NEW DELHI: Authorities are investigating a complaint about a contaminated cough syrup that allegedly caused kidney failure in a two-year-old child, bringing manufacturer Digital Vision under scrutiny for an adulterated product for the second time this year.
The Drugs Controller General of India has ordered a nationwide halt of the cough syrup’s sales and distribution. The investigations started last week when the department of paediatrics at the Postgraduate Institute of Medical Education and Research Chandigarh complained that the child suffered acute renal failure after consuming the cough syrup.
The premier medical institute found that the child was given Cofset AT syrup, which allegedly contained diethylene glycol, a chemical that probably caused the renal failure. The cough syrup is being analysed for the presence of diethylene glycol, said Narender Ahooja, the Haryana state drug controller.
Cofset AT is manufactured by Digital Vision, a company based in Kala Amb in Himachal Pradesh. Konic Goyal, managing director of Digital Vision, told ET the report was not conclusive.
“The samples were taken from an open bottle. So, saying that it was contaminated is wrong,” Goyal said. “The drug department has picked up sealed bottles from the market and sent it for further investigation. Till then, we should wait. I also don’t know whether the product which was prescribed and given to the child was my company’s product. Till all these things become clear, we should wait.”
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Digital Vision came under scrutiny earlier this year, when nine children in Jammu & Kashmir died after allegedly consuming a cough syrup made by the company that was also said to contain diethylene glycol. The company said at the time that its product was not connected to the deaths. Diethylene glycol is commonly used as a solvent. It can be poisonous if consumed directly.
In the latest incident, PGIMER complained about the allegedly adulterated Cofset AT syrup to the Drugs Controller General of India. The DCGI asked state drug controllers to halt the sale and distribution of Cofset AT in the country.
“The firm involved in manufacturing and marketing Cofset AT is the same that was found involved in the manufacturing and marketing of Coldbest syrup in March,” Ahooja said. “Based on the Regional Drug Testing Laboratory report, it was found that Coldbest was contaminated with diethylene glycol, which allegedly led to the death of nine children in Udhampur area of Jammu & Kashmir. Following this, several FIRs have been filed against the firm in Jammu & Kashmir, Himachal Pradesh, Haryana and Punjab.”
A probe has been conducted at the company’s facilities at Kala Amb in Himachal Pradesh. A joint investigation team of officers from Haryana and two officers from the Central Drugs Standard Control Organisation has collected sale purchase records of Cofset AT in Ambala and samples of the syrup for analysis.
“The joint investigation team has asked the police to register FIRs or add fresh offences in the earlier FIRs against the violators. Action has also been initiated to prosecute the firm,” Ahooja said. Letters have been sent to drug controllers in Punjab, Rajasthan, Maharashtra, Tamil Nadu and West Bengal, with the sales records showing that the drug in question was sold to companies in these states.
In the earlier case, 17 children had been affected and nine died between December-end 2019 and January 17 in Ramnagar block of Udhampur. The children were hospitalised with acute kidney failure.
“The common factor found among all these cases was that they took Coldbest,” said a government official. Goyal had told ET earlier that his company’s cough syrup had nothing to do with the deaths of the children in Jammu & Kashmir.
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