Big decision of Health Ministry: Pregabalin drug now included in Schedule H1, strictness on misuse

The Health Ministry on Friday (May 22) said that it has issued a notification regarding the inclusion of ‘Pregabalin’ drug under Schedule H1 of the Drugs Rules, 1945. This decision has been taken in view of the reports received from some states, which revealed misuse and abuse of Pregabalin.

Violation of the rules and non-compliance will lead to punitive action as per the ‘Drugs and Cosmetics Act, 1940’ and the rules made thereunder. The drug is prescribed to treat chronic pain, neuropathy, fibromyalgia and certain neurological conditions, but is reportedly being misused due to its hypnotic, euphoric and psychoactive effects, the ministry said.

The ministry said that all concerned parties, including manufacturers, distributors, wholesalers, retailers and pharmacists, are advised to ensure strict compliance with the provisions of this notification. There have also been reports of recent seizures of ‘Pregabalin’ being illegally stocked and sold without permission in some parts of the country.

Following this notification published in the ‘Gazette of India Extraordinary’, ‘Pregabalin’ will now be regulated under the more stringent ‘Schedule H1’ provisions under the ‘Drugs and Cosmetics Rules, 1945’ instead of the existing ‘Schedule H’.

The warning written on the prescription of the medicine under ‘Schedule H1’ ‘Drug – Caution’ states that this medicine is dangerous if taken without doctor’s advice and it cannot be sold in retail without the prescription of a Registered Medical Practitioner (RMP).

As per the revised classification, ‘Pregabalin’ can be sold only on the basis of a valid prescription issued by a Registered Medical Practitioner (RMP). Also, retailers will have to maintain separate registers to record details of prescriptions and sales and manufacturers will have to prominently display the prescribed ‘Schedule H1 drug warning’ label on the product packaging.

“The move aims to strengthen accountability throughout the supply chain, prevent unauthorized access, improve prescription monitoring, prevent illicit trafficking, and protect public health from drug misuse and abuse,” the ministry said.

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