Karnataka needs 16,800 Delamanid tablets; essential TB drug stocked out

For the past four months there has been a stockout of an essential Tuberculosis (TB) drug — Delamanid — in Karnataka, used to treat drug-resistant (DR) TB.

But officials say there is nothing to worry about as only 25 new TB patients are expected to need 16,800 tablets (672 tablets in each course) and in the absence of the drug they can use Bedaquiline instead. Members of Médecins Sans Frontières (MSF (Doctors Without Borders)) who are fighting for patients' access to this drug say the state is downplaying the drug shortage.

Delamanid is on the draft National List of Essential Medicines in India. There are around 3,000 drug resistant (DR-TB) patients in the state. Out of these, around 1,500 patients are H mono poly resistant, another 1,000 are rifampicin-resistant and another 500 are resistant to both rifampicin drug and additional TB drugs too.

"We have stock only for patients who are already on Delamanid who are only eight in number. There are also children among these but only a few. We placed the order some time ago for two pouches -- each pouch has 672 tablets -- for new patients who will need the drug. But there has been no supply from the Union government," said Dr Ramesh Reddy, Joint Director, TB, state health department.

Also read: 75 CBNAAT TB-testing machines idle in Karnataka as cartridges run out

"In the absence of Delamanid, we can treat the new patients with older regimen, with injectables, which will take up to 12 months instead of nine months," he said. Dr Reddy added, "New patients will be started on all-oral shorter regimen with Bedaquiline without Delamanid which is equally effective."

Leena Menghaney, South-Asia Head for MSF's Access Campaign and lawyer working on public health, told DH, "Shorter oral Bedaquiline regimen of nine months is not for patients with Pre-XDR-TB (denotes resistance to rifampicin and isoniazid) and fluoroquinolone resistance. This can't be a substitute. They require the full 18-month regimen."

"It cannot be just 25 patients. According to the government's own DR-TB survey, at least 20% are resistant to fluoroquinolone, which is 600 patients. The state is downplaying the figures. If the state is saying there are 500 patients eligible for the longer regimen then all 500 are eligible to receive Delamanid. This is the patient's right. Karnataka is not implementing the Programmatic Management of Drug-Resistant TB guidelines," she added.