India has opened an investigation after Uzbekistan alleged that at least 18 children had died after taking a cough syrup made by a pharmaceutical company in the South Asian country.
The children died after taking a cough syrup called Doc-1 Max, the Uzbek Health Ministry claimed.
The drug is manufactured by Marion Biotech, a drug maker based in the New Okhla Industrial Development Authority, also known as Noida, a satellite city outside the capital, New Delhi.
The Uzbek health ministry has alleged that the syrups were contaminated with ethylene glycol, a chemical used in the preparation of antifreeze, brake fluid, cigarettes, paints and some dyes, plastics, films and cosmetics.
The company has denied the allegations.
India’s Federal Health Ministry said that the Central Drugs Standard Control Organisation was in contact with the national drug regulator of Uzbekistan regarding the matter.
“Immediately on receipt of the information, joint inspection of the Noida facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report,” the health ministry said in a statement.
The ministry also said that Marion Biotech is a licensed manufacturer and holds a license for manufacturing of Doc-1 Max syrup and tablets for export purposes granted by the Drugs Controller in Uttar Pradesh.
Officials at Noida’s Food Safety and Drug Administration said they were looking at the ingredients to ascertain the quality of the cough syrup.
“Death has been recorded, but it may be due to overdose or an ingredient,” Dinesh Tiwari, Noida's assistant commissioner for food safety and drug administration, told The National.
“The sample has been collected and sent to a lab. Once we get the test report, we will take further action.”
Uzbek authorities said the medicines had been administered by parents on the advice of pharmacists and not a doctor's prescription.
The doses of 2.5ml to 5ml — given three to four times a day — exceeded what is recommended for children.
The samples of the cough syrup have been taken from the manufacturing premises and its production has been halted indefinitely.
“The lab report can take 15 to 20 days, depending on the process and complexities of the testing,” Mr Tiwari said.
“We have asked them to stop manufacturing the medicines and not to use the ingredients in other medicines.”
This is the second time this year that an Indian pharmaceutical company has been accused of manufacturing contaminated cough syrups.
The World Health Organisation issued an alert in October after 70 children, half of them between the ages of five months and four years, died of acute kidney failure in the Gambia.
The deaths were blamed on four cough and cold syrups made by Maiden Pharmaceuticals in the northern Haryana state.
The WHO alleged that the medicines contained either diethylene glycol or ethylene glycol — the same compound suspected by Uzbek authorities.
New Delhi launched an investigation and halted production of the medicine.
The drug company was initially barred from carrying out any production activities after local authorities found breaches of good manufacturing practices at the plant in a separate investigation.
However, the Health Ministry cleared Maiden Pharmaceuticals last week and said the cough syrup samples made by the company had been found to be of “standard quality”.
India's Minister of State for Chemicals and Fertilisers Bhagwanth Khuba informed parliament that samples tested “negative” for both the toxic chemicals mentioned by the WHO.
The government also said that the WHO had made a “premature link between the deaths of the children and cough syrups” that adversely affected the image of the Indian pharmaceutical industry.
The South Asian nation is known as the “pharmacy of the world”, with its pharmaceutical sector valued at $42 billion.
India exported pharmaceutical products valued at $137 million to Uzbekistan in 2021, according to the United Nations COMTRADE database on international trade.
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