(MENAFN- Live Mint)

Two Indian drugmakers have come under regulatory scrutiny after cough syrups made by them were linked to a number of child deaths in Madhya Pradesh and Rajasthan. The central drug regulator has swung into action after finding a toxic contaminant in one of the cough syrups tested. Some states have banned the sale of these drugs.

This isn't the first time cough syrups made in India have been linked to fatalities in children. In recent years, India-made cough syrups have come under global scrutiny-they have been linked to child deaths in Uzbekistan, Iraq and The Gambia, revealing regulatory gaps in India's pharma industry.

Mint unpacks why Indian cough syrups have time and again been linked to deaths in children.

What caused the deaths?

The recent deaths of 11 children in Madhya Pradesh and Rajasthan, all under the age of five, are suspected to have been caused by contaminated cough syrup, prompting states to swing into action and a central probe.

India's health ministry said in a statement that test samples of Coldrif cough syrup, made by Sresan Pharmaceuticals in Tamil Nadu, contained high levels of diethylene glycol. DEG is an industrial chemical used in antifreeze and brake fluids and can cause kidney failure and death when ingested even in small amounts.

The Union government is inspecting the manufacturing sites of all the cough syrups that were sampled, spread across six states.

Who are behind these cough syrups?

Sresan Pharma's Coldrif is at the centre of the controversy. Samples of the syrup tested by Tamil Nadu authorities revealed that it contained 48.6% diethylene glycol.

Jaipur-based Kaysons Pharma has also come under scrutiny over its cough syrup possibly leading to child deaths in Rajasthan, although the state government has not yet confirmed the link.

Also Read | Health ministry probe finds no contamination in MP cough syrups, advisory issue

What happened following the deaths?

Coldrif sales have been banned in Madhya Pradesh, Tamil Nadu, and Kerala with immediate effect. Madhya Pradesh has also banned all other products manufactured by Sresan Pharmaceuticals, and registered a case against the drugmaker. A doctor who prescribed the cough syrup to children has been arrested.

Rajasthan has suspended sales of 19 medicines from Kaysons Pharma following reports of adverse effects linked to its cough syrups. Two health officials and the state drug controller have been suspended for negligence.

The director general of health services in the Union ministry of health and family welfare has issued a nationwide advisory on judicious use of cough syrups in children, advising that these medicines should not be prescribed to children under the age of two.

Is cough syrup unsafe for children?

The US Food and Drug Administration doesn't recommend over-the-counter medicines for cold and cough symptoms for children under the age of two because they could cause serious and potentially life-threatening side effects, the regulator's website states. Over-the-counter medicines can be bought without a doctor's prescription.“Numerous OTC cough and cold products contain many ingredients that can lead to accidental overdosing," the US FDA says.

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Strict dosing is required for OTC drugs, according to medical experts. Dextromethorphan hydrobromide, a common ingredient in cough syrup, can cause side effects such as sleepiness, fast heart rate, seizures, and liver damage in children, although it is generally considered safe for adults.

The director general of health services in a recent advisory said most acute cough illnesses in children are“self-limiting" and often resolve without pharmacological intervention.

Where else have cough syrup-related deaths been reported?

In recent years, India-made cough syrups have been linked to child deaths in Jammu as well as in The Gambia and Uzbekistan. Earlier, Chennai, Mumbai, Bihar, and Gurugram saw mass child deaths due to contaminated cough syrup sales. Failure to regulate manufacturers who fail to test raw materials or final formulations is the reason behind this recurrence, say experts.

India's fragmented public health regulatory system is a key issue. While drug regulation in the country is primarily governed by the Drugs and Cosmetics Act of 1940, public health is a state subject. Therefore, health regulations are divided between the central regulatory authority and state-level drug regulatory authorities, making it difficult to enforce laws against poor manufacturing processes.

Also Read | India to rewrite drug-quality rulebook to match US, EU, Japan standard

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