The Ministry of Health and Family Welfare has formally added the widely used nerve-pain drug Pregabalin to Schedule H1 of the Drugs Rules, 1945 — a category reserved for substances with high abuse potential.

The Government of India has officially included Pregabalin — a drug commonly prescribed for neuropathic pain, epilepsy, and anxiety — in Schedule H1 of the Drugs Rules, 1945. As per the amendment, notified in the Gazette of India G.S.R. 377 (E) dated May 13, 2026 the new rules will come into force 180 days from the date of publication (13.05.2026), giving manufacturers, pharmacies, hospitals, and distributors time to comply with the enhanced regulatory requirements that apply to all Schedule H1 drugs.

What is Schedule H1?

Schedule H1 is a stricter sub-category under the broader Schedule H classification. Drugs placed in Schedule H1 can only be dispensed against a prescription from a registered medical practitioner, and chemists are required to maintain a separate register for such sales. The schedule typically covers drugs with a documented risk of misuse, dependence, or serious adverse effects.

Pregabalin, sold under various brand names and in numerous combinations, has seen significant off-label misuse in recent years due to its calming and euphoric effects at higher doses, prompting calls from medical bodies for stricter dispensing controls.

Summary

  • What changed: Pregabalin added as serial number 51 in Schedule H1 of the Drugs Rules, 1945
  • Why it matters: Schedule H1 requires mandatory prescription logs and stricter dispensing controls, addressing Pregabalin’s known misuse potential
  • Timeline: The public consultation process (Jan–May 2026), and the ~180-day window before enforcement kicks in (~November 2026)
  • Who’s affected: Manufacturers, pharmacies, hospitals, distributors, and patients currently using the drug