Centre proposes changes in Drug Rules to standardise blood product testing

The Union Health Ministry has proposed to amend the Drugs Rules, 1945, to align regulatory requirements for testing blood products with internationally accepted pharmacopoeial standards and remove testing requirements not warranted under global best practices.

It has issued a draft gazette notification, inviting public comments on a proposal to amend paragraph G (testing of blood products), Part XII C, Schedule F of the Drugs Rules 1945.

"The proposed amendment seeks to align regulatory requirements for testing blood products with internationally accepted pharmacopoeial standards and to remove additional testing requirements on products that are not warranted under global best practices," the ministry said.

 

According to the official monographs of Human Plasma for Fractionation in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and European Pharmacopoeia (EP), stringent testing protocols are prescribed for pooled human plasma.

Under these harmonised standards, the first homogeneous pool of plasma is mandatorily tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA and antibodies to HIV, the ministry said.

Pooled plasma must test negative for these viral markers before it is permitted for fractionation, it stated. Besides, only plasma pools that meet these safety requirements are used for manufacturing plasma-derived medicinal products.

Despite this, under the current regulatory framework, the final products manufactured from already tested and qualified plasma pools are again tested, the ministry stated.

This results in duplication of testing for the same viral markers at both the pooled plasma stage and the finished product stage. Such double testing is not aligned with international regulatory practices.

The proposed amendment is a progressive step towards 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.

Stakeholders are encouraged to review the draft notification and submit their comments and suggestions within the prescribed timeline, it added.