On January 19, 2018, the Central Drug Standard Control Organization (CDSCO) has published clarification regarding issuance of No Objection Certificate (NOC) for issuing Form 29 License used to manufacture drugs for the purposes of examination, test or analysis of biological products (Vaccines 86 r-DNA products).
Form 29 is a license to manufacture drugs for the purpose of Examination Testing and Analysis. An application for a Form 29 license shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereafter in this Part referred to as the Licensing Authority) in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured. A license in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time6.
However, the CDSCO on its previous notification has also 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 Drug and Cosmetic Rules"7.
CDSCO's further discussion with stakeholders has clarified the application process as:
- The applicants shall submit application for obtaining Form 29 license to the concerned State Licensing Authority (SLA).
- Firm shall simultaneously apply to CDSCO, HQ (Head quarter) 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.
- NOC for issuance of Form 29 will be issued by this Directorate (CDSCO) within 7 working days.
- The joint inspection will be
conducted based on risk based approach as per following
criteria:
- If the seed/strain falls under BSL - III & IV, joint inspection shall be conducted in such cases. 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 Sr.No. 4 above.
- In all cases, if the NOC from CDSCO, HQ is not granted within 7 working days after receipt of application, NOC will be deemed as granted.
- The State Licensing Authority (SLA) shall issue the Form 29 License for purposes of examination, test or analysis within 03 working days from the date of receipt of NOC from CDSCO-HQ.
- 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.8
Note - The CDSCO has requested all Drug Controllers of States and Union Territories and all Zonal/Sub zonal offices 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 86 r-DNA products).
Footnotes
6. http://www.cdsco.nic.in/writereaddata/GUIDANCE%20DOC.pdf
7. http://cdsco.nic.in/writereaddata/Circular%2013_12_2016(1).pdf
8. http://www.cdsco.nic.in/writereaddata/FORM%2029%20NOC%20DOCUMENTS.pdf
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