Drug regulator looks to limit alcohol content in medicines

India's drug regulatory authority is considering restricting the alcohol content in aromatic cardamom tincture (an intoxicating agent) and alcoholic preparations in which the content of alcohol is very high, after the Uttar Pradesh government raised concerns regarding its misuse by people.
According to the UP government, since such preparations are not very expensive, they are used as a substitute for liquor by many.

This, as per state officials, is not only resulting in a huge loss of revenue but is also a concern as far as public health is concerned.

The Drugs Consultative Committee (DCC), which comes under the Central Drugs Standard Control Organisation (CDSCO) and comprises a technical body of experts, will deliberate and make a decision on the issue soon. The drug regulatory authority had received a representation from the UP government to amend the provisions in the Drugs and Cosmetics Act and rules with respect to the misuse of the drugs containing alcohol/tincture, a person in the know told ET.

The issue was raised by the additional chief secretary (excise department) of the UP government.

It has been seen that aromatic cardamom tincture and other alcoholic preparations in which the content of alcohol is very high are being sold from medical stores and being misused as country liquor in Agra.

“A lot of cases have recently come forward of its seizure after police raids resulting in arrests of people, and hence it has become a nuisance for various states. UP has been vocal so far about it,” said a second person. The alcohol content in aromatic cardamom tincture is in the range of 84%v/v to 87%v/v. These are sold in 100ml packs. They are not very expensive and are being misused, the UP government told the drug regulatory authority.

The DCC under the drug regulatory authority is now considering various provisions like classifying these medicines under Schedule H 1 in place of Schedule K. Drugs which are classified under Schedule H are required to be sold on the prescription.

The DCC will deliberate if adequate amendments should be made so that allopathic medicines whose dosage is less than 1 ml should be packed in 30 ml or less. Experts are also considering allowing the sale of such drugs only in government hospitals and dispensaries and ban their sales from pharmacies and other non-government shops.