Hyderabad-based pharma Celon Labs’ cancer drug found substandard in Yemen and Lebanon

The WHO, in recent times, has alerted the public about four Indian products, including Methotrex (methotrexate) 50mg, manufactured by Celon Laboratories. The WHO flagged Methotrex back in December 2022.

The three other products are from Marion Biotech, Maiden Pharmaceuticals, and Galentic Pharma.

WHO’s statement on Methotrex 

Methotrex 50mg pack. (WHO)

“Following adverse events in pediatric patients receiving Methotrex 50mg, the health authorities in both Yemen and Lebanon conducted microbiological testing on the remaining unopened vials of the injection. Results in both countries were positive for Pseudomonas aeruginosa, indicating contamination of the products,” said the WHO statement.

It further states that Pseudomonas aeruginosa bloodstream infection is a serious infection that may lead to death and any product that has any contamination and is administered directly in the body would present serious risks to patients.

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Pharma company confirmed batch number

The WHO said that Celon Laboratories has confirmed that the batch number, manufacturing, and expiry dates combination match their internal records.

“At this stage, we have not had access to samples of the suspect products for our own confirmatory testing,” the company told the WHO.

The company also stated that Methotrex 50mg batch number MTI2101BAQ was intended to be sold exclusively in the Indian market.

“The batch, which was available in Yemen and Lebanon, was procured outside the regulated supply chain. So the manufacturer cannot guarantee the safety of this product, which was not destined for these markets,” said the pharmaceutical company.

The WHO said that it is likely that this product may have been distributed to other countries through informal markets. “It is important to detect and remove this contaminated product from circulation to prevent harm to patients,” said WHO.

Meanwhile, the Union Health Ministry said that the matters are referred to concerned zonal/subzonal office of the Central Drugs Standard Control Organisation (CDSCO) and investigated in coordination with the State Licensing Authorities (SLAs).

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Manufacturing of the drug halted

Speaking to South First, the Joint Director of Telangana Drug Control Administration G Ramdhan said that the department received the WHO report about Celon Labs through the CDSCO.

“Through the CDSCO, we received the report. After that, we sent the notice to Celon Labortaries and they replied,” said G Ramdhan.

However, the state regulator, as well as the CDSCO, didn’t find the reply satisfactory and so “for now we have halted the manufacturing of the particular category of drugs at the pharma,” said Ramdhan.

He said that the regulator is waiting for the reply and has taken the sample which the CDSCO is analysing.

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Celon Labs responds

A statement from Celon Labs, issued on 6 April, said the batch of medicines in question “had been sold over two years ago, in January 2021, for domestic use only and that it had passed all quality requirements for its release into the local market”.

It added: “No critical pharmacovigilance reports were reported from any end-users of this product in India.”

A spokesperson from the company said in the statement that Yemen’s Ministry of Health and the WHO informed it in October and November 2022, respectively, of a potential contamination issue with a certain drug labelled as manufactured by Celon.

“The Yemeni authorities secured the batch number, and Celon immediately initiated an internal investigation followed by a voluntary batch recall,” said the spokesperson.

“Retention batch samples were tested at an independent WHO-licensed quality control lab in India, which confirmed that there were no deviations from Celon’s manufacturing process specifications, no contamination, and that the product complied with all health and safety specifications,” they added.

The statement concluded: “Celon emphasises that there is no evidence of contamination at its premises,
and remains committed to ensuring its products meet the highest quality and safety standards.”