The Union Health Ministry has proposed amendments to the Drugs Rules, 1945, to bring India’s regulatory requirements for testing blood products in line with internationally accepted pharmacopoeial standards.
The move aims to simplify testing procedures while maintaining strict safety standards for patients. According to the ministry, the proposed changes will remove testing requirements that are not necessary under global best practices and reduce duplication in the current system.
Blood products used for medical treatment are made from human plasma, a component of blood. Before these products are manufactured, the plasma collected from multiple donors is pooled together and tested thoroughly to ensure that it is free from infections.
Under internationally accepted pharmacopoeial standards, such as the Indian Pharmacopoeia Commission standards, as well as those laid down in the British Pharmacopoeia, United States Pharmacopeia, and European Pharmacopoeia, strict testing protocols are already in place for pooled human plasma.
As per these standards, the first homogeneous pool of plasma used for fractionation must be tested for key viral markers. These include Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA, and antibodies to HIV. Only plasma pools that test negative for these viruses are allowed to be used for the production of plasma-derived medicinal products.
However, the ministry noted that under the current regulatory system in India, the finished blood products manufactured from these already tested plasma pools are again subjected to the same viral testing.
This means that the same viral markers are tested twice — once at the pooled plasma stage and again at the finished product stage. According to officials, such duplicate testing is not followed under most international regulatory practices.
“Under these harmonized 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 pooled plasma must test negative for these viral markers before it is permitted for fractionation. Only plasma pools that meet these safety requirements are used for manufacturing plasma-derived medicinal products,” as per the draft notification shared by the Union Health Ministry with the public on Saturday.
The ministry has invited public comments on the changes proposed to Para G (Testing of Blood Products), Part XII C, Schedule F of the rules.
Officials described the proposal as a step towards regulatory harmonisation and scientific rationalisation of testing procedures. It is also expected to reduce unnecessary compliance burdens on manufacturers while continuing to maintain high levels of safety.
Experts say that eliminating duplicate testing can also help streamline production processes for plasma-derived medicines without compromising quality or patient protection.
The ministry emphasised that only plasma pools that meet strict safety standards will continue to be used in manufacturing blood-derived medicines. Therefore, the safety of patients will remain a top priority.
“The proposed amendment is a progressive step towards regulatory harmonization, scientific rationalization of testing requirements, and reduction of avoidable compliance burden, while continuing to uphold the highest standards of patient safety."
“Stakeholders are encouraged to review the draft notification and submit their comments and suggestions within the prescribed timeline,” the Union Health Ministry said in a statement.
