India moves high-alcohol medicines to prescription-only to curb misuse

India has amended its Drugs Rules to require a doctor's prescription for oral medicines containing more than 12% ethyl alcohol in packs over 30 ml, ending a long-standing licensing exemption. The change, notified by the health ministry, moves affected cough syrups, tonics and tinctures—some up to 80–90% alcohol—into the stricter Schedule H1. Retailers must now log every sale and manufacturers add warning labels.
4 sources
- 01Business Standard — Centre amends drug rules to curb misuse of high-alcohol formulationsbusiness-standard.com
- 02National Herald — Centre tightens rules on alcohol-heavy medicinal formulations, ends licence exemptionnationalheraldindia.com
- 03India.com — No more OTC sale of THESE drugs as Govt makes prescription mandatory for over-12% alcohol medicinesindia.com
- 04CDSCO — Gazette Notifications (Ministry of Health & Family Welfare)cdsco.gov.in