There is an increasing clamour in the country for issuing compulsory licence on two new-generation drugs for the treatment of Drug-Resistant Tuberculosis - bedaquiline and delamanid. A large number of Indian and international civil society organisations, people affected with DR-TB and health experts are demanding the government to issue a government-use compulsory license for these two advanced drugs as DR-TB is emerging as a hope for fighting this public health crisis in the country. According to a government report, an estimated 1,30,000 persons get DR-TB in India annually. Not only in India, DR-TB is also a major public health problem across the globe. Out of the ten million people who fell ill with TB in 2016 alone, over half a million are estimated to have resistance to the currently used drugs namely, rifampicin and isoniazid. Under this background, both bedaquiline and delamanid 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. It is not for nothing that these two drugs were recommended by the World Health Organisation for DR-TB patients. But, both these potentially life-saving drugs are patented and are beyond the reach of the common people. While bedaquiline is sold under the brand name Sirturo by Janseen, a unit of Johnson & Johnson; delamanid is sold by Japan’s Otsuka Pharmaceutical and by Mylan in India. Subsequent to India’s adoption of the product patent regime for pharmaceuticals in 2005, bedaquiline and delamanid were two of the first TB drugs to be patented which will expire only in July and October 2023.
At present, access to these drugs is solely dependent on donations from Johnson and Johnson/USAID and Otsuka for the TB programme in India. While nearly 1.3 lakh DR-TB patients need treatment, the country gets only 10,000 doses of bedaquiline and 400 doses of delaminid as donations. But, once donations come to an end in April, 2019, India will have to pay Rs 1 lakh for a six-month delamanid course and bedaquiline Rs 58,000 for a six-month course. Prices of these drugs could be reduced by 95% through generic competition if the government exercises its option of issuing compulsory license. India exercised compulsory license option for the first time in 2012, and the Supreme Court upheld the manufacturer, Natco’s move to make a generic version of Bayer’s cancer drug Nexavar. The move cut the price of the drug by a whopping 97%, from Rs 2.8 lakh to Rs 8,800. India now needs access to these new TB drugs as the Indian government has set an ambitious goal of eradicating this fatal disease in India by 2025, much before the WHO target of 2030. For that the country has to make targeted strategies. One particular strategy can be voluntary licensing of these two drugs. In India, there are enough companies that can manufacture and market these drugs and cost can be brought down and at the same time, the innovator company will get their royalties. Another strategy could be to goad these companies on negotiating table to negotiate on prices. According to reports, the Prime Minister’s Office along with Union Health Ministry are already in talks with the companies to bring down the prices of these drugs. And, if the government runs out of all other options, it should seriously consider to invoke provisions of compulsory licensing as thousands of lives are at stake.