Notification / Circular No.: G.S.R. 164(E) dated March 09, 2026
Applicable Act / Rule: Drugs Rules, 1945
Applicable Section / Rule: Schedule F, Part XII C, Paragraph G
The Central Government has proposed amendments to the Drugs Rules, 1945 relating to requirements under Schedule F governing standards for biological and special products. The amendment concerns the testing requirements prescribed for final products under Part XII C of the Schedule. The draft rules have been issued for public consultation and stakeholders may submit objections or suggestions within thirty days from the date the Gazette containing the draft rules is made available to the public.
In the Drugs Rules, 1945, under Schedule F, Part XII C, Paragraph G, the following words shall be omitted:
“The final products shall be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody.”
The draft rules specify that the amendment will take effect from the date notified by the Government at the time of final publication of the rules in the Official Gazette.
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