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2026.03.09 G.S.R. 164(E)_Draft Notification regarding Blood product testing under Drugs Rules,1945


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Regulatory update
Manufacturer   |   Source: CDSCO
Published On: 09-03-2026
Enforcement Date: 09 March, 2026
2026.03.09 G.S.R. 164(E)_Draft Notification regarding Blood product testing under Drugs Rules,1945

The Ministry of Health and Family Welfare has issued a draft notification proposing amendments to the Drugs Rules, 1945. The amendment suggests omitting mandatory testing of blood products for HIV I & II antibodies, Hepatitis B surface antigen, and Hepatitis C antibodies. Stakeholders are invited to submit objections or suggestions within 30 days before finalization.


The Ministry of Health and Family Welfare has published draft rules under the Drugs and Cosmetics Act, 1940 to amend provisions in Schedule F, Part XII C of the Drugs Rules, 1945. The proposed amendment seeks to remove the requirement mandating testing of final blood products for HIV I & II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies. This change may reflect an effort to update or streamline regulatory requirements, possibly aligning with revised scientific standards or alternate testing frameworks. The draft has been released for public consultation, allowing stakeholders including manufacturers, laboratories, and healthcare professionals to submit feedback within 30 days. The final rule will be notified after considering the received objections and suggestions.

Applicable For: Manufacturer
Reference Number: CG-DL-E-10032026-270812 Notification Link

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