The Union Ministry of Health and Family Welfare (MoHFW) has brought the drug Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, in a move aimed at preventing misuse, illegal sale and unauthorised access to the medicine.
The MoHFW issued the notification through Gazette Notification G.S.R. 377(E) dated May 13, 2026, which was published in the Gazette of India on May 20.
The ministry said that the decision was taken following reports from several states regarding the misuse and abuse of Pregabalin, particularly among young people. The drug, commonly prescribed for chronic pain, neuropathies, fibromyalgia and certain neurological disorders, has reportedly been misused for its sedative, euphoric and dissociative effects.
Authorities have also reported seizures of illegally stocked and unauthorisedly sold Pregabalin from different parts of the country.
With the revised classification, Pregabalin will now be regulated under Schedule H1 instead of Schedule H, bringing stricter monitoring and compliance requirements for its manufacture and sale.
Under the new rules, the drug can only be sold against a valid prescription issued by a Registered Medical Practitioner (RMP). Retail chemists will be required to maintain a separate register documenting prescription and sales details of the medicine.
Manufacturers will also have to prominently display the mandatory “Schedule H1 Drug Warning” on product packaging, cautioning consumers against use without medical advice and prohibiting retail sale without prescription.
The ministry said that violations of the provisions would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules.
The move is aimed at strengthening prescription monitoring, improving accountability across the pharmaceutical supply chain, curbing illegal trafficking and protecting public health from drug misuse and abuse.
The Ministry has advised all stakeholders, including manufacturers, wholesalers, distributors, retailers and pharmacists, to ensure strict compliance with the notification.
