WHO impacted image of pharmaceutical products from India after Gambia deaths: DCGI

“DEG [diethylene glycol] and EG [ethylene glycol] were not detected in these products, and the products were found not to have been contaminated with DEG or EG, as per the test reports,” said Drugs Controller General of India (DCGI) head Dr VG Somani in his letter to World Health Organisation (WHO).

He added that there was no direct causal relationship between the consumption of the cough syrups and the deaths of children in Gambia.

“The WHO’s premature conclusion was unfortunately amplified by global media, building a wrong narrative against India’s pharmaceutical products,” said Somani.

‘Impacted image of India’s pharma products’

The DCGI said that the narrative was being built intentionally to target the quality of Indian pharmaceutical products.

“The statement issued by the WHO in October was unfortunately amplified by the global media, which led to a narrative being built intentionally targeting the quality of Indian pharmaceutical products,” said the DCGI in a letter to the WHO.

“This in turn adversely impacted the image of India’s pharmaceutical products across the globe and caused irreparable damage to the supply chain of pharmaceutical products, as well as the reputation of the national regulatory framework over an assumption that has yet not been substantiated by the WHO or its partners on the ground,” it added.

Deaths in Gambia

Suspecting that the deaths of several children in West Africa’s Gambia from kidney-related complications were linked to four cough-and-cold syrups manufactured by an Indian company, the WHO issued a medical product alert on 5 October.

The four products were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

Medical officers in Gambia raised an alarm in July after several children began falling ill with kidney-related problems three to five days after taking a locally-sold paracetamol syrup.

As many as 28 of them died by August, and the health authorities expected the toll to increase. The toll had risen to 66 by the time the WHO issued its alert in October.

The four products by the Indian pharma company were reported to the WHO in September.

Laboratory analyses of samples of each of the four products confirmed that they contained unacceptable amounts of DEG and EG as contaminants, the WHO said in its medical product alert. These are toxic to human beings.

These contaminants can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury leading to death.

“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” the WHO said.

The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, in coordination with Haryana’s drug controller, carried out an investigation of Maiden Pharmaceuticals to ascertain the facts.

The ministry said the four drugs were not licensed for manufacture and sale in India, and that they were not marketed or distributed in the country either.

Based on investigations conducted, the state drugs controller issued a show-cause notice to Maiden Pharma on 7 October, and stopped all the manufacturing activities on 11 October.

WHO not communicating: DCGI

The DCGI also said Gambia apparently claimed there was no direct causal relation established yet between the cough syrup consumption and the deaths, and that some of the children who died did not consume the syrups in question.

“We believe that th WHO would now allow the technical committee of subject experts constituted by India to arrive at a conclusion based on all the facts and evidence available. We would be more than willing to consider permitting WHO representatives to interact with this technical committee who investigated Maiden Pharmaceuticals in the country,” said the DCGI.

The earlier requests for sharing factual information related to the deaths of the children was requested through emails dated 15, 20, and 29 October, it added

“We also take this opportunity to reaffirm India’s drug regulatory system’s commitment to working closely and collaboratively with WHO in its efforts to ensure quality and safety of drugs,” it said.

The CDSCO asked the WHO on 4 and 10 October details on the causality relationship. The WHO, on 10 October, said its team in Gambia was finalizing the causal relations.

On 13 October, the WHO said it was yet to receive any further information in this regard and several partners on the ground were working on it.

“Each time, the WHO has maintained that it was in contact with its team handling the case assessment and would get back at the earliest, or that its ground partners were working on it. But information has yet to be exchanged by the WHO with the CDSCO,” said the DCGI.