Amid key victories in fight against TB, states face one battle: Shortage of drugs

India’s TB treatment schedule has two stages: a two-three month Intensive Phase (IP) marked by a combination tablet of four antibiotics, and Continuation Phase (CP), where a patient gets another combination medicine 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 dip in the supply of FDC drugs from the Centre. For 2023, data shows a 56.5 per cent decline in the supply of drugs for the first phase (IP) compared to 2022; and a 23 per cent drop for the second (CP) across the same period.

Supplies have improved in fits and starts but this year, data available until June shows, there was a 23.04 per cent dip in supply for the first phase, compared to the first six months of 2023, and a 28.8 per cent dip in supply for the second phase across the same period.

Records show this prompted the Centre to send several letters to states on these delays urging local procurement. The key factors behind the shortfall: the nodal procurement agency cancelled nine of its 26 tenders to purchase these drugs due to “administrative reasons”; and, three suppliers were blacklisted for violations ranging from forged bank guarantees to faulty pricing.

The Union Ministry of Health & Family Welfare did not respond to a detailed questionnaire from The Indian Express on the state of the shortage. But a letter sent by the Ministry to states this March said that TB drugs would “get delayed due to unforeseen and extraneous circumstances.”

It directed states to procure them locally for a period of three months, with no restrictions on size or formulation. “On case by case basis, reimbursement of costs towards drugs to the patient, if the district/ health facilities 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 for elimination of the disease. According to the latest WHO data, India was estimated to have had 27 lakh TB cases in 2023, of which 25.1 lakh patients (85 per cent) were receiving medication — a significant achievement since more than 50 per cent of those in this category succumb to the infection without treatment.

The treatment of Drug-Susceptible TB (DSTB) — mainly for newly diagnosed patients — involves six-nine months of antibiotics.

The drugs involved are Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in a single daily tablet for Intensive Phase; and Rifampicin, Isoniazid and Ethambutol in a single daily tablet for Continuation Phase. The duration and dosage of these tablets can vary, depending on age, infection level and treatment history.

While treatment is free in government facilities, patients opting for the private sector may end up shelling out around Rs 10,000 for six months of IP and CP and Rs 20,000-30,000 per month for drug-resistant cases.

Under the National TB Elimination Programme, the Centre is responsible for the procurement and supply of TB drugs, while states receive limited funds to make emergency purchases as a temporary measure.

Ideally, stocks for three months are maintained at the district, state and national levels and for two months at the block level. Experts say buffer stocks are crucial because those who miss scheduled doses risk contributing to the growing threat of drug-resistant TB, which primarily results from an incomplete course of treatment.

Among the states topping the charts 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 per cent of global TB cases and 29 per cent of TB deaths.

Letter after letter

The shortage was reflected in a series of letters sent to states, urging local procurement of medicines, mainly Isoniazid, Pyrazinamide, and Rifampicin, by the Central TB Division, which is the Union Health Ministry department responsible for implementing the elimination programme.

In eight letters, the Centre eased permission norms to give a three-month extension for local procurement.

Records show that another key hurdle for the availability of drugs was the cancellation of at least nine tenders issued by the Central Medical Services Society (CMSS) — the agency that procured drugs for Government health programmes — between January 2023 and August 2024 due to “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 CMSS tenders for Ethambutol for two years this February for failing to deliver the medicine after allegedly quoting incorrect prices; Maharashtra-based J Duncan Healthcare was barred for two years after allegedly submitting forged bank guarantees, including for two TB drugs tenders worth Rs 215.5 crore; and, Gujarat-based Centurion Laboratories was blacklisted for two years for alleged delays in supply.

For instance, the order blacklisting Centurion Laboratories warned: “Please note the significant delays in supply resulted into crisis in Anti TB Drugs among patients and hence, severely affected the National Programme.” The three companies did not respond to requests from The Indian Express seeking comment.

States scramble for stocks

To bridge the shortage, the government issued at least two tenders in July and August against the ones that previously failed. States are also preparing themselves better. Said a state official: “The crisis we faced earlier this year has abated…but we do not have the kind of buffer stocks that we used to maintain before.”

However, records show that states also faced challenges in local procurement. For example, on March 26 this year, responding to a Central letter on shortage, Health Minister of Congress-ruled Karnataka Dinesh Gundu Rao wrote to the then Union Health Minister Mansukh Mandaviya that the Centre’s “delayed communication to procure a critical drug” had come at a time when the Model Code of Conduct for the general elections was in place.

“It has been learnt that neither these medications are available in the quantities required by the state nor the procurement process can be hastened,” Rao wrote, adding that this has “adversely affected” procurement efforts.

A senior official from another state said they tapped into the buffer stock of loose medicines rather than procure afresh. “We were constantly moving medicines between facilities and monitoring stock levels. We also allocated funds to districts to purchase medicines from local stores,” an official said.

Another state official said, “We had to provide patients with supplies for four or five days, asking them to return thereafter, when normally we would give them a month’s supply.”

According to a senior official from a fourth state, local procurement was difficult without a state-specific rate contract — an agreement setting fixed prices for commonly used items for a certain period. “Without a robust procurement system, securing short-term supplies is challenging,” the official said.