Haryana government on Wednesday ordered the Sonipat-based pharmaceutical company to stop production of medicines days after a cough syrup manufactured there was linked to deaths in The Gambia.
Meanwhile, the Union Ministry of Health and Family Welfare has also set up a four-member panel to probe if the deaths in the Gambia were linked to the cough syrup manufactured by Sonepat-based Maiden Pharmaceuticals after the World Health Organisation issued an alert.
Here are all the updates on the deaths allegedly caused by the India-based cough syrup:
What happened?
Last week the WHO issued an alert about cough syrups produced by an Indian company after 66 children died in the Gambia. The four syrups— Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – were found to be manufactured from a company based in Haryana's Sonepat called Maiden Pharmaceuticals.
"Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. To date, these four products have been identified in the Gambia, but may have been distributed, through informal markets, to other countries or regions," the WHO said in a statement.
"Dozens of children [under the age of five] have died in the last three months," The Gambia's director of health services, Mustapha Bittaye, was quoted by Reuters. He said the autopsies suggested the "possibility of paracetamol" causing kidney failures.
WHO director Tedros Adhanom Ghebreyesus has asked all countries to "detect and remove these products from circulation to prevent further harm to patients".
What has India said?
While the Centre formed a panel to probe the WHO report on the cough syrups, the Haryana government has for now banned the company fro manufacturing any medicines.
The samples of the four cough syrups have been sent to the Central Drugs Laboratory (CDL), Kolkata. "The report is awaited and further action shall be taken accordingly. But, in the joint inspection conducted by the teams of the central and state drugs department, 12 flaws were found. Thus, we have decided that the production at this pharmaceutical company should be stopped. A notice has been issued to the company," Haryana health minister Anil Vij said.
According to Indian Express, several inspections were conducted on the pharma unit from October 1 to 11. Haryana health minister has confirmed that "12 shortcomings were found during the inspections at the pharma unit".
"In view of the seriousness of contraventions observed during the investigation and its potential risk to quality, safety, and efficacy of drugs being produced, all the manufacturing activities of the firm is being stopped with immediate effect…till further order in public interest, without prejudice to further action in the matter," the state and Central drug control officers said in an order.
Diethylene glycol's history of poisoning
Diethylene glycol has been found in several cough syrups that have caused poisoning in the past in India, Panama, Bangladesh, Nigeria and the United States.
The US Department of Health and Human Services, the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) issued guidance for the medical industry in 2007 to test glycerin for diethylene glycol, which they termed as "poison".
In 2020, 12 children died in J&K's Udhampur after consuming "poisoned cough syrup" from the brand Coldbest-PC. The Hindu had reported at the time that deaths due to glycol poisoning had happened in India multiple times before — in 1973 14 children had died in Chennai, in 1986 14 patients had died in Mumbai and 33 children died in 1998 near New Delhi. Diethylene glycol can cause renal failure, affect the liver and the central nervous system and even be fatal.