Last month, the World Health Organization highlighted two important milestones in India’s fight against tuberculosis: an 18% reduction in cases over the past 10 years, more than double the global rate; and a 24% reduction in deaths over the same period, more than the global average of 23%.
It frames the government’s 100-day intensive campaign that begins Dec. 7 to target select high-burden districts, but casts a shadow over these bright spots in the drive to end TB by 2025: record shortages in supplies of key TB drugs since 2023. Investigated by The Indian Express.
India’s TB treatment schedule has two phases: a two- to three-month intensive phase (IP) marked by a combination tablet of four antibiotics, and a continuation phase (CP), where the patient receives another combination drug with three antibiotics for four to seven months.
These are called fixed-dose combination (FDC) drugs. Data for 2022, 2023 and 2024 shows a progressive decline in the supply of FDC drugs from the Centre. For 2023, the data shows a 56.5 percent decline in the supply of drugs for the first phase (IP) compared to 2022; and a 23 percent decline for the second (CP) over the same period.
Supply has picked up and started but this year, data available till June shows, first phase supply was down by 23.04 per cent and supply was down by 28.8 per cent compared to the first six months of 2023. The second phase during the same period.
Records show that this has prompted the Center to send several letters to states asking for local procurement during these delays. Key factors behind the shortage: The nodal procurement agency canceled nine of its 26 tenders for procurement of these drugs due to “administrative reasons”; And, three suppliers were blacklisted for violations ranging from fake bank guarantees to faulty pricing.
The Union Ministry of Health and Family Welfare did not respond to a detailed questionnaire from The Indian Express on the shortage situation. But the ministry said in a letter sent this March that the tuberculosis drug “will be delayed due to unforeseen and external circumstances.”
It directed states to procure locally for a period of three months, without any restrictions on size or formulation. “On a case-by-case basis, reimbursement of cost of drugs to patients, if districts/health institutions are unable to provide free drugs,” it said.
Mission 2025
It was during the “End TB Summit” in New Delhi in March 2018 that the government announced a deadline of 2025 to eradicate the disease. According to the latest WHO data, there were an estimated 2.7 million TB patients in India in 2023, of which 25.1 million patients (85 percent) were taking medication – a significant achievement as more than 50 percent of this category died. Infection without treatment.
Treatment of drug-susceptible TB (DSTB)—mainly for newly diagnosed patients—consists of six to nine months of antibiotics.
Rifampicin, isoniazid, pyrazinamide and ethambutol are the drugs involved in a daily tablet for the intensive phase; and rifampicin, isoniazid and ethambutol in one daily tablet for the continuation phase. The duration and dosage of these tablets may vary depending on age, infection level and treatment history.
Although treatment is free in government facilities, patients opting for the private sector may pay around Rs 10,000 for 6 months of IP and CP and Rs 20,000 to 30,000 per month for drug-resistant patients.
Under the National Tuberculosis Eradication Programme, the Center is responsible for procurement and supply of TB drugs, while states receive limited funds to make emergency purchases as a temporary measure.
Ideally, storage is done at district, state and national level for three months and at block level for two months. Experts say buffer stocks are important because those who do not take prescribed doses contribute to the increased risk of drug-resistant tuberculosis, which is mainly the result of an incomplete course of treatment.
The states topping the chart in reported TB cases are: UP (6.3 lakh), Maharashtra (2.27 lakh), Bihar (1.86 lakh), Madhya Pradesh (1.84 lakh), and Rajasthan (1.65 lakh). Overall, India accounts for 26 percent of global TB cases and 29 percent of TB deaths.
Letter after letter
The shortage was reflected in a series of letters sent to states by the Central Tuberculosis Division of the Union Health Ministry, the department responsible for implementing the eradication programme, mainly asking for local procurement of isoniazid, pyrazinamide and rifampicin.
In eight letters, the Center eased the permission criteria to extend the three-month deadline for local procurement.
At least nine tenders issued by the Central Medical Services Society (CMSS), the agency that procures medicines for government health programs, between January 2023 and August 2024 were canceled for “administrative reasons.”
To compound the crisis, records show, at least three of the government’s TB drug suppliers were blacklisted by CMSS this year for various alleged violations.
UP-based Unicure India Ltd was barred from the CMSS tender for ethambutol for two years this February after failing to deliver the drug after quoting the wrong price; Maharashtra-based J Duncan Healthcare was banned for 2 years for submitting fake bank guarantees along with a TB drug tender worth Rs 215.5 crore. And Gujarat-based Centurion Laboratories was blacklisted for two years for allegedly delaying supplies.
For example, the order blacklisting Centurion Laboratories warned: “Please note that the significant delay in supply resulted in a crisis of anti-TB drugs among patients and thereby severely affected the national programme.” The three companies did not respond to The Indian Express’s request for comment.
States scrambling for stock
To address the shortage, the government had issued at least two tenders in July and August against earlier failures. States are also preparing themselves well. A state official said: “The crisis we faced earlier this year has eased … but we do not have the buffer stocks we maintained earlier.”
However, records show that states also face challenges in local procurement. For example, on March 26 this year, responding to a central letter about the shortage, Dinesh Gundu Rao, the health minister of Congress-ruled Karnataka, wrote to then Union health minister Mansukh Mandaviya that there had been a “delayed communication” from the Centre, to procure vital drugs. When the model code of conduct for elections was implemented.
“It is known that these medicines are not available in the quantity required by the state and the procurement process could not be expedited,” Rao wrote, “This has had an ‘adverse effect’ on procurement efforts.”
A senior official in another state said they tapped into buffer stocks of loose drugs instead of buying new ones. “We were constantly moving drugs between facilities and monitoring stock levels. We have also allocated funds to the districts to buy medicines from local shops,” said an official.
Another state official said, “We had to provide the patients with supplies for four or five days, after which they were asked to return, when we gave them a month’s supply.”
According to a senior official of the fourth state, local procurement was difficult without a state-specific rate agreement – an agreement to set a fixed price for commonly used items for a certain period. “Without a robust procurement system, securing short-term supply is challenging,” the official said.