The Ministry of Health and Family Welfare (MoHFW) on January 22, 2026, issued the Draft Drugs (...... Amendment) Rules, 2025 to further amend the Drugs Rules, 1945.
The following amendments have been stated:
• In Schedule H1 after serial number 50 and entries relating thereto, the following serial number and entry shall be inserted, namely: ―
“51. Pregabalin”
• Under the Table of Schedule V, unit mentioned against the Folic acid i.e. “mg.” shall be substituted with “mcg”.
The draft is issued after consultation with the Drugs Technical Advisory Board and is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. 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 [email protected].
[Notification G.S.R. 54(E) and G.S.R. 53(E)]
