Government Tightens Rules on High-Alcohol Medicines; Prescription and Licence Now Mandatory for Sale
New Delhi, 10 July (H.S.): The Central Government has tightened regulations governing the sale and distribution of medicines containing high levels of alcohol. Under the amended Drugs Rules, 1945, medicines with a high concentration of ethyl alcoh
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New Delhi, 10 July (H.S.): The Central Government has tightened regulations governing the sale and distribution of medicines containing high levels of alcohol. Under the amended Drugs Rules, 1945, medicines with a high concentration of ethyl alcohol will no longer be available without proper licensing and a valid prescription from a registered medical practitioner.

Under the revised rules, all medicinal preparations containing more than 12 percent ethyl alcohol and exceeding 30 ml in quantity will no longer enjoy the exemption previously available under the relevant Schedule of the Drugs Rules. Consequently, obtaining a licence for the manufacture and sale of such medicines will now be mandatory.

The government has also brought these medicinal preparations under Schedule H1. As a result, they can now be sold only against a prescription issued by a registered medical practitioner. Pharmacies will also be required to maintain detailed records of their sale. The move is aimed at preventing the misuse of such medicines and strengthening safeguards for public health.

According to a notification issued by the Ministry of Health and Family Welfare on Friday, certain medicinal preparations, including cardamom tincture, ginger tincture and other aromatic tinctures, contain as much as 80 to 90 percent ethyl alcohol. Several states had reported instances of these products being misused as intoxicants rather than for legitimate medical purposes, prompting the government to introduce stricter regulations.

The Ministry said that under the new rules, the sale of such medicines will be restricted to authorised pharmaceutical supply channels. This is expected to curb misuse while ensuring that genuine patients continue to receive these medicines as required through the established healthcare system.

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Hindusthan Samachar / Jun Sarkar


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