60 international organisations wrote to the PM Narendra Modi and sought compulsory licences for two medicines used to treat tuberculosis. The organisations requested that the government issue licences for bedaquiline and delanamid which are used to treat multi drug-resistant tuberculosis.
The two drugs are advanced medicines on the World Health Organization’s Essential Medicines List for the disease and 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.
It had been reported that a six-month course of bedaquiline would approximately cost $900 (nearly Rs 60,000) and a course of delaminid could cost each patient $1,700 (around Rs 1.11 lakh). Patients with drug resistant tuberculosis generally need a course of 18 months of both drugs which would amount to a medical bill of almost Rs 5.1 lakh per patient.
Under the Patents Act, the government could 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 as they believe that this could reduce the price of the two drugs by 95%.
Their letter to the PM read, “In the absence of government support and awaiting patent expires in 2023, a number of Indian manufacturers are hesitating to move forward with any plans for the production of these drugs. 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.”
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.
