The Indian pharmaceutical company which caused the death of 66 children in the African country has already been a blacklisted firm in India as well as abroad, the international media reported.
On October 5, the World Health Organization (WHO) issued a global alert over four cough syrups manufactured by an Indian firm Maiden Pharmaceuticals warning that they could be linked to the deaths of 66 children in The Gambia.
The syrups have been “potentially linked with acute kidney injuries and 66 deaths among children”, the WHO said. The manufacturer Indian firm Maiden Pharmaceuticals had failed to provide guarantees about their safety.
WHO Director-General Tedros Adhanom Ghebreyesus confirmed the products they were investigating as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The UN agency added: “All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulation Authorities.”
The fake and unhealthy syrups contained contaminants and unhealthy amounts of glycol. These contaminants in the syrups were potentially fatal due to their adverse effects on health causing abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury leading to death.
The laboratory analysis of samples of each of the four products confirms that they contained unacceptable amounts of diethylene glycol and ethylene glycol.
According to the Indian media reports, the said three-decade-old pharmaceutical firm was found to be blacklisted for its products in the Indian states of Bihar, Jammu and Kashmir, Gujarat, etc
The All India Organisation of Chemists and Druggists has clarified that Maiden Pharmaceuticals are only licensed to export products, but not to sell them in India.
The WHO has also raised concerns that the controversial product could have been present in other parts of the world as well.
“The involvement of an international organization in the matter has raised several questions on how India-based Maiden Pharmaceuticals’ products were able to get certified to export medicines abroad. But it is not the first time when the company has been called out for its substandard products,” Mint, the Indian financial daily reported.
Public Health Activist, Dinesh S Thakur shared several government documents and legal orders that throw light upon the history of legal actions against Maiden Pharmaceuticals.
In the Indian state of Haryana, the company was prosecuted by a central government drug inspector for quality violations under the Drugs and Cosmetics Act in 2017.
The company was fined in Kerala in 2017 in a case filed by the Drugs Inspector office of the Drugs Controller.
In Gujarat, it was called out for supplying its substandard medicine products in Gujarat and Kerala.
In 2011, the Bihar government blacklisted Maiden Pharmaceuticals Limited for supplying spurious and substandard syrups and tablets.
Recently, the authorities concerned in Jammu and Kashmir blacklisted the said company’s Cyproheptadine Hydrochloride Syrup IP for its substandard quality. The syrup is used to treat allergies generally in kids.
Apart from Indian states, many of its products are blacklisted in some countries across the world. In 2014, the company faced actions from the Vietnam government for violating the Quality Control Regulations and Drug Regulations.
Despite being fined and even blacklisted by some Indian states and countries for its substandard products, Maiden Pharmaceuticals got certification by the Central Drugs Standard Control Organisation through the COPP process.
The COPP certificate is considered to be one of the most important certificates for pharmaceutical companies. However, the issuance of the COPP certificate to a company whose certain products are blacklisted by nearly three states raises questions about the process.