HYDERABAD: Health authorities in Lebanon and Yemen have red-flagged a cancer drug made by Celon Labs in Hyderabad after they found life-threatening bacteria, pseudomonas, in one of the batches.
The ministry of health has informed the Lok Sabha that 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.
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 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.
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 Laboratories, a speciality generics firm focussed on critical care and oncology, was acquired by the UK-based biopharma player ZNZ Pharma 2 Limited for Rs 364 crore in November 2020. ZNZ Pharma, which picked up 74% stake, is backed by the UK’s publicly owned impact investor CDC Group Plc.
This was the third instance in recent times of Indian drugs coming under a cloud. Last October, Maiden Pharmaceuticals Ltd from Haryana was shut down after WHO linked a cough syrup manufactured by it to the death of 69 children in Gambia. Recently, the production licence of Noida-based Marion Biotech was suspended after a syrup it manufactured was linked to the death of 18 children in Uzbekistan last year.
The ministry of health has informed the Lok Sabha that 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.
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 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.
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 Laboratories, a speciality generics firm focussed on critical care and oncology, was acquired by the UK-based biopharma player ZNZ Pharma 2 Limited for Rs 364 crore in November 2020. ZNZ Pharma, which picked up 74% stake, is backed by the UK’s publicly owned impact investor CDC Group Plc.
This was the third instance in recent times of Indian drugs coming under a cloud. Last October, Maiden Pharmaceuticals Ltd from Haryana was shut down after WHO linked a cough syrup manufactured by it to the death of 69 children in Gambia. Recently, the production licence of Noida-based Marion Biotech was suspended after a syrup it manufactured was linked to the death of 18 children in Uzbekistan last year.
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The post is published through a syndicated feed and attributed to Times Of India
