Pregabalin Sale Only on Valid Prescription Now

New Delhi: The Union Health Ministry has brought pregabalin under the stricter Schedule H1 category following reports of its misuse and abuse.

The inclusion of the drug under Schedule H1 of the Drugs Rules, 1945, was notified through a gazette notification on May 20.

“The decision has been taken in view of reports received from certain states regarding the misuse and abuse of Pregabalin, particularly among youth,” the ministry said.

Pregabalin, used in the treatment of chronic pain, neuropathies, fibromyalgia and certain neurological conditions, has reportedly been misused for its sedative, euphoric and dissociative effects.

The ministry cited seizures of illegal stocks and instances of its unauthorised sale in parts of the country.

The drug was earlier regulated under Schedule H of the Drugs and Cosmetics Rules, 1945.

Under the revised classification, pregabalin can be sold only against a valid prescription issued by a registered medical practitioner.

Retailers will be required to maintain a separate register recording prescription and sales details, while manufacturers must display the prescribed ‘Schedule H1 Drug Warning’ label on product packaging, the ministry said.

It added that violations would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules.

The move 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,” the ministry said.