New Delhi

HealthMinistry on Friday said it has notified the inclusion of the drug ‘Pregabalin’ under Schedule H1 of the Drugs Rules, 1945. The decision has been taken in view of reports received from certain states regarding the misuse and abuse of Pregabalin, particularly among youth.

Violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and Rules thereunder.

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, informed the ministry.

All stakeholders, including manufacturers, distributors, wholesalers, retailers, and pharmacists, are advised to ensure strict compliance with the provisions of the notification, the ministry said.

Recent seizures of illegally stocked and unauthorisedly sold Pregabalin have also been reported from some parts of the country.

With the notification, published in the Gazette of India Extraordinary, 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 Schedule H1 prescription ‘Drug-CAUTION’ says that it is dangerous to take this preparation except in accordance with the medical advice — not to be sold by retail without the prescription of a Registered Medical Practitioner.

The revised classification mandates that Pregabalin can be sold only against a valid prescription issued by a Registered Medical Practitioner (RMP); 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.

“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,” said the ministry.