In the last seven months, seven India-manufactured cough syrups have come under the scanner of the World Health Organization (WHO) because of being contaminated with diethylene glycol and ethylene glycol. As a result, the syrups have been classified as ‘substandard’. Medical products that fail to meet their quality standards or specifications are called substandard, and are said to be “out of specification”. Four contaminated cough syrups have been identified in Gambia, two in Uzbekistan, and one in the Marshall Islands and Micronesia.
On Tuesday, April 25, the WHO issued an alert against a batch of contaminated Guaifenesin Syrup TG Syrup that was manufactured in India, and exported to Marshall Islands and the Federal States of Micronesia, located in Oceania. The fact that the batch is substandard was reported to the WHO on April 6, 2023.
According to the WHO, Guaifenesin is an expectorant, which is a type of cough syrup used to help clear mucus or phlegm from the airway, and helps relieve congestion and the symptoms of cough in case one has a flu.
Quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia analysed samples of Guaifenesin from the Marshall Islands and found that the cough syrup contained “unacceptable amounts” of diethylene glycol and ethylene glycol as contaminants, which are toxic to humans when consumed and can prove fatal. The cough syrups have also been identified in Micronesia.
QP Pharmachem Ltd, located in Punjab, India, is the stated manufacturer of the contaminated cough syrups, and Trillium Pharma, located in Haryana, India, is the stated marketer of the product.
According to the WHO, neither the manufacturer nor the marketer have provided guarantees to the UN health agency on the safety and quality of the products.
The following is the complete list of India-manufactured cough syrups that have come under the WHO scanner for being contaminated.
Contaminated India-manufactured cough syrups and countries they were exported to
Table of Contents
The seven contaminated India-manufactured cough syrups against which the WHO has issued alerts are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, Magrip N Cold Syrup, AMBRONOL syrup, DOK-1 Max syrup, and Guaifenesin.
Contaminated cough syrups identified in Gambia
In October 2022, the WHO issued an alert against four substandard cough syrups: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. These were identified in Gambia, and reported to the WHO in September 2022.
Maiden Pharmaceuticals Limited, located in Haryana, India, manufactured these cough syrups. According to a WHO statement dated October 5, 2022, the stated manufacturer had not provided guarantees to the UN health agency on the safety and quality of the cough syrups.
Laboratory analysis revealed that the cough syrups were contaminated with unacceptable amounts of diethylene glycol and ethylene glycol.
Contaminated cough syrups identified in Gambia
In January 2023, the WHO issued an alert against two contaminated cough syrups identified in Uzbekistan: AMBRONOL syrup and DOK-1 Max syrup. These were reported to the WHO in December 2022.
Both the cough syrups were manufactured by Marion Biotech Limited located in Uttar Pradesh, India.
Laboratory analysis conducted by the national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan revealed that both the cough syrups contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, and hence, were out of specification.
Contaminated cough syrup identified in Marshall Islands and Micronesia
Contaminated Guaifenesin, which has been identified in the Marshall Islands and Micronesia, may have marketing authorisations in other countries in the Western Pacific region, and may have also been distributed through informal markets to other regions, according to the WHO.
How are diethylene glycol and ethylene glycol harmful?
Diethylene glycol and ethylene glycol are toxic to humans, especially children, when consumed, because they can result in serious injury and toxic effects such as abdominal pain, diarrhoea, headache, acute kidney injury, vomiting, inability to pass urine, and altered mental state. These symptoms may even lead to death.
These are the reasons why the WHO has issued alerts against the seven India-manufactured cough syrups.
Early in April this year, the Centers for Disease Control and Prevention said that a highly-drug resistant bacteria was found in eye drops exported to the US from India, and that the pathogen spread from person to person in a long-term care centre located in Connecticut, the US media reported.
However, sources from the Indian health ministry said that tests proved that samples of the eye drops were of ‘standard quality’, and were not contaminated with any bacteria, according to media reports.
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