Sixty health organisations write to Narendra Modi, seek compulsory licences for tuberculosis drugs

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March 13, 2018

Bedaquiline and delanamid, which are used to treat multi drug-resistant TB, are available to very few Indian patients currently.

Sixty international organisations on Monday wrote to Prime Minister Narendra Modi, seeking compulsory licences for two medicines used to treat tuberculosis. The organisations requested that the government issue licences for bedaquiline and delanamid – used to treat multi drug-resistant tuberculosis – urgently.

The two drugs are advanced medicines on the World Health Organization’s Essential Medicines List for the disease. They are currently available to only very few of India’s 1.3 lakh drug-resistant tuberculosis patients because they are under patent by their manufacturers. The Health Ministry has only 10,000 doses of bedaquiline and 400 doses of delaminid that their manufacturers – Janssen in the United States and Otsuka Pharmaceuticals in Japan – donated.

Quoting unidentified officials in the Health Ministry, The Hindu reported on March 3 that a six-month course of bedaquiline is likely to cost $900 (nearly Rs 60,000) and a similar course for delaminid could cost each patient $1,700 (around Rs 1.11 lakh). Patients with drug resistant tuberculosis typically need a course of 18 months of both drugs, which means a medical bill of some Rs 5.1 lakh per patient.

Under the Patents Act, the government can issue a compulsory licence for a pharmaceutical company for public non-commercial use of their drugs. The 60 international organisations, which include tuberculosis survivors, health bodies and civil society groups, want the government to use this provision to encourage generic production. They believe this can reduce the price of the two drugs by 95%.

“In the absence of government support and awaiting patent expiries in 2023, a number of Indian manufacturers are hesitating to move forward with any plans for the production of these drugs,” their letter to the prime minister read. “Since it can take up to two years to develop and file a registration dossier with the Central Drugs Standard Control Organization and the WHO pre-qualification programme, plans to scale up the supply of these antibiotics to the tuberculosis programme need to be put in place now.”

Drug-resistant tuberculosis has become a major public health problem around the world. Of the 10 million people who contracted the disease in 2016 alone, more than half a million are estimated to have resistance to the most effective drugs used to treat tuberculosis so far – rifampicin and isoniazid.

The Indian government has said it has restricted access to bedaquiline and delanamid because data on phase-three trial for the two drugs has not been made available globally, and the drugs may have cardio-toxic side effects.

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