States crack down on Almont-Kid syrup after lab finds deadly ethylene glycol

The syrup containing levocetirizine dihydrochloride and montelukast sodium has been declared “Not of Standard Quality" (NSQ) by the Central Drugs Laboratory (CDL), Kolkata, after tests detected life-threatening contaminants, including toxic ethylene glycol at levels nearly fifteen times the permissible safety limit.

The cough syrup, manufactured by Tridus Remedies based in Bihar's Vaishali district, is prescribed for children to treat symptoms of congestion, runny nose, sneezing, itching and watery eyes.

Late last year, 24 children died in Madhya Pradesh and Rajasthan after consuming cough syrup Coldrif, which was contaminated with toxic industrial solvents including diethylene glycol (DEG) and ethylene glycol (EG).

States including Haryana, Himachal Pradesh, and Uttarakhand are pulling out all stops to prevent the sale and usage of Almont-Kid.

Haryana’s State Drugs Controller-cum-Controlling Authority has instructed officers to maintain a strict vigil, seize remaining stocks of the medicine's AL-24002 batch, and draw further samples.

“As the above-mentioned cough syrup formulations containing ethylene glycol (EG) above the permissible limits, the sale or distribution of these batches is strictly prohibited with immediate effect. Retailers, wholesalers, distributors, hospitals, and medical practitioners across Haryana are hereby instructed not to sell, distribute, prescribe, or use the above-mentioned batches of said drug," the Haryana Food and Drugs Administration wrote in a 9 January communication reviewed by Mint.

Ethylene glycol is a poisonous substance, whose ingestion can lead to severe organ failure or death, especially in children.

In Himachal Pradesh, State Drugs Controller Dr. Manish Kapoor ordered an immediate ban on the sale and distribution of Almont-Kid, with retailers and hospitals asked to stop using the formulation and report any existing stock to the administration immediately.

This followed a red alert from Kolkata's Central Drugs Laboratory (CDL), under the Central Drugs Standard Control Organization (CDSCO), that detected poisonous impurities after a rigorous analysis of a particular batch of Almont-Kid, manufactured in January 2025 by Tridus Remedies. Laboratory testing revealed the syrup contained 1.4876% w/w of Ethylene Glycol (EG), exceeding the permissible safety limit of 0.1%.

Queries emailed to the Union health ministry, CDL Kolkata, CDSCO and Tridus Remedies on Monday remained unanswered till press time.

Public health expert and physician Dr. Chandrakant Lahariya highlighted critical gaps in India’s drug regulation and usage that go beyond government standards.

He said that there are three major issues contributing to public health risks. “First, the over-prescription of medicines by doctors, the widespread practice of self-medication by individuals, and the unauthorized swapping of prescriptions by pharmacies, particularly in tier-2 and tier-3 cities," he said.

Dr. Lahariya specifically warned against the common but risky practice of giving cough syrups to children under four years old, and the misuse of antibiotics due to a lack of public awareness regarding the differences between viral and bacterial infections.

PTI earlier reported that the Telangana Drugs Control Administration has also issued a "stop use" notice and an urgent advisory to freeze all available stocks of the Almont-Kid batch (AL-24002) after the CDL Kolkata alert confirmed the presence of toxic ethylene glycol.

The official certificate of analysis was explicit regarding the dangers.

According to the documents reviewed by Mint, the analysis stated, “The sample does not conform to claim with respect to 'assay of Montelukast Sodium' and is also not of standard quality for the reason stated under 'Description'."

The discovery followed an inspection by CDSCO East Zone Drug Inspector Nitish Kumar. During the examination, the lab observed white crystalline, undissolved particles precipitated at the bottom of the bottles that failed to dissolve even after shaking. Furthermore, the syrup failed the “Assay of Montelukast Sodium" test, containing only 0.857 mg/5ml (21.425% of the claim) instead of the required 4 mg/5ml.

Over the past few years, Indian-manufactured cough syrups have been linked to over 140 deaths globally, including tragedies in Gambia, Uzbekistan, and Cameroon due to ethylene glycol poisoning.

Mint earlier reported that the government is working on a new licensing system that will enable India’s apex drug regulator to enforce more stringent storage and handling conditions and hold accountable the specific dealers involved in the distribution of substandard materials in India’s $60 billion pharmaceutical market. Under criticism for lax oversight, the Union government is planning a major overhaul of India’s drugs licensing regime, wherein a separate licensing system for the wholesale trade of bulk drugs or key starting materials, drug intermediates and active pharmaceutical ingredients will be introduced.