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National Health Programme

  1. Neonatal tetanus elimination strategy
  • Extensive iec to promote safe delivery
  • At home: five cleans: clean hands, place of delivery, tie, blade & umbilical stump
  • Correct medical practice in institutions
  • 100% coverage of pregnant women with tt2
  • Community based surveillance of neonatal tetanus
Classification of districts
Nomenclature Nnt prevalence per 1000 live births Tt2 coverage Attended deliveries
High risk >1 or <70% or <50%
Control <1 and >70% and >50%
Elimination <0.1 and >90% and >75%
  1. Integrated management of neonatal and childhood illnesses(IMNCI)
    A system of assessment, classification & management of common childhood illnesses. Three categories: pink (urgent referral), yellow (manage at the facility) & green (home management).
General danger signs to be looked for:
  • Child is unable to drink or breast feed
  • Child vomits everything
  • Child has had convulsions with this illness
  • Child is lethargic or unconscious
Treatment for various illnesses under (IMNCI)
  1. Diarrhoea:
    Treat with low osmolality ors (245 mmol/l – 2.6mg nacl, 1.5mg kcl, trisodium citrate – 2.9mg & 13.5g glucose) & zinc sulphate (20 mg od x 14 days)
  2. Measles: vit a according to the age & symptomatic management
  3. Pneumonia: classify it according to the respiratory rate
  4. Malaria
  5. Severe malnutrition: underlying cause of 50% deaths in children
  6. Helminthic infestation: albendazole for >2yrs & mebendazole for <2yrs.
Preventive & promotive component
  • Breast feeding: exclusive breast feeding for first 6 months of life
  • Immunization: according to epi
  • Iron & vit a supplementation
  • Nutritional counselling
  1. National leprosy elimination programme(India has eliminated leprosy in 2005)
  • LEPROSY:  Recognized in the oldest civilization of China, Egypt and India.
  • Chronic Infectious Caused by M. Leprae, acid fast, rod shaped bacillus.
  • Discovered by G. P. Hansen (Norway) in 1873.
  • First bacteria to be identified as causing disease in man.
  • Affects :
  1. Skin                            
  2. Peripheral nerves        
  3. Mucosa of the uppers respiratory tract                      
  4. Eyes etc.
  • Epidemiology :   affects all ages and both sexes.
  • Incubation period : long - 3 to 5 years.
  • Transmission : Directly - man to man.
  • Route – Respiratory tract or skin.
  1. 1955 – NLCP
  2. 1981 - WHO Study Group on Chemotherapy recommended MDT.
  3. 1983 – NLEP (MDT started) [There was a reduction of 85 % in the global prevalence of leprosy in     10 years with MDT.Encouraged by 10 years of intensive use of M.D.T.]
  4. 1991 - WHO resolved to ELIMINATE leprosy as a public health problem by year 2000 A.D.
  5. WHO Working Group on Leprosy outlined the STRATEGY for elimination.
  6.  1993 – World bank assisted MDT programme Phase I
  7. 2000 – NLEP Phase II
  • All the major endemic countries have implemented action plan.
  • Central idea : WHO – recommended M.D.T. accessible to all patients including those living in difficult to reach areas and population.
  • Advantages of MDT
  1. Highly effective                          
  2. Reduces the period of treatment. 
  3. Well accepted by patients.                      
  4. Easy in field application.
  5. Prevents development of drug resistance.              
  6. Reduces the risk of relapse.
  7. Interrupt transmission.                      
  8. Prevents disabilities.
  9. Improves community attitude.
  • Elimination of leprosy:
    Reducing the prevalence of leprosy to below one case per 10 000 population. Q
  • Achieved by :
  1. Making MDT accessible to all communities and areas.
  2. Treating all registered cases with MDT;
  3. Diagnosing and promptly treating all new cases;
  4. Improving quality of patient care, including disability prevention and
  5. management;
  6. Ensuring regularity and completion of treatment.
  7. Enlisting community support for the programme.
  8. Accelerated approaches to achieve leprosy elimination.
  • Main thrust ;
  1. Provide MDT services through every available health facility in the area;
  2. Conduct leprosy Elimination Campaigns ( LEC )  to improve MDT services and promote awareness in the community about leprosy so that the hitherto undetected “hidden” cases are detected.
  3. Apply innovative and flexible approaches to make MDT services accessible to underserved population and communities living in difficult geographical areas or situations by using Special Action Project for Elimination of Leprosy.
LEC : leprosy elimination campaigns
  1. Detect leprosy cases undetected.
  2. Capacity building measures for local health measures to improve MDT services
  3. Increasing community participation to strengthen elimination action at peripheral levels.
Diagnosis of leprosy:
Diagnosis of leprosy under NLEP is based only on the presence of the characteristic lesions (supplemented by thickened peripheral nerve). Skin smears are not taken to reach a diagnosis. There are only two categories of patients
  1. Multibacillary (MB) cases – Patients with 6 or more lesions with or without 2 or more peripheral nerve involvement.
  2. Paucibacillary (PB) cases – Patients with 5 or less lesion with or without 1 or no peripheral nerve involvement.
Disability care and prevention and rehabilitation
  • Grading: Hand and feet
  • Grade 0: No anesthesia, no visible deformity or damage
  • Grade 1: Anesthesia present, no visible deformity or damage
  • Grade 2: visible deformity or damage present
Grade 0: No eye problems, no evidence of visual loss
Grade 1: Eye problems present; vision 6/60 or better
Grade 2: Severe visual impairment, vision worse than 6/60. lagophthalmos, iridocyclitis, and corneal opacities.
A case of leprosy is a person, having one or more of the following,
  1. Hypopigmented or reddish skin lesion(s) with definite loss of sensation;
  2. Damage to the peripheral nerves, as demonstrated by loss of sensation and weakness of the muscles of    hands, feet or face;
  3. Positive skin smears.
A Guide for clinical classification:
  Paucibacillary leprosy (PB) Multibacillary leprosy (MB)
Skin lesions (Includes macules, papules and nodules) 2-5 lesions
asymmetrically distributed
definite loss of sensation
More than 5 lesions
Distribution more symmetrical,
Loss of sensation.
Nerve damage (resulting in loss of sensation or weakness of muscles supplied by the affected nerve) onlonly one nerve trunk Mamany nerve trunks.

  • Any patient showing a positive skin smear, irrespective of the clinical classification, should be treated with the MDT regimen for MB leprosy.
  • While Classifying leprosy, it is particularly important to ensure that patients with MB disease are not treated with the regimen for the PB form of the disease. Therefore, when classification is in doubt, the patient should be treated with the MDT regiment for MB leprosy.
Organizing diagnostic services-The most cost-effective Two basic principles
  • Provision of efficient health services for diagnosing and treating leprosy; and
  • Increasing the community’s awareness of early sings and the curability of leprosy, sometimes through special campaigns.
Treatment of leprosy:
All registered and newly detected cases must be started on and appropriate MDT regiment.
The WHO-MDT regimens are “robust” i.e. their efficacy is not impaired by minor irregularities in compliance.
Monotherapy used as a treatment of leprosy should be considered as UNETHICAL practice.

WHO-recommended MDT Regimens

(1) Multibacillary leprosy (MB)

 Day 1:
  • Rifampicin: 600 mg, supervised.
  • Dapsone: 100 mg, supervised.
  • Clofazimine: 300 mg, supervised
Day 2 – 28:       
Dapsone: 100 mg, daily unsupervised.
Clofazimine: 50 mg, daily unsupervised.
12 Blister Calendar Packs (BCPs) to be finished by the patient (ideally in 12 months) before being declared
as cured.               
(2) Paucibacillary leprosy (PB)

Day 1:
  • Rifampicin: 600 mg, supervised.
  • Dapsone: 100 mg, supervised.
Day 2 – 28:   
  • Dapsone: 100 mg, daily unsupervised.
6 Blister Calendar Packs (BCPs) to be finished by the patient (ideally in 6 months) before being declared as cured.
Both categories of patients (MB & PB) have to come to the nearest health center to collect the blister calendar pack for the coming month. If they don’t come for 12 consecutive months between any two doses, they are declared as defaulters and their name is deleted from the treatment register. They are then re-registered.
(3) Single Skin Lesion Paucibacillary leprosy : Now treated as PB Leprosy.

Points to remember:
  • For Children below 10 years, the dose may be adjusted, for example rifampicin 300 mg, dapsone 25 mg and clofazimine 100 mg once a month and 50 mg twice a week.
  • MDT drugs should not be given to patient with severe renal or hepatic dysfunction.
  • Dapsone should not be given to patients with severe anemia.
  • Patient known to be allergic to sulpha drugs should not be given dapsone.
  • Ofloxacin and minocycline are not recommended for use in pregnant women and children below five years of age.
  • In case of sever dapsone toxicity, PB patient should receive clofazimine 50 mg a day and a monthly dose of 300 mg as a substitute for dapsone. MB patients should continue treatment with rifampicin and clofazimine in the usual dosages.
National Leprosy Eradication Program – 1983
  1. Early detection by Active Surveillance
  2. Multi Drug Therapy
  3. Health Education
  4. Rehabilitation.
District infrastructure according to endemicity level:
  1. High Leprosy Endemic district         
    District Leprosy Unit
    Leprosy Control Unit –  1/450,000 Population – 1 M. O, 2 NMS, 20 PMV
    Urban Leprosy Centers – 1/50,000 Population; 1 PMW
  2. Moderate Endemic District  - 2 Mobile leprosy treatment Units
  3. Low Endemic District 1 Mobile Leprosy Treatment Units per district.
    SET centre (Surveillance, Education and Treatment): attached to PHCs; over 20-25000 population in rural endemic pockets; 1 PMW; worker supposed to examine 8000 people per year. Functions include Detection by HTH surveys; health education; Removal of misconceptions and stigma. Free treatment; tracing of contacts and their management.
Goal of NHP 2002: Elimination of leprosy by 2005.
Project Phase II Objectives:
  • Achieve elimination of leprosy at national level
  • Accomplish integration of leprosy services with general health services in 27 low endemic state and UTs.
  • To proceed with integration of services as rapidly as possible in 8 high endemic states.
  1. Decentralization and Institutional development
  2. Strengthening and integration of service delivery
  3. Disability care and prevention.
  4. IEC
  5. Training.
MLEC – Modified leprosy elimination campaigns: Organizing 1-2 wks camps in which services like case detection, treatment and referral to reconstruction facilities are provided. MLEC strategy in phase II are: 1 round in 1st year, 2 rounds in 2nd year followed by SAPELs and Voluntary Reporting during 3rd yr in high endemic states.
SAPEL – Special projects for the elimination of leprosy: Initiative aimed at providing MDT to patients living in special difficult to access or to those belonging to neglected population groups.

Strategy of National Leprosy Eradication Programme (NLEP)
  1. The Elimination of Leprosy as a Public Health Problem
    Elimination of leprosy as a public health problem is defined as a prevalence rate on the global level of less than one case per 10 000 persons
    The main components of the strategy for NLEP as a whole are:
    1. Early detection and regular treatment of patients;
    2. Providing Multi-Drug Therapy (MDT) to all patients at fixed in or a nearby village
    3. Education of the patients, their families, and community to remove misinformation, social stigma and ensure early reporting and accept regular, complete treatment.
    4. Integration of Vertical leprosy staff with General Health Care staff (e.g. PHC staff)
    5. Decentralization of leprosy control activity to the state
    6. Training to all General Health Care Service Staff
  2. Set centre (Survey Education and Treatment)
    A SET center is attached with a PHC in rural area and under the administrative control of the medical officer in-charge of the PHC. At one SET center, one paramedical workers (PMW) is posted cater a population of 20-25 thousand. The worker is supposed to conduct door-to-door survey and examine at least 8000 people per year. Non-medical supervisor supervises 5 such workers. The worker has to impart health education about the leprosy to the community and patients and provide treatment. Financial assistance is provided to the voluntary organization under the SET scheme to undertake leprosy work.
    Detection of early cases by house-to-house survey.
    Health education about the mode of spread and treatment of leprosy aimed at removing fears, misconceptions and stigma against leprosy;
    Free treatment of all cases at center or in the Central Clinic and the follow-up    of leprosy cases.
    Tracing of contacts and their chemo prophylaxis with DDS
  3. Leprosy elimination campaign (LEC) approach
    Introduction:  A comprehensive and influential approach to eliminate leprosy as of its an ultimate goal. This approach was first introduced in Tamil Nadu with the full involvement of administration by organizing an intensive campaign of a week in Feb. 1997. With three objectives: 
    Detect hidden cases of leprosy
    Increase community awareness, Involvement of general health workers after promoting their knowledge and skills
    Procedure: Involvement of the whole government machinery backed by political and administration support at the highest level and use of available electronics and print media for wide and repeated publicity has brought unprecedented useful awareness both among the community as well as the peripheral health workers, health guides, teachers, panchayat members etc., about the leprosy elimination as a goal to be attained within 3 years and that they have a useful role to play in attaining the same. This approach was well accepted and created a significant impact. The Govt. of India has advocated that such comprehensive approach should be adopted wherever possible.
    Funds:  The Govt. of India provides necessary funds from World Bank to District Leprosy Societies to meet additional costs involvement in orientation training of the staff and IEC activities.
Vision mass treatment
Mass treatment: A prevalence of more than 5 per cent severe and moderate trachoma in children under 10 years is an indication for mass or blanket treatment. The treatment consists of the application twice daily of tetracycline 1 per cent ointment to all children, for 5 consecutive days each month or once daily for 10 days each month for 6 consecutive months, or for 60 consecutive days . An alternative antibiotic is erythromycin.
  1. From the practical point of view, one of the main difficulties is the need for repeated applications of the antibiotic over long periods of time. Emphasis is now being placed on the active participation of the community itself in trachoma control activities and on the utilization of village health guides (primary health care workers). This makes possible a wider coverage and a greater efficacy of the programme .
  2. In case of yaws chemoprophylaxis is based on the following observations: A. treatment with a single injection of long-acting penicillin will cure infection B. the simultaneous treatment of all clinical cases and their likely contacts in the community will interrupt transmission in the community.
  3. Benzathine penicillin G is the penicillin of choice. The dose of BPG is 1.2 million units for all cases and contacts, and half that dose (0.6 million units) for children under 10 years of age.
  4. The WHO has recommended three treatment policies:
  5. TOTAL MASS TREATMENT: In areas where yaws is hyperendemic (I.e., more than "10 per cent prevalence of clinically active yaws), a great part of the population is at risk. The entire population including the cases should be given penicillin in the doses mentioned above
  6. JUVENILE MASS TREATMENT: In meso-endemic communities (5 to 10 per cent prevalence), treatment is given to all cases and to all children under 15 years of age and other obvious contacts of infectious cases
  7. SELECTIVE MASS TREATMENT: In hypoendemic or areas of low prevalence (less than 5 per cent) treatment is confined to cases, their household and other obvious contacts of infectious cases.
  1. Revised national tuberculosis control programme
    1. Tuberculosis (TB) is an infectious disease caused by a bacterium, Mycobacterium Tuberculosis. It spreads through air by a person suffering from TB. A single infectious patient can infect 10 or more people in a year.
    2. It primarily affects people in their most productive years of life and is commonly associated with poverty, overcrowding, and malnutrition.
    3. India contributes about 1/3rd of the global burden of tuberculosis. Every year, there are approximately 22 lakh new cases in the country.
    4. Around 1.2 million TB cases are detected every year under the programme of which about 30-35% are sputum-positive and rest are sputum negative patients. It is estimated that almost an equal number of TB cases report to the private sector. Trend of the TB cases in the country reported under the programme over last few years has been more or less static.
    5. Diagnosis of TB cases is made through quality sputum microscopy, by examining three sputum samples of the chest symptomatics. Facilities for sputum microscopy are available free of cost at RNTCP microscopy centers.
    6. TB is completely curable if full course of treatment is taken by the patient. All diagnostic and treatment facilities including supply of anti-TB drugs for full course of treatment are available free of cost for TB patients.
    7. The Government of India evolved the Revised National TB Control Programme (RNTCP) based on Directly Observed Treatment Short Course (DOTS) strategy with the objective of curing at least 85% of new sputum positive patients and detecting at least 70% of such patients.
    8. RNTCP was launched in the country in the year 1993 in a phased manner and by March 2006 the whole country was brought under this program.
    9. The success of depends on five components:
      1. Political commitment
      2. Good Quality sputum microscopy
      3. Directly observed treatment
      4. Uninterrupted supply of good quality drugs
      5. Accountability
DOTS strategy
  1. Under the DOTS strategy, patients swallow the drugs under direct observations of the health worker viz. the DOT provider.
  2. The selection of the DOT provider is not restricted to medical personnel. Any responsible person of the locality /community except a family member can function as DOTS provider.
  3. The patient is required to visit the designated DOTS center and consume the medicine in the presence of the DOT provider.
  4. In case the patient drops out/fails to attend the health facility on the scheduled day, then it is the responsibility of the DOT provider to retrieve the patient to the system and ensure completion of the treatment regimen.
  5. One of the unique features of this programme is the fact that patient wise treatment boxes are available with the DOT provider with the full regimen of drugs needed to complete the treatment.
  6. This facility ensures availability of anti-TB drugs for a patient for his/her full course of treatment on the very first day he/she is registered.
  7. Case Management: Patients are put into 2 different categories according to their disease status. The treatment protocols for the 2 categories are also given below.             
  1. CAT I         
    New sputum smear +ve                                        
    Sputum smear –ve
    Extra pulmonary – TB meningitis, disseminated TB, tuberculous pericarditis, peritonitis, bilateral and extensive pleurisy.
  2. CAT II Sputum smear +ve relapse/ failure/ Treatment after default            
  3. CAT III No longer present. Merged with Cat I               
Treatment :  Chemotherapy is divided in 2 phases; intensive phase, followed by continuation phase.

Intensive phase      Continuation phase
Category I                 2(HRZE)3                                   4(HR)3   
Category II                2(HRZES)3 + 1(HRZE)3               5(HRE)3
The number before the brackets refers to the number of months of treatment. The subscript after the brackets refers to the number of doses per week. H : Isoniazid(600 mg), R : Rifampicin(450 mg), Z : Pyrazinamide(1500 mg), E : Ethambutol(1200 mg), S : Streptomycin(750 mg)
DOTS is an alternate day Treatment regimen.
Drugs Daily Therapy Thrice-weekly Therapy
Isoniazid 5 mg/kg 10-15 mg/kg
Rifampicin 10 mg/kg 10 mg/kg
Pyrazinamide 25mg/kg 35 mg/kg
Streptomycin 15 mg/kg 15 mg/kg
Ethambutol 15mg/kg 30mg/kg
  1. Goal OF RNTCP
    The goal is to extend the RNTCP to cover the entire population of the country as soon as possible without compromising on the quality of diagnosis and treatment and all out efforts are being made in this direction. Subject to availability of resources, it is estimated that the RNTCP may cover the entire country by 2005.
  2. Objectives OF RNTCP
    The broad objective of the RNTCP is to cut down the pool of infection eventually to eliminate. The specific objectives of the programme are: -
    1. To cure at least 85% of all new sputum positive cases detected
    2. After having achieved the first objective, to detect at least 70%  of the estimated cases of TB.
  3. Components of DOTS:
    1. Case detection primarily by sputum microscopy
    2. Adequate uninterrupted drug supply-through patient wise boxes
    3. Short course chemotherapy under direct observation
    4. Systemic monitoring and accountability
    5. Political wall
  1. Current strategy
    1. Diagnosis by microscopy is the primary strategy for case detection. In a well-functioning programme the ratio or new sputum smear positive cases to new sputum smear negative cases is 1:1.
    2. Furthermore at least 2% of the adult out patients at general health facilities are chest symptomatic, i.e. have cough for 2weeks or more.
    3. Approximately 10% of patients undergoing sputum examination for diagnosis are found to be smear positive.
    4. The treatment is undertaken in two phases namely intensive phase and continuation phase. The intensive phase is directly observed treatment wherein the patient swallows the drugs on alternate days thrice a week in the presence of health functionary / worker (DOTS Agents) who is accessible and acceptable to the patient and accountable to the system.
    5. During the continuation phase, the patient is given medicines for one week in which the first dose is swallowed by the patient under the direct observations of the health functionary and at the end of the week the patient brings the empty blister pack as evidence of having consumed the medicines and then he is given medicine for the next week. The drugs of each dose of intensive phase and weekly dose of continuation phase are packed in multi blister compibacks.
    6. In all categories, the full requirement of drugs in respect of individual patient are packed in patient – wise boxes. At the specific intervals stipulated in the programme, sputum examinations are undertaken to monitor the progress of the patient towards care.
    7. Two important indices of programme monitoring are sputum conversion rate, which is done at the end of the intensive phase, and cure rate, which is determined at the completion of the treatment. Each and every patient registered in the programme is followed and at the end of the treatment, the treatment outcome of all patients registered is available to the programme.
    8. This aspect is completely different from the earlier programme where the treatment outcome was available only in respect of completion of treatment.
    9. For assessing the treatment outcome, the cohorts are studied. Results of the cohorts are available to the programme after a year and are reported on quarterly basis on the prescribed quarterly reporting formats.
  2. Operational management
    TB unit at sub district level: 5 lakh population; staff include Sr. treatment & Sr. TB lab supervisor
    DOT’s center or microscopy center covers one lakh population; staff includes treatment supervisor and lab technician.
Type of cases
  1. New          :  Never had T/T for TB or < 1 M
  2. Relapse     :  Declared cured but again sputum +ve
  3. Transfer in :  Into TB unit/district after starting T/T in another
  4. Failure       :  Smear +ve even after 5 months Rx
  5. Default      :  Received T/T for > 1 month and stopped ATT for > 2 months
  6. Chronic      :  Smear +ve after completing T/T regimen.
  7. Cured        :  Initially sputum positive case, remains sputum negative on 2 occassions one  at the end of T/t.
  8. T/t completed  : Initially sputum negative case who has completed the required duration of   T/t.
  1. Technical and managerial indicators
Indicator                                                                                                    Volume
Proportion of symptomatic patient in OPD to be referred to DOT center          2%
Proportion of symptomatic patients who are smear-positive                          8-12%
Percent smear positives among new TB cases                                              50%
Sputum conversion for new smear – positive TB cases at 3 months                > 85%
Percent of new smear – positive patient who are cured                                  > 85%
Proportion of seriously ill smear – ve in Cat I:                                               < 20% of cat I
Proportion of defaulters                                                                               < 5%                      
Checking of 100% of positive slides and 10% of sputum negative smears for quality assurance.
  1. Operational guidelines
    The RNTCP is implemented through TB Societies at the State and District levels.
    There is a State TB Officer and District TB Officer who are responsible for the effective implementation of the programme in the States and Districts respectively.
    The District TB Societies are headed by the District Collectors while the state level society is headed by the State Health Secretary.
    RNTCP has been expanding rapidly. As on date, the coverage is about 460 million.
    It is envisaged to cover 800 million population by the year 2004 and the entire country by 2005.
    Presently Tuberculosis Unit per 5 lakh population, 1 Microscopy Center per 1 lakh population
    During 2001 under RNTCP 4.7 lacs TB patients were initiated on treatment. Out of this more than 50% were sputum positive.
    Till date more than 1 million patients have been put on treatment under RNTCP averting nearly 2 lac death & preventing more than 2 million infections.
  1. TB-HIV Dual Infection
  • TB shortens the survival of patient with HIV infection and the cause of death for one out of every three people with AIDS worldwide.
  • Treatment of DOTS prolongs the life of HIV infected persons by at least two years, prevents drug resistance and blunts the increase in TB cases.
  • The RNTCP and National AIDS Control Organization (NACO) are collaborating to implement HIV-TB action plan.
  • It is envisaged to provides services for HIV infected TB patients under the same roof by establishing critical linkages between Voluntary Counseling and Testing Centers and RNTCP Microscopy Centers, by involving common NGOs and through combined IEC activities and infection control measures.
  1. Multi Drug Resistance
  • Studies undertaken by TRC, Chennai indicate presently primary drug resistance is 2-3%.
  • Drug - resistant tuberculosis is a symptom of poor programme performance.
  • Drug resistance arises because of improper/irregular/inadequate treatment.
  • Drug resistant tuberculosis is the symptom rather than the cause of poor tuberculosis control.
  • To improve tuberculosis control, it is essential to improve treatment of patients so that drug-resistant tuberculosis is not created. Among the few patients who are not cured, the overwhelming reason is failure to ensure that the drugs are taken as prescribed, rather than failure of the drugs to work properly.
  • WHO defines a multi-drug resistance strain as one that is at least resistant to isoniazid & rifampicin.
Extensively drug resistant tuberculosis (XDR) – cases that are resistant to almost all second line drugs are termed XDR and are defined as occurring when M.tuberculosis is resistant to
  1. rifampicin & INH
  2. resistant to fluoroquinolones &
  3. resistant to one or more of the following injectable drugs: amikacin, capreomycin & Kanamycin.
Management of Pediatric Tuberculosis Under the Revised National Tuberculosis Control Programme
The actual global disease burden of childhood TB is not known, but it has been assumed that 10% of the actual total TB caseload is found amongst children. Global estimates of 1.5 million new cases and 130,000 deaths due to TB per year amongst children is reported

Childhood TB prevalence indicates:
  1. community prevalence of sputum smear-positive pulmonary tuberculosis (PTB)
  2. age-related prevalence of sputum smear-positive PTB
  3. prevalence of childhood risk factors for disease
  4. stage of epidemic
Proper identification and treatment of infectious cases will prevent childhood TB. However often childhood TB is accorded low priority by National TB Control programmes. Probable reasons include:
  1. Diagnostic difficulties
  2. Rarely infectious
  3. Limited resources
  4. Misplaced faith in BCG
  5. Lack of data on treatment
Children can present with TB at any age, but the majority of cases present between 1 and 4 years. Disease usually develops within one year of infection - the younger, the earlier and the more disseminated. PTB is usually smear-negative. PTB to extra-pulmonary TB (EPTB) ratio is usually around 3:1. The PTB prevalence is normally low between the ages of 5 and 12 years, and then increases in adolescence when PTB manifests like adult PTB (post primary tuberculosis).
The guidelines are :-
  1. Diagnosis
    1. Suspect cases of PTB will include children presenting with: fever and / or cough for more than 3 weeks, with or without weight loss or no weight gain; and history of contact with a suspected or diagnosed case of active TB disease within the last 2 years.
    2. Diagnosis to be based on a combination of clinical presentation, sputum examination wherever possible, Chest X ray (PA view), Mantoux test (1 TU PPD RT23 with Tween 80, positive if induration >10mm after 48-72 hours) and history of contact.
    3. Diagnosis of TB in children should be made by a Medical Officer.
    4. The existing RNTCP case definitions will be used for all cases diagnosed.
    5. The use of currently available scoring systems is not recommended for diagnosis of Pediatric TB patients.
    6. Children showing neurological symptoms like irritability, refusal to feed,  headache, vomiting or altered sensorium may be suspected to have TBM. 
  2. Treatment of Pediatric TB
    1. DOTS is the recommended strategy for treatment of TB and all Pediatric TB patients should be registered under RNTCP.
    2. Recommended treatment regimens are based on the body weight of the child and there will be 2 generic paediatric patient wise boxes (PWBs) – one for the 6-10 kg weight band & the second for the 11 – 17 kg weight band.
    3. Drugs for paediatric TB cases under RNTCP are being supplied as PWBs similar to those supplied for adult patients – This will be the global ‘first’ for RNTCP, as no other DOTS program in the world has such PWBs for the T/t of TB in children.
  3. Chemoprophylaxis
    Asymptomatic children under 6 years of age, exposed to an adult with infectious (smear-positive) tuberculosis, from the same household,  will be given 6 months of isoniazid (5 mg per kg daily) as chemoprophylaxis.
Because of the emergence of MDR-TB (multiple drug resistance) to drugs used as the primary line of management for TB, the WHO has embarked on a programme of directly supervised regimens using drugs where no resistance has been reported. These regimens are only to be used in areas specified as suffering from MDR TB. It is also important that the secondary drugs are not used routinely and sold across the counter in such areas to avoid the emergence of resistance to these drugs. This is called DOTS Plus.
Epidemiological markers:
Prevalence of infection: tuberculin +ve – 30%. (0-4 yrs & > 20 yrs – 50%)
Incidence of infection: Annual Risk Infection – Tuberculin conversion – 1-2% (1.5%)
Prevalence of disease: 14-26/1000; prevalence of bacillary TB (Sputum +ve) – 3-8 (Avg-4)/1000 population.
Incidence of disease: new sputum +ve – 1.5/1000 (> 5 yrs)
Prevalence of drug resistance – 1-3% (New cases), 13 – 17% (Retreatment cases)
Diagnosis of smear positive pulmonary TB
  • New guidelines, effective from 1st April 2009
  • Identification of TB suspects
A pulmonary TB suspect is any person with cough for 2 weeks, or more.
At all outpatient clinics, hospitals and health facilities, both in the public and private sectors, all patients need to be systematically screened for cough by medical officers and health staff manning the health facilities. Additionally, in medical colleges and hospitals, in-patients also need to be screened for identification of TB suspects. Persons with cough for 2 weeks, or more, with or without other symptoms suggestive of TB, should be promptly identified as pulmonary TB suspects and steps taken to subject them to sputum smear microscopy for acid-fast bacilli, for diagnosis of TB.
Diagnosis of smear positive TB amongst TB suspects
Using the RNTCP laboratory form for sputum examination, the medical officer / health staff of the health facility sends the TB suspects for sputum examination to the laboratory of RNTCP designated microscopy centre (DMC). In the DMC laboratory the patient receives sputum containers with instructions to provide sputum specimens, which are then subjected for sputum examination. If the health facility is not a DMC then the patient may be referred to the nearest DMC, or else the patient’s sputum is collected and transported to the nearest DMC.
  1. The number of specimen required for diagnosis of smear positive pulmonary TB is two. 
    With one them being a morning sputum specimen.
  2. One specimen positive out of the two is enough to declare a patient as smear positive TB.
Recording and reporting
For 2009, no changes are required in the recording and reporting formats. The spot sputum specimen, irrespective of whether it is collected prior or after the morning specimen, should be recorded as specimen “a” (first specimen) in the laboratory register and the laboratory form for sputum examination. The morning specimen is always recorded as specimen “b”, i.e. second specimen, in the laboratory form for sputum examination and the laboratory register. The space for the “c” specimen should be left
Quality assurance of sputum microscopy
In view of these changes, it is of utmost importance to maintain the full range of External Quality Assessment (EQA) activities in all the RNTCP designated microscopy centres across all states and districts as per the existing guidelines. Each district should implement ‘on-site evaluation’ and ‘random blinded rechecking’ for all DMCs in the 3 district. In addition, each district needs to undergo at least one ‘panel testing’ and one ‘on-site evaluation’ by the Intermediate Reference Laboratory. It is the responsibility of the STOs, DTOs and the IRLs to ensure that EQA is maintained across all DMCs under their jurisdiction. In addition to EQA, Internal Quality Control and Quality Improvement activities need to be carried out as per RNTCP guidelines. For details of guidelines on quality assurance of sputum microscopy, please refer to “RNTCP laboratory network: Guidelines for Quality Assurance of smear microscopy for diagnosing tuberculosis”, published in 2005 by the Central TB Division, Directorate General of Health Services, Ministry of Health & Family Welfare, New Delhi, and available in downloadable format at www.tbcindia.org.
Training and communication
This change will be incorporated in the next version of all RNTCP training material. In the interim all concerned staff need to be briefed on the new policy. This change in policy needs to be communicated to all staff involved in identification of TB suspects, sputum microscopy and diagnosis of pulmonary TB, both in the public and private sector. All IEC material, on TB suspects and number of sputum samples for diagnosis, need to be changed to reflect the new policy. All partners of RNTCP, including PPM partners and TB/HIV partners at state and district levels need to be communicated the new policy.
  1. National AIDS control programme (NACP)
Indian scenario
  • 1st case – 1986
  • Type 4 Epidemic i.e. epidemic shifts from the highest risk group (CSWs drug users) to bridge population (clients of CSWs, STD patients, partners of drug users) to general population, this shift occurs when the prevalence in the first group is 5% and the time lag of 2-3 yrs between the shifts.
  • Urban to rural.
  • High –risk group to general population.
Group I: High prevalence states; Generalized Epidemic: HIV infection in high-risk group is > 5% and in low risk group (ANC mothers) is > 1%. (Maharasthra, TN, Karnataka, AP and Manipur).
Group II: Moderate prevalence states; Concentrate Epidemic: HIV infection in high risk group is > 5% and in low risk group (ANC mothers) is < 1% . Gujarat, Goa and Pondichery.
Group III: Low prevalence states; Low level Epideic: HIV infection in high-risk group is < 5% and in low risk group (ANC mothers) is < 1%.
HIV sentinel surveillance report among antenatal mothers from metro indicate:
  1. It has crossed 2% in Mumbai.
  2. 1% in Bangalore, Chennai, Hyderabad
  3. Below 1% in Kolkata, Ahmedabad and Delhi.
(2005 estimates):
  1. 5.134 million PLWA
  2. 1,04, 000 AIDS cases
  • Male: Female ratio is 3:1
  • Maximum cases in Tamil Nadu, Maharashtra, Manipur
  • Route of transmission sexual in 85% cases
Route Source of Infection of AIDS cases (%) Efficiency of transmission (%)
Blood transfusion 3% 90-95% (AI’09)
Sexual 84.5% 0.1-1.0%
Perinatal 2.5% 20-40% (33%)
IDU 3% 0.5-1.0%
Needle stick injury - < 0.5%
Mucountaneous - 0.05%
History NA 7%  

Aids Case Definition: WHO case definition: Age > 12 yrs with at-least 2 major and 1 minor signs.
  1. Unexplained chronic diarrhea for > 1 month
  2. Loss of > 10% body weight
  3. Prolonged fever for > 1 month
  4. Persistent cough for > 1 month
  5. Generalized pruritic dermatitis
  6. H/o. Herpes zoster
  7. Oropharyngeal candidiasis
  8. Chronic progressive or disseminated HS V infection
  9. Generalized Lymphadenopathy
  10. AIDS defining illness-Kaposi’s sarcoma’ cryptococcal meningitis; Ca cervix, primary lymphoma of brain
Expanded WHO case definition:
HIV serological test positive with one of the following conditions
  1. Unexplained chronic diarrhoea for > 1 month, Loss of > 10% body weight; Prolonged fever for > 1 month
  2. Cryptococcal meningitis
  3. Pulmonary or extra pulmonary tuberculosis
  4. Kaposi sarcoma
  5. Neurological impairment sufficient to prevent independent daily activity
  6. Candidiasis of the esophagus
  7. Recurrent episodes of life threatening pneumonia with/without etiological confirmation
  8. Invasive cervical cancer
Most Common Opportunistic Infection Tuberculosis
Antiretroviral therapy – It includes 3 classes of drugs (AI’09)
Nucleoside analogs – Didanosine, Zidovudine, Zalcitabine, stavudine, Lamivudine
Protease inhibitors – Saquinavir, Ritonavir, Indinavir, Nelfinavir
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) – Nevirapine, Delavirdine
NACP:     Milestones:
  1. 1985 – Task for constituted
  2. 1987 – National AIDS control programme Organization
  3. 1992 – National AIDS control programme
  4. 1992-1999 – NACP – phase I
  5. 1999-2006- NACP – phase II
  6. 2002 – National AIDS control Policy – aims to bring AIDS transmission to zero level by 2007.
  7. 2007 – 2012 – NACP Phase III
NACP Phase – I
  1. Increased awareness to 70-80% in urban area, but still low in rural areas.
  2. Modernization and strengthening of blood banks
  3. Licensing system of blood banks and phasing out of professional blood donors (AIIMS May’09)
  4. Availability of good quality condoms through social marketing
NACP Phase – II
  1. Shift focus from raising awareness to changing behavior through interventions.
  2. Support decentralization of service delivery–delivery to be flexible, evidence based, participatory and rely on local programme implementation plans
  3. Protect human rights
  4. Encourage management reforms.
  5. Objectives: Reduce spread of HIV infection in India
  6. Strengthen India’s capacity to respond to HIV/AIDS on a long-term basis.
  7. Targets: Prevalence rate in adult population to below 5% in Maharashtra; below 3%in AP, Karnataka; Manipur, TN and <1% in all other states.
  8. Reduce blood borne transmission to < 1%
  9. Awareness levels > 90% among youth and others in reproductive age.
  10. Condom use > 90% among high-risk categories.
  11. Provide services for STD treatment upto PHC level.
Project strategy-
  1. Deliver cost-effective interventions against HIV/AIDS
    Priority targeted-intervention in high-risk groups
    Preventive intervention for the general community
    Low cost AIDS care
  2. Strengthen capacity
  • Institutional strengthening
  • Intersectoral coordination      
SentinelSurveillance:                                                                                                        All over India. Unlinked anonymous testing. 50 sample size in STD clinics/ drug deaddiction centers       
0 sample size in Antenatal clinics.

Prevention of Mother to Child transmission
  1. Phase I of the feasibility study based on late introduction of Zidovudine (AZT) during antenatal period has been completed at 11 centres.
  2. Phase II  - Using Nevirapine has been started from Oct. 2001 at the 11 centres.
  3. Results of feasibility study indicate- Implementation of PMTCT can be done in existing framework of RCH
  4. It is proposed to introduce this intervention in 6 high prevalence states ion a priority basis.
Post Exposure Prophylaxis:
Antiretroviral drugs are given free of cost to all doctors and other paramedical staff in case of needle stick or sharp injury while attending to HIV/AIDS patients. Start as early as possible, after an exposure (after 72 hrs of exposure, it is of no use) 1 month of therapy.
H.I.V Testing policy in India:
Govt. of India guidelines are as follows.
  1. No individual should be made to undergo a mandatory testing for HIV
  2. No mandatory HIV testing should be imposed as a precondition for employment or for  providing health care facilities during employment.
  3. Adequate voluntary testing facilities with pre-test and post-test counseling should be made available throughout the country in a phased manner. There should be at least one HIV testing centre in each district in the country which can be done in a phased manner.
  4. In case a person likes to get his HIV status verified through testing, all necessary facilities should be given to that person and results should be kept strictly confidential and should be given out to the person and with his consent to the members of his family. Disclosure of the HIV status to the spouse of the person will entirely depend on the person’s willingness to share the information. However, the person should encouraged to share this information with the spouse and family as it helps the person in getting proper home-based care when he is  afflicted with AIDS.
  5. In case of marriage, if one of the partners insists on a test to check the HIV status of the other partner, such tests should be carried out by the contracting party to the satisfaction of the person concerned.
The HIV testing policy adopted in the NACO is found to be appropriate for the different types of   testing that have to be done. At present people are tested for -
  1. Screening in blood banks
  2. Epidemiological surveys; and
  3. Confirmatory testing for clinical management and voluntary testing.
In the case of screening for blood donation, a single test by rapid/elisa is done to eliminate the possibility of hiv-positive blood. In the case of epidemiological surveys also the same procedure is adopted, i.e. With one or two tests either with elisa or rapid or simple with high sensitivity. In both the above cases the testing is anonymous and the result is not given to the person concerned unless asked for. In the case of clinical management and for confirmatory testing of hiv status of persons who voluntarily ask for it, the sample will be tested with at least two elisa and one rapid/simple by a different antigen preparation. The result is given out with proper pre-test and post-test counseling.

NACP – III ...To Halt and Reverse the Epidemic
Goals and Objectives:
  1. Prevention of new infections in high risk groups and general population through:
    1. Saturation of coverage of high risk groups with targeted interventions (TIs)
    2. Scaled up interventions in the general population
  2. Providing greater care, support and treatment to larger number of PLHA.
  3. Strengthening the infrastructure, systems and human resources in prevention, care, support and treatment programmes at the district, state and national level.
  4. Strengthening the nationwide Strategic Information Management System.
The specific objective is to reduce new infection as estimated in the first year of the programme by:
Sixty per cent (60%) in high prevalence states so as to obtain the reversal of the epidemic; and
Forty per cent (40%) in the vulnerable states so as to stabilize the epidemic.
  1. Prevention of new infections in high risk groups and general population :   
Creating awareness about symptoms, spread, prevention and services available. (Communication - CAU)
Management of STI and RTI
Condom promotion
Integrated Counselling and Testing (ICT) (provider-initiated testing and counselling of patients)
Promotion of safe practices and infection control.
BCC through peer and outreach.
Building enabling environment.
Community organizing and ownership building. (CBOs).
Linking HIV related care and support services
Promotion of voluntary blood donation and access to safe blood.
  1. Target interventions to increase from 1030 to 2100 by 2011. 50% to be CBOs
  2. To increase condom use to 3.5 billion pieces/ yr by 2009 from 1.6 billion/ yr.
  3. To cover 50% of those with the STI symptoms and provide treatment.
  4. To raise voluntary blood donation to 90 per cent by end of the programme.
  5. ICTCs will be increased from 2815 to 4995.
  1. Providing greater care, support and treatment to larger number of PLHA :
    1. Under NACP-II, focus was given on low cost care, support and treatment of common OIs.
    2. ART programme was launched in 2004 in 8 institutions in 6 high prevalence states and Delhi. 
    3. As on 31st May 2006, a total of 54 ART centres were functional with 33,638 patients (including 1352 children) receiving free Anti Retroviral Therapy at these centres. 
    4. However, this constitutes only 10 per cent of the estimated eligible patient
  • 300,000 patients on ART by the end of 2011 through approximately 250 ART centres
  • Strategy:
    • Identification of institutions,
    • Strengthening referral linkages for CD4 testing,
    • Capacity building of ART teams and
    • Procurement of ARV drugs
(Priority being accorded to women & children referred from TIs and those below poverty line)

Key activities
  1. Preventive
    1. Develop risk reduction strategies for PLHA and their partners ;
    2. Build capacity of PLHA networks ;
    3. Establish linkages of TIs, ICTCs, PPTCT Centres, STD clinics with ART centres and TB clinic so that PLHA can access care, support and treatment services and behavioural communication;
    4. Partner referrals through counselling; and
    5. Screen TB/STI of PLHA.
Managing Opportunistic infections
Referral linkages will be strengthened;
Develop guidelines and capacities for establishing standards of care;
Smart card system will be integrated and up-scaled to track infections in individual patients.

The staff at PHCs and CHCs will be trained through NRHM, while in district and tertiary hospitals, through the state health system.
  1. Ensure transport subsidy for PLHA who are below poverty line;
  2. Ensure that women have access to treatment facilities
Providing Care and Support for Children Infected and Affected with HIV/AIDS
  1. Psycho-social and Livelihood Support
  2. Nutritional Support to PLHA receiving ART
Community care centers
Under NACP-II, 122 Community Care Centres were set up to provide treatment for minor OIs, but more importantly psycho-social support.
Services to PLHA:
  1. Counselling, in particular for drug adherence;
  2. Treatment support;
  3. Referral and outreach for follow up; and
  4. Social support services
Additional 228 CCCs over the next 5 years in partnership with PLHA networks in all A and B districts, and in C districts, based on PLHA load.
  1. ARV drugs will be provided to all those who need it.
  2. Seek to achieve drug adherence rates of 95 per cent and above.
  3. Targets,
    1. 250 ART centres
    2. 250 CD4 count machines (existing)
  4. ART clinics established in the Departments of Medicine to provide integrated HIV services .
  5. ART centres available - at districts in cat A and
    1. cat C, at districts if PLHA more                                                                        
    2. cat D, medical colleges.
  6. ART centre will contain a MO, 2 counselors, lab personal (ICTC and STI) and PLHA network person.
  7. Travel reimbursement to BPL people and Tribals.
Paediatric Care & Support
  1. Prevention, care and treatment of children infected or affected by HIV/AIDS;
  2. Prevent HIV infection to newborns through PPTCT programme scale-up.
  3. Paediatric “Centre of Excellence” in each region of the country.
  4. Paediatric ART Centres will consist of a full time paediatrician, counsellor trained in paediatric HIV infection, a laboratory technician and a nutritionist
External quality assurance
  1. A Consultant for every 10 ART centres, or at the state level.
Monitoring of ART Care by computerised MIS (provision of smart cards.)
Drug Resistance Monitoring Network
  1. NARI be the nodal institute and 2 reference labs with 10 sentinel labs.
Innovative Financing of ART Drugs
  1. Paediatric “Centre of Excellence” in each region of the country.
  2. Paediatric ART Centres will consist of a full time paediatrician, counsellor trained in paediatric HIV infection, a laboratory technician and a nutritionist
External quality assurance
  1. A Consultant for every 10 ART centres, or at the state level.
Monitoring of ART Care by computerised MIS (provision of smart cards.)
Strengthening the infrastructure, systems and human resources in prevention, care, support and treatment programmes at the district, state and national level.
  1. In NACP I & II, the focus was mainly on the technical aspects of prevention and control and technical knowledge and skills for diagnosis and clinical management.
  2. NACP-III aims to build capacity of the programme managers at the national, state and district levels in
    1. leadership and strategic management;
    2. technical and communication skills of the health professionals and health care providers at
      1. all levels of care and health care organizations,
      2. CBOs and NGOs; and technical, communications and counselling skills of the grass-roots level workers and functionaries of various government departments
  1. Managerial skills
  2. Technical skills
A Training Coordination Unit will be established at NACO.
  1. Capacity building:
  • Outsource an expert agency
  1. NACO Capacity Building Unit
  • Monitoring and evaluation of Training since the beginning.
Enabling Environment
  • Greater Involvement of People Living with HIV/AIDS (GIPA)
  • Reducing Stigma and Discrimination
  • ‘Rights based approach’
  • Human Rights, Legal and Ethical Issues
Monitoring & and Surveillance
Strategic Information Management Unit (SIMU):
  1. to maximize effective use of all available information and implement evidence based planning
  2. Will focus on strategic planning, monitoring and evaluation, surveillance and research.
  3. will be the basis for measuring performance, analyzing variances, identifying bottlenecks, alerting the programme managers and facilitating corrective measures.
  1. Will focus on:  tracking the epidemic, identifying pockets of HIV infection and estimating the burden of infection in the country.
  2. Will involve: 
  • BSS and HSS including measurement of HIV incidence,
  • STI surveillance and tracking of other surrogate markers, e.g. Hepatitis B, Hepatitis C etc.,
  • AIDS case reporting,
  • HIV associated morbidity and mortality,
  •  Anti-retroviral and STI drug resistance surveillance and
  • other methods /sources of data (e.g. ongoing surveys)

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