Six health organisations and survivors of drug-resistant tuberculosis, health organisations and the TB community have appealed to Prime Minister Narendra Modi to allow issuance of compulsory licence for two of the essential drugs bedaquiline and delanamid for drug-resistant tuberculosis (DR-TB) treatment so that Indian drug-makers can sell them at affordable prices.
According to India’s Scroll in news site “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.”
The Hindu on March 3rd reported “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, 1970 the government can issue a compulsory licence for a pharmaceutical company for public non-commercial use of their drugs.
Scroll in also reported that “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.”
According to India Today news site, health activist Ketholelie Angami said “The Patents Act provides for a special provision that empowers the central government to notify a compulsory licence for public non-commercial use. The license for Bedaquiline and Delamanid would encourage generic production and supply to Indias TB Control Program and reserving them for public health use”