USA – US FDA issues Drug Master File draft guidance for industry, Indian pharma sees immense value

US FDA has now issued the draft guidance on Drug Master File which are confidential documents submitted by active pharmaceutical ingredient industry detailing the chemical substances, manufacturing processes of the drug component along with information of its packaging, and storing. The regulatory has called for a 60 day review of the document and expects the industry to revert before December end.

India which is recognise as a API hub is known for its submissions of a DMFs are often considered more reliable in terms of quality, regulatory standing, and ability to meet Current Good Manufacturing Process (cGMP) requirements. The companies here have a solid presence in the US market and received 290 ANDA approvals from US FDA, ending 2018. Hence pharma companies view the draft guidance for DMF has vital source of information.

The regulatory note indicates that DMF holders can authorize one or more applicants or sponsors to incorporate by reference information contained in the File without having to disclose that information to the applicants or sponsors. DMFs are submitted solely at the discretion of their holders and are not required by statute or regulation. They are not typically submitted for non-proprietary materials. Ordinarily, FDA neither independently reviews nor approves DMF submissions. Instead, FDA customarily reviews the technical contents of DMFs only in connection with the review of applications that reference them…