Overview
- The Union Health Ministry issued a Gazette notification that withdraws the Schedule K exemption for oral preparations with more than 12% v/v ethyl alcohol in packs larger than 30 mL and places them under Schedule H1.
- Officials said the rule change follows state reports that some exempted tinctures and aromatic preparations contained very high alcohol levels, in some cases 80–90% v/v, and were being diverted for intoxication.
- Products moved to Schedule H1 will require licences to manufacture and sell, must be dispensed only on a registered medical practitioner’s prescription, and pharmacies must keep detailed sales and prescription records.
- The amendment was notified in early July and will take effect six months after publication in the Official Gazette, giving manufacturers, distributors and pharmacies time to obtain licences and update compliance systems.
- The move aligns alcohol limits across drug rules (including existing limits for Ayurvedic and homeopathic medicines) and forms part of a wider push by regulators to tighten controls on medicines prone to misuse.