Health Ministry invites public comments on draft drugs rules for blood testing products

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Proposal aims to align testing norms with global standards

New Delhi: The Ministry of Health and Family Welfare has invited public comments on a draft amendment to the Drugs Rules, 1945 aimed at updating testing requirements for blood products and aligning them with international pharmacopoeial standards.

In a draft Gazette notification GSR 164(E) issued on March 9, the ministry proposed changes to Para G (Testing of Blood Products), Part XII C, Schedule F of the rules. The notification was released for public consultation on March 11.

According to the ministry, the amendment seeks to remove duplicate viral testing requirements for blood-derived products that are already subject to rigorous screening at earlier stages of production.

Current testing process under review

Under internationally recognised pharmacopoeial standards, strict testing protocols are already applied to pooled human plasma used in the manufacture of plasma-derived medicinal products.

These standards are defined in the Indian Pharmacopoeia, as well as in the British Pharmacopoeia, United States Pharmacopeia, and European Pharmacopoeia.

Under these harmonised norms, the first homogeneous pool of plasma must undergo mandatory testing for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA, and antibodies to HIV. Plasma pools are allowed for fractionation only if they test negative for these viral markers.

Duplication in existing framework

Despite this screening process, India’s current regulatory framework requires the final plasma-derived products manufactured from already tested plasma pools to undergo testing again for the same viral markers.

Officials said this results in duplication of testing at both the plasma pool stage and the finished product stage, a requirement that does not exist in most international regulatory systems.

The proposed amendment seeks to remove this duplication while maintaining stringent safety standards.

Towards regulatory harmonisation

The ministry said the reform is intended to bring India’s drug regulation framework closer to global best practices while reducing unnecessary compliance burdens for manufacturers.

According to the draft notification, the amendment represents a step towards scientific rationalisation of testing protocols, regulatory harmonisation, and more efficient compliance processes without compromising patient safety.

Public consultation underway

The ministry has invited stakeholders, including pharmaceutical companies, healthcare professionals, and industry associations, to review the draft notification and submit comments and suggestions within the stipulated consultation period before the amendment is finalised.

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