NEW DELHI: Pregabalin, which is prescribed for the treatment of chronic pain, neuropathies and certain neurological conditions, has been brought under Schedule H1 of the Drugs Rules to strengthen regulation and prevent its widespread misuse, especially among the youth.
The Union Health Ministry took the decision after reports from a few states reported that the medicine is being misused and abused.
Officials said the notification was issued to curb easy access, enhance prescription monitoring, strengthen supply chain accountability, and safeguard public health.
The ministry notified the inclusion of the drug “Pregabalin” under Schedule H1 of the Drugs Rules, 1945 through a gazette notification, published in the Gazette of India Extraordinary 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 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 officials added.
Recent seizures of illegally stocked and unauthorisedly sold Pregabalin have also been reported from some parts of the country.
“With this 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,” they added.
The revised classification mandates that Pregabalin can be sold only against a valid prescription issued by a Registered Medical Practitioner (RMP).
Also, retailers will now need to maintain a separate register to record details of prescriptions and sales, while manufacturers will have to prominently display the prescribed “Schedule H1 Drug Warning” label on product packaging.
Now, violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and Rules.
“The measure 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,” officials added.
All stakeholders, including manufacturers, distributors, wholesalers, retailers, and pharmacists, are advised to ensure strict compliance with the provisions of the notification.
According to Prof. Om Prakash, Psychiatrist, Geriatric and ECT Specialist, Institute of Human Behaviour and Allied Sciences (IHBAS), it is an essential step to curb misuse and dependence while protecting genuine patients with neuropathic pain, epilepsy, fibromyalgia and anxiety.
He said now the drug is strictly prescription-only and will not be sold over-the-counter (OTC).
According to the notification, dated May 13, these rules “may be called the Drugs (Second Amendment) Rules, 2026. They shall come into force after one eighty days from the date of publication of these rules in the Official Gazette.”
