Centre proposes changes in Drug Rules to align blood product testing with global standards

NEW DELHI: (Mar 11) 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.