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Key Points

The central government is pushing to cancel Sresan Pharmaceuticals' license after their Coldrif cough syrup was linked to over 20 child deaths. Testing revealed the syrup contained nearly 50% diethylene glycol, a toxic substance that can cause kidney damage. While the CDSCO has recommended license cancellation, the final decision rests with Tamil Nadu's drug control authorities. Health officials are now advising against cough syrup use for children under 5 years due to the risks.

Key Points: Coldrif Cough Syrup Ban After 20 Child Deaths in MP Rajasthan

  • Coldrif syrup contained 48.6% toxic diethylene glycol instead of permitted 0.1%
  • Tamil Nadu FDA testing confirmed the syrup was dangerously adulterated
  • Multiple states including Kerala Punjab have banned Coldrif sales entirely
  • CDSCO found unbilled DEG containers at Sresan Pharma factory during inspection
2 min read

Cough syrup row: Govt proposes ban on 'Coldrif' maker; Tamil Nadu FDA to decide

Central govt pushes to cancel Sresan Pharma license after Coldrif cough syrup containing toxic DEG killed over 20 children across multiple states

"Cough and cold medications should not be prescribed or dispensed to children under 2 years - Dr. Sunita Sharma, DGHS"

New Delhi, Oct 8

While the central government proposed cancellation of the license of Tamil Nadu-based Sresan Pharmaceuticals in the wake of the death of over 20 children due to contaminated cough syrup, it is up to the state drug regulator to take the final decision, according to Health Ministry sources on Wednesday.

Coldrif, a cough syrup manufactured by Sresan Pharmaceuticals in Tamil Nadu's Kancheepuram, has been linked to the deaths of more than 20 children in Madhya Pradesh and Rajasthan.

On October 2, the Tamil Nadu drug control authorities declared that the Coldrif syrup sample they tested was adulterated. The sample contained diethylene glycol (48.6 per cent w/v), a poisonous substance "which may render the contents injurious to health", the report said.

Following the reports, several states, including Tamil Nadu, Kerala, Madhya Pradesh, Punjab, and Arunachal Pradesh, have banned the sale of Coldrif cough syrups. Others, such as Telangana, Karnataka, and Maharashtra, have issued an alert.

Sources from the Health Ministry said that CDSCO has already recommended cancellation of the license for the faulty drug maker, but the final call must be taken by the Tamil Nadu FDA.

“Form 25 or a license to manufacture common formulation allopathic drugs is given by the state drug controllers and is governed by them. The cancellation too has to be done by the state drug controller,” the sources said.

It added that the “CDSCO has already recommended cancellation of license for the firm in question after the presence of DEG in 'Coldrif' was confirmed”.

Diethylene Glycol (DEG) is a toxic substance linked with injury to the kidneys.

Inspection by the CDSCO found unbilled containers of DEG at Srisan Pharma's factory. The company was reportedly adding 46-48 per cent of DEG to cough syrup against the permitted limit of only 0.1 per cent.

Meanwhile, in an advisory issued to all states and union Territories, the Director General of Health Services (DGHS) Dr. Sunita Sharma urged the rational use of cough syrups in the paediatric population.

“Cough and cold medications should not be prescribed or dispensed to children under 2 years.”

“Most acute cough illnesses in children are self-limiting and often resolve without pharmacological intervention,” said Sharma, adding that cough and cold medications “are generally not recommended for ages below 5 years”.

It should be used “following careful clinical evaluation with close supervision and strict adherence to appropriate dosing, the shortest effective duration, and avoiding multiple drug combinations”.

- IANS

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Reader Comments

R
Rajesh Q
Why is there so much bureaucracy? Central government recommends cancellation but state has to decide? When children are dying, we need immediate action, not passing the buck between authorities.
A
Arjun K
This is why I only trust established brands for my children's medicines. The DGHS advisory is important - we should avoid unnecessary cough syrups for young children. Natural remedies like honey and steam work better for minor coughs.
S
Sarah B
The fact that they were adding 48% DEG instead of 0.1% shows complete negligence. This isn't just a mistake - it's criminal. Hope the Tamil Nadu FDA acts swiftly and sets an example for other manufacturers.
M
Michael C
While I agree the company should be punished, let's not forget that this highlights a larger systemic issue. We need better quality control across all pharmaceutical companies, not just reacting after tragedies occur.
K
Kavya N
As a pharmacist, I'm appalled. We need mandatory third-party testing for all medicines. The families who lost their children deserve justice and compensation. This should never happen again in our country.

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