The drug has reportedly been misused for its sedative, euphoric, and dissociative effects

In an effort to curb misuse and abuse, the Union Health Ministry has tightened norms involving the supply and sale of pregabalin, a drug used in treating nerve-related pain, that could be acute or chronic in nature. The drug has now been brought under Schedule H1 of the Drugs Rules, 1945 – requiring a doctor prescription for sale, besides meticulous record-keeping by the chemist. .

“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, on the drug that is used to treat chronic pain, neuropathies, fibromyalgia, and certain neurological conditions.

The drug has reportedly been misused for its sedative, euphoric, and dissociative effects, the note said, adding that seizures of illegally stocked and unauthorisedly sold pregabalin have also been reported from some parts of the country.

Dr Manish Chhabria, Senior Consultant Neurologist at Mumbai’s Sir HN Reliance Foundation Hospital, told businessline that pregabalin was a good drug commonly used by neurologists to treat neuropathic pain, sometimes defined by patients as tingling, or numbness, for example.

Doctors are aware of the dosage that needs to be given, he said, but when people take it for recreational uses in large doses it causes drowsiness and sleepiness, he added. The drug has been around for about five -six decades, he said, welcoming the Centre’s move to prevent the sale of the drug, over the counter.

The Indian Medical Association’s former President Dr RV Asokan also agreed that the drug was a good product used in treating diabetic neuropathy, for example. Tightening of norms comes down to its implementation, he pointed out.

According to pharma industry tracker Pharmatrac, the pregabalin segment is about ₹1,800 crore and companies including Sun Pharma, Torrent Pharma, Intas Pharma and Micro Labs, among others, sell in India.

Stricter norms

Following the government notification, 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 Health Ministry said. Schedule H1 requires the drug to be sold only on medical advice and on a prescription from a registered medical practitioner, besides requiring meticulous record keeping. 

“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; and violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and Rules thereunder,” the note said.

The crackdown 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, it added.

Published on May 22, 2026