The Union ministry of health and family welfare has removed cough syrups from the so-called Schedule K, which exempts medicines from manufacturing, distribution, and retail licensing regulations that are otherwise mandatory for drugs — a move widely seen as an effort to clamp down on the manufacture of sub-par cough syrups, and their sales, in villages and small towns, by establishments that do not process a drug retailing licence.
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There have been reports of rampant misuse of cough syrups across urban and rural India, with people seeing them as a cheaper and more accessible option to liquor and drugs. There have also been reports of people, especially children, dying from the use of sub-par cough syrups.
The health ministry gazette notified the removal of cough syrups from its list of Schedule K drugs (those that can be sold over the counter and by retail establishments other than pharmacies also); this means only pharmacies can now sell cough syrups.
The health ministry announced the change in a statement.
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To be sure, monitoring is lax, and even Schedule H drugs, which can only be sold on prescription are freely available across the counter, albeit only at pharmacies. In many towns and villages and even some cities, cough syrups are also freely available at many stores.
Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 for specified classes of drugs. Prior to this amendment, Schedule K drugs could be sold in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing provisions.
This exemption will no longer be available for cough syrups. “Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder,” said the health ministry’s statement.
The sale of cough syrups manufactured in India has also been marred by controversies related to contamination.
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Last year, at least 22 children were killed in India, mainly in Rajasthan, due to the consumption of contaminated cough syrup. The cough syrup was found to be contaminated with diethylene glycol (DEG), a toxic industrial solvent used in brake fluid and antifreeze, etc. In laboratory tests, the concentration of DEG was found to be hundreds of times above the permissible limit of 0.1%.
In the past, India-made cough syrups have been linked to the deaths of children in The Gambia and Uzbekistan.
The latest move is also prompted by a desire to crack down on the use of cough syrups as a substitute for narcotics; in recent years, the Border Security Force has seized huge quantities of India-made cough syrups being smuggled to Bangladesh.
“The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements. The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” said the health ministry, asking manufacturers, distributors, and retailers dealing with cough syrups to ensure strict adherence to the applicable licensing and regulatory requirements under the Drugs & Cosmetics Act.
