Universal access to quality tuberculosis (TB) diagnosis and treatment is a central component of the Revised National TB Control Program’s (RNTCP) National Strategic Plan 2012–2017 (NSP). The plan calls for the early detection and treatment of 90 percent of estimated TB cases in India by the end of 2015. However, according to a draft report from the Joint Monitoring Mission (JMM) to India, only 60 percent of TB cases are currently being detected.
In 2010, the World Health Organization (WHO) recommended using a new, rapid diagnostic tool for the detection of multi drug-resistant TB (MDR-TB) and HIV-associated TB: GeneXpert MTB/RIF. GeneXpert simultaneously tests for TB bacteria and resistance to the first-line drug rifampicin in approximately two hours. By comparison, standard cultures can take between two to six weeks to grow, and drug resistance testing can add an additional three weeks. GeneXpert has the potential to significantly increase TB diagnosis in India, but its rollout remains slow, and GeneXpert has yet to reach all corners of India.
The RNTCP’s NSP set a goal for scaling up GeneXpert to at least 950 sites across the country by the end of 2017, calling for 300 sites to become operational by the end of 2015 and 200 more by the end of 2016. By 15 September 2015, only 119 devices had been installed (1), and the government announced that the 300 mark would not be reached until February 2016 (2). Even when installed, GeneXpert machines are not always being properly used. In May 2016, the RNTCP announced the installation of 500 new GeneXpert devices within two to three months at designated sites around the country; however, lab technicians have yet to receive proper training on the test’s use (3). In some hospitals, GeneXpert machines have been available for months but are either not functional or not being used. The Dr. Baba Saheb Ambedkar Hospital in Delhi has had GeneXpert since April 2016, but has not conducted a single TB test using the machine (4). In other places, cartridge shortages and sub-optimal machine use contribute to undiagnosed TB cases and wasted money. The JMM report documents a 10-month long stock out of GeneXpert MTB/RIF cartridges in Andrah Pradesh, while in other locations underutilization of GeneXpert has lead to the expiration of many cartridges.
The NSP also aims for 50 percent of all patients with HIV experiencing chest symptoms to receive a GeneXpert diagnostic test. According to the JMM report, current estimates show only two percent actually being tested (1). GeneXpert is only available in 84 out of 7,742 integrated counseling and testing centers, designated microscopy centers, and antiretroviral therapy (ART) centers. The pilot project in which 30 selected ART centers are currently providing GeneXpert as the primary screening tool for HIV-associated TB should be scaled up to cover the entire country in order to meet this goal (2).
The government’s response to multiple appeals by Indian civil society groups concerned about GeneXpert’s slow rollout offers little assurance that these issues will be resolved without greater public scrutiny and accountability. The timeline below details key civil society petitions to the government on GeneXpert:
- September 15, 2015: DNP+ and 10 other civil society organizations write a letter to Health Minister J.P. Nadda re. “TB case detection: urgent need to scale-up rapid TB test machines and cartridges.” The letter expresses alarm that the TB program had obtained only 119 of the 300 GeneXpert machines promised by the end of 2015, more than two years after the government started planning for their procurement.
- February 11, 2016: Signatories to the letter sent 15 September 2015 write to congratulate the RNTCP on completing the procurement of 300 GeneXpert machines, albeit after a years-long delay. The letter requests that the RNTCP provide details on the installation and maintenance of GeneXpert machines across the country and commit to providing GeneXpert as the primary test for TB in people living with HIV in all ART centers.
- June 10, 2016: DNP+ writes a letter to Sunil Khaparde, DDG TB program, expressing concern about a number of TB diagnosis and treatment issues, including the under-utilization of GeneXpert machines in many hospitals.