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January 2017

 

Directorate General of Health Services decided to abolish practice of prior joint inspection for issuance of Form 29 licenses

 

CDSCO decided to abolish practice of pre-inspection by State Licensing Authority & Central Licensing Authority for issuing Form 29 License to manufacture drugs for purposes of examination, test or analysis for biological products (Vaccines & r-DNA products).

In order to promote research & development of new drugs, they have been decided to discontinue the practice of prior joint inspection for issuance of Form 29 licenses to vaccine & r-DNA products.

From now, the applicant shall submit application along with self -declaration to State Licensing Authority & Central Licensing Authority by hard copy and also by e-mail. The State Licensing Authority shall issue Form 29 Licenses within three working days of receipt of application without prior inspection. The receipt of Form 29 License shall also be confirmed by applicant on email to CDSCO, within three working days.

Directorate General of Health Services further notified that the joint inspection of such applicants shall be carried out after issuance of Form 29 Licenses, using the risk based approach.

On behalf of editorial team, I sincerely thank all authors for sharing their views and research with us. Hope we will receive similar support in future also

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