December 30, 2022
SINGAPORE – India has quickly launched a probe to protect its reputation as the pharmacy of the world, after Uzbekistan said 18 children died after consuming cough medicine made by an Indian company.
Uzbekistan is the second country after Gambia to link some children’s deaths to India-made cough syrups.
Uzbekistan’s Health Ministry said in a statement on Dec 27 that children with acute respiratory disease took multiple doses of Dok-1 Max syrup manufactured by Indian drugmaker Marion Biotech.
It said preliminary laboratory studies showed samples of the syrup contained ethylene glycol, which it termed “toxic”.
Ethylene glycol is a synthetic liquid substance used as a cheap adulterant in propylene glycol, which is a solvent in cough syrups.
While the Health Ministry did not give any details of when the deaths occurred, Podrobno.uz news portal reported that they took place in Samarkand region in December and that the children were as young as one.
“All children were given the drug without a doctor’s prescription,” said the ministry.
The parents administered the drug at home “for two-seven days, three-four times a day, 2.5-5ml (each time), which exceeds the standard dose of the drug for children”, it added.
The Uzbek State Security Service opened a criminal case into the deaths, even as the Indian Health ministry said that officials from India’s Central Drugs Standard Control Organisation (CDSCO) were in regular contact with Uzbekistan’s national drug regulator since Tuesday.
Indian Health Minister Mansukh Mandaviya tweeted that samples of the cough syrup had been taken from Marion Biotech’s manufacturing unit in Noida, a Delhi satellite city, and sent for testing.
“Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by Uttar Pradesh Drug Control and the CDSCO team. Further action as appropriate would be initiated based on the inspection report,” he said.
Noida is in the state of Uttar Pradesh
The company told Indian media that manufacturing of the cough syrup had stopped and it was waiting for the results.
The firm states on its LinkedIn page that it exported its products ranging from pharmaceuticals to herbal and cosmetic products to South-east Asia and other regions.
The deaths in Uzbekistan come at a time when India, known for its pharma manufacturing prowess in providing affordable medicines, has been fighting to protect its reputation following the deaths of 70 children in Gambia after consuming cough syrup made by Indian manufacturer Maiden Pharmaceuticals.
India has been at loggerheads with the World Health Organisation (WHO) over the Gambia deaths, and said the organisation prematurely blamed India-made cough syrups for the cases and had yet to provide any details to establish links between the syrup and the deaths.
India’s Drugs Controller General, Dr V. G. Somani, said samples of the syrups were found to be “complying with specifications” even as a Gambian parliamentary committee recommended the prosecution of the Indian manufacturer.
It also said that the children died of acute kidney injury linked to the consumption of contaminated medical products.
The WHO noted that the medicines in Gambia had high levels of ethylene glycol and diethylene glycol, another contaminant like ethylene. The firm has denied any wrongdoing.
India is the world’s third-largest producer of drugs and has built up a reputation as the pharmacy of the world, supplying high quality and low-cost medicines for a variety of diseases.
It meets 50 per cent to 60 per cent of global demand for many vaccines, including affordable antiretroviral drugs, 40 per cent of generics consumed in the United States, and 25 per cent of all the medicines dispensed in the United Kingdom, according to a report by the Federation of Indian Chambers of Commerce and Industry.
Still, the pharma sector has also faced regulatory issues including a lack of oversight.
In India, the deaths have once again put a spotlight on the regulatory mechanism amid calls for a transparent investigation.
“India supplies a whole lot of medical products and vaccines. Two incidents in close succession are a cause for alarm,” Dr Anant Bhan, a global health and ethics researcher, told The Straits Times. A good quality regulatory system looks at complaints, and figures out if there are any gaps. That builds confidence.”
The Indian government said it was taking the issue very seriously.
“Indian pharmaceutical industry has been a reliable supplier to countries across the world… and I think we take very seriously any such incidents when they come up,” said Ministry of External Affairs spokesman Arindam Bagchi.