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Hyderabad company’s cancer medicine found contaminated in Yemen, Lebanon: WHO

By U Sudhakar Reddy / TNN /

Mar 28, 2023, 10:11  ..

Health authorities in Lebanon and Yemen have red-flagged a cancer drug made by Celon Labs in

Hyderabad after they found life-threatening bacteria, pseudo.
The Union ministry of health has informed Lok Sabha that the the World Health Organisation (WHO) had issued an alert about four sub-standard and contaminated products – including Celon Lab’s methotrexate, an injectable chemotherapy agent and immune system suppressant.
Minister of state for health and family welfare, Bharati Pravin Pawar, said the alert was for Celon’s Methotrex 50mg vials.
Health authorities in Yemen and Lebanon ran tests on the drug after they observed adverse events in children and found it to be contaminated. “Patients receiving methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections,” the alert said.
It pointed out that the drug may have reached the two countries through the informal markets.

The batch, MTI2101BAQ, was meant to be sold only in India and both the West Asian countries procured it “outside the regulated supply chain”.

The manufacturer could not guarantee the safety of the product that was not destined for these markets, WHO said.

The organisation is worried that the drug may also have been distributed to other countries through informal

markets. “Therefore, detecting and removing this contaminated product from circulation is important to

prevent harm to patients.”
Joint director of Telangana Drug Control Administration, G Ramdhan, told TOI, “We have issued a show-cause notice to Celon Labs and told them to stop production of the drug.”

Celon Labs confirmed to WHO that the batch number they sent matched with their records but not had access to samples for their own “confirmatory testing”. Celon Laboratories, a speciality generics firm focussed on critical care and oncology, was acquired by the UK-based biopharma player ZNZ Pharma 2 Limited for ₹364 crore in Nove-mber 2020. ZNZ Pharma, which picked up 74% stake, is backed by the UK’s impact investor CDC Group Plc.

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