Why Has India Banned Cough Syrups For Kids Aged Under Four?

In a significant move responding to global concerns over the alarming link between cough syrups and child fatalities, India's drugs regulator has imposed a ban on the use of an anti-cold drug combination for children aged below four. This decisive action follows at least 141 deaths globally, raising serious questions about the safety of such medications for the vulnerable age group.

The World Health Organization (WHO) issued a warning on Wednesday, October 5, that the deaths in the West African country may have been caused by four "contaminated" and "substandard" cough syrups that were allegedly manufactured by Maiden Pharmaceuticals Limited, a company situated in Sonepat, Haryana.

The Regulatory Response

India's drug regulator, in a recent order issued on Dec. 18 and made public on Wednesday, mandates drugmakers to label their products with a clear warning: "The FDC should not be used in children below 4 years of age." This stern directive aims to address concerns surrounding the promotion of an unapproved anti-cold drug formulation in infants, sparking a crucial discussion that led to this stringent recommendation.

The fixed-drug combination (FDC) in question comprises chlorpheniramine maleate and phenylephrine, commonly found in syrups or tablets used to treat common cold symptoms. The World Health Organization, recognizing the potential risks, does not recommend the use of over-the-counter cough syrups or medicines for the treatment of coughs and cold symptoms in children younger than five years of age.

Global Impact and Quality Concerns

The ban comes in the wake of a series of child deaths since 2019, with authorities linking these tragedies to toxic cough syrups made in India. Notably, at least 141 deaths  have been reported in Gambia, Uzbekistan, and Cameroon since the middle of last year. Within India, 12 children lost their lives, and four others suffered severe disabilities in 2019 after consuming domestically-made cough syrups.

The WHO reportedly told the Drugs Controller General of India on September 29 that it was advising and providing technical help to The Gambia. It stated that the use of medications that might have been contaminated with Diethylene Glycol/Ethylene Glycol was suspected to be a significant contributing cause to the deaths and that its presence had been confirmed in some of the samples it tested. Four of the 23 samples tested, according to the preliminary data sent to WHO were found to contain the required amounts of diethylene glycol and ethylene glycol. According to the WHO alert, the four products are Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, Magrip N Cold Syrup, and Promethazine Oral Solution

These incidents have cast a shadow over the quality of pharmaceutical exports from India, often referred to as the "world's pharmacy" due to its role in supplying life-saving drugs at affordable prices. The regulatory order highlights the gravity of the situation, emphasizing the need for heightened scrutiny and stringent measures to ensure the safety of pharmaceutical products.

Industry Response and Mandatory Testing

In response to the ban, drugmakers are compelled to adhere to the regulatory directive, prominently displaying the warning on their products. Pharmaceutical companies must comply with these guidelines to maintain public trust and safeguard the health of vulnerable populations.

India has taken proactive steps to address the issue, introducing mandatory testing for cough syrup exports since June and intensifying scrutiny of drugmakers. While some manufacturers whose cough syrups were linked to child deaths have denied any wrongdoing, the regulatory measures aim to reinforce the commitment to safety and quality in pharmaceutical production.

This bold move not only safeguards the health of young children in India but also contributes to elevating the standards of pharmaceutical exports from the country.

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