Draft Amendment to Drugs Rules Removes Viral Testing Requirement

The Central Government has issued draft rules to amend the Drugs Rules, 1945, under the authority of the Drugs and Cosmetics Act, 1940. The proposal has been released after consultation with the Drugs Technical Advisory Board and is currently open for public comments.

According to the draft notification published by the Ministry of Health and Family Welfare, the amendment targets Schedule F, Part XII-C, Para G of the Drugs Rules, 1945. The government has proposed to remove the provision that requires final pharmaceutical products to be tested for HIV-I antibodies, HIV-II antibodies, Hepatitis B surface antigen, and Hepatitis C virus antibodies.

The draft rule specifically states that the sentence mandating these viral testing requirements will be omitted from the regulation. This proposed change forms part of the government’s ongoing efforts to update and streamline pharmaceutical regulatory provisions.

Stakeholders, pharmaceutical companies, and industry experts may submit objections or suggestions within 30 days from the date the Gazette of India notification is made available to the public. After reviewing the feedback, the government will finalize the amendment and announce the effective date through the Official Gazette.