Union Health Ministry brings pregabalin under Schedule H1 to prevent misuse

The Union Health Ministry has placed pregabalin, a drug used to treat chronic pain and some neurological disorders, in the stricter H1 Schedule category following reports of abuse and misuse. The Ministry announced the inclusion of pregabalin in Schedule H1 of the Medicines Rules 1945 through a newspaper advertisement on 20 May.

“The decision was taken considering reports from certain states regarding the misuse of Pregabalin, especially among young people,” the ministry said. he said.

Prescribed for the treatment of chronic pain, neuropathies, fibromyalgia, and some neurological conditions, the drug is reportedly abused for its sedative, euphoric, and dissociative effects. The ministry drew attention to the seizure of illegal stocks and the sale of pregabalin in some parts of the country.

The drug was previously regulated under Schedule H under the Drugs and Cosmetics Rules, 1945. Under the revised classification, the drug can now only be sold against a valid prescription issued by a Registered Medical Practitioner (RMP).

“Retailers will now have to maintain a separate register recording details of prescriptions and sales, while manufacturers will have to prominently display the prescribed ‘H1 Schedule Drug Alert’ label on product packaging,” the ministry said in a statement. Violations and non-compliance will attract penal action under the Drugs and Cosmetics Act, 1940 and relevant rules, the ministry said.

According to the statement, the move is intended to “strengthen accountability across the supply chain, prevent unauthorized access, improve prescription tracking, disrupt illicit trafficking, and protect public health from drug misuse and abuse.”