Alcoholic Tonics Now Need Doctor's Note

Oral medicinal formulations exceeding 12% ethyl alcohol will soon require a prescription, according to recent amendments to the Drugs Rules. This decision stems from complaints by states regarding the misuse of certain medicinal tinctures, which reportedly contained high levels of ethyl alcohol and were being consumed like liquor.

The amendment targets concentrated herbal extracts using ethyl alcohol as a solvent, such as cardamom and ginger tinctures. Previously exempt under Schedule K, these products will now fall under Schedule H1, necessitating a doctor's prescription for sale and requiring pharmacies to maintain sales records. This regulatory shift aims to enhance oversight and prevent diversion for non-therapeutic purposes.

Existing regulations permit specific alcohol limits for traditional medicines, with Ayurvedic, Siddha, and Unani syrups allowed up to 16% ethyl alcohol, and Homoeopathic medicines up to 12%. The new amendment seeks to establish a uniform framework for all medicinal products with high ethyl alcohol content, ensuring they are accessible for legitimate medical use while mitigating misuse. The rules will be enacted six months post-publication.