How children die from Indian cough syrup

Indian officials are investigating whether safety gaps in the supply of a pharmaceutical ingredient are to blame for the contamination of cough syrup that has killed at least 24 children in recent months, according to three people familiar with the matter.

The three health and drug safety officials from Tamil Nadu state told Reuters they believe the solvent used to make a batch of Coldrif cough syrup could have been contaminated with a toxic chemical when it was delivered to Sresan Pharmaceutical Manufacturer.

Sresan bought 50 kg of propylene glycol (PG) solvent from local chemical distributor Sunrise Biotech on March 25, which bought it the same day from Jinkushal Aroma, a small company that produces fragrance blends for liquid detergents and other chemicals, according to supplier interviews and an exclusive Naharmacemilutical research report, October 3 by NameRegulator p. Reuters.

The Tamil Nadu Drug Control Department did not respond to repeated requests for comment on its investigation.

Authorities said the Coldrif syrup was highly contaminated with a known industrial toxin, diethylene glycol (DEG). They are investigating how the chemical was added to the solvent, which is used in cough syrup as a base to dissolve its active ingredients.

The deaths, which began in September, have reignited concerns about safety standards in India’s $50 billion pharmaceutical sector, which has been marred by the deaths of more than 140 children in Africa and Central Asia in 2022 and 2023 from Indian cough syrups made with contaminated solvents.

In the wake of these deaths, New Delhi had pledged to improve quality controls.

Indian health officials say DEG is sometimes fraudulently or inadvertently used in medicines instead of the more expensive PG. Ingestion of high levels of it has been linked to acute kidney injury and death in children.

Reuters is reporting details for the first time about the focus of the Indian investigation, as well as violations of global pharmaceutical safety practices in the delivery of the chemicals to Sresan.

Sresan’s manufacturing license has been revoked and its founder G. Ranganathan is in custody. Attempts to contact representatives at Sresan’s corporate office and Ranganathan’s home were unsuccessful. Reuters was unable to locate a legal representative for Ranganathan.

The Central Drugs Standard Control Organisation, which oversees pharmaceuticals federally, referred questions to India’s health ministry, which in turn referred Reuters to a government statement saying it was conducting more inspections of drug facilities and reviewing pediatric use of cough syrups.

Chemical makers usually deliver PG solvents to customers in sealed containers to prevent contamination, but Sunrise confirmed to Reuters that it had repackaged the solvent unsealed before delivering it.

The Drugs and Cosmetics Act of India prohibits the sale and handling of pharmaceutical grade ingredients such as pharmaceutical PG by entities that do not hold drug licenses.

Neither Jinkushal nor Sunrise have licenses to handle pharmaceutical-grade ingredients, the two wholesalers confirmed to Reuters. The owners told them that they did not know that the PG they sold would be used to make drugs.

Both Sunrise operator Vipul Jain and Jinkushal owner Jitender Vishwakarma said they did not handle highly toxic DEG and did not know how the solvent could have been contaminated.

Reuters was unable to determine how the infection was caused or who was responsible.

Inspections by the state regulator after the deaths found hundreds of “critical” and “major” violations at Sresan’s plant outside the southern city of Chennai, including storing products in “unsanitary conditions” and “falsification of data,” according to the Oct. 3 report. However, the regulator did not link these breaches directly to the deaths.

Repackaged chemicals

The PG Sresan told inspectors he used was produced by South Korean manufacturer SK picglobal, according to a certificate of analysis Jinkushal and Sunrise shared with investigators, reviewed by Reuters.

The certificate included the date of manufacture of the PG, as well as details of its chemical content. Reuters could not independently verify the accuracy of the contents, although a spokesman for SK picglobal said the copy seen by the news agency appeared to be authentic.

SK picglobal exported the solvent in a sealed 215 kg drum to an Indian distributor, who sold it to Jinkushal.

Jinkushal’s Vishwakarma said he broke the seals and repackaged the solvent in his shop before selling some of it to chemical distributor Sunrise.

Sunrise’s Jain said he then transferred the chemical to Sresan in two containers without tamper-evident seals because the pharmacist did not want the entire initial stock of 215 kg.

SK picglobal’s spokesperson said the company strictly prohibits the repackaging or redistribution of its products

Asked whether such restrictions are included in its sales contracts, the company said it has told customers in meetings that it does not “guarantee the quality of products that have been repackaged or arbitrarily subdivided for sale.” He did not give further details.

Violation history

Sresan has previously been punished by authorities, with its founder jailed for one day in 2020 and 2022 over concerns about its products, before being fined, according to four officials familiar with the matter. They did not provide evidence of the sentences.

Tamil Nadu’s health minister told lawmakers last month that Sreesan had been punished in 2021 and 2023 for “minor violations,” without elaborating.

Despite Sresan’s track record and regulations requiring annual inspections, the drugmaker’s plant had not been inspected since 2023, two state health officials said.

Reuters could not independently confirm when Sresan was last inspected before the deaths.