Centre places pregabalin under stricter Schedule H1 category to curb misuse

Story by  PTI | Posted by  Vidushi Gaur | Date 22-05-2026
Representational Image
Representational Image

 

New Delhi

The Union Health Ministry has moved Pregabalin to the stricter Schedule H1 category following reports of its misuse and abuse, particularly among young people.

The decision was notified through a gazette notification issued on May 20 under the Drugs Rules, 1945.

According to the ministry, several states had flagged instances of misuse of pregabalin, a medicine commonly prescribed for chronic pain, neuropathy, fibromyalgia and certain neurological disorders.

Officials said the drug has increasingly been abused for its sedative, euphoric and dissociative effects. Authorities have also reported seizures of illegal stocks and unauthorised sales in different parts of the country.

Earlier, pregabalin was regulated under Schedule H of the Drugs and Cosmetics Rules, 1945. With its inclusion under Schedule H1, the medicine will now face tighter monitoring and stricter sale conditions.

Under the revised rules, the drug can only be sold on the basis of a valid prescription issued by a registered medical practitioner.

Retail chemists will be required to maintain a separate register containing details of prescriptions and sales related to the medicine. Manufacturers must also display the mandatory “Schedule H1 Drug Warning” prominently on product labels and packaging.

The ministry said any violation of the revised regulations would invite action under the Drugs and Cosmetics Act, 1940 and associated rules.

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According to the ministry, the step is intended to improve accountability across the supply chain, strengthen prescription monitoring, prevent unauthorised access and illegal trafficking, and protect public health from drug abuse.