Maiden pharma cough syrupsImage source, WHO
Image caption, The WHO has advised regulators to stop the sale of the four cough syrups

Concerns about effective regulation of the manufacture and trade of medicines are behind the deaths of nearly 70 children in The Gambia.

The World Health Organization issued a global alert last week over four brands of cough syrups, saying they could be linked to acute kidney damage.

The WHO says that the syrups contain unacceptable amounts of diethylene glycol and ethylene glycol.

According to the authorities in India and the manufacturer, the cough syrups have been exported to The Gambia.

Medicine being poured into a spoonImage source, Getty Images
Image caption, Supervision over the manufacture of medicines in India has been called into question

Some of its products have failed to meet quality control standards.

The company is shown in official records there.

Vietnam blacklists nearly 40 Indian pharmaceutical companies for exporting substandard products.

The company, based in Haryana state, said it was shocked by the deaths in The Gambia and had been following the protocols of the health authorities.

We're not selling anything in domestic market. We've been obtaining raw materials from certified & reputed companies. CDSCO officials have taken samples & we are awaiting the results: Maiden Pharmaceuticals Ltd on deaths of 66 children in Gambia allegedly due to their cough syrup pic.twitter.com/HFEJbx1POx

— ANI (@ANI) October 8, 2022
The BBC is not responsible for the content of external sites.View original tweet on Twitter

Drugs regulators were still testing, it said.

If something was found to be wrong, action would be taken, according to the minister.

Most of the world's medicines are produced in India.

It is a major supplier to a number of countries.

Indian pharmaceutical plantImage source, Getty Images
Image caption, India is a major global pharmaceutical manufacturer

The plants are required to follow strict quality control standards.

Quality-control problems at some plants have led to criticism and even bans by overseas regulators.

There is a fine of $242 and a prison sentence of up to two years for violating quality standards in India, according to a public-health activist.

This is the norm of punishment meted out unless there is a direct link between a drug and a death.

India is not included in the WHO standards for national bodies that regulate medicine and vaccines.

Leena Menghaney, from medical charity Médecins Sans Frontires, says that this may result in inconsistent regulatory control.

The Health Ministry in Delhi has launched an investigation, but says it's usual for the importer to test imported products to make sure they're good.

Markieu Janneh Kaira is the executive director of the Medicine Control Agency.

The agency did not respond to the request for clarification by the news organization.

The President of The Gambia, Adama Barrow, said he would get to the bottom of the causes of the tragedy and that a quality-control national laboratory for drugs and food safety would be created.

There would be safeguards to eliminate the import of sub-standard drugs in the country.

Low-income countries should be helped by countries with enough testing capacity.

This isn't about the countries responsibility only.

The National Agency for Food and Drug Administration and Control in Nigeria wants all imported pharmaceuticals to be cleared by approved agents before they leave India.

Reality Check branding
  • The Gambia
  • Pharmaceutical industry
  • India
  • Reality Check