New Delhi: After a clinical probe into the deaths of children in Jammu’s Udhampur in January found the presence of a “poisonous compound” in a cough syrup manufactured by Digital Vision, the drug has been halted. At least eight states have also been asked to stop its sale and distribution according to a report in the Indian Express.
“Prima facie, presence of Diethylene Glycol, a poisonous compound, in Coldbest-PC syrup caused the death of children from Udhampur district, PGIMER, Chandigarh, officials have told us,” said Surinder Mohan, the assistant drugs controller, Drug and Food Control Organisation, J&K.
Mohan also said that the samples of the syrup, manufactured by the Himachal Pradesh-based pharmaceutical company, have been sent to the Indian Institute of Integrative Medicine, Jammu, and Regional Drugs Testing Laboratory, Chandigarh, for further tests.
Konic Goyal, the managing director of Digital Vision, told the Indian Express that they “would not like to say anything” on the issue at the moment. The general manager (marketing), Sushil Yadav said, “Production of the medicine has been stopped and we have provided all information to the state drugs control authorities.”
The Jammu and Kashmir Drug Controller Latika Khajuria said that the final report from the Regional Drugs Testing Lab was awaited even though the PGIMER report had located the presence of Diethylene Glycol in the syrup. “Once we receive that report, we will find what actually led to the deaths. The syrup has already been recalled,” she said.
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In January, almost ten children died of a mysterious disease while six others were taken ill in J&K’s Udhampur district following which the Centre deployed a team of medical experts to probe the cause of deaths.
The Director Health Services (DHS), Jammu, Renu Sharma said that the deaths took place between December-end and January 17 in Udhampur’s Ramnagar block. “The patients were hospitalised with acute renal failure. The common factor found in all the deaths was that they took Coldbest-PC,” she said.
Sharma also said that of the 17 children who had been affected, nine had died.
The presence of an impurity, diethylene glycol, was detected in the cough syrup and found to be present in the solvent propylene glycol (PG), used in the syrup. Its origin has been traced to Chennai-based Manali Petrochemicals. The solvent was sold to two Delhi-based traders, who then sold it to a trader in Ambala, from where it found its way to the Kala Amb-based Digital Vision pharmaceutical unit.
The firm’s manufacturing licence has since been withdrawn.
Close to 5,500 units of the drug are being recalled from eight states and the Himachal Pradesh health safety and regulation authorities have suspended all production at Digital Vision’s unit at Kala Amb in Sirmaur district, where Coldbest-PC Syrup was manufactured.
In a letter to the Himachal Pradesh drugs controller, Jammu’s drugs controller said that after a team of doctors from PGIMER, Chandigarh visited Ramnagar last month to probe the probable cause of the deaths, Diethylene Glycol was found in below pharmaceutical preparation. The letter has also been copied to all state and UT Drug Controllers across India.
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The team of doctors from PGIMER comprised of experts from the departments of Paediatrics, Community Medicine and Virology. A senior PGIMER doctor, who was a part of the visiting team said that samples of the syrup contained Diethylene Glycol.
“The batch of the syrup believed to be containing the poisonous compound was produced in September 2019. As a precautionary measure, the entire stock is being recalled and production at the factory was stopped on February 17. We are also trying to reach users who bought it,” a Himachal official said.
The Himachal Pradesh drugs controller said that apart from those in Udhampur, no other case related to the cough syrup’s effects had been reported so far.
Haryana DGHS Suraj Bhan Kamboj said the state had banned the cough syrup and the department’s teams were “conducting raids at chemist shops to check availability”.