© Reuters. The logo of Marion Biotech, a pharmaceutical and healthcare company, is seen on a door in front of its office in Noida, India, December 29, 2022. REUTERS/Anushree Fadnavis
2/2
By Krishna N. Das
NEW DELHI (Reuters) – India may issue an alert on cough syrup exported by Marion Biotech, whose products have been linked to deaths in Uzbekistan, after tests showed many of the company’s drug samples contained toxins. a drug inspector said Saturday.
Indian police on Friday arrested three Marion employees and are searching for two directors after tests at a government laboratory found 22 of 36 “adulterated and spurious” syrup samples.
New Delhi is investigating the matter even as the government has rejected allegations that cough syrup made by another Indian company, Maiden Pharmaceuticals, killed children in The Gambia last year.
Vaibhav Babbar, an inspector involved in the Marion investigation, told Reuters the samples had been adulterated with ethylene glycol and diethylene glycol, the toxins the World Health Organization says were found in products sold by the two companies in the two countries.
Up to 70 children have died in The Gambia and 19 in Uzbekistan.
More than 300 children, mostly under the age of 5, in the Gambia, Indonesia and Uzbekistan died last year of acute kidney injury associated with contaminated medicines, the WHO said in January.
In addition, he said that the Philippines, Timor Leste, Senegal and Cambodia could be affected because they could have the medicines for sale. He also called for “immediate and concerted action” among its 194 member states to prevent further deaths.
“Because the drugs from Marion have gone to so many countries, I pray that nothing happens in other places,” Babbar said. “The Ministry of Health could issue an alert. It is possible that they will. It will be good to issue an alert.”
He said he did not know if an alert was under active consideration.
A spokesman for the Indian health ministry did not immediately respond to requests for comment. Marion did not return calls from Reuters and did not immediately respond to an email seeking comment.
A government alert would warn people in all countries to remove products from their shelves, although it does not carry a legal penalty.
Babbar said the drugs had also been exported to Kyrgyzstan and Cambodia.
Babbar was part of a team that inspected the Marion plant four times after Uzbekistan said in December that children died after consuming the company’s cough syrups. India discontinued production of the Marion soon after.
Analysis by the Uzbekistan Ministry of Health showed that the syrups, Ambronol and DOK-1 Max, were contaminated with unacceptable amounts of diethylene glycol or ethylene glycol, the WHO said in a medical product alert in January. The UN health watchdog said it was important to detect and remove these substandard products from circulation.
The syrups were given in higher doses than the standard for children, either because parents mistook the product for cold remedies or on the advice of pharmacists, according to the analysis.
India in October suspended production at Maiden for violating manufacturing standards after the WHO said four of its cough syrups could have killed dozens of children in The Gambia.
Maiden has denied that his drugs were to blame for the deaths in The Gambia, and tests by an Indian government laboratory found no toxins in them.