In yet another measure to facilitate ease of doing business in pharmaceuticals, the Drug Controller General of India (DCGI) has decided to discontinue the practice of prior joint inspection for issuance of Form 29 licenses to vaccine & r-DNA products as this will go a long way in promoting research & development of new drugs.
An office memorandum issued by the DCGI office said that in order to promote research & development (R&D) of new drugs, it has been decided to discontinue the practice of prior joint inspection for issuance of Form 29 licenses to vaccines & r-DNA products.
The applicant shall submit application along with self declaration (in format enclosed) to State Licensing Authority & Central Licensing Authority by hard copy and also by e-mail (dci@nic.in, testlicensebio@cdsco.nic.in and on email of the concerned State Licensing Authority). The State Licensing Authority shall issue Form 29 Licenses within three working days of receipt of application. The receipt of Form 29 License shall also be confirmed by applicant on email to CDSCO, within three working days. The joint inspection of such applicants shall be carried out after issuance of Form 29 Licenses, using the risk based approach, the DCGI in the memorandum said.
In another circular, the DCGI has clarified that the product manufactured under Form 29 license can be exported only for the purpose of examination, test or analysis including clinical evaluation involving human subjects and not meant for commercial purposes as per Drugs and Cosmetics Rules.
It is learnt that many applicants are requesting this office for issuance of export NOC for the batches manufactured under Form 29 License for commercial purpose, the DCGI said.