New Delhi: The Himachal Pradesh-based drug maker Digital Vision is once again under the scanner, this time for allegedly selling a contaminated cough syrup that led to kidney failure in a two-year-old child, ThePrint learnt.
Its cough syrup brand, Cofset AT, is alleged to be contaminated with Diethylene Glycol (DEG), a chemical known for causing kidney failure and neurological toxicity, according to the US Food and Drug Administration (FDA).
India’s apex regulator, the Central Drugs Standard Control Organisation (CDSCO), has asked the state drug regulators to check the samples of the drug across the country and stop its sale.
CDSCO has also written to the Himachal Pradesh’s drug controller to “alert its field staff for necessary actions” and “to look for the alleged drug in their region”.
The move was triggered after CDSCO received a complaint from PGI Chandigarh where a two-year-old child suffered renal (kidney) failure due to the alleged use of the drug. Kidney failure is otherwise not commonly seen among children.
“In the view of the seriousness of the issue, the office has directed the drug inspectors of this office to look for the alleged drug in the region. You are also requested to alert your field staff for necessary action in the matter,” Arvind Kukrety, Deputy Drug Controller India, CDSCO, wrote in the letter to the HP’s drug controller.
“It is requested that the current status of the case and manufacturing status of Digital Vision may also be communicated to this office and to associate this office in investigation of the said manufacturer…,” said the letter dated 5 August, a copy of which was accessed by ThePrint.
The letter attached the complaint by PGI.
The Himachal government had in February booked the same company, Digital Vision, for selling another “contaminated cough syrup” — ColdBest-PC cough syrup — which allegedly led to the death of nine infants in Jammu & Kashmir and one in Haryana.
Complaint against Digital Vision
The complaint, dated 4 August, was sent to CDSCO’s Chandigarh branch by Dr Bhavneet Bharti of the Department of Paediatrics at Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh.
The email titled “Regarding child with renal failure at PGI, Chandigarh and contamination of Syrup Cofset- AT with DEG”, said a two-year-old child had on 22 July “consumed number of drugs which were analysed in our pediatric biochemistry lab for the presence of DEG…”
“In our preliminary assessment, one of the drugs consumed by the child named Cofset AT was detected to have DEG. You may recall that we have earlier also reported the presence of DEG in ColdBest-PC…,” the email read.
State drug controllers spring into action
States have started collecting samples and collating data on supply of the drugs from the wholesalers.
Haryana State Drug Controller Narender Ahooja told ThePrint that “the investigation team has collated the sample of this alleged drug and also taken sales data from the company’s lead wholesaler in the state”.
“Out of the total 2,992 bottles of the syrup received, 2,972 bottles have been sold so far. The stock has been sent to Kolkata, Bangalore, Kala-Amb, Sikar, Jalgaon among other places, therefore concerned state FDAs have been informed to stop consumption of this drug in their states,” Ahooja said.
Similar steps have been taken in other states.
“We have started receiving the data from state drug controllers on the recent sale of the drug. They all are collaborating with each other and conducting a joint investigation on the matter,” said a senior official from CDSCO.
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