New Delhi, May 22: The Union Health Ministry has brought the drug Pregabalin under stricter regulatory control by including it in Schedule H1 of the Drugs Rules, 1945, citing growing concerns over its misuse and abuse, particularly among young people.
The decision follows reports from multiple states indicating that the drug, commonly prescribed for chronic pain and neurological conditions, is being used beyond medical purposes. Officials noted that Pregabalin has been misused for its sedative, euphoric, and dissociative effects, raising public health concerns.
With the latest notification published in the Gazette of India Extraordinary, Pregabalin will now be governed by the more stringent provisions of Schedule H1, replacing its earlier classification under Schedule H. The revised categorisation introduces tighter restrictions on its sale and monitoring.
Under the new rules, the drug can be dispensed only against a valid prescription issued by a Registered Medical Practitioner. Retailers are required to maintain a separate register documenting details of prescriptions and sales, ensuring traceability and accountability. Manufacturers must also display a clearly visible “Schedule H1 Drug Warning” label on the packaging.
The Health Ministry has directed all stakeholders in the supply chain, including manufacturers, distributors, wholesalers, retailers, and pharmacists, to comply strictly with the updated provisions. Any violation or non-compliance will invite penal action under the Drugs and Cosmetics Act, 1940, and related rules.
Authorities have also reported recent instances of illegal stocking and unauthorised sale of Pregabalin in different parts of the country, which contributed to the decision to tighten regulatory oversight. The move is aimed at addressing gaps in monitoring and preventing unauthorised access to the drug.
Officials stated that the revised classification seeks to strengthen accountability at every stage of the distribution chain while improving prescription tracking mechanisms. The measure is also intended to curb illegal trafficking and ensure that the drug is used only for legitimate medical purposes.
Pregabalin is widely used in the treatment of neuropathic pain, fibromyalgia, and certain neurological disorders. However, concerns over its non-medical use have prompted authorities to introduce stricter safeguards.
The ministry said the regulation is part of broader efforts to safeguard public health and minimise the risks associated with prescription drug misuse, particularly among vulnerable groups.
