India’s drug regulatory authorities have initiated inspections of Marion Biotech, an Indian drug maker whose paediatric syrup, exported to Uzbekistan, has been described as contaminated with a toxic substance and linked to 18 child deaths in the central Asian nation.
The Union health ministry said on Thursday that the Central Drugs Standard Control Organisation (CDSCO) and Uttar Pradesh state drug regulators had carried out inspections of Marion Biotech’s facilities in Noida after receiving reports of contamination from the Uzbek government.
Uzbekistan’s health ministry had on December 27 said that 21 children with acute respiratory disease had received excess doses of the syrup, Doc-1 Max, and 18 of them had died. It also said the preliminary lab investigations had found the syrup’s batch was contaminated with ethylene glycol, which can cause serious kidney injury.
India drug regulators spent several hours on Thursday on the company’s premises in Noida, Uttar Pradesh. A legal consultant to the group that owns Marion Biotech told TV channels on Thursday that the company had exported the medicine for nearly 10 years and not encountered any problems.
Union health minister Mansukh Mandaviya said on Thursday that the CDSCO had been “in regular contact with the drug regulators of Uzbekistan regarding the matter since December 27”.
The CDSCO has sent samples of the syrup — a cocktail of paracetamol and two other drugs — from Marion Biotech’s manufacturing premises to the Regional Drugs Testing Laboratory, Chandigarh. The health ministry said: “Further action as appropriate would be initiated based on the inspection report.”
Marion Biotech holds a licence for the manufacture of Doc-1 Max syrup and tablets for export, granted by the state drug regulatory authority, the health ministry said.
The deceased children in Uzbekistan, before admission to hospital, had received amounts of the syrup that exceeded the standard dose of the medicine for children, the Uzbek health ministry said.
India’s external affairs ministry said Uzbek authorities had initiated legal action against certain people, including representatives of the company there. “In this context, we are extending necessary consular assistance to those individuals or the individual,” a ministry spokesperson said.
The alert from Uzbekistan and follow-up actions by the CDSCO have emerged two months after authorities in the Gambia linked 66 child deaths in the west African nation to cough syrups from another Indian firm that they said were contaminated with ethylene glycol and diethylene glycol.
The World Health Organisation has said both are dangerous substances and “should not be in any medicine ever”. The similarities in the Uzbek and Gambian incidents are likely to dent India’s image in the pharmacy world, experts familiar with India’s pharmacological sector, and a paediatrician who had investigated a similar incident in Jammu and Kashmir three years ago, said.
“Such contamination could be due to deficiencies in manufacturing processes,” said the paediatrician, who had investigated the deaths of 12 children in Jammu and Kashmir during December 2019 and January 2020 that too were linked to ethylene glycol.
The external affairs ministry spokesperson said India’s pharmaceutical industry had been a reliable supplier to countries across the world. “We take very seriously any such incidents when they come up… let me not jump the process without the full investigation.”