India Proposes New Rules to Align Blood Product Testing with Global Standards

The draft notification has been released for public consultation, inviting stakeholders to submit comments and suggestions within the prescribed period.

The Ministry of Health and Family Welfare (MoHFW) has issued a draft Gazette Notification (GSR 164(E) dated 9 March 2026) proposing amendments to Para G (Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules, 1945, in a move aimed at harmonising India’s regulatory framework with internationally accepted pharmacopoeial standards.

The draft notification has been released for public consultation, inviting stakeholders to submit comments and suggestions within the prescribed period.

Proposal Aims to Remove Duplication in Testing

The proposed amendment seeks to streamline the regulatory process for testing plasma-derived medicinal products by eliminating duplicate testing requirements that currently exist under Indian regulations.

Under the existing framework, viral marker testing is conducted both at the pooled plasma stage and again at the finished product stage, even though the raw plasma used for manufacturing has already undergone rigorous safety screening.

Officials say the amendment would remove unnecessary duplication while maintaining strict patient safety standards.

Global Pharmacopoeial Standards Already Ensure Safety

According to the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP) and European Pharmacopoeia (EP), stringent testing protocols are applied at the stage where human plasma is pooled for fractionation.

Under these internationally harmonised standards:

• The first homogeneous pool of plasma must be tested for Hepatitis B surface antigen (HBsAg).

• The plasma pool must also be tested for Hepatitis C virus RNA and antibodies to HIV.

• Only plasma pools that test negative for these viral markers are approved for fractionation.

Once the plasma pool passes these safety tests, it is used to manufacture plasma-derived medicinal products, such as immunoglobulins and clotting factors.

Current Rules Require Additional Testing

Despite these rigorous upstream safety checks, India’s current regulatory framework requires the same viral markers to be tested again in the finished products, even though the source plasma has already been verified as virus-free.

Regulators say this double testing is not aligned with international regulatory practices and adds unnecessary compliance burdens without providing additional safety benefits.

Move Toward Regulatory Harmonisation

The Ministry said the proposed amendment represents a step toward scientific rationalisation of testing protocols and regulatory harmonisation with global standards.

The changes are also expected to:

• Reduce unnecessary regulatory compliance requirements

• Improve efficiency in manufacturing processes

• Align India’s pharmaceutical regulations with international best practices

Importantly, the Ministry emphasised that patient safety and quality assurance will remain the highest priority.

Stakeholder Consultation Invited

The draft notification has been released for public comments, allowing industry stakeholders, researchers and healthcare experts to review the proposed amendment.

The Ministry has encouraged all interested parties to submit feedback to help refine the proposed regulatory changes.

Officials say the consultation process will help ensure that the final regulations strike a balance between scientific rigour, regulatory efficiency and global harmonisation.