Indian civil society pushes for government use compulsory license on MDR-TB drugs

Advocates appeal to the Prime Minister of India to issue a government use compulsory license for bedaquiline and delamanid to encourage generic competition.

12 March 2018: Survivors of drug-resistant tuberculosis, health organisations and the TB community in India and across the globe have appealed to the Prime Minister of India to issue a government use compulsory license for two of the essential drugs for drug-resistant tuberculosis (DR-TB) treatment - bedaquiline and delamanid to encourage generic competition. 

Bedaquiline and delamanid adult formulations were added to the WHO Essential Medicines List (EML) for TB in 2015, and delamanid was added to the WHO EML for children in 2017.

The Patents Act provides for a special provision that empowers the Central Government to notify a compulsory license for public non-commercial use. The government use license for bedaquiline and delamanid thus issued will encourage generic production and supply to India’s TB Control Program and reserving them for public health use.

Drug-resistant TB is a major public health problem across the globe. Out of the ten million people who fell ill with tuberculosis (TB) in 2016 alone, over half a million are estimated to have resistance to the most effective drugs used to treat TB, rifampicin and isoniazid. These new TB drugs offer fresh hope to those at high risk of treatment failure; notably, people living with HIV co-infected with DR-TB, children with DR-TB, extensively and pre-extensively drug-resistant TB (XDR/pre-XDR-TB) patients and those with drug intolerance.

With about 1.3 lakh annual incident of multidrug-resistance TB (MDR-TB) in India, the Indian TB Control Program is in the process of introducing these new drugs through donations and will have to pay INR 1 lakh for a six-month delamanid course and bedaquiline INR 58,000 for a six-month course in the coming years. Prices of these drugs could be reduced 95% through generic competition.   

Lawyers Collective along with 59 other civil society organisations (India and international) and 31 individuals have written to the Prime Minister of India seeking a government use compulsory license on MDR-TB drugs called bedaquiline and delamanid.

The full text of the letter is available here.

Source: Lawyers Collective

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By TB advocates

Published: March 15, 2018, 5:30 p.m.

Last updated: March 15, 2018, 6:45 p.m.

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