The Union Health Ministry has brought Pregabalin, a widely prescribed drug used for chronic pain and neurological conditions, under the stricter Schedule H1 category of the Drugs Rules, 1945, following reports of misuse and illegal sales in several States.
The move is aimed at tightening prescription monitoring, restricting unauthorised access, and strengthening accountability across the pharmaceutical supply chain. The Ministry said the decision was taken after reports flagged the abuse of Pregabalin, particularly among youth, for its sedative, euphoric, and dissociative effects.
The notification, issued through Gazette Notification. Until now, the drug was regulated under Schedule H.
Pregabalin is commonly prescribed for chronic pain, neuropathies, fibromyalgia and certain neurological conditions. However, recent seizures of illegally stocked and unauthorisedly sold Pregabalin prompted the government to tighten controls.
Under the revised classification, the drug can now be sold only against a valid prescription issued by a Registered Medical Practitioner. Retailers will also be required to maintain a separate register documenting prescription and sales details.
Manufacturers have been directed to prominently display the mandatory “Schedule H1 Drug Warning” label on product packaging. The warning states that the preparation should not be taken except under medical advice and cannot be sold without a prescription.
The Ministry has also warned that violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940, and the rules framed under it.
The tighter controls are expected to increase scrutiny of the drug’s movement across the supply chain, from manufacturers and distributors to retailers and pharmacists. The Ministry said the measure is intended to curb illegal trafficking and safeguard public health from drug misuse and abuse.
All stakeholders, including manufacturers, wholesalers, distributors, retailers, and pharmacists, have been advised to ensure strict compliance with the notification.
