Cough syrup Coldbest-PC samples found substandard

Ambika Sharma
Tribune News Service
Solan, July 29

Two batches of the Coldbest-PC syrup, made by the Kala Amb-based Digital Vision pharmaceutical company, were declared substandard by the Central Drug Laboratory, Kolkata, in a drug alert issued by the Central Drug Standard Control Organisation yesterday.

The syrup had claimed the lives of 12 infants in Udhampur district of Jammu and Kashmir in February 2020 after an adulterant, DEG, was found in its samples. Its manufacturing was put on hold by the local licensing authorities last year.

The two batches, declared substandard now, were manufactured in January 2020 and September 2019 and its DEG content was 1.27 per cent w/w (weight of solute by weight of solution) and 7.71 per cent w/w. The Drug Control Department of Andhra Pradesh got these samples tested.

The working of the company has again come under scanner as it had challenged some laboratory reports after the death of the infants. The DEG is a solvent used to prepare cough syrup.

Assistant Drug Controller Garima Sharma said the permission to manufacture the cough syrup was cancelled last year after the case involving infants’ deaths had come to light. All product permissions involving the use of DEG had also been withdrawn from the manufacturing company. The cough syrup samples seized by the Andhra Pradesh authorities pertain to the batches manufactured earlier.

The Drug Controller General of India (DCGI) had cited a complaint made by a professor of the Department of Paediatrics, PGI, Chandigarh, where he had indicated the presence of toxic chemical DEG in this cough syrup. A two-year-old girl from Baddi was admitted in the PGI in July last year for treatment.

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