Teams of the Drug Controller General of India (DGCI) and Food and Drugs Administration (FDA) Haryana conducted investigations at Ambala and Kala Amb in Himachal Pradesh today following a complaint that a two-year-old girl had suffered renal failure after consuming a cough syrup containing diethylene glycol (DEG), a toxic chemical.
‘Documents, samples taken’
We have carried out joint investigations at Orison Pharmaceuticals and Shiva Medical Hall in Ambala and collected sale and purchase record of the drug. Teams have conducted detailed inspection and taken samples for testing. — Narender Ahooja, State Drug Controller, FDA Haryana
The syrup Cofset-AT had been manufactured by the pharmaceutical unit Digital Vision, based in Kala Amb, and was being marketed by Orison Pharmaceuticals of Ambala. In February, at least 12 children had lost their lives at Ramnagar in Udhampur district of Jammu and Kashmir after consuming Coldbest-PC syrup, manufactured by the same company.
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During testing, Coldbest-PC was found to be containing DEG, alleged to have caused the death of children by causing acute kidney injuries.
“We have carried out joint investigations at Orison Pharmaceuticals and Shiva Medical Hall in Ambala and collected sale and purchase record of the drug. Teams have conducted detailed inspection and taken samples for testing,” said Narinder Ahooja, State Drug Controller, Haryana.
He said the drug was found to have been sold to various dealers in Punjab, Rajasthan, Maharashtra, Tamil Nadu and West Bengal, as per sale record. “Letters have been sent to the Drug Controllers of these states, requesting them to stop consumption of the drug, collect samples and get these analysed for DEG,” said Ahooja.
He said investigations had been carried at another firm in Ambala that sold propylene glycol to the pharmaceutical company, allegedly laced with DEG. Similar investigations were carried at Digital Vision.
“Manufacturing is closed in the unit since March, when we suspended the licence after death of children in Ramnagar,” said Navneet Marwah, State Drug Controller, Baddi. The DGCI swung into action after receiving a complaint from the paediatrics department of the PGI, Chandigarh, that a two-year-old from Baddi was admitted on July 22 with renal failure.
“She had taken several drugs, which were analysed in the paediatrics biochemistry laboratory for the presence of DEG, qualitatively using gas chromatographic-mass spectrometry and confirmed by searching on the National Institute of Standards and Technology library,” read the PGI complaint.
Ahooja said legal action would be initiated against the firms and the manufacturing unit after receipt of the report on the samples. The Kala Amb unit and Ambala firm were facing criminal proceedings with regard to the adulterated Coldbest-PC, which had led to the Udhampur deaths.