On 24 March 2016, on the occasion of World Tuberculosis Day, JP Nadda, India’s health minister at the time, announced the launch of bedaquiline in India. Bedaquiline is a new anti-tuberculosis drug that works on patients with drug-resistant TB, or DR-TB. The government announced that it would be giving the drug for free, under a national programme to eliminate TB.
India is home to the most number of TB patients in the world. In 2017, 10 million new cases of TB were reported, of which 2.8 million patients resided in India. The country also has the highest number of patients with DR-TB, an advanced version of the airborne disease. The most powerful antibiotics do not work on such patients. When two of the most powerful antibiotics used to treat TB do not work on a patient, it is known as multi-drug resistant tuberculosis, or MDR-TB. If four main antibiotics do not work, it is known as extremely-drug resistant tuberculosis, or XDR-TB. By the Indian health ministry’s conservative estimates, India has 1,47, 000 DR-TB patients.
In 2012, bedaquiline became the first drug approved by the United States Food and Drug administration to treat DR-TB. Making it available to Indian patients was critical to containing the global pandemic. Nadda’s announcement was keenly followed within the global public-health community, which had been waiting for India to start using the most effective medicine for DR-TB.
India is accessing this drug solely through the Bedaquiline Donation Program, a collaboration between the United States Agency for International Development and the American pharmaceutical giant Johnson & Johnson, or J&J, which currently holds the patent for the drug. In December 2014, J&J announced that its subsidiary, Janssen Pharmaceuticals, would donate $30 million worth of bedaquiline to low-and middle-income countries over a four-year-long period. Until March 2019, when the donation program was phased out, India had received 10,000 doses. In April 2019, the company donated an additional 10,000 doses to India.
Three years after the glitzy launch of bedaquiline, responses obtained under the Right to Information Act reveal that the Indian health ministry does not have a clearly defined framework guiding its procurement of the drug, nor a spelled-out donation policy. In response to multiple right-to-information queries I filed in June 2019, the health ministry said that it had not signed a memorandum of understanding with USAID and J&J, nor laid down terms of references while signing on to the donation program. The ministry’s RTI responses and publicly available documents, such as the health ministry’s guidelines on the use of bedaquiline, show that the only paperwork done to bring bedaquiline to India was an import license granted to Janssen in January 2015.
In one of its RTI responses, the health ministry said that “there is no MOU or agreement carried out for the drug courses provided under USAID Bedaquiline donation program.” In another RTI query asking for specific terms of agreements for the additional 10,000 doses of bedaquiline that J&J donated in April 2019, the health ministry once again replied that “there are no terms of agreements carried out between USAID and RNTCP for additional 10,000 Bedaquiline courses under USAID donation programme in 2019.” The Revised National Tuberculosis Control Programme, or RNTCP, is the government’s division to address the TB epidemic in India.
Health activists, lawyers, and TB survivors told me that they were concerned at the lack of transparency with which the Indian government has procured the drug, and the government’s reliance on a temporary donation program, where patients must depend on the generosity of a pharmaceutical company. So far, the Indian government has depended entirely on donations from this program to procure bedaquiline. Further, there is little clarity on how the donations are being used, and how doctors determine which patients qualify to access the drug.
Currently, India has access to only 20,000 doses, when at least 1,47,000 patients qualify for it under the World Health Organisation’s treatment guidelines, which recommend that DR-TB patients be treated with bedaquiline. While the Indian health ministry on paper, allows bedaquiline for all patients with drug resistance, media reports estimate that only 2.2 percent of eligible patients are currently receiving the drug. The medicine is being given out through select authorised government hospitals.