TIRUNELVELI: The Tamil Nadu Government will file criminal action against the drug manufacturer, whose cough syrup has been banned in the wake of children’s deaths in Madhya Pradesh, Tamil Nadu minister Ma Subramanian said on Wednesday.
The government has issued its second notice against the drug manufacturer for the alleged presence of diethylene glycol in the cough syrup Coldrif, to explain why criminal action should not be taken, he said.
The company located some 40 km from Chennai has been making the cough syrup which contained 48.6 per cent of the ‘poisonous substance’ as per the findings of the State Drug Control department, he added.
On Wednesday Subramanian said the government is taking all measures to ensure the closure of the drug manufacturer. “On October 3, the samples collected by the drug controller declared the syrups to be adulterated. We have issued stop production order to the company. We have also asked the company why it should not be shut and asked for an explanation,” he said.
Maintaining that the government is expecting a response from the company for the notice it has sent, Subramanian said, “Whatever be their explanation, we will take action as per the law. The government is taking all measures to ensure the closure of the firm.”
Subramanian said, on October 7, through Drug Inspector another show cause notice has been issued against the company asking why criminal action should not be taken. “We will take criminal action against them,” he said. The factory was sealed by the district administration on Tuesday.
The company has been manufacturing the syrup for the last 14 years since obtaining license at its facility in Sunguvarchatram in neighbouring Kancheepuram district.
According to a report, Sresan Pharma, maker of the cough-syrup brand Coldrif that allegedly left at least 16 children dead in Madhya Pradesh, had flouted scores of quality standards, ranging from procurement of raw materials, storage and sample tests to manufacturing and distribution.
The drug manufacturing facility at Kancheepuram in Tamil Nadu was found to be in a “shoddy and neglected state” during a recent inspection by a central team. It has probably not been audited by the Tamil Nadu state Food and Drug Administration for a long time, the report said.
Officials directly involved in investigating the case said state-level authorities should have immediately cancelled the manufacturing licence of Sresan given the scale of the violations. Instead, the site inspectors issued only a stop-production order and a show cause notice, an action that is considered to be mild, they said.
Among the most critical violations, the inspectors found Sresan Pharma had not tested the raw materials before using them to make the medicines. It also did not conduct any tests before releasing the batches in the market.
Random samples of the cough syrups were found to be adulterated with DEG 48.6% w/v (weight in volume), which is an “order of magnitude” higher than the prescribed guidelines and can be highly poisonous, specifically in infants and children, a report said.
Children experience nausea, abdominal pain and vomiting, escalating to seizure, renal failure and critical kidney injuries. The spate of fatal incidents within a span of a week, with scores of others battling for their lives, has caused a nation-wide furore. States like UP, Rajasthan and Maharashtra have issued separate prohibition and probe orders against the drug.
Maharashtra FDA joint commissioner DR Gahane said the union government is following strict manufacturing standards of revised Schedule M regulations for safe medicines, but many units are still violating even the minimum quality standards.
The Tamil Nadu state drug regulatory agency issued a public interest alert on October 3 against use of the Coldrif brand cough syrup manufactured in May 2025 and expiring in April 2027, acting upon a lab report that showed adulteration due to DEG. It said the Drug Control Department has explicitly prohibited the purchase, sale and consumption of the batch (SR-13), citing serious health risks.
Meanwhile, the Madhya Pradesh government has announced a complete ban on the sale of a Cough Syrup across the state after children’s deaths due to kidney failure.
In the past 30 days, nine children have lost their lives in Chhindwara district due to kidney failure. Authorities suspect that these deaths may be linked to the consumption of a contaminated cough syrup.
Across Madhya Pradesh, raids are being conducted to seize the banned medicine. The Chief Minister has made it clear that those responsible will not be spared under any circumstances. Additionally, the sale and use of all medicines manufactured by M/s Sresan Pharmaceutical have been suspended with immediate effect.
Taking cue from the Madhya Pradesh ban on Coldrif Syrup Maharashtra’s Food and Drugs Administration (FDA) has also issued an urgent alert following reports of the deaths of children in Madhya Pradesh and Rajasthan linked to Coldrif Syrup.
Similary, the Uttar Pradesh government has banned the Coldrif cough syrup manufactured by Shreesan Pharmaceutical following reports of severe side effects, resulting in the death of children in different states. The government has also ordered an investigation of such syrups following which the Food Safety and Drug Administration is conducting raids on medical stores.
Meanwhile as Indian authorities advised the public to avoid two more brands of cough syrup -Respifresh and RELIFE syrups – on Wednesday following the deaths of 17 children aged under five linked to a toxic ingredient, the World Health Organization sought a clarification clarification from Indian Government on whether the cough syrup Coldrif linked to the deaths has been exported to other countries.
But authoritites asserted that Coldrif, made by Sresan Pharmaceutical Manufacturer, was only sold locally.
Nevwertheless, the WHO said it will assess the need for a Global Medical Products Alert on Coldrif syrup once it receives official confirmation from Indian authorities.
The Respifresh and RELIFE syrups also contain diethylene glycol, according to a public alert by Gujarat and other states on Wednesday that described it as “a toxic chemical that can cause serious poisoning, including kidney failure, neurological complications and even death, especially among children”.
