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”.
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