In the aftermath of the death of 66 children, allegedly from four cough-and-cold syrups shipped from India’s Maiden Pharmaceuticals, the Ivory Coast’s (Côte d’Ivoire) regulatory authority has stepped up its pharmacovigilance on commonly used syrups distributed in the country.
In an advisory to those who have marketing authorisations to sell “drinkable suspensions” in the region, the regulator AIRP sought products containing the active ingredients —“Paracetamol, Paracetamol/Phenylephrine Hydrochloride/Chlorpheniramine Maleate, Promethazine, Pheniramine Maleate/Ammonium Chloride/Menthol, Chlorpheniramine/Phenylephrine/Dextrometorphan maleate — to provide the Summaries of Product Characteristics (SPC) and the certificates of analysis of excipients with known effects, an industry source said. The details are to be submitted in 10 days, the regulator said in a communique dated October 11.
Citing the World Health Organization’s medical alert on the products following the Gambia incident, the AIRP said contamination of the suspensions were from two impurities, Ethylene Glycol and Diethylene Glycol. “At this stage of the investigations carried out by the AIRP, it should be emphasized that the said impurities themselves come from an excipient with notorious effects, Polyethylene Glycol (PEG), the monograph of which is described in the European Pharmacopoeia 8.0,” the regulator said.
Declaration on packaging
“As a reminder, the declaration of excipients with known effects is obligatory and must appear on the secondary packaging of medicinal products,” it added. Pharma industry insiders told businessline that more countries could issue similar guidelines, following the WHO alert. Following the Gambia incident, health authorities in different African countries especially, may want to review their stocks, local or imported, he said. Health authorities could ask for more documents, review certificates of analysis or may even pick up random samples for analysis in local laboratories or abroad. Pharmaceutical companies will not have a problem with this if theirs is a quality product, he said, especially since there was a bigger issue at stake here, involving the entire industry.
Health authorities in Liberia and Nigeria have also reportedly alerted their respective healthcare systems on the circulation of “substandard” syrups linked to the Gambia incident.
Within India too, States like Karnataka, Gujarat and Maharashtra are reported to have put syrups under the scanner, to ensure that its free of contaminants.