Govt Proposes Scrapping Mandatory HIV, Hepatitis Tests for Certain Blood Products

New Delhi: The Ministry of Health and Family Welfare has issued a draft notification proposing to amend the Drugs Rules, 1945 by removing the mandatory requirement for testing certain biological products for HIV and Hepatitis B and C markers under Schedule F.

The draft notification, published in the Gazette of India on March 9, 2026, states that the Central Government proposes to further amend the Drugs Rules, 1945 in exercise of the powers conferred under subsection (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board.

The draft rules have been published for the information of all persons likely to be affected, and the government has stated that they will be taken into consideration after the expiry of thirty days from the date on which copies of the Gazette containing the draft rules are made available to the public.

According to the draft notification, a key amendment has been proposed under Schedule F, Part XII C, Para G of the Drugs Rules, 1945. The notification states that the existing requirement mandating testing of final products for HIV I and HIV II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibody shall be omitted.

Drugs Rules, 1945, under the Schedule F, Part XII C, Para G states,

"Testing of Blood Products: The products manufactured shall conform to the standards specified in the Indian Pharmacopoeia and where standard of any product is not specified in the Pharmacopoeia, the standard for such product shall conform to the standard specified in the United States Pharmacopoeia or the British Pharmacopoeia. The final products shall be tested for freedom from HIV I and HIV II antibodies, 1081[Hepatitis B surface antigen and Hepatitis C virus antibody].

The notice states:

"In the Drugs Rules, 1945, under the Schedule F, Part XII C, Para G, the words “The final products shall be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody" shall be omitted."

The ministry has invited feedback from stakeholders before finalizing the amendments. According to the notification, “objections and suggestions that may be received from any person within the period specified above will be considered by the Central Government.”

Stakeholders have been given 30 days from the date of publication of the draft rules to submit their comments.

“Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall-C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in,” the notice added.

To view the official notice, click the link below: