Even as Drug-Resistant Tuberculosis (DR-TB) is becoming a major public health problem across the globe including India, a large number of Indian and international civil society organisations have appealed to Prime Minister Narendra Modi to issue a government-use compulsory license for two of the essential drugs for DR-TB treatment-- bedaquiline and delamanid-- for securing access to affordable DR-TB treatments across the developing world.

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.

“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 (XDR/pre-XDR) TB patients and those with drug intolerance”, the civil society organisations said in its letter to the Prime Minister.  

After a gap of 50 years, the new antibiotics, bedaquiline and delamanid, together with re-purposed drugs, now provide opportunities to countries with a high burden of TB to improve the safety and efficacy of its DR-TB treatment regimens and thus, prevent further infections, resistance and deaths. As a response to the ‘high unmet medical need’  for new treatment options for multidrug-resistant tuberculosis, bedaquiline and delamanid adult formulations were added to the WHO Essential Medicines List (EML) for TB in 2015 while delamanid was added to the WHO EML for children in 2017, the letter further said.

Subsequent to India’s adoption of the product patent regime for pharmaceuticals in 2005 (the WTO TRIPS deadline), bedaquiline and delamanid were two of the first TB drugs to be patented. The compound patents numbers for bedaquiline and delamanid are IN236811 and IN250365, which expire in July and October 2023, respectively.

Currently, access to the new, patented TB drugs is solely dependent on ‘mere imports’ that Johnson and Johnson (J&J)/United States Agency For International Development (USAID) and Otsuka donate to the TB programme in India. Not just in India, access to these critical drugs remains limited in other high burden countries in the developing world.

Once the USAID/J&J donation concludes in April 2019, the price for a six-month course of bedaquiline in India will be USD 900 and even higher in other middle-income countries. Additionally, the Japanese pharmaceutical corporation, Otsuka, charges an exorbitant USD 1,700 for a six-month delamanid course, the price of which is not expected to decrease substantially.

According to a study published in the Journal of Antimicrobial Chemotherapy, the target generic price for a six-month course of bedaquiline and delamanid is between USD 48 to 102 and USD 36 to 96, respectively. Thus, prices could fall by up to 95% through the generic production of these life-saving medicines, the civil society organisations said.

India’s role is thus critical and it needs to desist from endorsing secretive bilateral voluntary licensing deals between pharmaceutical companies for their own profits, and instead, operationalize generic supply through a government use license. The grant of a government use license on grounds of public non-commercial use (under section 92) would create competition, significantly reduce government expenditure, provide impetus to the scaling up of access to these new TB drugs globally and help kick start the generic supply of new TB drugs to the national TB programme by 2019, the civil society organizations in their letter further said.