Cough syrup deaths: pharma company owner arrested in Tamil Nadu, WHO informed of drug recall

New Delhi/Chennai/Bhopal, Oct 9 (PTI) The owner of Tamil Nadu-based Sresan Pharma which manufactured `contaminated' cough syrup Coldrif was arrested on Thursday in the wake of the deaths of more than 20 children who had allegedly consumed it, while the central drug regulator CDSCO said it had informed the WHO that the syrup, along with two other brands, has been recalled.

CDSCO, which has also started a pan-India drive to test, inspect and audit cough syrup manufacturers, has informed the World Health Organisation that cough syrups Coldrif, RespifreshTR and ReLife were recalled and manufacturers ordered to stop their production, though none of the products were exported from India, official sources said.

The global health agency had sought to know whether the cough syrup linked to children deaths was exported.

The CDSCO has started a drive to test, inspect and audit cough syrup manufacturers, and also asked all states and Union territories to provide a list of cough syrup manufacturing companies for auditing, sources said. No state so far has fully complied with Corrective and Preventive Action (CAPA) guidelines meant for ensuring safety and maintaining standards in pharmaceutical products, they added.

In Madhya Pradesh, two more children succumbed to kidney infections allegedly caused by the consumption of contaminated cough syrup, taking the toll to 22.

Madhya Pradesh police, with the help of Chennai cops, arrested G Ranganathan, owner of Sresan Pharma which manufactured Coldrif, in the wee hours of Thursday. Police had been searching for Ranganathan since October 7. The police also seized some documents from his Kancheepuram factory.

After being produced in the Chennai court for obtaining transit remand, he would be taken to Chhindwara, said an official.

On October 7, the Sriperumbudur Drug Control Inspector had issued a show-cause notice to the pharma company asking it to explain the discrepancies in the quality and labelling of the medicine. Officials from the TN Directorate of Drugs Control inspected the manufacturing facility and found that the medicines were allegedly stored in “unhygienic conditions” on the corridors, and they noticed certain risk of contamination.

The WHO, meanwhile, stated that it is closely monitoring recent media reports from India regarding clusters of pediatric illnesses and deaths in Madhya Pradesh and Rajasthan.

These reports, which have emerged during the week of September 29, describe symptoms consistent with acute renal failure and acute encephalitis syndrome, with suspected links to the use of oral syrup medicines.

The WHO has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified, sources said.

The global health agency has expressed deep concern over the developments and emphasized the potential risk of contaminated products being exported to other countries, particularly via unregulated channels and the regulatory gap in DEG/EG screening for domestically marketed medicines in India.

It has also stressed on identifying the source of the contamination and identifying and removing any contaminated pharmaceutical material which may be in circulation, the sources said.

The Drugs Controller General of India (DCGI) on Wednesday had urged drug controllers all states and Union territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing in them in the market.

In an advisory, the DCGI said that during recent inspections at manufacturing facilities and in the investigations of the drugs declared as not of standard quality, it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.

In MP's Chhindwara, five-year-old Vishal died on Wednesday evening and Mayank Suryavanshi, aged 4, succumbed late at night while undergoing treatment at a hospital in Nagpur in neighbouring Maharashtra, Additional Collector Dhirendra Singh Netri said. The toll due to suspected cough-related deaths has now gone up to 22, he added.

Some other children from MP were undergoing treatment in Nagpur. The Madhya Pradesh Police have formed a Special Investigation Team (SIT) to investigate the deaths.

Madhya Pradesh Chief Minister Mohan Yadav, who met the children undergoing treatment in Nagpur, alleged that the Tamil Nadu government was not cooperating in connection with the probe. His government will not spare anyone playing with the lives of children, he said, urging the Tamil Nadu government to take "concrete steps" and "proper action".

In Chennai, Tamil Nadu Health Minister Ma Subramanian said two senior drug inspectors were served notice as to why they had not inspected the Sresen Pharma manufacturing facility for two years, and later suspended.

"Tamil Nadu was the first to confirm the adulteration in the cough syrup (Coldrif) and we immediately informed the Union Health Ministry, Madhya Pradesh, Odisha, and even Puducherry about the health hazard of consuming the cough syrup," Subramanian told reporters.

"Based on a detailed investigation, steps will be taken to permanently close down the pharma company. A decision will be taken in three days’ time," the minister assured.

Also, Subramanian informed that the state stopped procuring Coldrif following the “adulteration” and had even banned its sale in the market. "Due to our prompt action, a major catastrophe was averted," he said.

The Supreme Court, meanwhile, agreed to hear on Friday a PIL seeking inquiry and systemic reform in drug safety mechanisms in the wake of deaths of children in Madhya Pradesh and Rajasthan.

The plea seeks a court-monitored probe into the incidents and urges the constitution of a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge. PTI JSP ADB PLB COR MAS CLS GK SJK VN KRK