Govt. moves Pregabalin to Schedule H1 following reports of drug abuse

Pregabalin has been included under Schedule H1 of the Drugs Rules, 1945, vide a Gazette Notification, according to information released by the Union Health Ministry on Friday (May 22, 2026). The move comes following reports received from various States regarding the misuse and abuse of the drug, particularly among youth.

The drug, which is prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and certain neurological conditions, has reportedly been misused for its sedative, euphoric, and dissociative effects. Recent seizures of illegally stocked and sold Pregabalin have been reported from some parts of the country.

With this notification, Pregabalin will now be regulated under the stricter provisions of Schedule H1, instead of the existing Schedule H, under the Drugs and Cosmetics Rules, 1945.

The H1 prescription drug comes with caution that it is dangerous to take this preparation except in accordance with the medical advice and that it cannot be sold by retail without the prescription of a registered medical practitioner.

Additionally, retailers must maintain a separate register recording details of prescriptions and sales; manufacturers shall prominently display the prescribed ‘Schedule H1 Drug Warning’ label on product packaging, and violation and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940, and Rules thereunder.

“The measure is aimed at strengthening accountability across the supply chain, preventing unauthorised access, enhancing prescription monitoring, curbing illegal trafficking, and safeguarding public health from drug misuse and abuse. All stakeholders, including manufacturers, distributors, wholesalers, retailers, and pharmacists, are advised to ensure strict compliance with the provisions of the notification,’’ the Ministry said.

Pregabalin belongs to a class of medicines known as gabapentinoids, which act on the central nervous system to reduce nerve-related pain and seizures. In India, the drug is widely prescribed for chronic pain associated with diabetes, spinal injuries and nerve disorders. Over the past decade, however, doctors and law-enforcement agencies have reported increasing non-medical use of the drug, particularly among young people and individuals with substance-use disorders.

Several de-addiction specialists have also flagged a rise in patients dependent on Pregabalin, particularly in Punjab, Haryana and parts of North India where opioid addiction remains a major concern. Globally, countries including the United Kingdom have tightened regulations around Pregabalin because of concerns over addiction and overdose deaths.