India Moves to Modernize Blood Product Testing Regulations

The Union Health Ministry plans to amend the Drugs Rules, 1945, to update blood product testing regulations aligning with global standards. The proposal aims to eliminate redundant testing, streamline processes, and maintain patient safety. Public comments on the draft have been invited for stakeholder involvement.

The Union Health Ministry has announced plans to update testing regulations for blood products, aiming to align them with internationally recognized pharmacopoeial standards. The ministry seeks to eliminate redundant testing practices that fall outside global best practices. It has issued a draft gazette notification seeking public commentary on these proposed amendments to the Drugs Rules, 1945.

The proposed changes focus on the alignment of testing protocols for human plasma across several leading pharmacopeias, including the Indian, British, United States, and European versions. Stringent tests for viral markers such as Hepatitis B, Hepatitis C, and HIV are already conducted on pooled human plasma before products proceed further into the manufacturing process.

Current regulations require repeated viral marker testing on finished products, although they have already been tested at the plasma stage. The ministry argues this creates unnecessary duplication and proposes a simplified process to ensure regulatory harmony, scientific precision, and maintained patient safety. Stakeholders are invited to review and submit feedback on the draft within the allotted timeframe.

(With inputs from agencies.)