No prescription, no sale: Centre cracks down on high-alcohol medicines

NEW DELHI: The Central Government has tightened regulations on the sale of medicines containing high levels of alcohol following reports of widespread misuse. Under the new directive, medicines with more than 12 percent ethyl alcohol content packaged in bottles exceeding 30 ml have been moved to Schedule H1, making a doctor's prescription mandatory for their purchase.

Previously, certain medicinal products, including tinctures of cardamom, ginger, and other spices, were exempted from licensing regulations under Schedule K of the Drugs Rules, 1945. However, authorities observed that some of these formulations contained an exceptionally high concentration of ethyl alcohol, ranging between 80 percent and 90 percent.

The strict measures were introduced after it was found that these over-the-counter products were being extensively purchased without medical supervision and abused as intoxicants. While the new regulation is not expected to adversely affect genuine patients, pharmacies will now have to exercise strict caution.

Under the updated guidelines, pharmacies must record the sale of these high-alcohol medicines in a special register, adhering to a compliance protocol similar to the one followed for antibiotics. Furthermore, medical stores are required to preserve all relevant sales documents, including the doctor's prescriptions, for a period of three years.