Ambika Sharma
Tribune News Service
Solan, August 8
State Drugs Controller Navneet Marwaha has ordered recall of Cofset-AT, a cough syrup manufactured by Kala Amb-based Digital Vision pharma company, after its consumption by a two-year-old girl from Baddi caused renal failure.
Nearly 3,000 bottles of batch number DL 5200, D/M 09/19,D/E 9/21, manufactured in September 2019, were sold to Ambala-based Shiva Medical Hall by the said company, from where they were distributed to Bengaluru, Kolkata, Jagadhari, Jalgaon, Nabha and Sikar.
Marwaha said they were closely monitoring the withdrawal of this cold syrup since August 5.
The working of the Kala Amb-based pharmaceutical firm, Digital Vision, in Sirmaur district has once again come under the scanner with the emergence of this case.
Reportedly, the state authorities had swung into action on August 5 after receiving a report from the Drug Controller General of India which had cited a complaint made by a professor of Department of Paediatrics, Advanced Paediatrics Centre, PGI Chandigarh, indicating the presence of toxic chemical diethylene glycol (DEG) in the cough syrup.
A two-year-old girl suffering from renal failure from Baddi was reportedly admitted at PGI Chandigarh 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district of Jammu and Kashmir in February this year, was already facing closure after its manufacturing licence was withdrawn. Same adulterant DEG was found in the Coldbest-PC syrup.
Marwaha said the additional drug controller Sirmaur has already lifted records pertaining to a specific batch of Cofset-AT manufactured in September 2019 along with its samples from the unit premises. They have 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 yesterday.
Since the firm was already facing criminal charges after the Coldbest-PC case, all aspects of sale and purchase of the excipients used to manufacture the cold syrup were already being inquired into by the police. The quality control wing it seems has failed to test the excipient at the pre-manufacturing stage as well as the cough syrup after it was manufactured.
August 08, 2020 at 08:24PM
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HP drugs controller orders recall of cough syrup after 2-yr-old girl suffers renal failure - The Tribune India
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