proposes to add cell or "Stem Cell derived products, Gene therapeutic products or Xenografts, etc," to the sub-rule (3) of rule 75, forms of application for licence to manufacture for sale or distribution of drugs specified in certain Schedules.
"In the Drugs Rules, 1945, under the sub-rule (1A) of rule 75A, the words “Recombinant DNA (r-DNA) derived drugs” shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs’, ‘Cell or Stem Cell derived products’, ‘Gene therapeutic products or Xenografts’, etc.,” said the draft amendment.
Under the rule 76 and 76A, wherever the words “Recombinant DNA (r-DNA) derived drugs” occurred shall be substituted with the words “Recombinant DNA (r-DNA) derived drugs, Cell or Stem Cell derived products, Gene therapeutic products or Xenografts, etc.”
Amendments have been proposed in Form 27D, Form 27DA, Form 28D and Form 28DA, to add these therapeutics to the forms.
As reported earlier, the Drugs Consultative Committee (DCC) in its meeting on June 17, 2025, has given its nod for the central government to go ahead with the amendment.
Earlier, the matter was discussed in the 63rd meeting of the DCC in January, 2024, where the Committee agreed with the proposal. It was later deliberated in the 91st Drugs Technical Advisory Board (DTAB) in August, 2024 and the Board agreed for the proposed amendment.
A draft notification was prepared in the matter, but later it was decided to conduct a stakeholder consultation and further deliberation in the DCC. The stakeholder consultation was conducted where all the stakeholders agreed with the proposed amendment, said the Committee in its latest meeting.
At present there are provisions under the Drugs & Cosmetics Act for grant of manufacturing permission for Vaccine, LVPs and r-DNA products under Form 28D and Form 28DA with the 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, gene therapy products, modified release dosage forms, and such other new drugs.
The DCC in January last year, agreed with the proposal for licensing of cell or stem cell derived products, gene therapeutic products, or xenographs, etc., through the endorsement of the Central licensing authority. Following this, the DTAB, in a meeting held on August 14, 2024, also considered the proposal for amendment of the Forms 27D, 27DA, 28D and 28DA to bring in these drugs also under its purview.
"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, gene therapeutic products or xenografts, etc.'," said the minutes of the DTAB meeting.
The Form 27D is for the industry to apply for grant or renewal of a licence to manufacture or sale or for distribution of large volume parenteral, sera and vaccines, recombinant DNA derived drugs, excluding those specified in Schedule X of the Rules. For 27DA is for loan license for the same purpose, while Form 28 D and 28DA is for licensing authority to issue the approval of manufacturing licence to these products and loan licence for the same purpose, respectively.
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