Notification: Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies

Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).

In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:

Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.

Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.