NEW DELHI/CHENNAI/BHOPAL: The Centre has pointed fingers at the Tamil Nadu Food and Drug Administration (TNFDA) for not yet cancelling the licence of Sresan Pharmaceuticals, the manufacturer of Coldrif cough syrup, linked to the deaths of at least 20 children in Madhya Pradesh.
According to sources in the Union health ministry, the TNFDA was directed by the Central Drugs Standard Control Organisation (CDSCO) to cancel the licence of the pharma company based in Kanchipuram, Tamil Nadu, on October 4. “The TNFDA is yet to cancel the license of the company despite CDSCO recommendations,” sources told TNIE.
However, Tamil Nadu State Drug Control Department on Wednesday initiated criminal proceedings against G Ranganathan, proprietor cum manufacturing chemist of Sresan Pharmaceuticals.
A special investigation team (SIT) from Madhya Pradesh arrived in Chennai and held discussions with the Tamil Nadu State Drug Controller. Ranganathan, who has been in the pharma manufacturing field for over 40 years, is absconding. The SIT lodged a police complaint against Ranganathan, sources said.
Since Sresan is already shut, the department’s show cause notice was pasted on the doors of the unit in Kanchipuram and on Ranganathan’s residence in Chennai. The notice gives Ranganathan time till October 12 to submit his response. Possibly on October 13, formal orders to cancel Sresan’s licence would be issued. Its current licence is valid till December this year, officials said.
Company owner absconding with wife: MP police
Convictions under the Drugs and Cosmetics Act 1940 stipulate a minimum jail term of 10 years, which may extend up to life imprisonment and with a fine of not less than Rs 10 lakh, said S Gurubharathi, Deputy Director of Drugs Control and Licensing cum Controlling Authority, TN. Officials said the show cause blames the manufacturer of misbranding.
For, the label of the container ought to have carried a warning that “fixed dose combination shall not be used in children below four years of age”. This is mandatory as per gazette notification dated 15 April 2025 of the Union health ministry and circular dated 18 December 2023 of the Central Drugs Standard Control Organisation. Failure to do so violates Section 18(a)(i) read with Section 17 (b) of the Drugs and Cosmetics Act 1940.
Meanwhile, Congress leader Rahul Gandhi is likely to travel to Chhindwara district on October 11 or 12, where he will meet the bereaved families. “Till now 20 children from Chhindwara, Pandhurna and Betul have died due to the unfortunate and painful incident. Five children are being treated in government and private hospitals in Nagpur and all efforts are underway to save their lives, MP deputy CM and health minister Rajendra Shukla said.
“Our SIT in coordination with the local police in TN, has conducted investigations and raids at multiple locations, but the company’s owner has gone into hiding along with his wife. We’re also investigating the role of the company’s directors and other officials, who might be directly or indirectly associated with the adulteration of the syrup,” a senior Chhindwara police officer told this newspaper.
Cough syrup unit was to be shut after December
Ranganathan, 75, has been running the Kanchi unit at its rented location (pic) since 2013. The owner of the building said Ranganathan had not paid rent for the last six months. Ranganathan was planning to stop the production of cough syrups after December because of advanced age, sources said
