India's medical regulatory body, the Central Drugs Standard Control Organisation (CDSCO), announced it had launched an investigation into Maiden Pharmaceuticals, the maker of four cough and cold syrups which the World Health Organization (WHO) last week said might be responsible for the deaths of dozens of children in The Gambia. 

Three more children admitted to hospital after consuming the allegedly tainted syrup died over the weekend with acute kidney injury. Gambian authorities say 81 more children remain in hospital. 

"I don't think such thing should happen in The Gambia," Alasan Kamaso, who lost his two-year-old son Musa, told DW.

Drug regulators from the CDSCO and India's Haryana state government are examining controlled samples from the batches sent to authorities.

As investigations began in India, many Gambians gathered at a square in SereKunda, outside the capital Banjul, over the weekend to mourn the children's deaths and pray for those still in a critical condition.

"We are having a candlelight vigil and a prayer service to make a call to action for the 66 children that died as a result of negligence," rights activist Madi Jobarteh said. Jobarteh blamed the tragedy on the government's failure to ensure systems were working in such a way that it would not have allowed harmful drugs to enter the country and kill children.

Wrong diagnosis blamed

It took Gambian authorities four days to link the suspicious deaths to kidney injuries after blood samples were sent to neighboring Senegal. The Gambia does not have testing equipment available to detect such cases. Doctors instead treated the children for malaria, asthma, and meningitis.

Last week, the WHO issued an alert against four cough and cold syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — that it says may be responsible for the children's deaths.

As a result, Gambian authorities were able to confiscate over 16,000 recalled doses of medication — including paracetamol and cough syrup made by Indian manufacturer Maiden.  

According to Kamaso, this was too little, too late. "After the death of the first few children, the government should have taken steps to find out the cause. Instead, it allowed it to [get] out of control," she told DW.

The WHO report says the children developed acute kidney injuries due to diethylene glycol poisoning discovered in the four syrups. "The four syrups have been sent for testing at a regional drug testing lab in Chandigarh. The results of which will guide [a] further course of action," an Indian health ministry official told DW.

President Barrow criticized for 'irresponsible' remark

Some Gambians have criticized President Adama Barrow for "downplaying" the death of the children. Speaking on national television, Barrow said the children's deaths were not so different from the country's infant mortality rate last year. However, his office was quick to go into damage control by saying the president was explaining disease patterns and was not insensitive to the loss of lives.

Despite the president's official statement, some Gambians remained critical of Barrow. For example, the Child Protection Alliance (CPA), a non-governmental children's welfare body, described President Barrow's comments as "disappointing" and "irresponsible."

"I believe that the president's address to Gambians should have been an assurance of commitment and will ... [he] owed [it] to Gambians to take full responsibility of his government's act of negligence [which] caus[ed] the death of at least 66 children," Lamin Fatty, the national coordinator of CPA, said.

Many residents now demand strong retribution against government officials who failed to react on time and the businesses that imported the drugs.

Opposition politician Nenneh Fred Gomez is calling on those responsible to be brought to justice: "incompetence and lack of concern led to the death of these vulnerable children."

Kamaso, who lost his son, wants justice and greater action to prevent what has been described as a crisis and a national tragedy from happening again. "Let the government screen all drugs coming into the country and scrutinize the people it issued import licenses to," Kamaso stressed. 

Previous drug deaths

In 2020, 17 children died in two Indian regions — Jammu and Kashmir — after consuming syrup with high levels of diethylene glycol. After this incident, India phased out cough syrups in favor of 'suspensions' that do not carry the risk of containing the toxin. A preliminary inquiry revealed that Maiden Pharmaceuticals manufactured the four cough syrups only for export to The Gambia.

Maiden Pharmaceuticals' director Vivek Goyal said they have been 'diligently following protocols set by health authorities, including the CDSCO, and the state drugs' controller of Haryana.

"We are shocked to hear the media reports regarding the death and are deeply saddened by this incident," Goyal said.

It is not the first time Maiden Pharmaceuticals has faced queries about its drugs. The company has been accused of producing poor-quality medicines in seven states across India; including Kerala, Gujarat, Jammu, Kashmir, and Bihar.

In 2015, Gujarat authorities flagged Macipro, a drug that contained popular antibiotic ciprofloxacin — it went on to fail a dissolution test. In 2014, it was one of 39 Indian drug companies blacklisted by Vietnam for quality concerns.

According to a CDSCO survey in 2014-2016, about 5% of Indian drugs, several of them manufactured by large pharma companies, failed the quality test. However, independent studies suggest this figure could be much higher.

Indian experts say that if the link between the deaths of the children and cough syrup is established, the company's executives could face a punishment of at least 10 years in prison.

Edited by: Chrispin Mwakideu