The manufacturer of Coldrif, a cough syrup linked to 22 child deaths in Madhya Pradesh since August, was arrested by the central Indian state’s police from Chennai in the early hours of Thursday.
Madhya Pradesh police sources said G. Ranganathan, the owner of Sresan Pharmaceuticals, would be taken to the heartland state after he undergoes a medical checkup and a Chennai court issues a transit remand.
Coldrif — said to contain the toxic diethylene glycol, commercially known as DEG — is manufactured on Sresan’s premises in the Kancheepuram district of Tamil Nadu.
The child deaths have put India’s drug regulatory framework under the scanner, three years after cough syrups manufactured in the country were linked to more than 140 child deaths in Uzbekistan, Cameroon and The Gambia.
The Central Drugs Standard Control Organisation (CDSCO) has halted the production of two other cough syrups, Respifresh TR and ReLife, both manufacturedby firms in Gujarat, reportedly after DEG was foundin them.
The Tamil Nadu government has suspended two senior drug inspectors on the charge of failing to conduct quality checks on medicines made by Sresan over the past two years.
“While Madhya Pradesh and the Union health ministry initially found no issues with the syrup, it was Tamil Nadu that detected the presence of DEG and confirmed theextent of contamination,” Tamil Nadu health ministerM. Subramanian told reportersin Chennai.
“Based on these findings, we immediately issued a ‘stop production order’ to the manufacturer on October 3. A closure order was also issued.”
Madhya Pradesh chief minister Mohan Yadav told reporters in Bhopal that the state police’s “prompt” action in making the arrest from Chennai was “clear proof of our government’s sensitivity”.
Reuters quoted a World Health Organisation spokesperson as saying: “WHO expresses deep concern over these developments and emphasises... the regulatory gap in DEG/ EG screening for domestically marketed medicines in India.”
Sources said the WHO had sought to know from Indian authorities whether Coldrif had been exported to other countries.
They added that the CDSCO had informed the global health agency that Coldrif and two other cough syrups had been recalled, and that none of them had been exported from India.
Doctors’ protest Doctors in Madhya Pradesh have been protesting against the arrest of a registered medical practitioner, Praveen Soni, for prescribing Coldrif.
In a letter to Union health minister J.P. Nadda, the Indian Medical Association on Wednesday said: “The immediate arrest of the doctor constitutes a classical example of legal illiteracy and sends a profoundly detrimental message to healthcare providers nationwide….
“A doctor prescribes a drug (even if generic) in good faith, based on its official approval by the competent regulatory bodies and itsavailability in the certified supply chain. They have no means or mechanism to ascertain manufacturinglapses, such as the hiddencontamination of excipients with toxic substances likediethylene glycol (DEG) orethylene dlycol (EG).”
Nationwide tests
The CDSCO has begun a pan-India drive to test, inspect and audit cough syrup manufacturers, official sources said on Thursday.
The apex drug regulator has asked all states and Union Territories for lists of the companies that manufacture cough syrup.
Sources say no state has so far fully complied with the Corrective and Preventive Action guidelines, which aim at ensuring drug safety and standards.
The Drugs Controller General of India had on Wednesday urged drug controllers in all the states and Union Territories to ensure the testing of raw materials and finished drug formulations before they reach the market.
It said recent inspections had found that several manufacturers were not testing every batch of excipients and active ingredients.