Cough syrups that killed Gambian kids not sold in India but spark questions on quality check

The cough syrups by an Indian pharmaceutical company, linked with deaths of 66 kids in Gambia, are not being sold in the market locally but was being exported, industry and government sources told Moneycontrol.

A preliminary investigation by the World Health Organization, as announced by the agency on October 5, has shown that four cough syrups, manufactured by New Delhi based Maiden Pharmaceuticals had caused deaths in at least 66 kids over the last few weeks in Gambia.

“As per our information, the drugs were not being sold anywhere in India and were being sent outside,” said Rajeev Singhal of the All India Organisation of Chemists and Druggists.

This was also confirmed by the officials in the Union health ministry and Viranchi Shah, president of the Indian Drug Manufacturers’ Association, who said that Maiden Pharma is not its member.

The drugs that have come under scanner for containing fatal impurities are Promethazine Oral Solution, Magrip N Cold Syrup, Kofexmalin Baby Cough Syrup, and Makoff Baby Cough Syrup.

An official attached with Central Drugs Standard Control Organisation said that the drugmaker had received licence from the state drug administrator for manufacturing the drugs in question.

He added that the drugs so far had been exported only to Gambia in West Africa.

“In such cases, the importing country is required to test products on quality parameters before releasing the batches in market for sale,” the official added.

Toxins to save cost?

The WHO has said that the chemicals in the cough and cold syrups that have caused deaths in kids aged under five years of age included Diethylene glycol (DEG) and ethylene glycol.

Also read I Urgent probe launched into Gambia cough syrup deaths as fatalities report awaited from WHO

These chemicals are toxic to humans when consumed and the effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

Industry sources said that glycerol is often used as a sweetening and thickening agent in cough syrups but is replaced by alternatives such as DEG and ethylene glycol sometimes to save cost.

“This has led to mass poisonings in some countries in the past including India,” said CEO of a Haryana based generic drug maker.

Haunting memories

The latest episode has refreshed memories of Diethylene glycol related deaths that have occurred several times in the country.

In the last case involving poisonous cough syrup in India, 12 children had died after consuming cough syrup sold under the brand name of Coldbest-PC in Jammu & Kashmir’s Udhampur between December 2019 and January 2020.

That was the fourth mass glycol poisoning event in India due to a pharmaceutical drug. The first such recorded instance was in 1973, when a similar incident at a Chennai hospital caused the deaths of 14 children.

Thirteen year later, in 1986, similar poisoning at Mumbai’s J J Hospital caused the deaths of 14 patients thought to be recovering and in 1998, 33 children died in two Delhi hospitals following similar poisonings due to spurious drugs.

It is for this reason, pointed out Dr Rajeev Jayadevan, clinician and medical researcher, that doctors, on most occasions, are wary about prescribing generic drugs without being sure of their quality.

“That’s not the situation in developed nations because the quality check is strict and assured,” he said.

Moneycontrol tried reaching Maiden Pharmaceutical director Naresh Kumar Goyal for his comments but he did not pick up the phone. The copy will be updated when he responds to a text seeking his version.