INDIA MAKES PRESCRIPTION MANDATORY FOR ALL SYRUPS AFTER SAFETY SCANDALS

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Thu 18 June 2026:

The Union Health Ministry has removed ‘syrups’ from Schedule K of the Drugs Rules, 1945, ending their over-the-counter availability. This change, effective June 9, 2026, means all syrup-based medicines, including cough syrups, now require a doctor’s prescription. The amendment followed a draft notification issued in December last year and was approved after review by the Drugs Technical Advisory Board.

In a notification issued on Tuesday, the Ministry of Health and Family Welfare removed the word “syrup” from the list of products exempted under the Drugs and Cosmetics Rules, 1945. Earlier, cough syrups, along with lozenges, pills and tablets for cough, could be sold without a prescription under certain conditions.

The decision follows child deaths in India and overseas linked to contaminated syrups, and aims to curb misuse, addiction, and unsafe self-medication.

Doctors welcomed the move as a vital public health step that could save lives, especially among children, by ensuring proper medical supervision.

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Health experts warn that unsupervised syrup use can lead to overdosing in children, masking of serious illnesses, harmful drug interactions, and addiction to ingredients like codeine. Contaminated syrups have caused fatal kidney injuries in children, with incidents reported in Madhya Pradesh, Rajasthan, The Gambia, and Uzbekistan. By enforcing prescriptions, the government aims to ensure correct diagnosis, safer dosing, and reduced misuse. 

Recent years have seen multiple mass child fatalities linked to contaminated Indian-made syrups, including 14 deaths in Madhya Pradesh in 2025 from Coldrif containing 48.6% diethylene glycol, and deaths in Rajasthan from unsafe formulations. Similar tragedies in The Gambia, Uzbekistan, and Cameroon have drawn WHO alerts. These incidents exposed regulatory gaps in domestic syrup sales despite tighter export testing rules. 

Hepatologist Dr. Cyriac Abby Philips, popularly known as “TheLiverDoc,” praised the amendment.

“Absolutely wonderful news and super effort from the Government,” he wrote on X, adding sarcastically that people would now need a prescription to obtain “tainted-organ-failure inducing, child-killing cough syrups.”

Journalist Rema Nagarajan criticised suggestions that improper dosage was the primary issue in deaths linked to contaminated syrups. 

“So incorrect dosage and incorrect spoon size were the reasons for all the cough syrup deaths???” she wrote, asking , “Giving poison/seriously adulterated cough syrup in the correct spoon size and correct dosage will help?” 

Manufacturers and retailers must now comply with full licensing, record-keeping, and quality-control norms for syrups under the Drugs and Cosmetics Act. Pharmacies will need to verify prescriptions and may face penalties for non-compliance. The government plans awareness campaigns, and experts expect a rise in doctor consultations, potentially offset by telemedicine services.

SOURCE: INDEPENDENT PRESS AND NEWS AGENCIES

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