Nigeria’s National Agency for Food and Drug Administration Agency Control (NAFDAC) issued an alert on Thursday to the public on “substandard (contaminated) paediatric cough syrups circulating in Gambia".
Nigerian officials have widely circulated the alert to all health care providers, professional bodies and association in the medicine supply chain.
Separately, Liberian health minister Dr Wilhelmina S. Jallah issued a similar alert, saying her ministry has informed Liberian health teams to “further inform all health service delivery points (hospitals, health centres, clinics and community health teams)".
According to the World Health Organization (WHO), four cold and cough syrups made by Maiden Pharmaceuticals Ltd have been potentially linked with acute kidney injuries and the Gambian tragedy.
These syrups are: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The Nigerian agency said: “The stated manufacturer of the products is Maiden Pharmaceuticals Ltd (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products. All batches of these products listed above should be considered unsafe."
“The substandard products in this alert are unsafe and their use, in children and adults will result in serious injury or death. To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions. That is why we have heightened our vigilance," it added.
Uday Bhaskar, director general of Pharmaceuticals Export Promotion Council of India (Pharmexcil), the government agency for the promotion of pharma exports, expressed concern over the impact of the controversy on India’s pharma products’ image. Bhaskar said more countries could turn cautious about buying drugs from India.
“NAFDAC has issued an alert notice. Similarly, other countries may come up with this kind of notification and this will certainly create a lot of negativity about the Indian products. We (India), predominantly are generic players. May be bigger countries may not take such alert action but rest of the world will certainly think in this direction to withdraw Indian products," said Bhaskar.
India, whose reputation as “the pharmacy to the world" grew after the covid pandemic, is the largest provider of generic drugs globally.
The annual report for 2020-21 issued by the department of pharmaceuticals stated the Indian pharmaceutical industry is the world’s 3rd largest by volume and 14th largest in terms of value.
Indian pharma exports have grown 103% since 2013-14, from ₹90,415 crore in 2013-14 to ₹1.83 trillion in 2021-22. The exports achieved in 2021-22 are the pharma sector’s best performance to date.
Exports have grown by almost $10 billion in these eight years.
Taking serious note of the WHO alert, Indian authorities have stopped all production at Maiden Pharma and suspended its licence while investigations are on.
National Agency for Food and Drug Administration Agency Control directed “all importers, distributors, retailers and consumers and stakeholders to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the substandard cough syrups."
Queries emailed to the Nigerian high commission in Delhi did not elicit a response.
