The World Health Organization (WHO) issued a warning on October 5, raising concerns about deaths in a West African country possibly linked to four cough syrups manufactured by Maiden Pharmaceuticals Limited in Sonepat, Haryana.
Responding to these alarming findings, India's drug regulator issued a crucial order on December 18, requiring drugmakers to prominently label their products with a clear warning: "The FDC should not be used in children below 4 years of age." This directive aims to address concerns related to the promotion of an unapproved anti-cold drug formulation in infants, initiating a vital discussion that led to this stringent recommendation.
The banned fixed-drug combination (FDC) contains chlorpheniramine maleate and phenylephrine, commonly used to treat common cold symptoms. Recognizing potential risks, the WHO advises against using over-the-counter cough syrups or medicines for children under five.
This ban follows a series of child deaths since 2019, with authorities linking them to toxic cough syrups made in India. Reports indicate at least 141 deaths in Gambia, Uzbekistan, and Cameroon, with 12 children in India losing their lives in 2019. The WHO alerted the Drugs Controller General of India in September, suspecting contamination with Diethylene Glycol/Ethylene Glycol in some samples.
The four implicated products are Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, Magrip N Cold Syrup, and Promethazine Oral Solution.
The incidents have raised concerns about the quality of pharmaceutical exports from India, known as the "world's pharmacy." The regulatory order underscores the gravity of the situation, emphasizing the need for stringent measures to ensure pharmaceutical product safety.
In response to the ban, drugmakers are obliged to comply with the regulatory directive, prominently displaying the warning on their products. This proactive step is crucial for maintaining public trust and safeguarding the health of vulnerable populations.
India has taken decisive measures, introducing mandatory testing for cough syrup exports since June and intensifying scrutiny of drugmakers. While some manufacturers deny wrongdoing, these regulatory measures reinforce the commitment to safety and quality in pharmaceutical production.