The manufacturing licence of Tamil Nadu based Sresan Pharmaceutical company involved in making the adulterated cough syrup Coldrif has completely been revoked, and the company has been ordered to shut down, the state government informed on Monday.
The state Drug Control Department officials had during an inspection found the cough syrup contained 48.6 per cent of Diethylene Glycol (DEG), a toxic substance. This medicine is linked to the death of children in Madhya Pradesh.
The officials had also found that the company lacked proper good manufacturing practices (GMP) and good laboratory practices (GLP), and they recorded over 300 critical and major violations.
The company's owner, G Ranganathan, was recently arrested by a special investigation team from Madhya Pradesh.
“The drug manufacturing license of Sresan Pharmaceuticals has been completely cancelled, and the company has been closed. Orders have been given to conduct a detailed inspection of other drug manufacturing companies located in Tamil Nadu,” the government said in a release.
Earlier in the day, a team from the Enforcement Directorate raided the premises of Sresan Pharmaceuticals and some officials, in a Prevention of Money Laundering Act (PMLA) case.
At least seven premises in Chennai were covered by the Enforcement Directorate under the Prevention of Money Laundering Act (PMLA), they said.
The premises of key employees of Sresan Pharmaceuticals and P U Karthikeyan, the arrested director in-charge of Tamil Nadu Food and Drug Administration (TNFDA), were also covered in the raids.
Karthikeyan was arrested by the Tamil Nadu Directorate of Vigilance and Anti-Corruption (DVAC) in a bribery case in July.
The ED sources said the profits derived from the sale of the "adulterated" cough syrup are proceeds of crime under the PMLA and the agency is looking to gather evidence to prove this.
The ED action came after the federal probe agency registered a criminal case under the anti-money laundering law, taking cognisance of the police FIR filed against Sresan Pharmaceuticals in Madhya Pradesh and the one in the Tamil Nadu bribery case.
At least 22 children, mostly under the age of five, have died due to suspected kidney failure after being administered Coldrif in Madhya Pradesh.
Licensed in 2011 by the TNFDA, the Kanchipuram-based Sresan Pharmaceuticals continued operations unchecked for over a decade despite its dismal infrastructure and multiple violations of national drug safety rules, the Central Drugs Standard Control Organisation (CDSCO) has said.
The cough syrup was found to be "dangerously" adulterated with diethylene glycol (DEG), a highly poisonous substance.
The owner of Sresan Pharmaceuticals, G Ranganathan, was arrested by Madhya Pradesh Police on October 9.
Following the children's deaths, the Madhya Pradesh government suspended two drug inspectors and a deputy director of the FDA.
It also transferred the state's drug controller and ordered an investigation into the deaths, while police arrested a doctor from Chhindwara district on charges of negligence.
The Tamil Nadu government has also suspended two senior state drug inspectors and ordered the closure of the accused pharma company.
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