Pregabalin moved to Schedule H1 of the Drugs Rules to curb misuse
The Health Ministry announced on 22 May 2026 that the drug Pregabalin has been moved from Schedule H to the stricter Schedule H1 of the Drugs Rules, 1945, following reports of misuse among youth.
Summary
Pregabalin, a drug prescribed for chronic pain, neuropathies and fibromyalgia, has been placed under Schedule H1 of the Drugs Rules, 1945 through Gazette Notification G.S.R. 377(E) dated 13 May 2026, published on 20 May 2026, the Health Ministry said on 22 May. The move follows reports from some States of misuse, particularly among youth, and seizures of illegally stocked Pregabalin. Pregabalin was earlier under Schedule H. It can now be sold only on a valid prescription from a Registered Medical Practitioner, retailers must keep a separate register of prescriptions and sales, and packs must carry the Schedule H1 warning; violations attract penal action under the Drugs and Cosmetics Act, 1940.
Key facts
- Drug
- Pregabalin (for chronic pain, neuropathies, fibromyalgia)
- Change
- Schedule H → Schedule H1, Drugs Rules 1945
- Notification
- G.S.R. 377(E), dated 13 May 2026; gazetted 20 May 2026
- Reason
- Misuse, particularly among youth; illegal stocks seized
- New rules
- Sale only on RMP prescription; separate register by retailers; Schedule H1 warning label
- Penalty law
- Drugs and Cosmetics Act, 1940
Practice MCQs 2 questions
In May 2026, the drug Pregabalin was brought under which Schedule of the Drugs Rules, 1945 to curb its misuse?
Show answer
Correct answer: C — Schedule H1
Pregabalin was moved from Schedule H to the stricter Schedule H1 by G.S.R. 377(E).
Consider the following statements about the May 2026 notification on Pregabalin: 1. Retailers must maintain a separate register recording details of prescriptions and sales of the drug. 2. The notification was issued under the Narcotic Drugs and Psychotropic Substances Act, 1985. Which of the statements given above is/are correct?
Show answer
Correct answer: A — 1 only
Retailers must keep a separate register. The change was made in the Drugs Rules, 1945, with penalties under the Drugs and Cosmetics Act, 1940, not the NDPS Act.