Without a magic wand, India cannot eliminate TB by 2025

GeneXpert

Only 93,000 MDR-TB cases have been diagnosed till 2015 in India.

At the end of 50 years of tuberculosis control activities, the disease remains a major health challenge in India. As per new estimates, the number of new cases every year has risen to 2.8 million and mortality is put at 4,80,000 each year. These figures may go up when the national TB prevalence survey is undertaken in 2017-18. Against this backdrop, the Ministry of Health and Family Welfare, in its national strategic plan for tuberculosis elimination (2017-2025), has set a highly ambitious goal of “achieving a rapid decline in burden of TB, morbidity and mortality while working towards elimination of TB by 2025.”

Though the Revised National Tuberculosis Control Programme (RNTCP) has treated 10 million patients, the rate of decline has been slow. Providing universal access to early diagnosis and treatment and improving case detection were the main goals of the national strategic plan 2012-17. But the RNTCP failed on both counts, as the Joint Monitoring Mission report of 2015 pointed out. Going by the current rate of decline, India is far from reaching the 2030 Sustainable Development Goals — reducing the number of deaths by 90% and TB incidence by 80% compared with 2015. Yet, the latest report for TB elimination calls for reducing TB incidence from 217 per 1,00,000 in 2015 to 142 by 2020 and 44 by 2025 and reduce mortality from 32 to 15 by 2020 and 3 per 1,00,000 by 2025.

Incidentally, nearly 50% of people in India are latently infected with TB. According to CDC, 5-10% of infected people will develop TB disease at some time in their lives. “About half of those people who develop TB will do so within the first two years of infection,” the CDC says. With the latently infected people acting as a reservoir, it will be nearly impossible to eliminate TB in India by 2025.

Radical approaches are needed to come anywhere close to reaching these ambitious targets. Most importantly, the TB control programme plans to do away with the strategy of waiting for patients to walk in to get tested and instead engage in detecting more cases, both drug-sensitive and drug-resistant. The emphasis will be on using highly sensitive diagnostic tests, undertaking universal testing for drug-resistant TB, reaching out to TB patients seeking care from private doctors and targeting people belonging to high-risk populations.

The other priority is to provide anti-TB treatment — irrespective of where patients seek care from, public or private — and ensure that they complete the treatment. For the first time, the TB control programme talks of having in place patient-friendly systems to provide treatment and social support. It seeks to make the daily regimen universal; currently, the thrice weekly regimen is followed by RNTCP, and the daily regimen has been introduced only in five States. There will be a rapid scale-up of short-course regimens for drug-resistant TB and drug sensitivity testing-guided treatment. In 2013, India “achieved complete geographical coverage” for MDR-TB (multi-drug-resistant tuberculosis) diagnosis and treatment.  Yet, only 93,000 people with MDR-TB had been diagnosed and put on treatment till 2015; several MDR-TB cases are simply not diagnosed.

What next?

Though Bedaquiline, the drug for people who do not respond to any anti-TB medicine, is provided in six sites in the country, the number of beneficiaries is very small. It has been a battle to get the drug for treatment, as in the case of an 18-year-old who had to approach the Supreme Court for help. Yet, the report envisages a countrywide scale-up of Bedaquiline and Delamanid.

In a marked departure, the report underscores the need to prevent the emergence of TB in susceptible populations. One such segment is those in contact with a recently diagnosed pulmonary TB. Incidentally, active-case finding is already a part of the RNTCP programme but rarely implemented. It wants to increase active case finding to 100% by 2020. Since RNTCP expenditure has increased by 27% since 2012 and is inadequately funded, the Ministry proposes to increase funding to ₹16,500 crore.

Acknowledging that the business-as-usual approach will not get the Health Ministry anywhere close to the goals, it has earmarked critical components that will be addressed on priority. These include sending customised SMSes to improve drug compliance, incentivising private doctors to notify cases and providing free medicines to patients approaching the private sector, facilitating nutritional support to TB patients, including financial support, rewarding States performing well in controlling TB, and using management information systems to monitor all aspects of TB control. “The ultimate impact of this national strategic plan will be transformational improvements in the end TB efforts of India,” the report says. It plans to take a “detect-treat-prevent-build approach” in its war against TB.

Published in The Hindu on March 19, 2017

Why is TB bacteria not on WHO’s deadly superbug list?

Pharmacy - Photo R. PrasadOf the estimated 10.4 million new tuberculosis cases globally in 2015, nearly 0.5 million estimated cases were multidrug-resistant (MDR) TB cases. Another nearly one million were resistant to rifampicin drug alone. India accounted for 2.84 million new cases in 2015, of which 79,000 had MDR-TB. There were 1.4 million TB deaths worldwide in 2015.

For the first time in nearly 50 years, two new drugs, bedaquiline and delamanid, were approved by the US Food and Drug Administration for use in MDR-TB cases. The accelerated approval of bedaquiline by the FDA was based on interim Phase IIa data. The lack of large-scale safety data and the paucity of effective TB drugs, especially for MDR-TB, are the reasons why the World Health Organisation insists that the drug be used only when all “options to treat TB using existing drugs have been exhausted”. The WHO also makes it abundantly clear that all efforts should be taken to avoid TB bacteria from developing drug resistance to bedaquiline as a result of misuse.

Despite the gravity of the situation and a near-empty drug chest to fight TB in India, a WHO list, released on February 27 of drug-resistant bacteria that pose the “greatest threat to human health” and for which new drugs are desperately needed, has no mention of Mycobacterium tuberculosis, the bacteria which causes TB.

Not a priority pathogen?
This is the first time that the WHO has released such a list and the prime objective of listing the “priority pathogens”, in its own words, is to “guide and promote research and development of new antibiotics… and to address the growing global resistance to antimicrobial medicines”.

The list is divided into three categories — critical, high and medium —based on the urgency of need for new drugs. While the WHO reasons that malaria and HIV have not been included in the list as they are not bacterial infections, it cites a completely different reason for not including TB bacteria. According to the WHO, TB bacterium was not included in the list as it is already targeted by other “dedicated programmes”.

In a strongly worded open letter to WHO’s Director-General Dr Margaret Chan, The International Union Against Tuberculosis and Lung Diseases, or simply The Union, says it is “outrageous” that Mycobacterium tuberculosis was not considered for inclusion as it is “already a globally established priority for which innovative new treatments are urgently needed”.

“This explanation defies reason [and] contradicts the stated intent of the global priority pathogens list’s methodology to define the list,” the letter reads. “TB’s exclusion sends the false and counterproductive message that drug-resistant TB is not an urgent public health threat,” the letter says. It also send a strong message to policymakers to “deprioritise TB research”, it adds.

Meets criteria for inclusion
The reason why The Union has reacted so strongly is because the TB bacteria meets each of the 10 criteria used for inclusion in the list — how deadly the infections are, the number of infected people in a community, prevalence of resistance, how easily the bacterium spreads from one person to another, options to prevent the infection in hospital and community, treatment options and whether new drugs are already in the R&D pipeline.

The WHO states that new antibiotics most urgently needed will never be developed in time if it is left to market forces alone. This is best demonstrated in the case of TB. It took nearly 50 years for new TB drugs to be approved for MDR-TB and not a single antibiotic has been developed for drug-sensitive TB in half a century.

Since the WHO has stated that the list has been developed to allow periodic revisions and inclusions of other pathogens, including viruses and parasites, The Union wants the TB bacteria to be included in the list before the WHO publishes the full protocol and results by the end of May 2017.

Published in The Hindu on March 5, 2017

Nandita: Deaf but not out

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Nandita Venkatesan lost her hearing in the blink of an eye due to TB injection. – Photo: R. Prasad

When she woke up after a short afternoon nap on November 22, 2013, two days after her 24th birthday, Nandita Venkatesan could see her mother and brother talking to her but could understand nothing; she could hear sounds but could not comprehend them. The noisy world around her almost fell silent. Her hearing loss was 80 per cent in the left ear and 50-60 per cent in the right ear. It has since deteriorated to over 90 per cent in both ears. The villain was the second-line anti-tuberculosis injection kanamycin that she had had for about three months.

Venkatesan’s first tryst with tuberculosis (TB) was in August 2007 when she was diagnosed with intestinal tuberculosis just a month after starting college in Mumbai. Popping 10-15 pills a day for 15 months and battling with the side effects of medication left her with little time to enjoy the pleasures of college life.

As if once was not enough, TB came to haunt her again; she suffered a severe reinfection in 2013. “The memories of the first bout came back to haunt me,” she says in an email. But what she did not realise was that the bacteria were intent on striking a body blow.

The TB infection was severe and medicines alone were ineffective the second time around. “The gnawing abdominal pain was far more severe than the first time and continued despite the medication. I convulsed with acute pain and it started hampering my day-to-day activities. Anything I ate immediately hurt my stomach and passed out undigested,” Venkatesan recalls. The only option left was to undergo a surgery to remove the infected portion of her intestine.

As she was wheeled in to the operation theatre, she reassured herself that things couldn’t get out of hand and she would be on the road to recovery very soon. But that was not to be. Normal life after surgery was short-lived; in a week, she was back in a bigger hospital as her condition had turned critical. Days stretched to months and one surgery turned to four as the infection spread. She underwent three major operations back to back and began second-line drugs after the second surgery when doctors found TB had spread beyond the intestine and she was not responding to first-line drugs. But the culture test result revealed that she was not infected with drug-resistant TB.

Walking skeleton

Solid food was ruled out and only small sips of water every hour were allowed. Nutrition plays a crucial role in recovering from TB but she had to subsist on IV fluids alone and this took a huge toll on her body. She became a walking skeleton after losing 23 kg. Her hair started to fall out. “I vividly remember going for a small walk in the hospital and seeing a reflection of myself in a glass window — with bald patches. I couldn’t recognise myself,” Venkatesan says.

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Nandita at the hospital.

“I was in hospital for two months. Since TB had started to spread to other parts of my body, it led to serious complications. Honestly, I didn’t know if I would survive, all I knew was that I was not going to give up,” she says.

After the surgeries, Venkatesan thought she was done with her quota of pain. Little did she realise that the worst was yet to come: her ordeal had just begun with permanent hearing loss. Soon she was hurtling from one problem to another — low BP, low sugar leading to memory loss on five occasions, and elevated creatinine levels.

“It felt like I would never be able to laugh again in my life,” she says. “But I soon realised I had to make the best of the worst situation. I could not sit and feel sorry for myself. In concentrating too much on the closed doors, I forgot to pay attention to the small windows of opportunity and hope. The way out, I felt, was to accept the situation and learn from it. Acceptance helps you move on and find solutions rather than wallowing in self-pity.”

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Despite being profoundly deaf, she still dances.

Surviving two bouts of TB infection has taught her to be a fighter and never give up even when pushed to the edge. The inner strength that once turned her into a warrior while in hospital emerged once again. She went back to dancing, her first love, but this time without the luxury of hearing the music. “I took to dance as a way to emerge from my closet and as a means to regain my shattered confidence. I saw it as a means to channel my pent-up energy and exasperation,” Venkatesan says. When she learnt that her dance school was organising a programme, she embraced the opportunity.

Determination, perseverance and imagination have been her strengths. Though profoundly deaf (she can only hear sounds as loud as the bursting of crackers), she slowly learnt to grasp dance steps and co-ordinate with her partners. The dancer in front of her acted as a cue and she memorised the beats, lyrics and steps. She could also feel the vibrations of the rhythm with the help of a hearing aid. “I also use number counts to grasp the beats. For example, if the beats are: Tai…Ta Ka Ki Ta, I convert them to numbers 1…1-2-3-4,” Venkatesan says. “Dance has proved to be incredibly cathartic. It has helped me embrace this ‘rebirth’ and the next stage of my life with more conviction. I guess, ultimately, the desire to dance won against the instinct to flee!”

Battle ready

It may not be an exaggeration to say that Venkatesan has mastered the art of adaptability. Having learnt to lip-read quite well, she has now started learning sign language. She has also learnt to handle everyday challenges like crossing the road by following a person. Venkatesan has been working in a financial newspaper in Mumbai since April this year. “I took a big step towards conquering my disability and kicking TB out of my life,” she says about her decision to work.

Besides actively participating in several programmes to raise awareness about TB as a survivor, Venkatesan is thinking big. She will be participating in the international group action.org’s TB R&D media and public speaking programme to be held in Berlin in January 2017. She also intends to pursue a doctorate in a few years.

“I am far more comfortable in my skin than before. The deafness does bother me sometimes but I have understood what I am capable of,” she says. As a message to other TB survivors, Venkatesan says: “The key is this: be brave; be determined. Take it as a second chance at life. Besides, when life pushes you over, you ought to push back harder!”

Published in The Hindu on December 10, 2016

Mumbai researchers use blood samples to diagnose pulmonary TB, MDR-TB

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Dr. Deepak Modi and other researchers have found two microRNAs at abnormal amounts in people with drug-sensitive TB and MDR-TB.

Mumbai-based researchers have identified two microRNA biomarkers present in serum samples that could potentially be used for TB diagnosis and TB disease prognosis. It could be used both for drug-sensitive pulmonary TB and MDR-TB diagnosis. The results were published in the journal Tuberculosis.

Compared with controls, the microRNA miR-16 level in 30 newly diagnosed drug-sensitive pulmonary TB patients was 5-6 times higher and the miR-155 level was about two times lower.

Of the 30 patients studied, serum samples collected from 10 patients were tested for the two microRNAs at the time of diagnosis and after the completion of treatment. “The levels of miR-16 and miR-155 returned to normal level once the patients completed the treatment,” says Dr. Deepak Modi from the National Institute for Research in Reproductive Health, Mumbai and one of the authors of the paper.

The changes in the levels of the two microRNAs during the course of treatment are, however, not known as samples were not collected at different time points. “We plan to undertake a longitudinal study soon,” he says.

MDR-TB diagnosis

The levels of these two microRNAs are very different in people with MDR-TB compared with drug-sensitive pulmonary TB and healthy individuals. Serum samples from 19 MDR-TB patients were studied by the researchers.

The miR-16 shows better predictive value than miR-155 in both drug-sensitive pulmonary TB and MDR-TB cases.If the miR-16 is elevated 5-6 times in people with drug-sensitive TB, it is two times lower than the normal level in people with MDR-TB. In the case of miR-155 the reduction is only slightly less compared with drug-sensitive TB (it is intermediate between drug-sensitive TB patients and normal level). “We don’t know why the two microRNAs behave differently in MDR-TB patients compared with drug-sensitive TB,” Dr. Modi says.

The use of these biomarkers may expedite the diagnosis of MDR-TB. In India, patients are usually first treated with drug-sensitive TB drugs. It is only when they do not show any improvement even after a couple of months of medication is MDR-TB suspected. “In patients undergoing TB treatment if the miR-16 level is lower or if the miR-155 level is not increasing then MDR-TB should be suspected,” says Dr. Modi.

“The miR-16 shows better predictive value than miR-155 in both drug-sensitive pulmonary TB and MDR-TB cases,” says Vishal Wagh from the National Institute for Research in Reproductive Health, Mumbai and the first author of the paper.

Advantage blood test

“The blood-based TB diagnosis using these biomarkers has great advantages. Even in adults a good number of them are unable to give sputum samples. Children, especially younger children, do not produce sputum samples. So diagnosis of pulmonary TB in these cases is difficult when we rely on sputum samples,” says Dr. Chander Puri, Pro-Vice Chancellor of MGM Institute of Health Science, Mumbai and who was not involved in the study.

The researchers are expanding the study to cover a larger population of drug-sensitive, MDR-TB and extra pulmonary TB patients. “There is no reason why the biomarkers should not be present in the blood even when TB is extra-pulmonary,” says Dr. Puri.

The difference 

The serum test developed by the NIRRH researchers is different from the serological test for TB, which is banned both by the World Health Oraginsation and India’s RNTCP. While the banned serological test is based on antibody response for diagnosing active tuberculosis (both pulmonary and extra-pulmonary), the one now being tested relies on microRNAs.

Published in The Hindu on November 6, 2016

Indian researchers enhance BCG vaccine efficacy using anti-leprosy drug

BCG vaccine

The TB bacteria load was 50 times less in mice that got the vaccine and anti-leprosy drug than mice that got only the vaccine. Dhiraj Kumar Singh (left), Dr. Anand Ranganathan (middle) and Prof. Gobardhan Das

Indian researchers have been able to bring about more than 50-fold improvement in the efficacy of the commonly used TB vaccine — Bacillu Calmette Guerin (BCG) — by giving mice anti-leprosy drug (clofazimine) for a month along with a single dose of the vaccine. The duration of protection lasted till the end of the trial protocol period of 120 days. Results were published on August 29, 2016 in The Journal of Infectious Diseases.

“But the mice vaccinated with BCG will remain equally protected if just two doses of anti-leprosy drug are given on the day of vaccination and on day seven. This is because the drug has a long half-life of 28 days in mice,” says Prof. Gobardhan Das, the corresponding author of the paper from the Special Centre for Molecular Medicine, Jawaharlal Nehru University (JNU), Delhi.

To test the efficacy of the novel strategy, the BCG vaccinated mice that were co-treated with anti-leprosy drugs for a month were exposed to TB bacteria. “Sixty days after infection, there was more than 100-fold reduction in the TB bacterial load in the lungs of the mice that got both the vaccine and drug compared with mice that did not the vaccine and drug,” says Dhiraj Kumar Singh, a co-author of the paper from JNU. “The bacterial load was more than 50 times lesser in mice that got the vaccine and drug compared with mice that got only the vaccine.”

“This is an exciting advance over Prof Das’ earlier work on the limited efficacy of the BCG vaccine,” says Prof. Anand Ranganathan, a co-author in the paper from the Special Centre for Molecular Medicine, JNU. “It should be noted that a new anti-TB vaccine is unfortunately still a good decade or two away. Given this, an improvement in the existing vaccine, through administration of an existing drug, is as good as it can get.”

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The anti-leprosy drug increases the amount of central memory T cells in mice.

BCG efficacy 

The BCG vaccine efficacy is critically dependent on the generation of long-lasting memory cells called the central memory T (Tcm) cells. The Tcm cells, in turn, generate effector memory T (Tem) cells that kill the TB bacteria. Though BCG has more than 80 per cent efficacy in protecting children from meningitis and military TB, the vaccine’s efficacy diminishes with time, particularly in TB endemic regions.

This is because people in TB endemic countries are continuously exposed to TB bacteria as every third person harbours them. With regular exposure to TB bacteria, the Tem cells that fight the bacteria get used up and the pool of Tcm cells that get converted to Tem cells eventually get exhausted, thereby rendering the host to TB infection, explains Singh. If the Tcm cells are much higher in number to start with then they can convert to Tem cells for a longer period of time and produce a much rapid and stronger response against TB bacteria and protect the individual from TB infection for an extended period.

Tinkering with protection

This is precisely what the team led by Prof. Das achieved. The researchers nearly doubled the size of  central memory T (Tcm) cell pool by administering anti-leprosy drug (5 mg/kg body weight) to mice that were already vaccinated with BCG. “Initially after vaccination both Tcm and Tem cells are produced.  Because we don’t want Tem cells, we try to make most of the cells into Tcm cells. This is achieved by administering the anti-leprosy drug on the same day of BCG vaccination.  Since the drug blocks the potassium channel of Tem cells, the production of Tem cells is slowed down or inhibited and the cells are pushed to become Tcm cells. This leads to an increase in Tcm pool,” says Prof. Das.

“Our study suggests that clofazimine [anti-leprosy drug] treatment enhances the pool of Tcm cells induced by the BCG vaccine, and these cells have the potential to continuously replace Tem cells at the site of infection,” they write. “Therefore, clofazimine might function as an effective immune modulator to enhance the efficacy of BCG vaccination in humans.”

“Adults who have already been vaccinated with BCG can be given another dose of BCG along with clofazimine anti-leprosy drug. Since mice were protected for 3-4 months, we can conservatively say that the vaccine protection could last for 40 years in humans,” says Prof. Das.

The next step is to test the novel strategy in monkeys and then in humans. “I would like to carry out the test in monkeys if I get funding,” Prof. Das says.

Published in The Hindu on August 30, 2016

Pharmacies in India may not be causing TB drug-resistance

Pharmacy - Photo R. Prasad

Thirty-seven per cent of 622 pharmacies in Mumbai, Delhi and Patna handed out antibiotics to TB ‘patients’ with symptoms. – Photo: R. Prasad

If an earlier study revealed the tendency of private practitioners to liberally use antibiotics to treat tuberculosis leading to a delay in TB diagnosis and treatment and increase the chances of TB spreading within a community, pharmacies in Delhi, Mumbai and Patna are no better. A study published on August 25, 2016 in the journal The Lancet found that a majority of 622 pharmacies in the three cities dispensed antibiotics to TB patients even when they did not carry a prescription.

According to government guidelines, “pharmacies are required to counsel patients with TB, identify and refer persons with tuberculosis symptoms to the nearest public health facilities for testing” and dispense TB drugs. Much like the private practitioners, pharmacies tend to be the first point of contact for primary care in India.

Srinath Satyanarayana, the first author of the paper from McGill University, Montreal, Canada used standardised TB patients — healthy individuals trained to pose as TB patients and interact with pharmacists — to understand how pharmacies in the three cities treated patients presenting with TB symptoms or microbiological confirmation of pulmonary TB. The other main objective was to determine whether the pharmacies were contributing to the inappropriate use of antibiotics.

The standardised patient 1 presented with 2-3 weeks of cough and fever and was directly seeking drugs from a pharmacy. The standardised patient 2 presented with one month of cough and microbiological confirmation of TB from a sputum test.

Only 13 per cent of simulated patients with TB symptoms and 62 per cent of patients with microbiological confirmation were correctly managed.As expected, liberal dispensation of antibiotics was seen in the case of standardised patient 1. Only 96 of 599 pharmacies (16 per cent) refereed such patients to health-care providers. But ideal case management was in only 13 per cent of the cases as a few pharmacies handed out antibiotics to the patients even while referring them to a physician. Antibiotics (37 per cent), steroids (8 per cent) and fluoroquinolones (10 per cent) were given to standardised patients with symptoms.

“That nearly 37 per cent of the pharmacies are handing our antibiotic to persons presenting with TB symptoms is really worrisome,” says Dr. Satyanarayana in an email to me. But more worrying is the dispensation of fluoroquinolones. “Fluoroquinolones are an essential part of MDR-TB treatment regimen and emerging regimens, so quinolone abuse is a concern,” they write.

In stark contrast, in the case of standardised patient 2 who had a microbiological confirmation of TB disease 67 per cent (401 of 601) of pharmacies referred the patient to a health-care provider.  Like in the earlier case, ideal case management was seen in only 62 per cent as the standardised patient did receive antibiotics (16 per cent) or steroids (3 per cent) even while being referred to a health-care provider.

“In case of TB patients with microbiological confirmation of TB disease, antibiotics (without anti-TB properties) will be ineffective and un-necessary, and can delay the initiation of proper therapy for patients. These patients will continue to spread the disease in the community and TB disease will continue to progress in the concerned individual. Steroids reduce body immunity, suppress symptoms temporarily and can worsen the TB disease,” Dr. Satyanarayana says.

Silver lining

The only silver lining is that none of the pharmacies in all the three cities handed out first-line anti-TB drugs to these “patients.” So pharmacies are unlikely sources of irrational drug use that contributes to multidrug-resistant tuberculosis. “Also, pharmacies are not trying out high end antibiotics such as fluoroquinolones when they realise that the patient has some underlying illness such as TB,” he says.

“TB Drug resistance occurs primarily due to incorrect regimens, intake of drugs irregularly or intake of drugs for very short duration of time. From our study, it appears that pharmacies are not playing a role in deciding the anti-TB regimens and are also not dispensing anti-TB drugs over-the-counter, at least in the three cities that we studied. So the drug resistance in India could be due to either patient related factors or provider related factors or due to health system related factors (which has not created a system for all TB patients in country to access quality assured diagnosis and treatment free of cost and seamlessly),” Dr. Satyanarayana says.

One reason why pharmacies did not dispense anti-TB drugs could be because they belong to a more stringent Schedule H1 category of drugs where details of the prescription and name of the doctors and patients have to be documented and the registry has to be retained for two years.

Indian private sector bears 2-3 times higher TB burden than estimated

GeneXpert

A major revision of the TB burden estimates might be required both for India and the world.

A study has found that in 2014 there were 2.2 million TB patients treated in India’s private sector alone. This is 2-3 times higher than current estimates.

In all probability, the higher TB burden in the private sector might still be an underestimation as drug-resistant TB cases were not taken into account. Thus, the private sector is treating an enormous number of patients for TB, appreciably higher than has been previously recognised. In contrast, the State-run Revised National Tuberculosis Control Programme (RNTCP) treated 1.42 million TB patients in 2014.

According to a 2015 WHO report, six million new TB cases were reported to WHO from across the world in 2014. And India’s TB contribution accounted for 26 per cent of these reported cases. But based on the results of the study, a major revision of the TB burden estimates in India and worldwide might be required. Under-reporting of TB cases could be significantly fuelling drug resistance and have implications for patients across the globe.

More importantly, the results of a study published on August 25 in the journal The Lancet suggests that TB incidence is considerably higher than previously recognised, Prof. Nimalan Arinaminpathy, the first author of the paper from the School of Public Health, Imperial College London, says in an email to me.

India has to redouble efforts to reach patients being treated in the private sector.

Lack of systematic data

Despite the private sector treating more patients than the public sector, systematic data on the private sector was lacking. So the study by Prof. Arinaminpathy looked at the sales of anti-TB drugs containing rifampicin by pharmacists across the country in 2013 and 2014. The team then used this figure to calculate the number of cases. The authors adjusted for TB overdiagnosis in the private sector. There was much variance in the number of patients treated in the private and public sector in different States. For instance, the public sector in Orissa had 1.5-2.8 times the volume of TB medicines prescribed than the private sector but Bihar had three times the volume of TB medicines prescribed in the private sector than public sector. But on a national level, there was nearly twice as much TB treatment in the private sector as in public sector in 2013 and 2014.

The 2.2 million cases treated in 2014 in the private sector was arrived at by considering that TB patients underwent four months of treatment on average and only 50 per cent of TB diagnosis in the private sector was correct. The number of patients treated in the private sector increases when higher accuracy of positive TB diagnosis and shorter average treatment duration were considered.

The results of the study have major implications for TB strategy for India. The disorganised private sector poses several challenges to TB control. Since free TB care is assured even to patients opting for private sector, India has to “redouble efforts to reach patients being treated in the private sector and to deliver the highest possible standards of TB care.”

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Indians spent $59 million for TB drugs alone in the private sector in 2014.

Second, surveillance of TB in the private sector has to be strengthened. In 2014, as against 2.2 million cases, only a little over 100,000 cases were notified by doctors in the private sector. “But the government has been making strong progress in engaging with providers in the private sector. There has been a rapid increase of private-sector notifications in the last two years (there were essentially zero in 2011). These are encouraging first steps, and our results show the scale of the challenge ahead,” he says.

 Finally, there is a compelling need to find the true TB burden in the country. “TB burden is typically measured through TB prevalence surveys, the most recent of which was in Gujarat. We may soon see the opportunity to conduct these surveys more broadly across the country, which would cast critical light on the TB burden in India as a whole,” says Prof. Arinaminpathy.

There is an economic cost attached to the disease. Since TB treatment in private sector is met primarily by out-of-pocket expenditure, as no medical insurance in India covers treatment cost, a six-month treatment course for first-line TB drugs would cost $20. The 2.2 million patients seeking care in the private sector would have therefore spent $59 million for drugs alone.

Published in The Hindu on August 25, 2016