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Health ministry issues draft amendment to move preparations with higher alcoholic content under Schedule H1
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Gireesh Babu, New Delhi
October 22 , 2025
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The Union health ministry has proposed an amendment to the Schedule K of the Drugs Rules, 1945, to move all oral formulations with higher alcoholic content more than 30 ml to Schedule H1 for enhanced regulation of its sales.
The Ministry said that draft rules shall be taken into consideration on or after the expiry of a period of 30 days from the date of its publication in the Official Gazette. Objections and suggestions may be received from any person within the period will be considered by the Central government.
The extent of exemption under the Schedule K, as per the draft, will be amended to “All provisions of Chapter IV of the Act and rules thereunder except for all oral formulations containing more than 12% alcohol v/v (ethyl alcohol) packed and sold in packings or bottles of more than 30 milliliters.”
The Schedule H1 will be amended to insert, "All oral formulations containing more than 12% alcohol v/v (ethyl alcohol) packed and sold in packings or bottles of more than 30 milliliters". 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.
As reported earlier, the Drugs Consultative Committee (DCC), the advisory committee that advises the Central and State Governments on matters that require uniform implementation across the country, in its meeting on June 17, 2025, 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 on its sales.
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 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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