Expert Drug Panel Clears Proposal to Amend Licensing Forms for Advanced Biologics, Xenografts
New Delhi: The apex advisory body functioning under the Central Drugs Standard Control Organisation (CDSCO), Drugs Consultative Committee (DCC), during its 66th meeting held on June 17, 2025, approved a key amendment to the Drugs Rules, 1945, that allows inclusion of "Cell or Stem Cell derived products, Gene Therapeutic products or Xenografts, etc." in drug licensing application forms.
The amendment specifically applies to Form 27D, 27DA, 28D, and 28DA, which are used for granting manufacturing licenses for biologics, vaccines, and other high-end therapeutic products.
As per the meeting minutes, “DCC was apprised that the matter was deliberated in the 63rd meeting of DCC wherein the committee agreed with the proposal and thereafter the matter was deliberated in the 91st DTAB meeting wherein the Board 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.’”
The committee was also informed that although a draft notification was prepared in the matter, it was decided to first conduct a stakeholder consultation along with further deliberation in the DCC. Subsequently, a consultation was held, and “all stakeholders agreed with the proposed agenda.”
Following this, the DCC deliberated the proposal in detail and “agreed with the proposal to appropriately amend the Drugs Rules, 1945.”
This amendment is expected to strengthen India's regulatory infrastructure for high-innovation biologics and regenerative medicine, offering both central and state licensing authorities a formal basis to evaluate and process applications for such therapies.
