Government Places Pregabalin Under Schedule H1 Amid Concerns Over Rising Drug Misuse

Summary:
India’s Union Health Ministry has moved Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, following growing reports of misuse and abuse, particularly among youth. Widely prescribed for chronic pain, nerve disorders, fibromyalgia, and neurological conditions, the drug has increasingly been misused for its sedative and euphoric effects. Under the revised regulations, Pregabalin can now only be sold with a valid prescription, while retailers must maintain detailed sales records and manufacturers are required to display Schedule H1 warning labels on packaging. The government said the move aims to strengthen monitoring, curb illegal distribution, improve accountability across the supply chain, and protect public health amid rising concerns over addiction and non-medical consumption in several parts of India. 

The Union Health Ministry announced on Friday (May 22, 2026) that Pregabalin has been brought under Schedule H1 of the Drugs Rules, 1945, through a Gazette Notification. The decision follows reports from multiple States highlighting increasing misuse and abuse of the medication, especially among young individuals.

Pregabalin is commonly prescribed for chronic pain, neuropathic disorders, fibromyalgia, and certain neurological illnesses. However, authorities noted that the medicine has increasingly been abused because of its sedative, euphoric, and dissociative properties. In recent months, several instances of illegal stocking and unauthorised sale of the drug have also been detected in different regions of the country.

Under the new notification, Pregabalin will now fall under the more stringent Schedule H1 category instead of Schedule H under the Drugs and Cosmetics Rules, 1945.

Medicines listed under Schedule H1 carry a warning stating that they should only be consumed under medical supervision and cannot be sold without a valid prescription issued by a registered medical practitioner.

The revised regulations also require retailers to maintain a separate register documenting prescription and sales details. Manufacturers must clearly display the mandatory “Schedule H1 Drug Warning” on packaging, while any breach or non-compliance may invite legal action under the Drugs and Cosmetics Act, 1940, and related rules.

According to the Ministry, the move is intended to improve accountability throughout the supply chain, restrict unauthorised availability, strengthen prescription tracking, prevent illegal distribution, and protect public health from substance misuse. Manufacturers, wholesalers, distributors, pharmacists, and retailers have been instructed to ensure full compliance with the updated provisions.

Pregabalin belongs to the gabapentinoid class of medicines, which act on the central nervous system to manage nerve-related pain and seizures. In India, it is widely used to treat chronic pain linked to diabetes, spinal cord injuries, and nerve disorders. Over recent years, medical professionals and law enforcement agencies have reported a rise in non-medical consumption of the drug, particularly among youth and individuals struggling with substance dependence.

De-addiction experts have also observed increasing cases of Pregabalin dependency, especially in Punjab, Haryana, and several parts of North India where opioid addiction remains a significant issue. Internationally, countries such as the United Kingdom have already introduced tighter controls on Pregabalin due to concerns surrounding addiction and overdose-related fatalities.