Pregabalin to Be Sold Only Under Tighter Prescription Monitoring: Health Ministry

New Delhi: In a significant move aimed at tightening regulatory control over the misuse and unsupervised sale of habit-forming medicines, the Ministry of Health and Family Welfare (MoHFW), through a recent Gazette notification, has notified the inclusion of Pregabalin under Schedule H1 of the Drugs Rules, 1945, thereby bringing the drug under stricter prescription and sale monitoring requirements across the country.

Issued under the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB), the amendment has been notified through the Drugs (Second Amendment) Rules, 2026 and will come into force after 180 days from the date of publication in the Official Gazette.

Pregabalin is widely used in the treatment of neuropathic pain, epilepsy, generalized anxiety disorder, and fibromyalgia. However, in recent years, regulatory authorities and enforcement agencies have expressed concern over its increasing misuse, dependence potential, and unauthorised over-the-counter availability through pharmacies.

The amendment follows the publication of draft rules vide G.S.R. 54(E) dated January 21, 2026, which were made available to the public on January 27, 2026, inviting objections and suggestions from stakeholders within a period of thirty days. The Central Government stated that all objections and suggestions received from the public were duly considered before finalising the amendment.

Now, in line with the above, the final notification issued by the Ministry inserts Pregabalin as a new entry under Schedule H1 of the Drugs Rules, 1945.

Schedule H1 drugs are a restricted category in India under the Drugs & Cosmetics Rules, primarily for antibiotics, anti-TB drugs (like Rifampicin, Isoniazid, Ethambutol), and some psychotropic meds, requiring strict prescription, record-keeping (for 3 years), and red "Rx" labeling to combat antibiotic resistance and misuse. They are a stricter subset of Schedule H, demanding pharmacists maintain a separate register with prescriber/patient details for every sale, a key difference from regular Schedule H drugs.

Drugs listed under Schedule H1 cannot be sold without a valid prescription from a registered medical practitioner.

The Gazette notification stated:

"In exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:

1. (1) These rules may be called the Drugs (Second Amendment) Rules, 2026.

(2) They shall come into force after one eighty days from the date of publication of these rules in the Official Gazette.

2. In the Drugs Rules, 1945, in Schedule H1 after serial number 50 and entries relating thereto, the following serial number and entry shall be inserted, namely: ― “51. Pregabalin”

To view the official notice, click the link below: