According to the World Health Organisation (WHO) 2016 TB report, there were an estimated 480,000 new cases of multi-drug resistant tuberculosis (MDR-TB) globally and India, China and the Russian Federation accounted for 45% of these cases.
The overuse of antibiotics worldwide has caused many bacteria to become resistant to the drugs, including rifampicin and isoniazid drugs, which are used to treat TB.
India accounts for 24% of all TB cases in the world, and the spread of the disease in the country is larger than previously projected. While India has been engaged in TB control efforts for decades now, the disease continues to remain one of our greatest public health challenges. It is estimated to kill 480,000 Indians every year. Moreover, government data reveals a 35% rise in drug-resistant TB case notifications in 2016.
In the recently released National Strategic Plan (NSP) for TB elimination 2017-2025, the health ministry said the key threats for TB eradication are amplification of drug resistance and insufficient budgetary outlay for health in the national budgets, which in turn compromises the allocation to TB.
Under the draft NSP, the ministry seeks funds of Rs16,649 crore for 2017 to 2020. According to a report by IndiaSpend, this is five times what the TB programme received in the last three years put together—Rs3,323 crore.
WHO also recognizes that funding for TB research globally is much lower than what is required.
“Despite some progress in the pipeline for new diagnostics, drugs and regimens, and vaccines, TB research and development remains severely underfunded. At least $2 billion per year is needed for TB research and development. Funding during the decade 2005-2014 never exceeded $0.7 billion per year," according to the WHO report.
In India, too, focus on TB research, especially drug-resistant TB, needs to be enhanced significantly.
“WHO reports that the last time a drug was introduced specifically for the treatment of TB was in the late 1960s. Resistance to antimicrobials is growing at a faster rate than discovery of newer, more potent drugs to overcome that resistance. Therefore, it is crucial that India focuses its research efforts on developing solutions for drug-resistant TB," Suneela Thatte, president of Indian Society for Clinical Research, said.
Globally, there are nine drugs in advanced phases of clinical trials, including bedaquiline, delamanid and linezolid, for the treatment of drug-susceptible TB, and drug-resistant TB. Also, 13 vaccine candidates are in clinical trials, the WHO report said.
According to data from QuintilesIMS, a healthcare information and technology firm, around 24 molecules are available in India for the treatment of drug-resistant TB, which include fluoroquinolones and second-line injections as well as new drugs like bedaquiline. However, bedaquiline is currently provided only at six government TB centres and another new drug delamanid is yet to get approval from the drug regulator.
Under the NSP, the government plans to introduce a shorter MDR-TB regimen and envisages country-wide scale-up of new drugs like bedaquiline and delamanid.
“We do have access to some potential new drugs and treatments, but we need to undertake research to study their effects. For instance, one of the clinical trials proposed by ICMR (Indian Council for Medical Research) includes assessing the safety and efficacy of using metformin, a diabetes medication, as an adjunct therapy for TB. Should the study show positive results, it would transform TB therapy for a long time," said Sundeep Salvi, director of the Chest Research Foundation.
Lack of awareness about correct treatment among doctors, especially in the private sector, indiscipline among patients to complete treatment and limited diagnostic capabilities for drug-resistant TB are the other key challenges.
Lokesh Sharma, head public health-Africa, Middle East, South Asia, QuintilesIMS, said about 50% of TB patients go to private doctors for treatment and the government has started engaging more with the private sector to educate them on the treatment options, which is a step in the right direction.
Currently, standard treatment for TB lasts six months and treatment for drug-resistant TB extends up to 24 months. At government centres, the treatment is free of cost, while average cost of standard treatment in the private sector is about Rs2,500. For drug-resistant TB, the cost is about Rs5,000 per month for about 24 months, said K.S. Satish, senior consultant pulmonologist at Fortis Hospital in Bengaluru.
He added that patients approaching practitioners in alternate health systems such as homeopathy and ayurveda for treatment is also an area of concern because TB cannot be treated by these therapies.