'Pregabalin' Drug Under Regulatory Lens Amid Rampant Misuse Concern

The Centre is mulling tighter controls on the sale of the anticonvulsant drug pregabalin following growing concerns over its misuse and use for intoxication. Doctors commonly use the drug for the management of neuropathic pain, fibromyalgia, and as an adjunct therapy for certain types of seizures in adults and children aged one month and above.

However, amid repeated reports from state drug regulators highlighting the abuse potential of pregabalin, which is otherwise widely prescribed for legitimate medical purposes, the Union Health Ministry has issued a draft notification proposing amendments to the Drugs Rules, 1945, to bring pregabalin and its formulations under Schedule H1. It is a regulatory category meant for medicines that require strict monitoring and prescription-only sale.

As per the draft notification, pregabalin would be added as serial number 51 in Schedule H1 of the Drugs Rules. This would mean that pharmacies can dispense the drug only against a prescription issued by a registered medical practitioner (RMP). In addition, chemists would be required to maintain detailed records of its sale, including the prescriber’s name and address, patient details, the name of the drug, and the quantity supplied.

The Ministry has invited objections and suggestions from the public and stakeholders before taking a final decision on restricting the drug’s sale. An official said the draft amendment will be considered after the expiry of 30 days from its publication in the Gazette of India. Once finalised, the amended rules will come into force three months after the final notification is published in the Official Gazette.

The Schedule H1 provisions’ measure is intended to curb misuse while ensuring access for patients who genuinely require the medication.

The proposal follows recommendations made by the Drugs Technical Advisory Board (DTAB) at its 65th meeting held on December 20, 2024. Earlier, the Drugs Consultative Committee (DCC) had examined concerns regarding the misuse of pregabalin along with the opioid analgesic tapentadol. The committee had constituted a sub-committee to assess the extent of abuse and suggest regulatory measures.

Evidence shared by state authorities, particularly Punjab, played a significant role in prompting the move. The Food and Drugs Administration (Drugs Wing) of the Punjab government reported extensive misuse of pregabalin-based formulations. Between January and December 2024, enforcement teams seized such drug formulations worth Rs 5.97 crore from 72 premises across the state.

During the same period, licences of 12 firms were cancelled, licences of 46 firms were suspended, and 11 complaints were filed in courts for violations related to the sale and distribution of pregabalin-containing medicines.

Punjab’s drug regulatory authority informed the DCC that higher-strength formulations, especially those containing 150 mg and 300 mg of pregabalin, are being misused for their intoxicating effects. The regulator requested that pregabalin and its preparations be included in Schedule H1 to prevent unrestricted access and curb abuse.

The state authority further suggested that approvals granted by the Drugs Controller General of India (DCGI) for higher-dose pregabalin formulations may need to be reviewed. It argued that these strengths have limited therapeutic use and are more prone to misuse, warranting closer scrutiny.

At present, pregabalin formulations are not listed under either Schedule H or Schedule H1 of the Drugs Rules, 1945. The drug is available in the market in multiple strengths, ranging from 75 mg to 300 mg per unit dosage form.

The health officials say that placing pregabalin under Schedule H1 would strike a balance between medical necessity and regulatory oversight, helping prevent abuse while ensuring continued availability for patients who depend on the drug for legitimate treatment needs.