Drug regulator calls for cancelling licence of Noida-based firm
The central drug regulator has recommended cancellation of the licence of Noida-based pharmaceutical firm Marion Biotech, whose cough syrup has been linked to the deaths of 18 children in Uzbekistan, after an analysis found that its products did not meet quality standards, officials from the state and the Centre said on Saturday.
Noida police on Friday arrested three officials of the company on the basis of an FIR lodged by the Central Drugs Standard Control Organization (CDSCO) in connection with an ongoing investigation that found Marion’s product samples adulterated and not of standard quality. Marion Biotech’s Dok-1 cough syrups allegedly led to the deaths of the children in December 2022. “The CDSCO has made a recommendation to the licencing authority, which is the state drug control department, to cancel the company’s licence. We are reviewing paperwork and have initiated the process,” Gautam Buddh Nagar’s drug inspector Vaibhav Babbar said.
Speaking on condition of anonymity, a central government official said that during investigation it was found that the firm was not following regulatory guidelines.
“Investigations have found that Marion Biotech’s manufacturing practices were flawed. While they do not supply their drugs in the Indian market, they will have to recall their products from the countries where they have operations. The state enforcement agencies have already started the process of licence cancellation,” the official said.
HT tried to reach out to the firm’s officials, but couldn’t get a response immediately. The FIR against the company said that central and state drug authorities checked samples of Marion Biotech’s drugs during joint inspections on December 27, 29 and 30. These were sent to the government’s regional drug testing laboratory in Chandigarh and 22 of the samples were found to be “not of standard quality”.
“The government analyst of Regional Drugs Testing Laboratory, Chandigarh, vide test report CHD/LS/22-23/380 dated 14.01.2023 has declared the subject sample to be ‘Not of Standard Quality’ for the reasons that the sample does not conform to claim as per Patent and Proprietary…” said the CDSCO letter to the company, seen by HT.
According to people familiar with the matter, the company was also violating schedule Mgood manufacturing practices in production, and its licence was suspended in January.
WHO also issued a “medical product alert”, referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022. The statement added that the samples of both products tested by Uzbekistan health ministry found they contained “unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants”. It mentioned that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.