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CDSCO comes out with clarification about issuance of NOC for Form 29 license

Laxmi Yadav, Mumbai
Monday, March 4, 2019, 08:00 Hrs  [IST]

The Central Drug Standard Control Organization (CDSCO) has come out with clarification about issuance of no objection certificate (NOC) for issuing Form 29 license to manufacture drugs for the purposes of examination, test or analysis of biological products (vaccines and r-DNA products).

The applicants are now required to apply CDSCO headquarters for issuance of NOC to obtain Form 29 with the documents as mentioned in the checklist & undertaking with a copy to concerned CDSCO, zonal office by hard copy as well as soft copy through e-mail and simultaneously submit application for obtaining Form 29 license to the concerned state licensing authority (SLA).

NOC for issuance of Form 29 will be issued by CDSCO within 7 working days. If the NOC from CDSCO-HQ is not granted within 7 working days after receipt of application, NOC will be deemed as granted.

The SLA can issue the Form 29 License for purposes of examination, test or analysis within three working days from the date of receipt of NOC from CDSCO-HQ.

Earlier SLA used to issue Form 29 licenses within three working days of receipt of application. The receipt of Form 29 License was also required to be confirmed by the 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, said the DCGI in a circular.

The joint inspection shall be conducted in cases wherein the seed/strain falls under BSL - III & IV. The applicant shall also inform about the BSL of the microorganisms/ strains with supporting documents while submitting the application.

If seed/stain falls under BSL I & II, joint inspection may not be required, provided that the manufacturing facility is already jointly inspected earlier. The joint inspection shall be conducted for all new facilities which have never been licensed/incorporated.

The joint inspection shall be conducted within 15 working days from the date of receipt of application wherever required as per above criteria.

In case of non-compliances observed during the joint inspection, the firm is required to submit the Corrective and Preventive Action (CAPA) along with supported documents within 30 days to CDSCO-HQ for review. In case of unsatisfactory reply and/or compliance, Form 29/NOC so granted may be cancelled/suspended, said the circular.

The CDSCO has requested its zonal/sub zonal offices and drug controllers of states and Union territories to advise the concerned manufacturers situated in their jurisdiction to comply with the above pathway for obtaining NOC and license in Form 29 to manufacture drugs for the purposes of examination, test or analysis for biological products (vaccines and r-DNA products).

 

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Yogesh Pandey Sep 9, 2019 1:23 PM
Please send me the list of documents required to get NOC form CDSCO for issue form No. 29 for manufacturing drug for the purpose of examination, test & analysis under the provision of Drugs & cosmetic Act & Rules.
Vikas Kumar Mar 4, 2019 7:27 PM
This article refers to an old office order released last year on 19 Jan 2018.
 
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