The Ministry of Health and Family Welfare (MoHFW), Department of Health and Family Welfare, has issued a draft gazette notification (G.S.R. 745(E)) proposing the inclusion of four widely used medications under Schedule H1 of the Drugs Rules, 1945. The move aims to enforce tighter prescription monitoring and prevent misuse of these substances across the country.
The draft proposal, formulated after formal consultation with the Drugs Technical Advisory Board (DTAB), proposes to insert the following substances under Schedule H1 after entry serial number 52:Flupentixol (Entry 53);Zopiclone(Entry 54);Gabapentin(Entry 55); and Carisprodol (Entry 56)
Schedule H1 drugs are subject to stringent sales and distribution regulations. Under these compliance rules, chemists and pharmacists are mandated to sell these medicines strictly against a valid registered medical practitioner’s prescription. Additionally, pharmacies must maintain a dedicated register documenting the patient’s name, doctor’s details, date of supply, and quantity dispensed, retaining these records for a minimum of three years for regulatory inspection.
The Central Government has opened the draft rules for a 30-day public consultation window from the date of gazette publication. Objections and suggestions from stakeholders, industry representatives, and the general public can be addressed to the Under Secretary (Drugs), MoHFW, New Delhi, or submitted via email to drugsdiv-mohfw@gov.in.
Once finalized, the amended rules will come into force after 180 days from their publication in the Official Gazette, giving manufacturers, distributors, and retailers time to align packaging labels and documentation practices with Schedule H1 compliance norms.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
