New Delhi: The Drugs Technical Advisory Board (DTAB) has recently recommended for amendment of the Drugs and Cosmetics Rules, 1945 regarding submission of documents to get approval for manufacturing license for drugs.

The board further recommended issuing appropriate guidelines for the applicability of provisions for modified release dosage forms, products involving complex or special manufacturing technology.

DTAB was apprised that, the Drugs and Cosmetics Rules, 1945 have been amended mandating the submission of BA/BE studies for grant of manufacturing licence. As per the GSR 327(E), the applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing licence of an oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.

The Rules have also been amended making it mandatory to submit evidence of stability, safety of excipients, etc. to State Licensing Authority along with application before grant of product manufacturing licences.

In this context, DCC in its 56th meeting deliberated the concept of the “Dossier Approval” in respect of formulation development data, including stability data and BA/BE data, generated under the valid licence under the Drugs and Cosmetics Rules, 1945.

It was deliberated that any person/ institution can develop a drug formulation and can generate dossier of the product development containing detailed data on formulation development, BA/BE study data, stability data, excipients compatibility, etc, and submit to the licensing authority for approval. Once such dossier is approved by licensing authority under Drugs and Cosmetics Rules, 1945, the same may be submitted by a manufacturer under an agreement for technology transfer etc. between the person/institution who has developed the formulation and the manufacturer for seeking grant of manufacturing licence for the same product subject to submission of following:

• Equivalency report showing the similarity of raw materials, API and excipient source and specifications, packaging materials specifications, SOPs, testing methods, manufacturing and packaging processes, equipment design and principle, batch size and finished product specifications between manufacturers product and the product developed by the person/institution.


• Comparative evaluation data including multimedia comparative dissolution profile to show the similarity between the two products.


• Six months accelerated and long term stability data for the drug formulation generated at the applicants manufacturing site.

Accordingly, Drugs and Cosmetics Rules may be amended to make necessary provisions in this regard, states the committee report.

DTAB deliberated the issue and recommended for amendment of the Drugs and Cosmetics Rules, 1945 regarding dossier of approval and submission of the same for grant of manufacturing license for drugs. Further, DTAB opined that in such cases the technology followed at manufacturing site must be same as that approved through dossier approval.

The Board also recommended that appropriate guidelines shall be issued for the applicability of these provisions for modified release dosage forms, products involving complex or special manufacturing technology.