Prime Minister Narendra Modi wants to rid India of tuberculosis (TB) by 2025. This is an ambitious deadline five years in front of the global elimination deadline. Can this goal be achieved or is the new deadline simply political point scoring?
The state of TB in India
India has a bad track record in meeting these self imposed elimination deadlines. The most recent example of this is kala-azar, or leishmaniasis. The National Health Policy 2017 aimed to eliminate the disease by the end of 2017. This deadline was not achieved. Similar elimination deadlines were failed in 2015 and 2010.
India faces considerable issues with TB, with far more cases of TB than of kala-azar. India accounts for 23 percent of TB cases worldwide, with 2.79 million cases in 2016 and 423,000 deaths. India also accounts for the most child deaths from TB, with 55,000 deaths associated with the disease in 2015. It will be a far more significant task to eliminate the disease.
The Prime Minister has launched the TB-free India Campaign to attempt to combat the disease. He has stressed that state cooperation will be vital to ensure a thorough and coordinated response to eliminating the disease.
Grassroots campaigns are also essential, according to the PM. He uses the term “TB-free village, panchayat, district and state” in describing the methodology, and talk about the importance of front line workers.
India has shown huge successes in this method before. Polio elimination is a prime example of this.
The campaign placed a huge emphasis on cooperation between boots on the ground and larger organisations, both public and private. Partnerships with pharmaceutical companies allowed steady supplies of vaccinations, while cooperation between central and state government allowed supply chains down to the village level.
Previous campaigns have achieved a huge degree of success by also focusing on the spreading of information, an example being the polio eradication campaign. This aspect would be vital for the elimination of TB as early diagnosis and subsequent treatment can help to limit the spread of the disease. This will also be critical to reducing the spread of drug-resistant tuberculosis (DR-TB).
A rapid reduction in TB cases may be critical to India’s success in eliminating the disease, particularly targeting DR-TB. Every year there is an estimated increase of 480,000 cases of DR-TB globally. Many of these occur in India.
As more and more strains of TB do not respond to first line therapies, the disease becomes ever more difficult to eliminate. Compounding the issue is the fact that access to treatment for DR-TB is limited for Indian patients.
A major controversy has taken place in India recently regarding bedaquiline and delamanid. Whilst controversial and in need of further study, these medications are considered the most effective front-line treatments for DR-TB, though the claim is disputed.
During the trials for bedaquiline, it was found that more people died in the treatment group than in the placebo control group, raising questions about its safety. The World Health Organization appear to have acknowledged this fact, recommending all those receiving the drug be monitored for the duration. Delamanid was shown in stage III human trials to be far less effective than initially thought, showing only marginally better results than a placebo.
Fewer than 1,000 DR-TB patients in India received bedaquiline and just 81 receive delamanid. This has led to pressure being placed on the government to issue a compulsory licence (CL) so that manufacturers can produce generic versions of bedaquiline and delamanid without the permission of Johnson & Johnson and Otsuka, the drugs’ respective developers.
The government has commenced negotiations with the firms to boost access, reports Livemint. The government is petitioning the drugmakers for the medications to be included as part of the Revised National Tuberculosis Control Program (RNTCP). This aims to achieve a ‘TB-free India’ and promote universal access to TB treatment and control services.
The government presently has access to 10,000 doses of Bedaquiline and 400 doses of Delamanid. J&J have reportedly offered to provide one course of Bedaquiline treatment to the government free, if the government buys four courses at Rs 58,400 (US$900) each. This is the standard price in similar markets such as South Africa. One course of Bedaquiline consists of 188 tablets and lasts a patient six months.
J&J is also said to be in the early stages of talks to grant a voluntary licence to generic drugmaker Macleods Pharmaceuticals. This would allows Macleods to produce a generic version of Bedaquiline. Mylan, which distributes delamanid in India, is proposing a ‘Make in India’ initiative to lower the price of the drug once current stocks are spent.
‘The ground reality’
The PM has acknowledged that despite India’s awareness of the TB crisis, government policy has failed in adequately responding to it. “The ground reality still remains that we have not been successful in curbing tuberculosis yet,” Mr Modi says. “If something doesn’t yield desired results even after 10-20 years, then we need to change our approach and analyse the work done.”
The government campaign to eliminate TB notes that the poor are disproportionately affected. To help in addressing this, a total of USD 100 million per year has been pledged by the government for providing nutritional support to the patients suffering from disease.
However, to be more than just empty words, the campaign must find effective means of providing treatment to the many that cannot afford it. It must also delve into rural areas to prevent remote locations becoming reservoirs for the disease, creating the possibility of future outbreaks. The task is ambitious and, without extensive plans, may become yet another missed deadline.
Johnson & Johnson and Otsuka were approached by Health Issues India for comment. At the time of writing, they have not responded.