Nearly four years after contaminated Indian-made cough syrups were linked to child deaths overseas and months after similar concerns resurfaced domestically, the Union Health Ministry has moved to tighten controls on the sale of syrup formulations, including cough syrups, by withdrawing a long-standing regulatory exemption that allowed their sale in small villages without licensed pharmacies.
The amendment to the Drugs Rules, 1945, notified by the Ministry, removes syrup formulations from a category of medicines that could previously be sold in villages with populations below 1,000 without complying with certain retail licensing requirements under Schedule K.
The move marks one of the latest regulatory steps taken by the government to strengthen oversight of medicines following growing scrutiny of pharmaceutical quality, supply chains and dispensing practices after a series of child deaths linked to contaminated syrups in India and abroad.
Under the earlier provisions, specified medicines could be stocked and sold in remote villages even when sellers did not possess a retail drug licence. The exemption was originally introduced decades ago to improve access to medicines in areas where licensed pharmacies were scarce.
However, public health experts and medical associations have increasingly argued that changing healthcare realities, expanding pharmacy networks and concerns over misuse, overdosing and quality control have made the exemption difficult to justify.
With the amendment, syrups, including cough syrups, can now be sold and dispensed only through licensed pharmacies operating under the provisions of the Drugs and Cosmetics Act and related rules.
Officials said the objective is to strengthen regulatory oversight and ensure better accountability across the distribution chain.
The decision comes against the backdrop of multiple incidents that raised concerns about syrup formulations. Internationally, investigations in 2022 and 2023 linked contaminated paediatric cough syrups exported from India to child deaths in countries such as Gambia and Uzbekistan. Global health agencies detected toxic chemicals, including diethylene glycol (DEG) and ethylene glycol (EG), in certain products.
Closer home, authorities in Madhya Pradesh launched investigations late last year after the deaths of children following consumption of medicines, including cough syrup. Similar concerns were reported in other states like Rajasthan, renewing debate over monitoring and quality assurance of liquid formulations.
The government subsequently intensified inspections of manufacturing units, strengthened quality-control measures and mandated testing of cough syrup consignments before export. The latest amendment addresses another critical point in the supply chain — retail sale and distribution.
Medical experts say cough and cold syrups require careful supervision because they are frequently used in children and are often purchased without medical consultation.
Dr. Sivaranjini, a paediatrician, welcomed the move.
"No more OTC sale of cough and cold syrups was long awaited. It will protect many children from overdose-related complications, including respiratory depression, coma, arrhythmias, hypertension, etc."
Dr. (Prof.) Mohsin Wali, Senior Consultant and Head of Preventive Cardiology at Pacific One Health, said concerns surrounding cough syrups extend beyond contamination alone.
"Cough syrups and other similar syrups contain cough suppressants like codeine sulphate and dexmethorphan (DXM). Some countries in the African subcontinent have reported deaths in children, and the DGCA and other authorities have made detailed enquiries and found that an industrial-quality solvent like Dexmethorfan was detected, which caused kidney failure and severe metabolic acidosis and deaths in some cases. This also brought a bad name to our country and resulted in banning these products."
He added, "In some cases, codeine-containing syrups were also used for non-medical uses by young adults due to morphine-like pleasure-giving effects and resulting in severe addictions, which is a serious concern. Some ingredients in such syrup also have hallucinogenic effects and are misused."
"Mothers also sometimes use these syrups to quiet very young children, as these induce sleep due to basic ingredients like antihistaminic agents. The problem is increasing day by day."
"It is in the fitness of things that to avoid overuse, misuse, and addictive use and to continue exports respectfully, such products should be brought under control and made available only on prescription."
"The recent gazette notification is in order and was necessary to save lives and to prevent abuse of such commonly marketed drugs."
Paediatricians have repeatedly cautioned against indiscriminate use of cough and cold medicines, particularly among young children, where incorrect dosing can result in serious adverse effects.
Dr. Anil Kumar J. Nayak, National President of the Indian Medical Association (IMA), described the notification as an important public health intervention.
"We welcome this gazette notification and congratulate the ministry. Selling these syrups over-the-counter was causing severe problems. Some people were using them for substance abuse; you could find two or three empty syrup bottles in almost any public toilet. This was fuelling the drug trade."
He added: "Also, these syrups were sometimes given to children under three years old, putting their lives at serious risk. By removing them from OTC availability, the government ensures they can only be obtained through a prescription from a qualified doctor, such as an MBBS graduate or a higher specialist. We hope the government strictly enforces this..."
The public health experts noted that while the amendment represents a significant policy shift from prioritising access alone to balancing access with safety and accountability, enforcement will be crucial. “Ensuring that unlicensed sales do not continue informally and that adequate pharmacy services are available in underserved regions will determine the effectiveness of the reform,” they said.
