The Ministry of Health and Family Welfare has notified the Drugs (2nd Amendment) Rules, 2025, effective from 1st March 2026, bringing a change to the particulars required to be maintained as part of stored labelling information.
Previously, the labelling data was limited to basic identifiers such as the unique product identification code, proper and generic name of the drug, brand name, details of the manufacturer, batch number, dates of manufacturing and expiry, and the manufacturing licence number. Going forward, this scope has been broadened to also include the qualitative details of excipients, ensuring that, along with core product and manufacturing particulars, the formulation components beyond the active ingredient are mandatorily disclosed.
Source: Ministry of Health and Family Welfare
