Govt Panel Tightens Prescription Norms, Brings 4 Drugs Under Schedule H1, Retains Dicyclomine in Schedule H
Antibiotics Labelling
New Delhi: In a significant regulatory move aimed at curbing drug misuse and intoxication, the Drugs Consultative Committee (DCC) has approved the classification of certain medicines under stricter regulatory schedules, with Dicyclomine retained under Schedule H and Flupentixol, Zopiclone, Gabapentin, and Carisoprodol included under Schedule H1 of the Drugs Rules, 1945.
The matter was discussed during the 68th meeting of the Drugs Consultative Committee, held on March 20, 2026, through virtual mode, where members deliberated the proposal for submission of report of the expert committee constituted to examine the proposal for listing of certain drugs to Schedule H1 and Schedule X of Drugs Rules, 1945 in light of misuse and intoxication
The decision follows the submission of a report by an expert subcommittee constituted to examine whether certain drugs should be brought under stricter control—namely Schedule H1 and Schedule X—based on their potential for misuse and intoxication.
Schedule H and H1 are categories of prescription drugs in India under the Drugs and Cosmetics Rules, 1945, which cannot be bought over-the-counter without a doctor's prescription. While Schedule H contains general prescription drugs, Schedule H1 (introduced in 2013) covers specific antibiotics, anti-TB drugs, and habit-forming drugs, requiring strict retail sale records, including patient/doctor details maintained for three years.
DCC was apprised about the key recommendations of the sub-committee to examine the matter. DCC deliberated the matter in detail and approved the recommendations of the sub-committee for:
1. Retention of Dicyclomine in Schedule H
2. Inclusion of Flupentixol, Zopiclone, Gabapentin, and Carisoprodol in Schedule H1
As per the recommendations, Dicyclomine will continue to remain under Schedule H, which includes prescription drugs that can only be sold on the prescription of a registered medical practitioner. Meanwhile, Flupentixol, Zopiclone, Gabapentin, and Carisoprodol have been placed under Schedule H1, indicating a higher level of regulatory scrutiny due to their increasing misuse and dependency risks.
