India: Health Ministry's Ambitious National Strategic Plan (NSP) 2017-25 For Elimination Of Tuberculosis

As per the World Health Organization's Global Tuberculosis (TB) Report of 2017, the estimated incidence of TB in India was approximately 28, 00,000 - accounting for about a quarter of the world's TB cases12.The Revised National TB Control Programme (RNTCP) of India is an on-going Centrally Sponsored Scheme, being implemented under the umbrella of National Health Mission. The programme was initiated in 1997 and was expanded to cover the entire country in 2006. The programme, since then, has achieved global benchmark of case detection and treatment success and has achieved Millennium Development Goals (MDGs) in 2015 of halting and reversing the incidence of TB.

The major initiatives taken in 2017 by the Health Ministry in this regard include:

1) Expansion of Daily Regimen for treatment of TB across the country;

2) Scale up of Bedaquiline;

3) Conditional approval of Delamanid;

4) Release of guidelines on Programmatic Management of Drug-Resistant TB (PMDT) in India; and

5) Analysis of National Drug Resistance Survey data and many more.

NATIONAL DRUG RESISTANCE SURVEY

The First National Drug Resistance Survey commenced in July 2014, and 95% of the enrolments were completed by July 2015. However, the rest of the 5% took longer and were completed only by May 2016. The time lag can be attributed to paucity of previously treated TB patients diagnosed in certain Designated Microscopy Centre (DMCs), though they had such patients during the period of sample size determination period in 2012.

The survey provided a statistically representative national estimate of the prevalence of anti-tuberculosis drug resistance among new and previously treated patients in India, and will contribute to a more accurate estimate of anti-tuberculosis drug resistance globally. A total of 5280 sputum smear-positive pulmonary TB patients (3240 new and 2040 previously treated) diagnosed at the DMCs of RNTCP were enrolled in the survey. The survey results shows that:

  • Multi-Drug Resistant TB (MDR-TB) is 6.19% among all TB patients with 2.84% among new and 11.60% among previously treated TB patients.
  • Among MDR-TB patients, additional resistance to any fluoroquinolones was 21.82% and 3.58% to any second-line injectable drugs.
  • Among MDR-TB patients, additional resistance to at least one drug from each of the two classes, i.e. fluoroquinolone and second-line injectable drugs eXtensively Drug Resistant TB (XDR-TB) was 1.3%.
  • Any first- or second line drug resistance among all TB patients is 28.0% with 22.54% among new and 36.82% among previously treated TB patients.
  • Any isoniazid resistance is 11.06% and 25.09% among new and previously treated TB patients, respectively. Any pyrazinamide resistance is 6.95% and 8.77% among new and previously treated TB patients, respectively13.

MDR-TB rates at the national level are still within the range of previous state-level surveys conducted in India.

However, more than a quarter of TB patients in India have drug resistance to one or the other anti-TB drug.

NATIONAL STRATEGIC PLAN (NSP 2017-25)

One of the landmark achievements of 2017 is approval of bold and ambitious National Strategic Plan (NSP) 2017- 25 for TB Elimination, which is a framework to provide guidance for the activities of stakeholders including the National and State Governments, Development Partners, Civil Society Organizations, International Agencies, Research Institutions, Private Sector, and many others whose work is relevant to TB elimination in India.

It is crafted in line with other health sector strategies and global efforts, such as the draft National Health Policy 2015, World Health Organization's (WHO) End TB Strategy and the Sustainable Development Goals (SDGs) of the United Nations (UN). To achieve a rapid decline in the burden of TB morbidity and mortality, while working towards elimination of TB in India by 2025, it is essential to collect complete information of all patients of tuberculosis with implementation of key strategies like –

I. Private sector engagement

II. Active Case finding

III. Drug resistant TB case management

IV. Addressing social determinants including nutrition

V. Robust Surveillance system

VI. Community engagement & Multi-sectoral approach14.

The NSP is aiming to achieve elimination of TB by 2025. During the plan period, targets are

1. 80% reduction in TB incidence (i.e. reduction from 211 per lakh to 43 per lakh)

2. 90% reduction in TB mortality (i.e. reduction from 32 per lakh to 3 per lakh)

3. 0% patient having catastrophic expenditure due to TB.

The requirements for moving towards TB elimination have been integrated into the four strategic pillars of "Detect – Treat – Prevent – Build" (DTPB).

The NSP 2017-25 for TB Elimination also has provision of incentives for patient support like-

Patient Support Incentives: Majority of TB patients notified, are from the age group of 15-45 years and are from the lower socio-economic strata of the society. Hence, the Ministry of Health and Family Welfare approved Rs. 500 per month during the treatment of all TB patients notified in NIKSHAY under RNTCP. The financial incentives will support TB patients to prevent catastrophic expenditure, attract notification from private sector and encourage them to complete treatment.

Incentives for TB Notification: An incentive of Rs. 1000 will be provided for notification of TB patients. Rs. 500 to be given at notification and Rs. 500 for reporting treatment outcome. The incentives will be provided upon Notification in the TB reporting software, Nikshay, through a smooth and transparent manner.

RNTCP IMPLEMENTATION STATUS

1. Case Finding & Diagnosis of Tuberculosis: NSP 2017-25, advocates early identification of presumptive TB cases, at the first point of care - be it private or public sector, and prompt diagnosis using high sensitivity diagnostic tests to provide universal access to quality TB diagnosis including drug resistant TB in the country. The National Policy for diagnosis suggests:

  • yy Drug Sensitive TB: Direct sputum smear microscopy by Ziehl-Neelsen acid-fast staining/ Fluorescence Microscopy is the primary case detection tool in RNTCP for patients with infectious tuberculosis presumed to be drug sensitive and is also for monitoring their response to treatment.
  • yy Drug Resistant TB: Patients at risk of DR TB as defined by the programme MDR-TB, are diagnosed using WHO endorsed rapid diagnostics (WRD) like Cartridge Based Nucleic Acid Amplification Test (CBNAAT) / Line Probe Assay (LPA). Response to treatment for MDR is monitored by follow-up culture on Liquid Culture (MGIT) system (critical follow-ups requiring clinical response) and identification of Mycobacterial species is performed by commercial Immunochromatic Test (ICT).

2. Treatment of TB Services: Universal access to free, standard treatment services for all TB patients in the country encompasses an ambit of services in and around each patient's care cascade. Strengthening of these patient centered treatment services in RNTCP, with enhanced capacity to rapidly accommodate new drugs and treatment modalities, will be the cornerstone of the current NSP. The major initiatives taken in 2017 are:

  • Expansion of Daily Regimen for treatment of TB across the country India TB Report 2018 32
  • Scale up of Bedaquiline
  • Conditional Approval of Delamanid
  • Release of Guidelines on PMDT in India
  • National Training of Trainers (ToT) on Guidelines on PMDT
  • Introduction of Medication Event Reminder-Monitor Device (MERM) boxes.

3. TB-HIV: Tuberculosis and HIV duo form a deadly synergy the patients with these diseases more often likely to suffer unfavourable outcomes. HIV infection increases the risk of progression of latent TB infection to active TB disease, thus, increasing the risk of death if not treated timely for both TB and HIV. HIV prevalence among incident TB patients is estimated to be 4.00%. 87,000 HIV associated TB patients are emerging annually. By numbers, India ranks 2nd in the world and accounts for about 10% of the global burden of HIV-associated TB.

Interventions to reduce the burden of TB among people living with HIV include early provision of antiretroviral therapy (ART) for people living with HIV in line with WHO guidelines and the three I's for HIV/TB: intensified TB case-finding followed by high quality anti-tuberculosis treatment, isoniazid preventive therapy (IPT) and infection control in HIV care setting.

TB IS A DANGEROUS EPIDEMIC DISEASE/ NOTIFIABLE DISEASE

Further, on March 16, 2018, Ministry of Health and Family Welfare (MoH&FW) through a gazette notification, stated that TB is a dangerous epidemic disease/notifiable disease and released TB reporting measures - where all the health care providers treating TB patients are expected to inform the public health departments about every

TB patient they find and treat15. Further, in the interest of public health to control and prevent the tuberculosis disease, the Central Government has specified the following measures, namely:-

1) The Healthcare Providers, termed as Clinical Establishment henceforth; shall notify every tuberculosis patient to local Public Health Authority, namely, District Health Officer or Chief Medical Officer of a District and Municipal Health Officer of urban local bodies in whatever way they are known; or their designated District Tuberculosis Officers in a format as specified in –

a. Annexure-I by the Medical Laboratories;

b. Annexure-II by the Medical Practitioners.

2) All Pharmacies, Chemists and Druggists dispensing anti-tubercular medicines, shall notify respective tuberculosis patients along with the details of medicines as per Annexure-III and maintain a copy of prescription - Annexure IV, the treating Medical Practitioner as per Schedule H1 of the Drugs and Cosmetics Rules, 1945; and shall furnish the same either electronically or in hard copy, to the Nodal Officer of the District or any Officer authorized by Nodal Officer.

3) Considering the importance of patient support needed for complete and appropriate treatment of all, tuberculosis patients are encouraged to self-notify themselves with their own details and that of treating medical practitioners.

Secured web portals like https://nikshay.gov.in and Secured web portals like https://nikshay.gov.in and www.tbcindia.gov.in shall be made available by the Central Tuberculosis Division for all practitioners, clinical establishments, pharmacies, chemists, druggists and patients for online submission of information.

Noncompliance to the reporting measures

The Clinical Establishment, Pharmacy, Chemist and Druggist, failing to notify a tuberculosis patient to the nodal officer, as mentioned above and local public health staff of general health system of rural or urban local bodies, not taking appropriate public health action on receiving tuberculosis patient notification as per the paragraph above, may attract the provisions of sections 269 and 270 of the Indian Penal Code (45 of 1860):

Section 269 of the Indian Penal Code (45 of 1860) prescribed that "Negligent act likely to spread infection of disease dangerous to life - Whoever unlawfully or negligently does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both."

Section 270 of the Indian Penal Code (45 of 1860) prescribed that "Malignant act likely to spread infection of disease dangerous to life - Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both."

Note- These measures shall prevail over the earlier measures issued vide order F.No. Z-28015/2/2012-TB, dated the May 07, 2012 and its amendment dated July 23, 2015.

Conclusion

Surveillance in TB is not only about detecting TB Cases. FFor an effective surveillance the approach of adherence monitoring, surveillance of Drug resistance and surveillance using genomics is required, which will eventually prevent emergence and spread of resistance, and will also help to detect epidemic patterns of disease within localities. The major initiatives taken by the Health Ministry in this regard will help the country to achieve elimination of TB by 2025.

Footnotes

 12 http://apps.who.int/iris/bitstream/10665/259366/1/9789241565516-eng.pdf

13 https://tbcindia.gov.in/showfile.php?lid=3314

14 https://tbcindia.gov.in/showfile.php?lid=3314

15 http://www.egazette.nic.in/WriteReadData/2018/183924.pdf

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