By: IPP Bureau
Last updated : May 23, 2026 8:46 am
New regulation mandates stricter prescription monitoring, sales record maintenance, and enhanced compliance across the pharmaceutical supply chain
The Ministry of Health and Family Welfare has brought Pregabalin under Schedule H1 of the Drugs Rules, 1945, in a major regulatory move aimed at preventing misuse, strengthening prescription monitoring, and curbing unauthorised sales of the drug across India.
The decision was notified through Gazette Notification G.S.R. 377(E) dated May 13, 2026, and published in the Gazette of India Extraordinary on May 20, 2026.
The ministry said the move follows reports from several states highlighting increasing misuse and abuse of Pregabalin, particularly among youth populations.
Pregabalin is commonly prescribed for chronic pain, neuropathic disorders, fibromyalgia, epilepsy, and other neurological conditions.
However, authorities noted that the drug has increasingly been misused for its sedative, euphoric, and dissociative effects. Recent seizures involving illegally stocked and unauthorisedly sold Pregabalin products also prompted regulatory intervention.
With the revised classification, Pregabalin will now be subject to stricter controls applicable to Schedule H1 medicines instead of the existing Schedule H category.
Under the new provisions, the drug can only be sold against a valid prescription issued by a Registered Medical Practitioner (RMP). Retail chemists will also be required to maintain separate registers documenting prescription and sales details for regulatory inspection.
Additionally, pharmaceutical manufacturers must prominently display the prescribed “Schedule H1 Drug Warning” label on all product packaging. Violations or non-compliance may attract penal action under the Drugs and Cosmetics Act, 1940 and associated rules.
According to the ministry, the measure is intended to strengthen accountability across the pharmaceutical supply chain, prevent unauthorised access, improve prescription tracking, and safeguard public health from growing drug misuse and abuse risks.
The ministry has advised all stakeholders, including manufacturers, distributors, wholesalers, retailers, and pharmacists, to ensure strict compliance with the revised regulatory framework.
The official notification can be accessed through the Gazette Notification on Pregabalin Inclusion Under Schedule H1.