Alcohol content in drugs to be regulated
September 3, 2023
NEW DELHI : The union health ministry is considering a proposal to regulate alcohol content in drug preparations such as aromatic tincture in order to curb their illegal sale at pharmacies. They are most often used as ‘country liquor’ by 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 existing Schedule K drugs.
Schedule H1 are drugs which cannot be purchased without a doctor’s prescription. 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 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, exhibiting an annual growth rate of 6.3% during 2023-2028.
Raghuvanshi in a communication seen by Mint to all state drug controllers, said “DCC was apprised about the representation received to take necessary action to amend the provisions in the Drugs and Cosmetics Act and Rules thereunder with respect to the misuse of the drugs containing alcohol/ tincture."
He said 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 being consumed as ‘country liquor’.
Aroma chemicals refer to chemical compounds that are volatile in nature but are appealing to consumers. Industry reports say the demand for herbal tinctures has increased in most emerging nations, and their supply has grown 80% worldwide to treat illnesses with drugs having a herbal extracts with ethanol functioning as the solvent.
“The alcohol content in Aromatic Cardamom Tincture is in the range of 84%v/v to 87%v/v and 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 adding that being 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.
Queries sent to the health ministry for comments remained unanswered.
There have several incidents where police have unearthed trafficking in such products. In 2018, UP police seized 555 bottles of aromatic cardamom tincture worth ₹250,000 and arrested two people.
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