Centre Proposes Amendment to Drugs Rules 1945

On 9th March 2026, the Ministry of Health and Family Welfare invited public comments on a draft amendment to the Drugs Rules, 1945, proposing changes to testing norms for blood products to align India’s regulations with internationally accepted pharmacopoeial standards.

Key Points

Draft Notification: The proposed amendment was issued through Draft Gazette Notification GSR 164(E) and seeks changes in Para G (Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules.
Removal of Duplicate Testing: The amendment proposes removing duplicate viral testing requirements for blood products that have already been tested at the pooled plasma stage.
International Standards: Global pharmacopoeias such as the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP) require rigorous testing of the first homogeneous pool of human plasma used for fractionation.
Viral Screening Requirements: Plasma pools must be screened for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA, and antibodies to HIV, and only virus-negative plasma pools can be used to manufacture plasma-derived medicinal products.
Current Indian Practice: Under existing regulations in India, finished blood products are again tested for the same viral markers, even when the source plasma pools have already been tested and qualified.
Regulatory Rationalisation: The proposed amendment aims to eliminate redundant testing, streamline compliance processes, and harmonise India’s regulatory framework with global best practices.
Patient Safety: The ministry stated that the changes will reduce unnecessary compliance burden while maintaining strict safety standards for blood products.