Centre proposes stricter cough syrup rules

New Delhi: Following the death of 22 children due to consumption of contaminated cough syrups in Madhya Pradesh three months ago, the Union health ministry has proposed amendments in the country's drug rules to ensure a tougher criterion for their over-the-counter (OTC) sales in India.

According to a draft notification, the ministry has proposed to drop the word 'syrup' from the Schedule K of the Drugs and Cosmetics Act, which exempts a segment of drugs from stringent manufacturing, distribution and sales related regulatory provisions of the Drugs Rules, 1940.

Under this category, an exemption was earlier given to a defined set of household remedies, which were allowed to be sold without a formal sales licence in villages with a population of not more than 1,000 people, provided there is no licensed dealer nearby. This includes medicines such as anti-inflammatory tablets, including aspirin, paracetamol tablets, analgesic balms, antacid preparations, gripe water for use by infants and cough syrups. People in the know told Business Standard that medications covered under Schedule K of the Drugs Rules are subjected to relaxed regulatory requirements, meaning they would face less strict licensing and monitoring.

"Some medicines in liquid form were listed simply as syrup, placing them in this category. Over the years, authorities observed that several medicinal syrups were being misused or illegally sold, especially cough and cold formulations," an official with the regulatory authority said.