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As the World Health Organization (WHO) on Tuesday flagged 20 contaminated drugs as being linked to over 300 global deaths, seven of which are India-manufactured cough syrups, Union Health Minister Mansukh Mandaviya said there is zero tolerance on spurious medicines. He also said that an extensive risk-based analysis is being done to ensure the quality of medicines, and that India will “never bargain” on the quality of medicines, news agency PTI reported.
The health minister stated that India is always alert to ensure that no one dies of spurious drugs.
India will never bargain on quality of medicines; always alert to ensure no one dies of spurious drugs: Health Minister Mansukh Mandaviya
— Press Trust of India (@PTI_News) June 20, 2023
According to a report by The Indian Express, the 20 contaminated drugs flagged by the WHO were made by 15 different manufacturers in India and Indonesia, were syrups of cough medicines, paracetamol or vitamins.
The seven India-manufactured cough syrups flagged by the WHO
According to the WHO, the India-manufactured cough syrups were manufactured by three different companies: QP Pharmachem in Punjab, Maiden Pharmaceuticals in Haryana, and Marion Biotech in Uttar Pradesh.
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.
These seven India-manufactured cough syrups have been flagged 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.
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QP Pharmachem is the stated manufacturer of a batch of contaminated Guaifenesin Syrup TG Syrup which was 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.
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 manufactured these cough syrups.
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.
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.
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.
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