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Dr Sanjay Sarin
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India is presently home to one in four patients of TB globally and constitutes 26 per cent of the global TB burden. According to the WHO Global TB Report (2013), 75 per cent of the missed cases of TB reside in 12 countries with India leading the list of countries and accounting for nearly 31 per cent of those cases estimated at 9.3 lakhs. Additionally, there were 4.5 million new cases of MDR-TB worldwide in 2012 with a large percentage of this increase being in India, Ukraine and South Africa. This is an alarming situation and threatens to roll back the tremendous progress made by India’s Revised National Tuberculosis Control Program (RNTCP) in the last few years.
RNTCP released its National TB Strategic Plan for 2012-17. The key elements of this plan which has set an ambitious goal of testing 48 million new people for TB include –
- “early and improved” diagnosis of all TB patients including those with drug resistance and HIV-associated TB;
- “access to high-quality treatment to all patients” who have been diagnosed
- Emphasis on “scaling up access to effective treatment” for those with drug resistance
- Increase focus on decreasing death and morbidity figures.
- Extend RNTCP services to patients diagnosed and treated in the private sector.
Out of all the above objectives, perhaps the most radical is the extension of services to patients being managed in the private sector. This affirms the fact that effective management and control of TB in India has to be inclusive of the private sector.
Private sector currently plays a significant role in India’s healthcare scenario by providing access to close to 70 per cent of patients. It is the first point of contact for most suspects1, which makes it critical for RNTCP to engage with the healthcare providers in the private sector and achieve its goal of universal access to TB care. Private sector has its own challenges however especially in case of TB, where many a times it takes weeks and often months to get access to the right technology and drugs and that too at a very high cost. On account of low penetration of healthcare insurance in the Indian populace, majority of patients end up spending this money from their own pockets which further exacerbates the socio-economic situation of these patients.
In the past there has been limited engagement between RNTCP and the private sector except a few projects. Ironically, private sector has often been blamed for fuelling the spread of TB/MDR-TB on account of irrational diagnostic and treatment prescriptions. In fact the plan states that RNTCP will endeavour to overcome the barriers of mistrust and fully encompass and improve the spectrum of TB care being provided through the private sector.
However, in order to do so, there are significant challenges that will need to be overcome, foremost amongst them will be to ensure that the private sector follows and adheres to the International Standards of TB Care (ISTC) in terms of both drug regimens and WHO approved diagnostic tests which will require a concerted effort from the government, civil society and the private sector.2 In a recent study done by TB Alliance and IMS Health, it was reported that the private sector will need to ensure proper usage of recommended TB regimens to prevent the development of resistance against both existing and new TB drugs. The research further indicated that in countries with large private TB drug markets such as India, creating effective public private links could help increase access.3
Previous efforts have shown that effective engagement with private sector has always yielded good results. For example in 2003, the RNTCP launched intensified PPM DOTS activities in 14 urban districts 4 as a part of which medical consultants and field supervisors were recruited and posted in these districts. The data from the intensified PPM sites showed an overall increase in the number of TB cases notified under RNTCP.
Currently, there are close to 150 industries partnering with RNTCP, prominent amongst them being Tata Steel, Reliance Industries, Birla group, Jubilant Organosys, Becton Dickinson (BD) and Eli Lilly with their engagement varying from community activities, workplace DOTS programmes, laboratory strengthening, home-based care of MDR-TB patients and technology transfer in the manufacturing of MDR TB drugs. BD has been partnering with FIND and RNTCP to enhance access to advanced TB diagnostics in the Intermediate Reference Labs of RNTCP. BD further partnered with Alliance Biosciences (a US-based company) and FIND to develop a National Centre for Training in Biosafety. Very recently, BD partnered with the National Institute of TB and Respiratory Diseases, a designated National Reference Lab to create a Centre of Excellence in mycobacteriology aimed at capacity building in liquid culture and DST and evaluation of novel TB diagnostic technologies.
In another instance, the RNTCP initiated a public private partnership on TB culture and DST as a part of which it is offering an opportunity to the labs in the private sector to get empanelled with the programme and offer TB culture and DST to patients being treated in the private sector at fixed charges. Under this initiative, several accredited labs from the private sector are now a part of this extended network.
Another challenge in the private sector has been the rampant use of serology-based tests due to lax regulatory controls along with financial incentives. Taking note of WHO’s negative policy guidance on serology based tests, this situation changed in 2012 when the Government of India banned the use, import, manufacture and sale of antibody- based tests for TB and discouraged the use of Interferon-gamma release assays such as ‘TB Gold’.
This further underlines the need to develop strategies to provide access to quality assured and nationally/internationally approved TB diagnostics via the private sector. Initiative for Promotion of Quality and Affordable Tests6 (IPAQT) is one such initiative which is engaged in increasing access to WHO endorsed TB diagnostic technologies via affordable pricing through a coalition of private laboratories in India supported by manufacturers of TB diagnostic technologies (LED microscopy, liquid culture, line probe assays and cartridge-based molecular test) and non-profit organisations (Clinton Health Access Initiative, IUATLD etc). IPAQT members include over 50 private sector labs, 10,000 collection centres and have presence across the country. Any private laboratory that has been accredited by RNTCP, National Accreditation Board of Laboratories (NABL) and College of American Pathologists (CAP) can become a member of IPAQT. The manufacturers currently supporting IPAQT include Hain (Hain Genotype MTBDRplus), Cepheid (Xpert), Biomerieux and BD for liquid culture.
It is clear that a mere mention in the strategic plan and adoption of standards alone may not lead to improved TB management and control practices in the private sector. This will require consistent and ongoing engagement with the diverse private sector including taking cognizance of the ongoing efforts in this domain with a view and intent for potential scale-up for the ultimate benefit of TB patients in India.
References:
1. J Glob Infect Dis. 2011 Jan-Mar; 3(1): 19–24.
2. Bull World Health Organ. 2004 August; 82(8): 580–586.
3. http://www.tballiance.org/acces s/tb-market-detail
4. http://www.who.int/bulletin/volumes/85/5/06-036277/en/
5. O. Ferroussier, M. K. A. Kumar, P. K. Dewan, P. K. J. Nair, S. Sahu, D. F. Wares, K. Laserson, C. Wells, R. Granich, L. S. Chauhan. Cost and cost-effectiveness of a public-private mix project in Kannur District, Kerala, India, 2001–2002; INT J TUBERC LUNG DIS 11(7):755–761
6. www.ipaqt.org