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Children dying from Indian cough syrup due to safety lapses and weak oversight

According to three sources familiar with the issue, Indian officials are looking into whether a safety lapse in the supply chain of a pharmaceutical component was responsible for the contamination of cough syrup which has caused the deaths at least 24 children over the past few months.

Three health and drug safety officers from Tamil Nadu said they believed the solvent used in the production of a batch Coldrif cough medicine could have been contaminated by a toxic chemical at the time when it was delivered to the drugmaker Sresan Pharmaceutical Manufacturing.

Sresan purchased 50 kg of propylene glycol solvent (PG) on March 25 from Sunrise Biotech, which bought it that day from Jinkushal Aroma. This small company makes fragrance blends to liquid detergents and chemicals.

The Tamil Nadu Drugs Control Department has not responded to requests for comments about its investigation.

The authorities have confirmed that the Coldrif Syrup was heavily contaminated by diethylene glycol, a well-known industrial toxin. The authorities are looking into how the chemical was mixed with the solvent used to dissolve the active ingredients in the cough syrup.

More than 140 children will die in Africa and Central Asia by 2022 or 2023 due to cough syrups manufactured in India with contaminated solvents.

New Delhi pledged to act in the wake of these deaths.

Indian health officials claim that DEG is often used fraudulently or accidentally in medicine instead of the more expensive PG. It has been shown that children who consume high doses of DEG can suffer acute kidney damage or even die.

The report provides details about the Indian investigation and breaches of global pharmaceutical safety standards in the delivery to Sresan of chemicals.

Sresan has had its manufacturing license revoked, and founder G. Ranganathan remains in custody. The attempts to contact Ranganathan and Sresan corporate offices were unsuccessful. Ranganathan's legal representative could not be identified.

The Central Drugs Standard Control Organisation (CDSCO), which supervises the pharmaceutical industry federally, referred questions to India's Health Ministry, which, in turn, referred to an official government statement stating that it was conducting additional inspections at drug facilities and reviewing the paediatric usage of cough syrups.

Chemical manufacturers typically deliver PG-solvents to their clients in sealed containers, to prevent contamination. However, Sunrise confirmed that it had repackaged it without a sealing before delivering.

The Drugs and Cosmetics Act of India prohibits entities without a drug licence from selling or handling pharmaceutical-grade ingredients such as medicinal PG.

The two wholesale distributors have confirmed that neither Jinkushal or Sunrise has a licence to handle pharmaceutical-grade materials. The owners of the two wholesale distributors said that they were unaware that the PG sold by them would be used in making medication.

Sunrise operator Vipul Jin and Jinkushal's owner Jitender Vishwakarma both said that they had never handled highly toxic DEG, and were unaware of how it could have been contaminated.

It was not possible to determine how or who caused the contamination.

According to a report published on Oct. 3, inspections by the state regulator following the deaths revealed hundreds of "critical" or "major" violations in Sresan’s factory, outside of the southern city Chennai. These included "storing products under unhygienic circumstances" and "falsifications of data." The regulator did, however, not link these breaches directly to deaths.

Repackaged chemcials

According to a certificate shared by Jinkushal, Sunrise, and investigators, the PG Sresan claimed it used was made by SK picglobal in South Korea.

The certificate also included information about the chemical composition of the PG and the date it was manufactured. The contents of the certificate could not be independently verified, but a spokesperson for SK picglobal said that the copy seen appeared to be genuine.

SK picglobal sold the solvent to Jinkushal in a 215 kg sealed barrel.

Vishwakarma, a Jinkushal employee, said that he had broken the seals on the solvent and repackaged it in his shop before selling some to Sunrise Chemicals.

Sunrise's Jain claimed that he transported the chemical from Sresan to Sunrise in two containers with no tamper proof seals, because the drugmaker did not want the entire 215 kg supply.

The spokesperson for SK picglobal said that the company prohibits repackaging or redistribution.

When asked if these restrictions are included in the contracts for sale, the company responded that they have told their customers in meetings that "we do not guarantee the quality of the products that have arbitrarily been subdivided or re-packed." The company did not give any further details.

History of Violations

Four officials who are familiar with the case said that Sresan was previously penalised. Its founder had spent a day behind bars in 2020 and 2022 because of concerns over his products. Then, he received a fine. Four officials familiar with the matter said that they did not have any documentation to support their penalties.

Tamil Nadu's Health Minister told lawmakers last week that Sresan was penalised for "minor" violations in 2021-2023, without giving specifics.

Two state health officials said that despite Sresan’s excellent track record and the regulations requiring annual inspections, their factory has not been inspected for more than a decade.

It was not possible to confirm independently when Sresan's last inspection took place before the deaths. Reporting by Krishna N. Das in Chennai, Rishika Sadam in London, Joyce Lee and Aditya Chaturvedi at New Delhi, and Jennifer Rigby and Jennifer Ang in Seoul.

(source: Reuters)