DCGI simplifies regulatory processes for vaccine & r-DNA products

While streamlining the issuance of Form 29 licenses, the Drug Controller General of India has also removed the need for joint inspections of vaccines and r-DNA products manufactured for R&D purposes


New Delhi: The office of Drugs Controller General India (DCGI) under the Directorate General of Health Services has decided to discontinue the practice of prior joint inspection for issuance of Form 29 licenses to vaccine and r-DNA products. As per the revised memorandum issued on December 13, 2016, the applicant shall submit application along with self declaration in a prescribed format to State Licensing Authority & Central Licensing Authority by hardcopy and by an emails to [email protected], [email protected], and on the email of the concerned State Licensing Authorities. The State Licensing Authority shall now issue Form 29 licenses within three working days of receipt of the application.

The new order is to promote research and development of new drugs. Form 29 licence is issued to manufacture drugs for the purposes of examination, test, or analysis for biological vaccines and r-DNA products.

In another order, it has been decided that Central Drugs Standard Control Organization (CDSCO) will now communicate the recommendations of Committee to the concerned applicants within five working days. CDSCO reviews applications in consultation with the various committees like the subject expert committee, investigational new drug committee, cell biology-based therapeutic drug evaluation committee, technical committee, and apex committee.

Further, the timelines for CDL Kasauli to review and process applications referred for CMC or post approval change have been streamlined. CDL Kasauli will now issue its comments within 30 days to CDSCO. The applicants will also have to submit their responses to queries raised by CDL Kasauli on behalf of CDSCO within 30 days. Failure to furnish the requisite information sought by CDL Kasauli within the prescribed time of 30 days will be presumed that the applicant is not interested in pursuing the application and the application would be treated as terminated for further processing.

It has been also further clarified that product manufactured under Form 29 license can now be exported only for the purpose of examination, test, or analysis including clinical evaluation involving human subjects and not meant for commercial purposes. Several applicants had been requesing DCGI for issuance of export NOC for the batches manufactured under Form 29 for commercial purpose.