The Central Government has introduced the changes in the Drugs Rules, 1945, under which the oral medicinal products containing high manufacturing of ethanol (containing more than 12% of ethyl alcohol) are included under Schedule H1 when sold at the bottle size more than 30 ml. The move comes to prevent the misuse of alcohol containing medicines – it will create tighter rules on mixing and prescribing medicines as well as the dispensing of alcohol from medicine cabinets nationwide.
The new regulations permit the sale of these drugs from pharmacy shops only on prescription from a registered medical practitioner. In addition, every chemist is required to keep a separate record of all purchases and have dispensing and prescription records held for three years to be used for inspection by the regulators.
The change mainly affects some cough syrups, tonics and other oral medications containing “hotter” doses of ethyl alcohol. These medicines are used safely and effectively by patients when prescribed by a doctor, but there is a concern that they are increasingly being diverted for recreational use as they are available as retail medicines without a prescription.
The recommendation came from Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) after analysing the potential for abuse of these medicines, and recommending close monitoring.
The government’s explanation confirmed that any medicines that were already approved would not be banned, and that its medicine was not affecting the medical efficacy of these medicines. Rather, it assures their responsible use under proper medical supervision and its minimization of diversion and abuse.
The Centre has placed these products under Schedule H1, thus reinforcing pharmacovigilance and providing closer monitoring and tighter regulation on high alcohol medicinal formulations in comparison with other medicines that require increased vigilance, such as some antibiotics and anti tuberculosis drugs.