Maiden Pharma has registration nixed over Gambia deaths

An Indian trade organisation has expelled drugmaker Maiden Pharmaceuticals for failing to provide information on cough syrup-related deaths among children in Gambia, now under investigation by the World Health Organisation (WHO).

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) said it was suspending the company's registration, which means it will no longer be eligible for incentives under India's market access initiative.

Pharmexcil is also considering making a recommendation to the Directorate General of Foreign Trade that Maiden's import/export license be cancelled, which would prevent it from doing any business overseas.

Last week, the WHO said it suspected four syrup-based medicines supplied by Maiden – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – were contaminated with "unacceptable amounts of diethylene glycol and ethylene glycol."

DEG and ethylene glycol can be found as contaminants of glycerin, an excipient widely used in oral liquid medicines, and companies using glycerin should carry out testing to ensure they are not present.

A letter from Gambia's Medicines Control Agency dated October 4 – addressed to Atlantic Pharmaceuticals Co Ltd – urged the company to finalise the recall of contaminated, substandard and falsified medicinal products that your company imported from Maiden Pharmaceuticals. It also required the company to put all Maiden Pharma stock into quarantine.

In a statement reported by Livemint.com, Maiden Pharma said: "We're not selling anything in domestic market. We've been obtaining raw materials from certified & reputed companies. CDSCO [Central Drugs Standard Control Organisation] officials have taken samples & we are awaiting the results."