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The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters that require uniform implementation of drug laws across the country, has given its nod to amend the Drugs Rules, 1945, to bring drug preparations with alcohol content of 30 ml or above under Schedule H1 for enhanced regulation of its sales.
Currently these formulations are under the Schedule K, which exempts them from certain regulatory provisions of the Drugs and Cosmetics Act, in terms of sales. Moving them to Schedule H1, which is for prescription drugs that have high potential for abuse and addiction, is expected to curb the misuse of such products.
The Committee was considering a draft notification prepared by the central licensing authority to amend the Drugs Rules to regulate the alcohol content in tinctures and other alcoholic preparation, as per the recommendation of the DCC and the Drugs Technical Advisory Board (DTAB) in their previous meetings.
The draft notification is to amend the Drugs Rules removing the exemption provided for alcoholic preparations containing the alcohol content 30ml or above in Schedule K and including such preparations in Schedule H1.
"DCC discussed the draft notification prepared for the purpose and after detailed deliberation agreed with the proposal to appropriately amend the Drugs Rules, 1945," said the minutes of the 66th Committee meeting held on June 17, 2025.
The proposal was deliberated in the DCC earlier in its 61st meeting, in June, 2023, after it received a representation informing that Aromatic Cardamom Tincture and other alcoholic preparations, in which content of alcohol is very high, are being sold from medical stores and are being misused as country liquor.
The alcohol content in Aromatic Cardamom Tincture is in the range of 84%v/v to 87%v/v and is being sold in 100 ml 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, observed the Committee.
Being cheap, they are misused as liquor by economically weaker people posing a big concern for public health.
"After detailed deliberation, the Committee recommended that the rules may be amended and exemption provided for alcoholic preparations containing the alcohol content 30ml or above in Schedule K may be removed and such preparation may be included in Schedule H1. The Committee recommended suitable amendments in Drugs Rules, 1945 to restrict pack size of these items to maximum 30ml," it said in its meeting in June, 2023.
The matter was also discussed in the DTAB meeting on January 25, 2024, where it agreed to the proposed amendment.
"DTAB deliberated the matter and agreed that the rules may be amended and exemption provided for alcoholic preparations containing the alcohol content 30ml or above in Schedule K may be removed and such preparations may be included in Schedule H1," said the Board meeting in January.
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