2026.06.01 G.S.R. 444(E)_Notification for amendment in Schedule V w.r.t. unit of measurement of Folic Acid under the Drugs Rules, 1945

The Ministry of Health and Family Welfare has notified the Drugs (Fourth Amendment) Rules, 2026, following consultation with the Drugs Technical Advisory Board and consideration of stakeholder feedback received on the draft notification issued earlier in January 2026.

Key points include:

1. The amendment introduces a change in Schedule V of the Drugs Rules, 1945, specifically relating to the unit of measurement prescribed for folic acid.
2. Under the revised provision, the unit against folic acid has been changed to micrograms (mcg).
3. The amendment aims to standardise the declaration and measurement of folic acid in accordance with current regulatory and scientific practices.
4. The revised requirement will become effective six months from the date of publication in the Official Gazette, providing manufacturers adequate time to update product specifications, labels, documentation, and regulatory records where applicable.