Uttar Pradesh has allowed Marion Biotech to resume most production at its factory, which was linked to cough syrups causing child deaths in Uzbekistan last year, Reuters reported on Wednesday. Marion Biotech is among three Indian companies whose cough syrups the World Health Organization (WHO) and other agencies have linked to the deaths of 141 children in Uzbekistan, Gambia and Cameroon, in one of the world’s worst such waves of poisoning.
In December 2022, Uzbekistan claimed that at least 18 children in the country had died after allegedly consuming an India-manufactured cough syrup.
According to Uzbekistan’s health ministry, laboratory tests of a batch of syrups found “the presence of ethylene glycol”, which is considered to be a toxic substance. The ministry said ethylene glycol were administered in doses higher than the standard for children, either by their parents, who mistook it for an anti-cold remedy, or on the advice of pharmacists.
On January 12, WHO had issued a ‘medical product alert’, referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.
On October 11 (Wednesday), Reuters reported that the drug controller of Uttar Pradesh has issued an order, which says there is no known case of a lack of quality in other medicines.
“There is no known case of a lack of quality in other medicines manufactured by the firm,” the drug controller of the state said for Marion. Earlier, it had cancelled the firm’s licence in March.
“The appeal of the manufacturing firm is partially accepted,” the official, Shashi Mohan Gupta, said in the September 14 order.
“Its permission to make products using propylene glycol (PG) is cancelled, and it is allowed to make and sell all other products.”
On Wednesday, Gupta said Drugs Controller General of India (DCGI) Rajeev Raghuvanshi had written to Marion Biotech to initiate a plan of corrective and preventive actions by the company.
Raghuvanshi and the company did not immediately respond to Reuters’ queries.
In March 2023, the Uttar Pradesh Ministry of Food and Drug Safety cancelled the drug license of Noida-based Marion Biotech. The decision to cancel Marion’s license was taken unanimously by the Central Drugs Standard Control Organisation and the State health regulator.
The licence cancellation letter, issued on March 7, stated that during the investigation conducted by government agencies in January, a total of 33 samples were picked up by the drugs inspector, out of which 22 samples were declared as ‘not of standard quality’. The 22 samples fell under the category of adulterated or spurious drugs.
The company later appealed to the state government against the decision, following which it was allowed to resume output on August 11 of all products not containing propylene glycol (PG), the September 14 order shows.
Speaking on condition of anonymity, two other sources told Reuters that the Marion factory remains closed for now, pending an inspection and a review of its paperwork.
In August 2023, Uzbekistan state prosecutors alleged that the distributors of the contaminated Indian cough syrup paid local officials a bribe of $33,000 to skip mandatory testing.
In Uzbekistan, a total of 21 people have been put on trial, 20 of whom are Uzbeks and one Indian, over the deaths of the children. Three of those on trial (an Indian and two Uzbekistan nationals) are executives of Quramax Medical, the company that sold medicines produced by India’s Marion Biotech, in Uzbekistan.
Quramax CEO Singh Raghvendra Pratar, allegedly paid officials at the state centre for expertise and standardisation of medicinal products worth $33,000 so that they would skip a mandatory inspection of its products, as per state prosecutor Saidkarim Akilov.
Uzbekistan state prosecutors also said on Wednesday that Quramax had imported Marion Biotech medicines at an inflated price via two Singapore-based intermediary companies, which prompted tax evasion charges.
Source: Business Today