Death of children in Gambia linked to consumption of Indian made cough syrups, US CDC report states

A joint probe was conducted by the Centers for Disease Control and Prevention (CDC) of the US and the Gambian health authorities on the made-in-India cough syrups on the link to the death of 66 Gambian children.

As per the joint probe report, there was a strong link between the death of many children in Gambia and the consumption of made-in-India cough syrups that were allegedly contaminated.

A CDC report released on Friday stated, "This investigation strongly suggests that medications contaminated with Diethylene Glycol [DEG] or Ethylene Glycol [EG] imported into the Gambia led to this Acute Kidney Injury (AKI) cluster among children," as reported by news agency PTI.

As per the report, "Patients with DEG poisoning can experience a range of signs and symptoms, including altered mental status, headache, and gastrointestinal symptoms; however, the most consistent manifestation is AKI, characterized by oliguria (low urine output) or anuria, progressing over 1-3 days to renal failure (indicated by elevated serum creatinine and blood urea nitrogen),”

CDC stated that they were contacted by Gambia's Ministry of Health (MoH) to assist in characterising the illness (multiple cases of Acute Kidney Injury and deaths in children), describing the epidemiology, and identifying potential causal factors and their sources in August last year.

The report also said that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents.

"Among reports of AKI associated with DEG-contaminated medical products, this is the first in which DEG-contaminated medications were imported into a country, rather than being domestically manufactured,” it said.

The US Food and Drug Administration (FDA) also said there was no indication that contaminated cough and paracetamol syrups that caused deaths of children in Gambia last year have entered the US drug supply chain.

The report also said that the medications for export might be subject to less rigorous regulatory standards than those for domestic use. "Simultaneously, low-resource countries might not have the human and financial resources to monitor and test imported drugs," it stated.

Earlier in January, the US Food and Drug Administration had also that it was working with the WHO and foreign regulatory authorities to support an investigation into contaminated cough syrups that have killed nearly 300 children in Africa and Asia.

In October 2022, the World Health Organization (WHO) had issued an alert stating that the four cough syrups being supplied to Gambia by the India-based Maiden Pharmaceuticals Ltd were of substandard quality and claimed that they were linked to the death of many children in Gambia.

Maiden Pharma has a large international presence and has its supply chain to multiple countries in Africa, Asia, Eastern Europe, the Middle East and Russia. The company was established in 1990 and within three decades it has attained a sound production line and established itself in the field of research and development. The four drugs are Promethazine Oral Solution BP, KOFEXMALIN Baby Cough Syrup, MaKOFF Baby Cough syrup and MaGrip n Cold Syrup, which are licenced to Maiden Pharma for export purposes only.

In October, the government gave clean chit to Maiden Pharmaceuticals stating that the paediatric cough syrups made by the company are of “standard quality", citing tests conducted on samples seized from the firm’s Haryana factory in October. The government had asked the WHO as well as Gambian authorities for the samples that are blamed for the children’s death, but has had no response yet.

Union Minister of State for Health Bharati Pravin Pawar in a reply to Lok Sabha on February 3 had said that after testing, the samples of the cough syrups have been declared to be of standard quality.

The samples were found to be negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG), Pawar had said in a written reply to a question.

Meanwhile, On 3 March, three employees of another Noida-based pharmaceutical company, whose cough syrup was linked to the deaths of 18 children in Uzbekistan last year, were arrested on Friday. The arrests were made after an FIR was lodged against five officials, including two directors, of Marion Biotech. The FIR was lodged over a complaint by a drugs inspector of the Central Drugs Standard Control Organization (CDSCO), the officials said. The accused have been identified as Atul Rawat, Tuhin Bhattacharya and Mool Singh and were arrested from Marion Biotech Pvt Ltd. Before the arrests were made, the central and the Uttar Pradesh state drug authorities had checked samples of Marion Biotech's drugs. Upon checking, it was found that 22 of the samples tested were "not of standard quality" (adulterated and spurious), according to the complainant drug inspector.

Marion Biotech, which has its office in Sector 67 in Noida, had come under the scanner in December last year for its cough syrup Dok-1 that is suspected to have led to the death of 18 children who consumed it in Uzbekistan after which the CDSCO launched a probe into the matter.

(With inputs from PTI)