Production of a cough syrup manufactured by Himachal Pradesh-based pharmaceutical company Digital Vision has been halted and at least eight states have been asked to stop its sale and distribution after a clinical probe into the deaths of nine children in Jammu’s Udhampur last month prima facie found presence of a “poisonous compound”.
“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,” Assistant Drugs Controller, Drug and Food Control Organisation, J&K, Surinder Mohan said.
He said they have sent samples of the syrup to the Indian Institute of Integrative Medicine, Jammu, and Regional Drugs Testing Laboratory, Chandigarh, for further tests.
J&K Drug Controller Latika Khajuria said even though PGIMER’s report had found presence of Diethylene Glycol in the syrup, they are still waiting for the final report from Regional Drugs Testing Lab. “Once we receive that report, we will find what actually led to the deaths. The syrup has already been recalled,” she said.
Dr Renu Sharma, Director Health Services (DHS), Jammu, said nine deaths took place between December-end and January 17 in Ramnagar block of Udhampur. “The patients were hospitalised with acute renal failure,” she said. “The common factor found in all the deaths was that they took Coldbest-PC.”
Dr Sharma said 17 children were affected, of whom nine died.
Around 5,500 units of Coldbest-PC Syrup are in the process of being recalled from at least eight states. Himachal Pradesh health safety and regulation authorities have suspended all types of production and manufacturing at Digital Vision’s unit at Kala Amb in Sirmaur district, where the drug was manufactured.
Drugs Controller, Jammu, has written to Drugs Controller, Himachal Pradesh that a team of doctors from PGIMER, Chandigarh visited Ramnagar last month to look into the probable cause of the deaths. “It has been given to understand…that Diethylene Glycol has been found in below pharmaceutical preparation…” the letter states.
The visiting team had experts from the departments of Paediatrics, Community Medicine and Virology. “We took samples and found that the syrup contained Diethylene Glycol,” a senior PGIMER doctor who was part of the visiting team said.
The letter, dated February 15, which has been also copied to all state and UT Drug Controllers across India, mentions that Diethylene Glycol has been found in “Coldbest PC syrup”
A Himachal official said: “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.”
HP Drugs Controller Navneet Marwaha said that besides HP and J&K, the syrup was sold to distributors and dealers in Uttarakhand, Haryana, Uttar Pradesh, Tiruchirappalli (Tamil Nadu), Shillong (Meghalaya), and Tripura. He said that barring the cases in Udhampur, no other case related to the cough syrup’s effects has been reported so far.
According to its website, Kala Amb-based Digital Vision was established in 2009 and offers a wide range of pharmaceuticals, medicines and protein powders — the company’s annual turnover is Rs 45 crore.
The cough syrup was marketed by the company’s sister concern in Ambala.
Konic Goyal, managing director of Digital Vision, said they “would not like to say anything” on the issue at the moment.
Sushil Yadav, general manager (marketing), said, “Production of the medicine has been stopped and we have provided all information to the state drugs control authorities.”
Uttarakhand, Drugs Controller Tajber Singh confirmed that sales and distribution of Coldbest-PC has been stopped in the state.
Haryana DGHS Dr Suraj Bhan Kamboj also said the state has banned the cough syrup and the department’s teams are “conducting raids at chemist shops to check availability”.
With inputs from Gagandeep Singh Dhillon in Shimla, Lalmani Verma in Dehradun and Sukhbir Siwach in Chandigarh
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