Vietnam and at least three Indian states had taken action against Maiden Pharmaceuticals for the poor quality of its drugs before the company’s cough and fever syrups allegedly caused the deaths of over 60 children in the African country of The Gambia last month.
The World Health Organization issued an alert on October 5 advising regulatory authorities and the public to stop consumption of four medical products made by Maiden Pharmaceuticals that were found to be substandard.
The WHO identified the products as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all manufactured by Maiden Pharmaceuticals, a company based in Haryana, India.
These drugs are said to have claimed the lives of 66 children in The Gambia.
The four products may have also been distributed to other countries or regions through informal markets, the WHO said.
Also read: Gambia cough syrup deaths: Samples sent for testing, results to come in two days
According to the global health body, the lab analysis of each of these products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
The @WHO issued a Medical Product Alert a couple of days back about DEG poisoning and death of over 60 children in Gambia. https://t.co/vPgriIIJuO
This thread documents the persistent, callous, unaccountable and nonchalant attitude of every #publichealth
— Dinesh S. Thakur (@d_s_thakur) October 6, 2022
A team of drug regulators from the Centre as well as the state have started investigating the matter and samples of the products have been taken for testing.
Controversy track record
Sonipat-based Maiden Pharmaceuticals has been embroiled in controversies over substandard drugs earlier too.
Also read: Urgent probe launched into Gambia cough syrup deaths as fatalities report awaited from WHO
According to a right to information petition filed by advocate Prashant Reddy in 2015, Maiden Pharmaceuticals was among 39 Indian drug companies that Vietnam blacklisted for violating drug quality standards in the country.
“In view of the fact that a large number of Indian companies have been listed as defaulters by the Vietnamese authorities, it is requested that necessary background checks on these companies may kindly be undertaken in India to see if there are complaints against them from other countries and steps be initiated to penalise them for bringing bad name to the Indian pharma industries abroad,” Deepak Mittal, consul general, wrote in a letter to the health secretary in 2013.
According to the government of India’s extended licensing, laboratory and legal node (XLN) database, the Gujarat and Kerala governments reported substandard batches of medicine produced by Maiden Pharmaceuticals at least six times in the past nine years.
Kerala government officials on the XLN database highlighted that the products made by Maiden Pharmaceuticals were found to be of substandard quality at least five times in 2021 and 2022. All batches of the drugs were manufactured in Haryana.
The Kerala health department officials drew samples of metformin, a drug used to treat type-2 diabetes, from a hospital in Palakkad in March 2022 and from a primary health centre in Ernakulam in September 2022.
Almost all the samples made by the company at its plant in Haryana reported on the XLN database were found to be either failing the dissolution test or not compliant with IP standards.
Banned in Bihar
The Bihar government blacklisted two pharmaceutical companies, including Maiden Pharmaceuticals, for supplying sub-standard drugs in 2011. According to the Bihar government’s official order, the company was found to be supplying ‘spurious’ and ‘substandard’ medicines in the state several times.
The Bihar government barred the company from taking part in the state’s tendering process for medicine supplies.
Two directors of Maiden Pharmaceutical – Naresh Kumar Goel and technical director MK Sharma – were accused of violating drug quality standards in 2018 in a case filed by the Drugs Inspector of the Central Drugs Standard Control Organisation in Ghaziabad.
Moneycontrol reached out to the directors and promoters of Maiden Pharmaceuticals for a detailed response on the allegations against the company. However, the company remained incommunicado on the matter. The story will be updated if the company responds. The company's office in Delhi's Pitampura has been closed since yesterday.
VG Somani, the Drug Controller General of India, did not respond to texts and calls from Moneycontrol seeking comment on the matter.