More than 70 children in the African country of Gambia have died, and the World Health Organisation (WHO) has linked their deaths to four cough syrups made by Maiden Pharma Company. This article addresses the possible effects and India's response to them.

The listed manufacturer of the product is Maiden Pharmaceuticals Limited (Haryana, India). Four subpar items that were found in The Gambia and submitted to WHO in September 2022 are referred to as WHO Medical Product Alerts. Medical items that are "out of specification" are those that do not fulfil the required quality standards or specifications. At the present, investigations are also being carried out by India and The Gambia.

• Promethazine Oral Solution
• Kofexmalin Baby Cough Syrup
• Makoff Baby Cough Syrup
• And Magrip N Cold Syrup 

The Haryana-based company's production operations have been put on hold, according to regulators, who discovered it had violated a number of safety regulations.

These four items have so far only been found in The Gambia, although they may have travelled via unofficial marketplaces to other nations or regions.

Potential consequences

1. When taken by humans, diethylene glycol and ethylene glycol are fatally poisonous.
2. Toxic effects can include abdominal pain, nausea, vomiting, diarrhoea, the inability to pass urine, headaches, altered mental status, and severe renal injury that may be fatal.
3. All batches of these items should be viewed as unsafe until they can be inspected by the appropriate National Regulatory Authorities.
4. The dangerous goods mentioned in this warning might cause significant harm or even death if used, particularly by youngsters.
5. The 66 child fatalities in West Africa might seriously damage India's reputation as the "pharmacy of the world."
6. Medical officials in The Gambia, a major tourist destination, discovered an upsurge in instances of acute renal damage among children under the age of five in late July, prompting the WHO's involvement.
7. Since then, the government of The Gambia has prohibited the use of all paracetamol syrups and advised citizens to take pills instead.

India's reaction

The World Health Organisation said that India is assessing samples of cough syrups made by local company Maiden Pharmaceuticals for export after the deaths of scores of children in the Gambia were related to its products.

A four-person panel was established by the Union Ministry of Health and Family Welfare on wednesday to review reports it had requested from the World Health Organisation in order to determine whether the deaths were related to cough syrups produced by Maiden Pharmaceuticals, a company based in Sonepat.

After four inspections by drug control inspectors found breaches of good manufacturing standards and shortcomings in paperwork, the firm halted production. It was discovered throughout the examination that the company had been producing and testing pharmaceuticals without following the different good manufacturing procedures and in direct violation of them.

As required by the Drugs and Cosmetics Act, the company has not kept and submitted comprehensive records of manufacture and testing. All of the company's manufacturing activities have been suspended with immediate effect pending further orders in the public interest due to the seriousness of the violations found during the investigation and the potential risk they pose to the quality, safety, and effectiveness of the drugs being produced. This does not preclude further legal action.

Disclaimer- The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of M3 India.
About the author of this article: Dr Monish Raut is a practising super specialist from New Delhi.