WHO alert: In yet another embarrassment for the Indian pharma industry, the World Health Organization (WHO), on Tuesday, flagged the issue of contaminated cough syrup made by an Indian company.
According to the latest warning issued by the WHO, contaminated syrups were found in the Marshall Islands and Micronesia-- a country spread across the western Pacific Ocean comprising more than 600 islands. The substandard syrup – Guaifenesin Syrup TG Syrup – was reported to WHO on April 6.
Notably, Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough.
The health agency said that the samples of the syrup from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia. The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Manufacturer is an Indian pharma company
The stated manufacturer of the affected product is QP Pharmachem Ltd which is headquartered in Punjab.
Besides, the stated marketer of the product is Trillium Pharma which is based in Haryana. "To date, neither the stated manufacturer nor the marketer has provided guarantees to WHO on the safety and quality of these products," read the statement released by the UN health agency.
Further, it claimed that the product may have marketing authorizations in other countries in the Western Pacific region. It may have also been distributed, through informal markets, to other countries or regions, it warned.
It is worth mentioning the latest alert came nearly six months after more than 300 children, majorly aged under 5, died of acute kidney injury in Gambia, Indonesia and Uzbekistan. The WHO linked the death with contaminated medicines manufactured in India.
Risks
According to WHO, Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The substandard product referenced in the latest alert is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
Company says conspiracy to defame Indian govt
Reacting to the latest alert, Managing Director of QP Pharma Chem Limited, Sudhir Pathak said that someone had duplicated the syrup to defame the Government of India.
"Food And Drug Administration (FDA) of Punjab doubt that someone has duplicated the product (cough syrup) sent to Cambodia and then sold it in the Marshall Islands and Micronesia to defame the Government of India," Sudhir Pathak, MD of the firm based in Dera Bassi, Punjab told news agency ANI.
Pathak said that the FDA department had taken samples of cough syrup which were sent to Cambodia for testing. "The FDA department has taken samples of cough syrup sent to Cambodia for testing. A total of 18,336 bottles of cough syrup were sent," he added.
Also Read: Child deaths in Gambia linked to consumption of made-in-India cough syrups: US report
