Centre tightens controls on Pregabalin amid rising misuse concerns

The Union Health Ministry has brought the drug Pregabalin under the stricter Schedule H1 category of the Drugs Rules, 1945, in an effort to curb misuse and strengthen regulation across the pharmaceutical supply chain.

The decision follows reports from several states highlighting the growing abuse of the medication, particularly among young people. Authorities have also recorded instances of illegal stocking and unauthorised sale of the drug in different parts of the country.

Pregabalin is commonly prescribed to treat chronic pain, neuropathic disorders, fibromyalgia and certain neurological conditions. However, health officials said the medicine has increasingly been misused for its sedative, euphoric and dissociative effects.

The revised classification was formally notified through a publication in the Gazette of India Extraordinary. With the change, Pregabalin will now be regulated under Schedule H1 instead of Schedule H, subjecting it to tighter monitoring and stricter prescription controls.

Under the new rules, the drug can only be sold against a valid prescription issued by a registered medical practitioner. Retail chemists will also be required to maintain a separate register recording details of prescriptions and sales involving the medicine.

Manufacturers must additionally display the mandatory Schedule H1 warning label prominently on product packaging. The caution notice states that the drug should not be taken except under medical supervision and cannot be sold without a doctor’s prescription.

The Health Ministry said the move is intended to improve accountability at every stage of distribution, prevent unauthorised access and strengthen monitoring of prescription medicines.

Officials added that the tighter controls are aimed at curbing illegal trafficking and protecting public health from the growing problem of prescription drug abuse.

The ministry has advised manufacturers, distributors, wholesalers, retailers and pharmacists to ensure strict compliance with the notification. Violations may invite penal action under the Drugs and Cosmetics Act, 1940, and related rules.

With IANS inputs