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Bedaquiline and TB UPSC NOTE


What is Bedaquiline?

  • Bedaquiline is an anti-tuberculosis drug.

  • Bedaquiline is a crucial drug in the treatment of multidrug resistant TB patients for whom the first-line drug treatment — using Isoniazid, Rifampicin, Pyrazinamide and Ethambutol — has stopped working.

Who made bedaquiline?

  • The anti-tuberculosis drug Bedaquiline is manufactured by J&J.

    • Johnson & Johnson’s (J&J) is a U.S. pharmaceutical giant.

  • Janssen Pharmaceutical (a subsidiary of J&J) made bedaquiline around 2002. 

  • The recent WHO recommendation of bedaquiline being a core drug for the treatment of drug-resistant tuberculosis (DR-TB) is largely based on the evidence produced through collective efforts. 

  • However, J&J has claimed sole ownership of it, protected by its aggressive patenting strategies.

What has J&J done?

  • Johnson & Johnson’s patent on bedaquiline expired on 2023 July 18.

  • This long-awaited expiry will allow generic manufacturers to supply the drug, but J&J appears intent on maintaining its monopoly over the bedaquiline market.

  • J&J has filed secondary patents over bedaquiline till 2027, which were granted in 66 low-and middle-income countries. 

  • It includes 34 countries with high burden of TB, multidrug-resistant TB (MDR-TB), and TB/HIV.

  • Over the past week, J&J has faced public outrage for seeking to extend its patent on bedaquiline. 

  • A first of its kind deal between J&J and the Global Drug Facility (GDF), a non-profit distribution agency housed in the WHO, could expand access to the drug. 

  • Researchers estimate that, with the introduction of competition from India, the price of bedaquiline will reduce in the range of $48-$102 for a six-month treatment course — which is three to six times lower than the current globally negotiated price paid by countries ($272) when it is procured through the GDF.

Will the drug be available in India?

  • Other DR-TB drugs like linezolid have decreased in prices by over 90% with generic competition once Pfizer’s patent expired in 2015. 

  • Therefore, national TB programmes are waiting for the generic supply of bedaquiline from Indian manufacturers to reduce prices.

  • In India, a ‘pre-grant opposition’ was filed by a patient group and two TB survivors — both of whom had to endure the more toxic DR-TB treatments that lasted up to two years and caused excruciating side effects: they both lost their hearing.

  • As a result of their legal challenge, in a landmark decision, the Indian Patent Office rejected the U.S. corporation J&J’s secondary patent which would have extended its monopoly for four more years. 

  • Indian manufacturers will now be able to supply affordable, quality assured generic versions of bedaquiline in India as the primary patent expired on July 18.



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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: Bedaquiline and TB UPSC NOTE
Bedaquiline and TB UPSC NOTE
Learnerz IAS | Concept oriented UPSC Classes in Malayalam
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