| RNTCP is underfinanced/focused only on the control of smear-positive TB |
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(1)
The overall budget of RNTCP must be increased for the next phase (2012–2017)
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(2)
The next phase of RNTCP must finance currently available best diagnostic techniques for smear-positive TB, extrapulmonary-TB and MDR-TB (liquid culture, molecular assays)
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| Doctors in the private sector beyond the scope of RNTCP/lack of other national TB guidelines |
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(1)
Involve private doctors in the process of development of RNTCP policies and guidelines
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(2)
Develop national guidelines for diagnosis and management of all types of TB (broader than RNTCP guidelines, aiming at all sectors)
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(3)
Disseminate the guidelines actively to ensure their penetration in the private sector
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| TB is not listed as a “critical disease” by CDSCO & DCGI |
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(1)
Reclassify TB tests as “critical devices”
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(2)
Re-design the process of licensing so that it ensures that the tests are validated against a reference standard in national centres (not only manufacturing license)
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(3)
CDSCO must ban sales of currently available TB serologics due to high public health importance and oblige NABL to respect the ban in accredited labs
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(4)
RNTCP should advise DCGI on acceptable performance characteristics for all TB tests (like NACO did for rapid HIV tests)
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Lack of alternative rapid, simple or blood-based test for TB (all types of TB) on the market
No affordable instrumentation/reagents available for liquid culture or PCR on the market |
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(1)
Encourage R&D in the Indian industry by providing an advance promise of prospective purchase by the government in case the test passes external validation.
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(2)
Protect Indian market by eliminating inaccurate TB tests from the market through improved CDSCO regulation
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(3)
Encourage (Indian) industry to undertake external validation of existing Indian commercial PCR kits, and support development of high quality generic molecular tests and automated liquid cultures
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| Private diagnostics market in general has weak regulation (i.e. no transparency in pricing, widespread referral fees) |
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(1)
Put protection of patients’ expenditure at the centre of the regulation of the private sector
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(2)
Regulate prices of TB diagnostics by reimbursing good procedures to the private sector at a fixed price. Reimbursement to the private sector should also result in weaker incentive for labs to rely on referral fees. Reference pricing (fixed as the reimbursement fee by the government) would homogenize prices across private labs in India
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(3)
Reinforce the ban of referral fees
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(4)
Overall, improve regulation of private healthcare in India (by implementing Clinical Establishments Act)
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| Government financing of healthcare is largely insufficient in India |
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(1)
Overall expenditure on health must be increased. Patients’ access to high-quality diagnostics will not improve unless a dramatic expansion takes place of reimbursement of such techniques within RNTCP and to private sector
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(2)
If national health care expenditure is to be increased, this should not be consumed only by reimbursement of drugs, but also by diagnostics
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