India’s Health Ministry has issued new regulations for over-the-counter syrup-based medicines – including cough mixture – which are now banned from sales without a doctor’s prescription, reports THE POST.
The legislative amendments are aimed at strengthening regulatory oversight of syrup formulations, and “to align the exemption framework with current public health and safety requirements”.
The move comes after the government removed the word “syrups” from a category of exempted drugs under Schedule K, firming up regulatory oversight of such formulations.
The change will improve control over the manufacture, sale and distribution of syrup formulations.
“Schedule K” of the Drugs Rules, 1945 contains categories that are exempt from certain provisions of the law governing their manufacture, sale and distribution, subject to specified conditions.
Before the amendment, cough syrups could be sold in villages with a population of less than 1 000 without requiring compliance with certain retail sale licensing norms. With the latest change, the exemption will no longer apply to cough syrups.
Now, the sale and dispensing of these medicines in such villages will have to be done only through duly licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
THE POST article – Doctor's prescription now mandatory to buy cough syrups (Open access)
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