Centre proposes changes in Drug Rules to align blood product testing with global standards
New Delhi, Mar 11 (PTI) 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.
