The World Health Organization has warned of the spread of contaminated quantities of Indian medicines after the discovery of Pseudomonas aeruginosa in an injectable chemotherapy agent and immune system inhibitor called methotrexate, which is manufactured in India.

Edited by| Paul Mitchel

Health   section -   CJ journalist

 March 29, 2023

      India is known as the “pharmacy of the world” as its factories manufacture 20 percent of the globe’s generic drugs and 50 percent of vaccines. However, the sector has long been plagued by safety concerns and regulation breaches.

Last year, Indian-made cough syrups were linked to the deaths of over 300 children in Gambia, Uzbekistan, and Indonesia.

In October and November 2022, approximately five percent of the 2,767 drugs and medical devices tested by the Indian government’s regulator were found to be spurious, not of standard quality, adulterated or misbranded.

More than 80 companies that failed quality testing stated on their website that they sold their products abroad, including two firms that export to the United Kingdom.

The methotrexate injections were only found to be contaminated after children administered the drug reported adverse effects.

It is unclear at this stage whether anyone in Yemen or Lebanon has died after receiving the medicine or which other countries the drugs could be circulating in.

“Patients receiving [the] methotrexate treatment may have weakened immune systems and be more vulnerable to opportunistic infections,” the WHO said in its alert.

  “Therefore, detecting and removing this contaminated product from circulation is important to prevent harm to patients.”

 

The contaminated batch of methotrexate, MTI2101BAQ, was only meant to be sold in India but is believed to have reached the Middle East through informal markets.

In February, Global Pharma Healthcare, an Indian pharmaceutical company based in the southern Indian city of Chennai, recalled its Artificial Tears Lubricant Eye Drops.

The product, which was distributed in turn by two American pharmaceutical companies, was linked to an outbreak of pseudomonas infections and three deaths in the United States.

Last Thursday, the Indian authorities revoked the manufacturing license of Marion Biotech, a firm based in the northern Indian state of Uttar Pradesh, whose two cough syrups were linked to the deaths of 18 children in Uzbekistan.

The ban came after the Indian government’s laboratory found 22 samples of the company’s cough syrups were “adulterated and spurious” during testing in December.

India is a preferred global source of pharmaceuticals as it is extremely cheap to manufacture drugs while the country is also home to a low-cost skilled workforce.

India’s production of affordable HIV antiretrovirals, cancer drugs, as well as tuberculosis, malaria, and Hepatitis C medications, to name a few, are considered key tools in fighting some of the world’s deadliest diseases.

But some Indian companies and regulators do not adequately quality test their active pharmaceutical ingredients (APIs) or finished products before export, while corruption is also rife, according to Prashant Reddy, a co-author of the book “The Truth Pill: The Myth of Drug Regulation in India”.

“The Indian government pats itself on the back as the pharmacy of the world – it is one of the country’s few big success stories so there is no incentive to really crackdown,” adds Mr. Reddy.

“It is a systemic issue. The implementation of standards and enforcement by drug regulators is sporadic across different Indian states and many drug labs do not do comprehensive testing of their products and only do a small subset.”

{source}<script async src="https://pagead2.googlesyndication.com/pagead/js/adsbygoogle.js?client=ca-pub-4474625449481215"
crossorigin="anonymous"></script>
<!-- moss test ad -->
<ins class="adsbygoogle"
style="display:block"
data-ad-client="ca-pub-4474625449481215"
data-ad-slot="6499882985"
data-ad-format="auto"
data-full-width-responsive="true"></ins>
<script>
(adsbygoogle = window.adsbygoogle || []).push({});
</script>{/source}