Maiden Pharma blamed for 66 deaths in The Gambia is a repeat offender in India: Reports

Media reports said that several drugs manufactured by the company have been found below the stipulated norms.

In 2021 and 2022, the authorities in Kerala detected that the medicines produced by the company did not meet the standards at least five times, reported India Today.

In 2021, the authorities in Kerala found its type-2 diabetes drugs Metformin 1000 Tab and Metformin 500 mg Tab failed to pass the dissolution test, its medicine called Easiprin did not meet IP standard and flagged Maikal D Tab as 'poor quality'.

In 2020, Jammu & Kashmir administration said Cyproheptadine Hydrochloride Syrup IP was below the prescribed standards.

In 2013, the Gujarat government notified that Maiden Pharma's Macipro Tab had dissolution issues.

In 2008, Bihar found four batches of Erythromycin stearate 125 mg syrup to be of poor quality.

In 2011, Bihar authorities said the firm's Methylergometrine tabs were fake.

Also, Vietnam banned Maiden Pharmaceuticals in 2011 and 2013.

Maiden on its website says it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.

Maiden has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets.

Maiden on its website says it sells its products at home and exports to countries in Asia, Africa and Latin America, although Goyal said they were not currently selling in India.

India Today reported that the company has been misleading its consumers by saying that its drugs are certified by the World Health Organisation (WHO), and adhered to its good manufacturing practices (GMP) norms.

The four cough syrups -- Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup -- have been named by WHO in its medical alert.

"To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," the alert said.

Polypropylene glycol is added to cough syrups for solubility but in the syrups exported to the Gambia the manufacturer also added diethylene glycol (DEG) and ethylene glycol both considered as contaminants and toxic in the syrups.

Due to the presence of these in high amounts, the kids suffered kidney and liver malfunction and fatal injury.

In its statement WHO said that laboratory analysis of samples of the products "confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants," adding that those substances are toxic to humans and can be fatal.

WHO chief Tedros Adhanom Ghebreyesus told reporters that the four cold and cough syrups under probe may "have been potentially linked with acute kidney injuries and 66 deaths among children."

In 2018, an Indian government drug inspector prosecuted the company for quality violations under the Drugs & Cosmetics Act.

In 2014, Maiden was one of 39 companies blacklisted by Vietnam after it violated Quality Control Regulation and Drug Regulation.

Flaws in the system?

Despite the grave irregularities, Kerala, Gujarat and Bihar had only given a warning about the companies malpractices, according to India Today. It added that no stringent action was taken against the company and its violations were not brought under scanner for ensuring accountability.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) the exporters body under the Union Commerce Ministry has asked Maiden to furnish its licensees, list of importers, manufacturing licence copies and product permissions, the report said.