WHO issues a 'medical product alert' for Marion Biotech cough syrup

The World Health Organization (WHO) has issued a “medical product alert” for two sub-standard products made by Noida-based Marion Biotech — Ambronol syrup and DOK-1 Max syrup.
 

Marion Biotech’s cough syrup was linked to the death of 18 children in Uzbekistan. Following the development, the Indian drug regulator has been in touch with the Uzbekistan drug regulator. The production at the factory site has been stopped, and the Uttar Pradesh Food Safety and Drug Administration (FSDA) has also suspended the company’s licence.
 

This WHO Medical Product Alert refers to two sub-standard (contaminated) products, identified in Uzbekistan and reported to WHO on December 22, 2022. Sub-standard medical products are products that fail to meet quality standards or specifications and are therefore “out of specification”.
 

This is the second medical product alert issued to an Indian company by the WHO for manufacturing a contaminated or sub-standard drug in recent months. In October, the WHO had issued a medical alert for cough syrups of Haryana based Maiden Pharma.
 

The WHO has said Marion Biotech had not provided guarantees to them on the safety and quality of these products.
 

“Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan, found both products contained unacceptable amounts of diethylene glycol and /or ethylene glycol as contaminants,” the global agency added.
 

It expressed concerns that both of these products may have marketing authorisations in other countries in the region. “They may also have been distributed, through informal markets, to other countries or regions,” WHO said.
 

Meanwhile, laboratory reports from testing of samples sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh, are awaited. “After we get the laboratory reports on this firm, further action will be taken, and they are likely to be prosecuted,” a UP FSDA official told Business Standard.
 

However, the manufacturing license of another north India firm Maiden Pharma was not cancelled or suspended by the Haryana FDA. After a joint inspection by the state and central regulators, the firm was sent a notice, to which it responded saying that it has taken corrective action to fix the current Good Manufacturing Practice (cGMP) violations at the site. A re-inspection of the site is now planned. 

LATEST DEVELOPMENTS

• Dec 27 & 29: Joint team of central and state-level inspectors visit Marion Biotech 
• Dec 29: Company halts production at site
• Dec 30: Pharmexcil suspends membership as firm fails to respond to show cause notice
• Dec 30: UP FSDA sends show cause notice to Marion Biotech after GMP lapses found in plant
• Co fails to respond to notice within 7-day deadline
• Jan 9: UP FSDA suspends licence of Marion Biotech 
• Jan 11: WHO issues medical product alert for 2 Marion Pharma drugs