Centre puts drug pregabalin under Schedule H1 to prevent misuse

The Union Health Ministry has brought pregabalin, a drug used for treating chronic pain and certain neurological conditions, under the stricter Schedule H1 category amid reports of its misuse and abuse.

The ministry notified the inclusion of pregabalin under Schedule H1 of the Drugs Rules, 1945, 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.

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.

The ministry cited seizures of illegal stocks and sales of pregabalin in parts of the country.

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

Under the revised classification, the drug can now be sold only against a valid prescription issued by a registered medical practitioner (RMP).

Retailers will now have to maintain a separate register recording details of prescriptions and sales, while manufacturers must prominently display the prescribed ‘Schedule H1 Drug Warning’ label on product packaging, a ministry statement said.

The ministry said violations and non-compliance would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules.

According to the statement, 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.”