On October 5, the World Health Organization (WHO) declared that cough syrups made in India may have contributed to the deaths of more than 60 children in The Gambia, a country in West Africa. The company behind these syrups, Maiden Pharmaceuticals, is situated in Haryana’s Sonerpat and has a checkered past.
Given that India has long been known as the “pharmacy to the world,” the announcement was more than simply an accusation; it was a damning assertion.
The Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup brands of cough syrup were all found to contain “unacceptable” levels of the hazardous chemicals Diethylene Glycol and Ethylene Glycol, which can cause severe kidney impairment.
As the news spread like wildfire, I also began networking with various Ministry of Health and Family Welfare and Central Drugs Standard Control Organization (CDSCO) officials. The general impression was that WHO was in “revenge mode” against India, even though they all provided me tidbits of information about what respective departments are trying to accomplish.
An ex-drug regulator who has long worked with Maiden Pharma’s compliance problems claimed “The entire Gambian media was blaming E Coli for the deaths and WHO suddenly chose Maiden. Gambian media was not crying foul play by the Indian manufacturer but WHO did. I trust no one – neither WHO nor Maiden.”
After experiencing the biggest flash floods, he claimed that The Gambia put the fatality down to an E Coli epidemic. In a news conference, even the minister of the Gambia stated that the death pattern is consistent with prior years.
In conclusion, there are two possibilities that explain the entire scenario. The first is that India is being misrepresented by WHO. Second, India must strengthen its compliance with Good Manufacturing Practices (GMP) and close long-standing regulatory deficiencies.
First, the regulators discovered that the invoices for propylene glycol, a component used in cough syrups that were allegedly contaminated with lethal amounts of hazardous Diethylene Glycol and Ethylene Glycol, were missing batch numbers, expiry and manufacturing dates, and the name of the manufacturer.
They also discovered that Maiden Pharma had not tested the purity of propylene glycol for the presence of diethylene glycol and ethylene glycol. How is it possible for a company that produces medications for children to forego such important tests?
Third, the company didn’t provide the log books of the tools and equipment used in the production and testing of the questioned medications.
Diethylene Glycol and Ethylene Glycol-related controversies have already occurred in India (DEG). 12 infants died in 2020 from DEG-laced cough syrups produced by the Himachal Pradesh-based pharmaceutical company Digital Vision.
As this was a domestic problem, there was no involvement of WHO or any other health regulator, hence there was no one to assign blame to or fabricate conspiracies against.