WHO Prequalifies Ethionamide for Indian firm

The World Health Organization (WHO) in early April 2023  pre-qualified ethionamide, manufactured by Indian pharmaceutical company, Micro Labs Limited. (1)

Ethionamide, an antibiotic sold under brand name Trecatora, is for the treatment of tuberclosis. It acts by either killing or preventing growth of bacteria and is largely used under a doctor's prescription.

The TB causing bacteria, called Mycobacterium tuberculosis, is known to infect the lungs although it has also been associated with attacks on other body parts such as the brain, spine and kidney.

The pre-qualification announced in early April 2023 was was in response to an earlier application by Micro Labs Limited, which also manufactures drugs for cardiology, diabetology, anti-infectives, and ophthalmology.

Prior to the pre-qualification, a comprehensive evaluation procedure was carried out including a thorough assessment of the API master file by the WHO prequalification team to “verify compliance with WHO norms and standards.”

The file provides information on the preparation, control and stability of an API, in this case Ethionamide.

In addition, an evaluation of the the sites where the API will be manufactured was carried out to confirm “compliance with WHO Good Manufacturing Practice requirements.”

WHO says its prequalification of APIs “facilitates production of quality medicines by identifying such APIs for use by manufacturers of finished pharmaceutical products.”

Ethionamide, which comes with a chemical name  2-ethylthioisonicotinamide, is a yellow crystalline, nonhygroscopic compound with a faint to moderate sulfide smell. 

There are 250mg of ethionamide in the Trecator tablet  with the FDA listing the inactive ingredients in the product as croscarmellose sodium, FD&C Yellow 6, magnesium stearate and microcrystalline cellulose. (2)

Other ingredients include polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide.

With the number of newly diagnosed TB cases having increased from 5.8 million in 2020 to 6.4 million in 2021, the pre-qualification of ethionamide by WHO, is a major boost in the fight agains the disease. (3)

Statistics by WHO shows there was an increase in the number of people with undiagnosed TB in 2020 and 2021 due to the few reported cases for the two years.

With low level diagnosis of TB, WHO says there is likelihood of "an increased number of TB deaths and more community transmission of infection and then, with some lag-time, increased numbers of people 

developing TB."

Globally, at least 10.6 million people were infected with TB in 2021, nearly 4.5% increase from the 10.1 million reported in 2020.

WHO says the TB incidence rate, or new cases per 100 000 population per year, increased by 3.6% between 2020 and 2021, reversing  declines of about 2% per year for most of the previous two decades. 

Moreover, the burden of drug-resistant TB surged between 2020 and 2021, with 450 000 new cases of TB patients resistant to the rifampicin, also known as rifampin, which is sold under brand names brand names of Rifadin and Rimactane.

In 2019, the U.S. Food and Drug Administration (FDA) approved Pretomanid tablets, in combination with bedaquiline and linezolid, for the treatment of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB.

A tablet of Pretomanid contains 200 mg of pretomanid and several excipients such as colloidal silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. 

Elsewhere, WHO has prequalified oseltamivir (phosphate) an anti-viral treatment manufactured by by Shanghai Desano Chemical Pharmaceutical Co Ltd. (4)

The generic version of the medicine, sold under brand name Tamiflu 30 mg and comes in hard capsules containing oseltamivir phosphate, was approved by the U.S. Food and Drug Administration in 2016  for the treatment of the influenza A and B in patients two weeks of age and older. FDA approved the original Tamiflu in 1999.

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-approves-first-generic-version-widely-used-influenza-drug-tamiflu

The prequalification of ethionamide and oseltamivir comes at a time when market analysts predict growth in the global API market.

Some market analysts project the annual growth to be around 6.52%, with the size of APIs market is expected to increase from US$ 190.5 billion in 2022 to more than US$ 261.3 billion by 2027. (5)

References

1. https://extranet.who.int/pqweb/news/newly-prequalified-active-pharmaceutical-ingredient-api-50

2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013026s029lbl.pdf

3. Tuberculosis deaths and disease increase during the COVID-19 pandemic (who.int) 

4. https://extranet.who.int/pqweb/news/newly-prequalified-active-pharmaceutical-ingredient-api-49

5. https://www.businesswire.com/news/home/20230110005779/en/Global-Active-Pharmaceutical-Ingredients-APIs-Market-AnalysisForecast-Report-2022-2023-2027---ResearchAndMarkets.com

About the Author

Shem Oirere graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy, and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.