66 Children Died in The Gambia after Consuming India-Manufactured Cough Syrup, Probe Launched
Manas Dasgupta
NEW DELHI, Oct 6: Indian drug regulator has launched a probe into the manufacturing of a cough syrup by a Haryana-based pharmaceutical company considered to have caused deaths so far of 66 children in The Gambia.
The probe was undertaken within hours of the World Health Organisation (WHO) issued an alert saying that the Indian cough syrup could potentially be linked to the death of children in The Gambia, official sources said.
The World Health Organisation (WHO) on Wednesday warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Sonepat in Haryana could be the reason for the deaths in the West African nation.
The Gambian government has launched a door-to-door campaign to collect cough and cold syrups blamed for the deaths of the children from kidney injury. India is testing samples of the cough syrups produced by Maiden Pharmaceuticals, a government official said. The deaths of 66 children in the West African country is a blow to India’s image as a “pharmacy of the world” that supplies medicines to all continents, especially Africa.
“Samples have been sent to a central pharmaceutical laboratory for testing,” Anil Vij, the health minister of Haryana state where Maiden has its factories. “Strict action will be taken if anything is found wrong.” The Union Health Ministry would take all “required steps” in the matter, two officials said, adding that the government was awaiting a report establishing “causal relation to death with the medical products in question” from the WHO.
The sources said the exact “one-to-one causal relation of death” has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
“Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana. While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc,” the sources said.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia. It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority. A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the manufacturer licensed by the State drug controller for the products under reference, and holds manufacturing permission for these products. “The company has manufactured and exported these products only to The Gambia so far,” the source said.
It is a practice that the importing country tests the products for quality before sanctioning their usage there. As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.
Naresh Kumar Goyal, a Maiden director, said it heard about the deaths only on Thursday morning and were trying to find out details. “We are trying to find out the situation because it cropped up only today,” he said by phone. “We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India.” He declined to speak further.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the U.N. agency was investigating the deaths from acute kidney injuries with India’s drug regulator and the drug maker. The agency informed the Drugs Controller General of India of the deaths late last month after which the regulator launched an investigation with state authorities, in tandem with the WHO, the two India health ministry sources said.
The WHO said laboratory analysis of Maiden cough syrup had confirmed “unacceptable” amounts of Diethylene Glycol and Ethylene Glycol, which can be toxic and lead to acute kidney injury.
Maiden, which launched its operations in November 1990, manufactured and exported the syrup only to Gambia, the Indian ministry sources said. Maiden says on its website it has two manufacturing plants, in Kundli and Panipat, both near New Delhi in Haryana, and has recently set up another one.
It has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets. Maiden says on its website it sells its products at home and exports to countries in Asia, Africa and Latin America, though Goyal said they were not currently selling in India.
The WHO said the Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – may have been distributed elsewhere through informal markets but it had only been identified in The Gambia.
