In a gazette notification, the Union health ministry announced the amendment of the Drugs Rules, 1945, by placing all formulations of pregabalin under Schedule H1 of the rules.
Drugs listed under Schedule H1 require retailers and pharmacists to keep detailed records of their sales, such as the patient’s details, the name and address of the prescribing doctor, and the quantity of the drug supplied.
According to the rules, these records must be preserved for three years and made available for inspection by authorities.
Until now, pregabalin was classified under Schedule H of the Drugs Rules, meaning it could be sold against a prescription from a registered medical practitioner without additional documentation requirements.
The notification, issued last week, will be finalised after the completion of a 30-day period. “The amendment shall come into force after three months of publication of the final rules in the Official Gazette,” the notification stated.
Usually available in the market in different strengths ranging from 75 milligrams (mg) to 300 mg per unit dosage form, pregabalin is generally prescribed by doctors for the management of neuropathic pain and to treat fibromyalgia.
“Pregabalin’s moving annual turnover (MAT) for calendar year 2025 was Rs 1,721 crore, with 102.15 million units being sold in the period,” said Sheetal Sapale, vice president (commercial) at market research firm Pharmarack.
Officials in the know added that pregabalin capsules and tablets are also used along with other medications to treat certain types of seizures in adults and children aged one month and older.
However, several states had expressed concerns over the continued misuse of pregabalin for intoxicating purposes to the Drugs Consultative Committee (DCC) of the Central Drugs Standard Control Organisation (CDSCO).
In 2023, the Punjab Food and Drug Administration (FDA) had contended that drug formulations containing pregabalin 150 mg and 300 mg per dosage form were being misused for intoxication.
“These formulations are being seized from licensed chemists and unlicensed premises by the Drugs Control Officers of FDA Punjab due to violations of the provisions of the Drugs and Cosmetics Act and other rules,” the minutes of the DCC meeting held in 2023 stated.
In response, the advisory panels recommended bringing pregabalin under Schedule H1.
The Punjab FDA had also asked for a re-evaluation of the continuing DCGI approvals of dosage forms containing pregabalin 150 mg and 300 mg on the grounds that the said drugs do not have much therapeutic usage and are being misused for intoxication.
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