Indian medical associations deny shortage of GeneXpert TB tests

Mumbai, September 26, 2022:

Close on the heels of MSF raising concern over delays in supply of GeneXpert TB tests by the US Corporation Cepheid affecting national TB programmes in low-and middle-income countries, Indian medical associations have maintained that there is hardly any shortage of GeneXpert TB tests in the country.

Dr Ishwar Gilada, infectious disease expert and secretary general, the Organised Medicine Academic Guild (OMAG), an umbrella body of 15 professional post-graduate doctors’ association said, “So far, we have not come across a shortfall in supply of GeneXpert TB tests in the country. DOTS (Directly Observed Therapy, Short-Course) centres, equipped with GeneXpert TB tests under the National Tuberculosis Elimination Programme (NTEP) have hardly reported a shortfall in such tests till date.”
 
However, Dr Gilada, said there is not enough buffer stock of GeneXpert TB tests at healthcare facilities due to Covid supply chain challenges and an increasing demand for GeneXpert TB tests. “This shortfall in buffer stock has not impacted TB diagnosis.  In case certain pockets of the country face shortage of GeneXpert TB tests in absence of buffer stock, the interinstitutional arrangement or public-private partnership can be forged to tide over the shortage,” he stated.
 
Cepheid has commenced operation of its Bangaluru plant producing cartridges for the GeneXpert diagnostic systems. GeneXpert, a cartridge based nucleic acid amplification test (CBNAAT) is a widely accepted diagnostic test for TB. This test is a rapid diagnostic test for TB detection as well as rifampicin resistance in direct smear negative cases. Rifampicin is a drug commonly used in treating TB bacteria in the first line of treatment. It gives a result in less than 2 hours. So far Cepheid has three manufacturing plants and the Bengaluru plant is one of them.
 
During the Covid-19 pandemic, the US based corporation has come out with four-in-one respiratory test to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus, which is almost exclusively used in high-income countries. Experts attributed delay in supply of the critical GeneXpert TB test to the combination "four-in-one" test leading to production constraints at Cepheid plants.
 
The Stop TB Partnership's Global Drug Facility (GDF) has recently communicated that there could be significant supply delays of the critical GeneXpert TB test due to production constraints by Cepheid. DGF says that the delays are caused by Covid supply chain challenges and an increasing demand for GeneXpert TB tests. Countries placing larger orders may face delays of up to 6 months. The backlog of orders for TB tests is expected to last through March 2023. GDF facilitates global access to quality-assured TB diagnostics and treatments through a one-stop procurement and supply mechanism for national TB programmes.
 
Until additional suppliers enter the market, many TB testing services in low- and middle-income countries still rely exclusively on the GeneXpert TB tests supplied by Cepheid. With national programs in high TB burden countries working hard to ramp testing back up to the same or higher levels as before the Covid pandemic, any supply delays of TB tests by Cepheid are unacceptable, especially as the corporation seems to prioritise sales of Covid tests to wealthy countries over supplying TB tests to high TB burden countries, MSF stated.
 
India detects 20-25 lakh TB cases every year, and nearly 4 lakh die of it. At present, 13.5 lakh are undergoing TB treatment. The government has set the target of making India TB-free by 2025, five years before that global target of eliminating the disease.Pharmabiz