The Central Government has amended the Drugs Rules, 1945, to require a doctor's prescription for the sale of certain oral medicines containing more than 12% ethyl alcohol, NDTV reported. The change brings the medicines under Schedule H1, ending their over-the-counter sale.
The amendment applies to oral formulations containing more than 12% ethyl alcohol that are sold in bottles larger than 30 ml. The affected products include certain cough syrups, tonics and other oral medicinal formulations that exceed the specified alcohol limit.
The move is aimed at curbing the misuse of alcohol-containing medicinal formulations while ensuring that patients who need them for treatment can continue to access them under medical supervision. The amendment does not ban the manufacture or sale of these medicines but requires licensed pharmacies to dispense them only against a valid prescription.
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Under the revised Schedule H1 rules, pharmacists must maintain a separate register recording the patient's name, the prescribing doctor's details, the name of the medicine and the quantity supplied.
The government notified the change through the Gazette of India under the Drugs (Fifth Amendment) Rules, 2026.
Schedule H1 already covers medicines including certain antibiotics, anti-tuberculosis drugs and other medicines that require stricter regulatory oversight because of concerns over misuse and public health. The newly covered alcohol-containing oral formulations will now be regulated under the same framework.
The decision follows concerns raised by health authorities about the misuse of alcohol-containing medicinal preparations, particularly among young people and individuals consuming them without medical advice.
According to NDTV, the government said the measure is intended "to curb the misuse and abuse of high alcohol medicinal formulations while ensuring that patients with genuine medical needs continue to have access to them under medical supervision."
NDTV also reported that the new regulation is expected to strengthen monitoring of the sale and use of these medicines while allowing patients with legitimate medical needs to obtain them through a doctor's prescription.
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