Delhi-based Maiden Pharmaceuticals Ltd, which allegedly exported faulty cough syrup to the Gambia that led to the death of 66 children, has defaulted many times and had flouted rules before as well, a report in India Today stated. The pharma company, as per the report, has been flagged in many Indian states over the years for their medicines failing the quality and safety parameters. The World Health Organization (WHO) on Wednesday issued an alert against four cough syrups made by Maiden because they contained diethylene glycol and ethylene glycol. Both chemicals can be fatal for human bodies, as they can lead to severe liver and kidney damage.
The company has been reportedly under scanner for many years and has been questioned about its quality control standards in the past as many state governments, and authorities have flagged it.
Medicines under scanner
According to the report, the Bihar government had blacklisted Maiden Pharmaceuticals in 2011 for supplying substandard drugs. A drug named Methylergometrine tablets, which was taken from a hospital in Munger was found to be spurious. Another batch of drugs, Erythromycin Sterate Syrup 125mg/5 ml was found to be of unsatisfactory quality.
According to the extended licensing, Laboratory and Legal Node (XLN) database maintained by the Government of India, Kerala and Gujarat state governments have repeatedly issued warnings against the company’s illegal practices. A Kerala drug inspector even filed a case in 2005, after which the company was fined in 2017.
In another case, a central government drug inspector prosecuted the company in Sonipat for quality violations under the Drugs & Cosmetics Act. The company was charged for offences related to adulteration.
Company at a glance
As per Maiden Pharma’s website, the company has got WHO-GMP and ISO 9001-2000 Certifications. It has declared: “All products manufactured in our plants are equivalent to International Quality Standards & GMP norms are followed at each manufacturing step. Production is done under a highly controlled, fully air-conditioned in a hygienic environment.”
Besides medicines, the company also manufactures a range of products such as capsules, injectables, syrups, ointments, and tables across various therapeutic areas.
The company started its operations in November 1990 and claims to have a significant global presence in African countries, such as Algeria, Senegal, Nigeria, Cameroon, Kenya, and Tanzania.
As per its website, the company also exports its medicines to South East Asian countries, such as Laos, Vietnam, Thailand, Cambodia, the Philippines, Malaysia and Indonesia, among others. It also has footprints in South American countries such as Ecuador, Chile, Venezuela, Surinam, and Paraguay, among others. It is also present in Russia, Poland and Belarus.
The WHO warning has come as a shock for many as India produces a third of the world's medicines, mostly in the form of generic drugs. It is home to some of the fastest-growing pharmaceutical companies, and therefore, the country is known as the world's pharmacy.
Public health activist Dinesh Thakur, who is based in St Petersburg, has tweeted a long thread on the matter and has also raised questions about the drugmaker.
On Wednesday, WHO alerted that four “contaminated” and “substandard” cough syrups made by Maiden Pharmaceuticals Limited in Haryana, which have been largely used for paediatric use, are believed to contain chemicals that are toxic and potentially fatal. The four products named by WHO in its report are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
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