Credit: DH Photo
For five months and twenty days, Kamala Devi* diligently took close to six pills, the prescribed fixed drug combination, determined to get rid of the spectre of tuberculosis from her life. The disease had caused considerable disruptions in her daily schedule, bearing an impact on her personal life and threatening her job as a custodian at a private hospital in Bagalkot.
The last week of treatment was pending when she returned to the Bagalkot General Hospital to get a refill of her prescription. “The pharmacist told me that the drug was out of stock. They asked me to come again next week. I have gone without the tablet for four days now,” she says. As a single mother and sole wage earner in her family of four, buying the medication out of pocket is out of the question.
Doctors had warned that even a day’s disruption in the course of treatment could make the disease worse. Devi had a taste of this when she stopped the daily dose of anti-TB treatment after her symptoms vanished, three months into the course. “The disease returned and it was worse than before. I was coughing more, there was more phlegm build-up and I was so tired I could barely move. I did not want to go through that again,” she recalls. Forced to embark on a fresh six-month treatment course, she had been conscientious about taking the daily dose of late.
After the four-day interval in treatment, Devi fears that her efforts may have been in vain and that additional costs loom. “I have to now factor in tests because of the interruptions,” she says.
In the state’s capital, Srinivas P* finds himself in a similar bind. “Both my wife and I are undergoing treatment. I was in the last month of my treatment and she is in her first. Both of us have not received our medication from the Urban Primary Health Centre this month,” he explains.
As an electronics operator at a local manufacturing company, his wage cannot account for the medication expenses. “It can cost Rs 1,200 per month to buy the tablets for two people. If such expenses continue, we will have to discontinue the treatment,” he adds.
Several states, including Maharashtra, Odisha, Chhattisgarh, Bihar and Karnataka have reported acute shortages in anti-tuberculosis medication, putting the health and welfare of about 28.2 lakh patients in jeopardy.
On the ground, tuberculosis health visitors – the liaison staff placed at hospitals to monitor TB prevention and control – explain that the first line of treatment consisting of the 4 fixed drug combination (4FDC) of Isoniazid, Refampicin, Pyrazinamide and Ethambutol and the 3FDC of Isoniazid, Refampicin and Ethambutol are in short supply. To treat drug-sensitive tuberculosis, patients are usually prescribed the 4FDC for two months and the 3FDC for four months.
Many patients have foregone treatment for several days, interrupting a medical schedule that doctors say should not be broken at any cost.
With India accounting for 27% of the world’s TB disease burden, the impact of hitches in the daily dose of TB medication can have devastating consequences for the lakhs of people in active treatment. This could cause relapse of symptoms, magnify the incidence of drug-resistant strains of TB and increase the chances of the spread of these strains, say medical personnel, health functionaries, social workers and activists. Even though 85% of TB cases can be cured, the country has already witnessed an 11% spike in mortality rate due to all forms of the disease between 2019 and 2020.
DH Illustration
Frequent interruptions
On the heels of widespread reports of deficient supplies of drug-resistant TB medication in September of last year, this is the second instance of scarcity in TB drugs within the ensuing seven months. While stockouts during the Covid-19 pandemic have been linked to global shortfalls, the most recent incidents do not have such precursors.
This time around, the Central TB Division, the authority that procures and distributes drugs to state warehouses, notified states on March 18 that a tendering issue had caused disruptions in the supply of drug-sensitive anti-TB treatment. The division also authorised states to procure the required drugs locally, approving alternatives to the 3FDC and 4FDC.
Following such a notification, Karnataka’s Health Minister, Dinesh Gundu Rao, wrote to Mansukh Mandaviya, the Union Minister of Health and Family Welfare, requesting support to maintain the supply of critical drugs.
“While I do not wish to accuse the Union government of callousness, I have to point out that state support for the TB patients has been jeopardised by this action of the Centre,” he wrote. As the notification was issued after the model code of conduct (MCC) came into force, the state government was having difficulties in procuring the required quantity of drugs.
Stopgap measures
District administrations and individual officials from the National TB Elimination Programme have started requisitioning the drugs. “We received word from the government of India about issues with drug procurement and have obtained permission from the Election Commission to notify people and supply the drugs. The ministry is putting in all efforts to obtain the drugs at both the state and district levels,” Rao tells DH.
Some patients have also been asked to buy medications from local pharmacies with the reassurance that costs would be reimbursed. However, both programme officials and patients have had limited success. “This is a stop-gap measure but if the shortage continues, I do not know if we will be able to keep it up,” says a TB health visitor in Bengaluru.
“The problem is that, even if new cases are detected, we are not able to source medication for them,” he adds.
The availability of anti-tuberculosis medication in the open market has declined over the years. Dr Madhusudhan Kariganaru, a private practitioner, explains that pharmacies have stopped stocking fixed drug combinations, after the government made it mandatory for health functionaries to log the amount of tablet strips issued in the Ni-Kshay app, to minimise interruptions in the course of treatment.
“Due to these complexities, even though private practitioners would diagnose patients with TB, following the necessary tests, go on to ask patients to take the prescriptions to PHCs and other centres that issue drugs. The government medications are of superior quality but are unavailable,” he adds.
As a result, even people who can afford to buy drugs are unable to find pharmacies that stock them. The case of Jyothi K M, a 20-year-old woman from Ballari district, illustrates the crisis that many patients face today. Early this month the PHC that Jyothi’s father, Manjappa KM, frequents reported shortages. Every pharmacy that he subsequently approached did not stock the drug. “Ultimately, due to the additional costs and unavailability, we had to approach the PHC again. They are providing 1-2 strips at a time now,” says Manjappa K M, a mechanical supervisor in Ballari.
Availability and adherence
Adherence to medical schedules has been a core issue in addressing the TB epidemic in India — only 50% of diagnosed patients follow treatment schedules, according to a 2017 study.
A 2010 study, which samples over 538 patients in Mumbai, found that major prohibitive factors in patients who did not adhere to the daily dose of anti-TB treatment included the unavailability of pills and increased costs due to transport from the facility.
More than a decade later, these challenges have persisted, explains Bijaylaxmi Rautaray, a social worker in Bhubhaneshwar, who has experience bridging the gap between people and public healthcare systems.
Even when the general hospital is at a distance of 30 km away, travel costs and the disillusionment with public health systems can demotivate people from accessing medicines.
In one case, a patient Pritesh P* (73), was asked to come back to collect medicines from the community health centre located in Kordha district, Odisha, no less than three times. On the third visit, the family was told that stocks were yet to be replenished and that only medications for three days could be provided.
After Pritesh’s diagnosis in February last year, his family has spent upwards of Rs 4,000 in treatment costs in the private sector. The circuitous path severely demotivated the family. “What is the use of giving three days' medicine? It would be better for us to continue private medicines or let him die without medicines,” a member of the family said.
Tuberculosis is never just clinical, explains Chapal Mehra, a New-Delhi-based public health specialist, who works extensively on infectious diseases. It is a biosocial disease and affects the most economically impoverished sections of the population, he adds. “There are several impediments that contribute to patients being beleaguered mentally — including impact on family, stigma and availability of medication,” he says.
Even though the National Tuberculosis Elimination Programme (NTEP) has put in place guidelines to increase interactions between health functionaries and patients and has created counselling roles, these challenges are rarely understood and therefore continue to impact patients.
“One major issue with the way that the TB elimination programme is functioning is that there is very little investment in the community. TB survivors have valuable experience with recovery and this can help others as well. The success of the National AIDS Control Organisation can be replicated with TB as well,” says Ganesh Acharya, a TB survivor and activist based in Mumbai.
A threat looms
Following closely after the COVID-19-induced disruptions in the supply chain, the recent shortages could portend a greater threat of drug-resistant tuberculosis.
The World Health Organisation has emphasised that reduced sensitivity (RR-TB) to Refampicin, the most effective line of treatment against the disease, and to multiple drugs (MDR-TB) — like Refampicin and Isoniazid — is a matter of great concern.
“If the first line of treatment is not properly adhered to, RR-TB and MDR-TB are only bound to grow. This does not only mean that patients who suffer interruptions are affected, but also that drug-resistant strains can spread in the community and can occur in patients who are contracting TB for the first time,” explains Dr Kariganaru.
Not only are these cases hard to diagnose, but resistance to these drugs also mandates the use of a second line of treatment that is more complicated, prolonged and expensive.
For instance, Madappa G*, 60, a patient from Dharwad, was diagnosed with TB over two years ago. Two courses of the first line of treatment proved ineffective. “The doctors told me that I had a stronger version of TB that would need different medications,” he says. This year, he found that these drugs had damaged his liver.
As of March 2021, an estimated 1,24,000 MDR-TB and RR-TB cases were diagnosed in the country — the highest in the world. Over 56% of estimated MDR-TB cases go undiagnosed and 64% are untreated.
“If we are having trouble managing the current TB burden due to erratic drug supply this will result in drug resistance, and an increase in multi-drug resistant TB will require a higher quantum of funding and effort,” explains Prasanna Saligram, a health activist and member of the Sarvatrika Arogya Andolana Karnataka
In the past, many states had specific domicile requirements to access drugs to treat more extreme forms of drug resistance. In 2017, the New Delhi High Court overruled such guidelines.
However, the availability of treatment for MDR-TB and more extreme strains remains abysmal at the grassroots level of the public healthcare system.
The WHO’s Global TB report stated that one of the barriers to accessing treatment for drug-resistant TB is the centralised management of TB, which heavily relies on hospitals. It advocates for greater decentralisation of services and the expansion of ambulatory care models.
Pharmacy of the world
Drug scarcities, in a country that has earned the reputation of being the "pharmacy of the world", points to a series of missteps at both bureaucratic and political levels.
Generally, pooled procurement has several benefits. “There are bulk discounts due to economies of scale, increased bargaining power with drug manufacturers and hence more efficiency. It is worrying that such a process has been interrupted,” says Saligram. Centralised procurement also allows for bulk quarantining and testing, an essential protocol that helps maintain the quality of distributed drugs.
The quantity of drug procurement is at a massive scale with tens of lakhs of TB patients. “This is a very large population to not consider. The government is aware of the required quantity, has previous connections with manufacturers and the bargaining power,” explains Mehra.
“Frequent drug stockouts indicate a systemic problem. This is being allowed to happen and signifies a lack of will,” he adds.
Stockouts also indicate the lack of a buffer stock with both the state and union governments, which could have mitigated some of the damage caused due to delayed procurement.
There are enough working success stories that can demonstrate the efficacy of pooled procurement. “The drug procurement and distribution systems in Tamil Nadu and Kerala are examples that show us how public health systems can meet citizen needs in a timely manner. Several states — close to 20 — have approached TN to replicate the model,” says Dr Gopal Dabade, president of the Drug Action Forum, Karnataka, a group campaigning for access to medicines in the state.
“There is an immediate need to course correct and look at domestic models that have been functioning for three decades,” he points out.
Reflection and course correction are central to addressing behemothic diseases such as TB. Public trust is crucial, however, issues with drug availability undermine trust and medical compliance.
Two years ago, President Draupadi Murmu launched the Pradhan Mantri TB Mukt Bharat Abhiyaan, aiming to eradicate tuberculosis by 2025. With less than a year left to achieve these goals, activists contextualise what the scarcity of anti-TB treatment means. “Without the necessary action to back it, this is all empty sloganeering,” says Acharya. Addressing the spread of TB requires robust campaigns to prevent infection, he adds.
TB is a complicated biosocial disease that requires the consideration of diverse socio-economic, caste, gender and nutritional disparities. “We are failing on even providing the basics — treatment. Eliminating TB by 2025 is nothing but a pipe dream,” says Mehra.
(*Names changed to respect privacy)