NEW DELHI : The Union Health Ministry is considering a proposal to regulate alcohol content in drug preparations such as aromatic tincture. The aim is to curb their illegal sale at pharmacies as these are often used as ‘country liquor’ by the economically weaker sections.
As part of the proposal, the government plans to amend the Drug Rules, 1945 to bring alcohol-based drug formulations under Schedule H1 from the existing Schedule K drugs.
Schedule H1 drugs cannot be purchased without a doctor’s prescription. In addition, the bottle size of such products is being reduced from 100ml to 30ml.
The suggestion was made by experts during a recent meeting of the drugs consultative committee chaired by Rajeev Raghuvanshi, Drugs Controller General of India (DCGI).
India is incidentally one of the leading consumers and exporters of aromatic chemicals in the Asia Pacific region. According to a market research report, the Indian market size was $252 million in 2022 and is expected to reach $378 million by 2028, with a CAGR of 6.3% during 2023-2028.
The committee was informed that aromatic cardamom tincture and other alcoholic preparations, in which the content of alcohol is very high, are being sold by medical stores and often being consumed as ‘country liquor’.
“The alcohol content in Aromatic Cardamom Tincture is in the range of 84%v/v to 87%v/v and these are being sold in 100ml packs. They are specified under class 10(iv) of Schedule K of the Drug Rules, 1945 and are being misused due to exemptions as per the said Schedule,” said the top regulator. In addition, as they are available relatively cheap, they are being misused as liquor by economically weaker people posing a big concern for public health.
Aromatic cardamom tincture has potential pharmacological applications such as antioxidant, analgesic, antibacterial antioxidant, and anti-inflammatory activities.
There have several incidents where police have unearthed trafficking in such products.