The Central Government has amended the Drugs Rules, 1945, to introduce stricter regulations for medicines containing more than 12% ethyl alcohol. Under the revised rules, such formulations will now require a valid licence for sale and can only be dispensed on a doctor’s prescription.
The amendment aims to address concerns over the misuse of alcohol-containing medicinal products, particularly those that were previously available over the counter. Health experts believe the move will help reduce accidental consumption, dependence and self-medication while ensuring that these medicines remain available for patients who genuinely need them.
Neurologists and public health specialists have welcomed the decision, noting that repeated or inappropriate use of high-alcohol medicinal formulations may lead to neurological complications, cognitive impairment, balance disorders, and alcohol dependence. They stressed that while these products have legitimate therapeutic uses, medical supervision is essential for their safe use.
Experts also pointed out that certain pharmaceutical tinctures and aromatic preparations contain high concentrations of ethyl alcohol because it acts as an extraction solvent and preservative. However, these formulations have sometimes been misused as an alternative source of alcohol by individuals with alcohol dependence.
According to specialists, the revised rules are a targeted regulatory measure and will apply only to formulations containing more than 12% alcohol by volume (v/v) in quantities exceeding 30 mL. As a result, most paediatric syrups, cough syrups, and other oral liquid medicines with low or no alcohol content are unlikely to be affected.
Public health experts also emphasised that the effectiveness of the new regulation will depend on strong enforcement, quality control, and adherence to testing standards across the country. They said the amendment supports responsible dispensing practices while maintaining access to essential medicines for patients under appropriate medical supervision.
The revised framework is expected to strengthen patient safety, reduce the risk of diversion and misuse, and promote the rational use of alcohol-containing medicinal formulations as part of broader public health efforts.
