The Ministry of Health and Family Welfare (MoHFW) has published a draft notification proposing amendments to the Drugs Rules, 1945. These amendments aim to enhance transparency and provide more comprehensive information on drug labels.
These draft rules propose the inclusion of “details of excipients” on all drug labels. Excipients are inactive ingredients used in medications to bind, dissolve, or enhance the stability of active components.
Existing label requirements are being tightened. The amendment proposes replacing semicolons with full stops (periods) after “date of expiry” and “manufacturing license number” to improve clarity and separation of information.
The draft notification is open for public feedback till August 11, 2024.
Individuals and stakeholders can submit their objections or suggestions through mail or email to the MOHFW at drugsdiv-mohfw@gov.in
This initiative seeks to strengthen drug regulations and ensure patient safety and informed decision-making. By including details of excipients on labels, the draft rules aim to provide a detailed picture of the medications patients are taking.
