The government has brought Pregabalin – a drug usually prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions – under the stricter provisions of Schedule H1 of the Drugs Rules to prevent its misuse and strengthen regulation.
With this revision, Pregabalin will now be regulated under the stricter Schedule H1 category instead of the existing Schedule H classification under the Drugs and Cosmetics Rules, 1945.
The revised classification mandates that Pregabalin can be sold only against a valid prescription issued by a Registered Medical Practitioner (RMP) and cannot be sold over the counter.
In addition, retailers will now be required to maintain a separate register recording details of prescriptions and sales. Manufacturers must also ensure that product packaging prominently carries the prescribed “Schedule H1 Drug Warning” label.
The Union Ministry of Health and Family Welfare announced the decision through Gazette Notification G.S.R. 377(E) dated May 13, 2026, and published in the Gazette of India Extraordinary on May 20, 2026.
The move comes amid growing concerns over the increasing misuse and abuse of Pregabalin, particularly among youth. In a press release, the Ministry stated that the drug has been reportedly misused for its sedative, euphoric, and dissociative effects. It also pointed to recent seizures of illegally stocked and unauthorisedly sold Pregabalin in some parts of the country.
The Ministry has advised all stakeholders—including manufacturers, distributors, wholesalers, retailers, and pharmacists—to ensure strict compliance with the provisions of the notification.
“Violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and Rules thereunder,” it stated.
Through this measure, the government aims to strengthen accountability across the supply chain, prevent unauthorised access, enhance prescription monitoring, curb illegal trafficking, and safeguard public health from drug misuse and abuse.
