India Pharma Outlook Team | Wednesday, 11 March 2026
The Ministry of Health and Family Welfare (MoHFW) has published a draft Gazette notification proposing an amendment to the Drugs Rules, 1945, to make changes to the requirements of testing of blood products.
The amendment will help to eliminate the condition that final blood products must be tested to determine the presence of HIV I and II antibodies, Hepatitis B surface antigen (HBsAg), and Hepatitis C virus antibodies.
It is believed that the transfer of pharmacopoeial standards to internationally accepted standards will see the harmonization of the regulatory structure in India with the global best practices of pharmacopoeia, and would remove unnecessary pharmacopoeia-related testing measures that are not globally best practices (Ministry).
In the present scenario, blood products that are produced out of plasma are subjected to various tests per the regulatory system applied in India, and this includes the finished product test. Nevertheless, pharmacopoeial standards established internationally. It already specify strict testing at the pooled plasma level.
According to these standardized guidelines, the initial homogenous stock of plasma has to be screened compulsory to the main viral indicators such as: Hepatitis B surface antigen, Hepatitis C virus RNA, and HIV antibodies. Fractionation and subsequent processing of plasma-derived medicinal products of plasma into liquid form is only approved of plasma pools that do not test positive of these markers.
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Even with this rigorous screening procedure, contemporary Indian regulations require one more test on the same viral markers in the end product, which is duplication, and is not exercised in most other regulatory systems in the world.
The proposed amendment, according to the Ministry, would be an advance of the harmonization of regulatory processes, the scientific rationalization of the testing norms, and the decrease in the unnecessary compliance costs of manufacturers without deteriorating patient safety standards.
