New Delhi: After the Uzbekistan cough syrup row, the World Health Organisation (WHO), on Tuesday, issued a product alert over yet another India-made syrup after finding contaminated cough syrup in Marshal Islands and Micronesia. The product alert has been raised over the manufacturing and marketing of contaminated syrup by Punjab-based QP Pharmachem Ltd and Trillium Pharma.
The WHO said that samples of the syrup from a batch in the Marshall Islands and Micronesia were found to contain “unacceptable amounts of diethylene glycol and ethylene glycol”, chemicals toxic to humans that can prove fatal when consumed.
The UN Health Body issued a warning stating that the syrup is unsafe for use, especially in children, due to the presence of high level of contaminants. “Its consumption can cause severe injury and even death.”
As per the medical alert, syrup’s stated manufacturer is QP PharmaChem Ltd in Punjab and its stated marketer is Trillium Pharma in Haryana. WHO said neither the stated manufacturer nor the marketer has provided guarantees to it on the safety and quality of these products.
Quality control laboratories of the Therapeutics Goods Administration, Australia’s drug regulatory authority analysed the samples of the syrup. The product contains a compound called guaifenesin — an expectorant used to relieve chest congestion and cough.
What Are The Risks?
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal, the WHO said. “The substandard product referenced in this Alert is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”
WHO said the product referenced in this Alert 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.
Duplication To Defame India?
Sudhir Pathak, Managing Director, QP Pharma Chem Limited said Food And Drug Administration of Punjab doubts 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. 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..
This is the fourth instance since October when foreign health authorities have raised quality concerns about drugs from India. Authorities in the Gambia and Uzbekistan had linked child deaths last year to Indian-made cough syrups contaminated with the same compounds found in the syrup from the Marshall Islands.