Centre proposes amendment to Drugs Rules to align blood product testing with global standards

The Union Health Ministry has proposed amendments to the Drugs Rules, 1945 to align regulatory requirements for testing blood products with internationally accepted pharmacopoeial standards and eliminate tests considered unnecessary under global best practices.

In a draft gazette notification issued recently, the ministry invited public comments on the proposal to amend paragraph G (testing of blood products), Part XII C, Schedule F of the rules. The move aims to harmonise India’s regulatory framework with international standards while reducing duplication in testing procedures.

According to official monographs of Human Plasma for Fractionation in the Indian Pharmacopoeia , as well as global references such as the British Pharmacopoeia , United States Pharmacopeia , and European Pharmacopoeia , stringent testing protocols are prescribed for pooled human plasma .

Under these harmonised standards, the first homogeneous plasma pool must undergo mandatory testing for viral markers including Hepatitis B surface antigen (HBsAg) , Hepatitis C virus RNA , and antibodies to HIV . Only plasma pools that test negative for these markers are permitted for fractionation (the process of separating plasma into its individual components, such as clotting factors, immunoglobulins, and albumin, for use in medicines) and subsequent manufacturing of plasma-derived medicinal products .

However, under the current regulatory framework, the final products manufactured from already tested and qualified plasma pools are again tested for the same viral markers. The ministry noted that such duplicate testing leads to unnecessary repetition and is not aligned with international regulatory practices.

The proposed amendment seeks to remove repeated testing at the finished product stage, thereby ensuring regulatory harmonisation, scientific rationalisation of testing requirements, and reduction of avoidable compliance burden, while continuing to uphold the highest standards of patient safety.

The ministry said the amendment is expected to improve efficiency and reduce regulatory duplication while maintaining safety and aligning India’s blood product testing rules with international best practices.

Stakeholders have been encouraged to review the draft notification and submit their comments and suggestions within the prescribed timeline.