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Sunday, August 9, 2020

Drugs Controller tells Kala Amb company to recall cough syrup - The Tribune India

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Ambika Sharma

Tribune News Service

Solan, August 8

State Drugs Controller Navneet Marwaha has ordered to recall Cofset-AT, a cough syrup, made by Digital Vision, a pharmaceutical company at Kala Amb, after a two-year-old girl from Baddi suffered renal failure after its consumption.

About 2,997 bottles of the syrup, manufactured in September 2019, were sold to Ambala-based Shiva Medical Hall from where these were supplied to Bengaluru, Kolkata, Jagadhri, Jalgaon, Nabha and Sikar. Marwaha said they were closely monitoring the withdrawal of the syrup since August 5.

The working of Digital Vision has again come under the scanner.

The state authorities swung into action on August 5 after receiving a report from the Drug Controller General of India (DCGI) who had cited a complaint made by a professor of department of paediatrics, PGI, Chandigarh, indicating the presence of toxic chemical diethylene glycol (DEG) in the cough syrup.

The two-year-old girl from Baddi, suffering from renal failure, was reportedly admitted to the PGI on July 22.

The firm, whose Coldbest-PC cough syrup had claimed the lives of 12 infants in Udhampur district of Jammu and Kashmir in February this year, was facing closure after its manufacturing licence was withdrawn. Same adulterant, DEG, was found in Coldbest-PC syrup.

Navneet Marwaha said the additional drug controller had lifted records of a specific batch of Cofset-AT and samples from the unit. They had been sent for lab analysis and its reports were awaited.

Following a request by the state drug authorities, the DCGI also issued an alert for withdrawing this drug from the market on Thursday.

Since the company is already facing criminal charges, all aspects of sale and purchase of the excipients, used to manufacture the cold syrup, are being inquired by the police.

THE TRIGGER

The state authorities swung into action on August 5 after receiving a report from the Drug Controller General of India who had cited a complaint made by a professor of department of paediatrics, PGI, Chandigarh, indicating the presence of toxic chemical diethylene glycol in the cough syrup




August 09, 2020 at 08:42AM
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Drugs Controller tells Kala Amb company to recall cough syrup - The Tribune India

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