Maker Of Cough Syrup Under WHO Probe For Child Deaths Was Reported In India For Substandard Products

Haryana-based Maiden Pharmaceutical Limited, which is now under a probe by the World Health Organization (WHO) after four cough syrups manufactured by it have been blamed for at least 66 child deaths in The Gambia has reported for substandard products in India also.

According to the data available on the FDCA website, drugs manufactured by Maiden has been reported as substandard six times since 2015.

Company is a repeat offender. Cited by Kerala and Gujarat for making substandard/adulterated drug no less than 6 times.

But yeah, who cares? As usual, CDSCO will blame the Haryana State DRA and the the state will sit on it.

Pharmacy to the developing world ? pic.twitter.com/8CCrEW5PSk

¡ª Dinesh S. Thakur (@d_s_thakur) October 5, 2022

Five of the reported samples were from Kerala, while one was from Gujarat.

WHO alert on four cough syrups

On Wednesday the WHO had issued a medical product alert on four cough and cold syrups made by Maiden Pharmaceuticals and said that these "substandard" products are unsafe, especially in children, and may result in serious injury or death.

"The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is conducting further investigation with the company and regulatory authorities in India"-@DrTedros https://t.co/PceTWc836t

¡ª World Health Organization (WHO) (@WHO) October 5, 2022

The four products red-flagged by the WHO are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

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"Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants," the WHO said in its alert.

"While the contaminated products have so far only been detected in The #Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients"-@DrTedros https://t.co/ENnBpIBVpF

¡ª World Health Organization (WHO) (@WHO) October 5, 2022

Citing risks, it said that Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. "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," it noted.

All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities, WHO warned and added that the substandard products referenced in the alert are unsafe and their use, especially in children, may result in serious injury or death.

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Probe launched in India

Following the WHO alert, the Central Drugs Standard Control Organisation (CDSCO) has reportedly launched a probe.

"Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana," a source told PTI.

"While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," the sources said.

According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.

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Cough syrup-related death in Kashmir

This is not the first time cough syrups manufactured by Indian Pharma companies have been linked to child deaths.

In 2020, some 12 infants had died in Jammu and Kashmir¡¯s Udhampur after consuming adulterated Coldbest-PC cough syrup by Himachl-based Digital Vision Pharma Pvt Ltd.

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