Anti TB-Campaign

CONTENT

?
The preamble.
?
The principles of treatment of tuberculosis.
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Classification of cases and proposed treatment regimen.
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Issue of referring a patient : when?
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What are the problems for the primary care physicians.
?
What is expected from the Government.
We extend our heart felt thanks and gratitude to all the members of the
consensus team and our colleagues who joined voluntarily in the subsequent
meeting and contributed actively to make this draft possible.
We extended thanks to all our staff members and people who supported us
selflessly to prepare and publish the draft.

This consensus draft is published by : Institute of Pulmocare & Research on 24th March, 2010
The draft has been made for public interest to strengthen the existing anti TB campaign
The draft has already been forwarded to different authorities as the Govt. of India (Health & Family
Welfare department, Human RD), WHO, RNTCP etc.
The concept, the credit (if any), the copyright (if applicable) shall go to the Institute of Pulmocare &
Research, Kolkata.
This printed version is published for free of cost distribution amongst the colleagues and concerned
people.

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LIST OF DOCTORS CONTRIBUTING IN MAKING THE DRAFT

Consensus members :
1. Dr. Dhiman Ganguly
2. Dr. Rupak Ghosh
3. Dr. Saikat Nag
4. Dr. Sujan Bardhan
5. Dr. Saibal Ghosh
6. Dr. Angira Dasgupta
7. Dr. Malay Maitra
8. Dr. Abhijit Mukherjee
9. Dr. Somnath Mitra
10.Dr. Parthasarathi Bhattacharyya

Members who have attended the presentation along with the consensus members :
1. Dr. PDO Davies (as an observer)
2. Dr. Amit Podder
3. Dr. Anirban Sarkar
4. Dr. Ansuman Mukherjee
5. Dr. Debajyoti Pal
6. Dr. Dhrubajyoti Roy
7. Dr. J. L. Ghosh
8. Dr. M L Gupta
9. Dr. Monotosh Khanra
10.Dr. Pawan Agarwal
11.Dr. Ranjan Das
12.Dr. Shankar Saha
13.Dr. Subhasish Chakraborty
14.Dr. Sumita Basumallik
15.Dr. Supriya Sarkar

Anti TB-Campaign
THE PREAMBLE
Although TB is a global emergency and RNTCP is a very well organized anti tuberculosis campaign in
India, treating TB appears at times difficult for several reasons and the provided guideline is often found
inadequate to help in the ground situations. RNTCP has been a bold and effective campaign in this regard
and, incidentally, it caters to about 50% of the diseased population in the country although it covers 100%
of the geographical areas. The rest 50% of patients are treated outside RNTCP and there is hardly any
control on the treatment of this segment of patient population. Naturally, without a database regarding the
treatment of about half of the patients, the claimed success of the RNTCP program is doubted and certainly
diluted. Incidentally, the so called PPM (private public mix) in anti TB campaign is still in its infancy and
many of us appreciate that there is a huge communication gap between people working in RNTCP and
those working outside the programme regarding the treatment of the patients. There are often questions
about the scientific rationale of some of the RNTCP recommendations too. Amidst this scenario, we have
been observing an increased trend of development of drug resistant disease (especially MDR) and advent
of XDR tuberculosis globally. In India, prevalence of MDR disease is rising and an estimated prevalence is
about 3% in new cases and 17% in patients who has received anti tubercular treatment earlier. The
situation may turn worse if emergency measures are not taken to tackle the scenario. Each of us feel that
there is more scope for improvement in making the anti-TB campaign more effective especially in a
situation of growing drug resistance and increasing prevalence of HIV co-infection. Therefore, we decided
to come out with a bunch of proposals to add momentum in the success of the anti TB campaign of the
country through RNTCP.
As with all our friends facing TB in their practice, we are concerned about the developments and the
difficulties of treating the disease. We, in our limited resources, therefore decided to publish our views to
help the campaign.
While making the draft, we have appreciated the lacunae in providing evidence through generating
operational data in many areas despite the good work being done by the RNTCP and other authorities. We
have, therefore, adopted a policy to form a consensus of opinion that may have a significant role to play in
any humane activity amidst the dearth of evidence from scientific and tangible operational research. Since,
we are essentially treating physicians and not full time paid TB specialist or researcher, our approach may
appear more logical and feasible but may seem, at times, not well supported by scientific evidence
especially when there is a real dearth of database. We believe that an honest consensus with people
thoroughly involved in an issue of human interest can largely overcome problems from dearth of data to
help making a decision and an effective solution of an emergency issue to a large extent. We, therefore,
leave our thoughts and the draft to the global medical intelligentsia to carry forward our opinion formed out
of experience and possibly realizations to bring forth a more effective anti-TB campaign in future. This
effort is no way to criticize anybody or to invite any controversy; it is sincerely meant to strengthen
the global anti TB campaign.
The present draft is just the outline of our opinion pool which is meant to bring forth the background for a
more detailed and effective interactions and operational research to form an acceptable consensus in
future. There is enough room for discussion, modification, improvisation and completion of the draft.
Certain areas are not elaborated in order to avoid controversy and avail more time for development of a
better insight to do so.
Time and logistic constraints have appeared important hurdles for us to make the draft. We wish that the
initial draft will be circulated well across the country and the globe and will ignite positive criticism to enable
the right people to come forward with a better and an acceptable statement in near future with involvement
of our colleagues from all across the country and abroad in an ideal private-public mix.
We wish inputs regarding our efforts from all concerned; kindly mail your views to IPCR by mail
(ipcr_india@yahoo.com) or by logging on to www.pulmocareindia.org
Let us all add the little of our best to treat TB and help humanity.

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ABBREVIATIONS USED IN THE DRAFT ARE GIVEN BELOW :

RNTCP

Revised National Tuberculosis Control Program.

TB

Tuberculosis.

ATD

Anti Tubercular Drugs

NTM

Non Tubercular Mycobacteria.

MT

Mantoux Test.

PCR

Polymerase Chain Reaction.

QFT-G

QuantiferonGold Test.

API

Association of Physicians of India.

IMA

Indian Medical Associations.

PPM

Private Public Mix.

OTC

Over the Counter.

EATD

Empirical Anti Tubercular Drugs.

MDR-TB

Multi Drug Resistant Tuberculosis.

XDR-TB

Extensive Drug Resistant Tuberculosis.

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Anti TB-Campaign
THE PRINCIPLES OF TREATMENT OF TUBERCULOSIS
The preamble :
DOTS is a great success and RNTCP is a great campaign. However, amidst phenomenal input and
claimed success by the RNTCP, certain lacunae in the program are being detected by the concerned
people and, incidentally, there has been simultaneous reports of increasing prevalence of drug resistance
and multi-drug resistant disease.
It is a fact that despite almost complete coverage of the country under RNTCP and that despite the best
possible efforts, about 50 % of the TB patients of our country are not treated by the RNTCP. Therefore, one
needs to know the factors for adherence by such huge population to the non RNTCP treatment and
simultaneously, take care to ensure the best quality treatment in this non RNTCP private sector. This
demands immediate and intense operational research.
Hence, it is an urgent need to take both the private (non-RNTCP) and public (RNTCP) sector treatment
under uniform principles and practice of therapy. The present draft is prepared keeping this fact in mind.
We are sure that there are many other issues not incorporated in the draft; some areas are already taken
care by the RNTCP and there may be difference of opinion on the draft as well. We appreciate that an
upsurge of differences and questions about the logistic issues related to the implementations of the
principles are likely after the publication of the draft as we have already experienced it in our mini
consensus meetings. We like to say that this is a set of principles only and in forming principles we felt that
we must remain as close as possible to the ideal. Any point in the draft may be discussed and argued and
any proposal may be scrutinized thoroughly and discussed widely to make it operationally feasible. We
would love to see wide scale discussion and debate with involvement of the intelligentsia in a private-public
mix. TB is a national issue and the draft is an outcome of our concern about the national health.
The principles of treatment are outlined in different categories as follows.
Administrative :
?
TB should be declared as an emergency issue for the nation (National Health Emergency).
?
All TB patients will have to be notified and treated. Notification of TB cases shall be mandatory for both
the private sector and the public sector authorities.
?
Everybody should not treat TB: doctors will be specified for treatment (different levels of doctors will
be designated (as a) Level 1= grass root level doctors, Level 2= specialists, and Level 3 = referral
level doctors) and the role of each level has to be specified.
?
The regimen for a patient should be initiated by specified doctors.
?
The regimens are to be defined as standard by the experts in PPM and a uniformity of treatment has to
be followed. If there is any deviation at any point of time, it has to be done through the level 2 or level 3
TB treating doctors and this should also be notified and treated. There should be flexibility in offering
extra treatment in certain situations; this decision has to be through consultation of level 2 or level 3
doctors and it has to be documented and notified.
?
Specialists should be marked for referral in specific situation.
?
Specific situations for referral / evaluations and admissions shall be clearly noted.
?
Regular training and appraisal is a must for all categories of workers under the guidance and control
of RNTCP
?
TB clinics should be specified with bare minimum facilities both for the Govt. and the private sector
(the basic minimum requirements are to be qualified and all the centers shall work only upon RNTCP
certification; they will be under monitoring by the RNTCP and the details of the facilities (including the

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infrastructure, manpower, capabilities etc) shall have to be available on internet for verification by the
public). This is to ensure the uniformity of the standard across the country.
?
All investigations will be RNTCP guided or guided and funded.
?
Laboratory and other facilities should be RNTCP arranged or certified and all of them should be under
quality check up by RNTCP ( by team of experts from the country and , if necessary abroad).
?
RNTCP centers or RNTCP certified centers / pharmacies should have universal coverage for supply of
drugs.
?
Follow up responsibility will stay with the RNTCP and the treating physician with involvement of the
NGOs.
?
All activities (including monitoring by RNTCP) are to be recorded for publications and verifications; all
data are to be uploaded in appropriate software that will enable access in internet so that the client
and everybody interested can verify it.
?
There will be good incentive (fees as per the local standard and other facilities) for private sector
workers (doctors and others) for being selected in the TB campaign but non-adherence / poor
performance on their part will lead to blacklisting them and striping off the power of treating TB in
future.
?
There shall have to be some incentive for good compliance and completion of the treatment by the
patient as well (for example, extra allocation of sugar or kerosene oil from the local ration shop at
subsidized price etc).
?
Apart, they can be given certificate of completion in local social programs. The details of the social
reward have to be decided locally by the treating team. There should be a system to bring the
defaulters back to treatment with counseling etc.
?
The domiciliary treatment has to be restricted for selected categories of patients and the neglected /
dying TB hospitals and sanatoriums are to be rejuvenated at the earliest with adequate modernization
for provision of evaluation, admission, and supervised treatment of the appropriate cases.
?
Adequate arrangements are to be made by the RNTCP for admission of all infective cases when
domiciliary isolation for a stipulated period is not possible or there is chance of drug resistance. The
isolation should be continued till a patient becomes sputum negative. Sanatorium treatment for all
infective MDR, XDR, and treatment failure cases should be a must. These three categories of patients
will stay in three different areas in a sanatorium with restricted intergroup mixing.
?
The supply of quality medicine has to be assured with random checking of the bioequivalence; the
quality control has to be strict and TB drug manufacturing license has to on the basis of strict quality
assurance.
?
Selected retired experts from both private and public sectors who have direct contributions in anti-TB
campaign with a non controversial track record shall be selected in the monitoring team and very
selected retired and existing experts shall have extra power to exercise in the campaign especially in
the role of watch dog and everything has to be evidence based as far as possible and will have to be
available on record (especially on internet) for verification. Some selected persons will be entrusted
with the think tank responsibility in the whole campaign. There shall be regular updating and
appraisal of the efforts. Any problem in implementation shall have to catch quick attention of
appropriate authority and the think tank.
?
Operational research shall have to be highly encouraged.
?
Monitoring on the foreign national infiltration and normal traffic has to be ensured to prevent dilution in
the performance and success of the campaign.

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Scientific :
TB needs prolonged treatment with multiple drugs.
?
?
The drug regimens has to be specified with certain flexibilities on involvement of the referral doctors.
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The prescription of second line drugs will be restricted to be done by the second line doctors only.
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Chance of resistance increases on premature withdrawal / non compliance.
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DOTS is the best policy so far to ensure compliance.
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It is better to over treat the disease than under treating TB.
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Appropriate referral and hospitalization is necessary for successful anti-TB campaign.
?
There should not be any role of treating latent tuberculosis or offering INH chemoprophylaxis in high
prevalent society as ours. The issue should be discussed thoroughly at the appropriate level. Pending
evidence, all such cases merit a discussion in a clinical board with at least two level II (two) TB treating
doctors and as the next course of action full treatment according to the existing Category I may be
considered. Appropriate research should be initiated to generate evidence for the best course of
action at the earliest.
Legal :
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Delay / non compliance is a social crime on the part of the patient.
?
Detection of vested interest at any level by anybody in the anti-TB campaign is a criminal offence and a
liability for punishment. Similarly, lethargy or any callous act imparting difficulty in the process of anti
TB campaign is as serious as a criminal offence and makes one liable for legal action and
punishments.
Clarification :
1.

RNTCP certification : RNTCP shall be the main body (with the help of the think tank, experts, and
other people) to certify TB treating a) doctors, b) HCWs, c) NGO, d) hospitals (Private and public), e)
clinics, f) drug dispensing centers, g) referral and hospital facilities, and others in the TB treating
campaign. The RNTCP decisions shall be published in the internet and they should be displayed
locally at the block and panchayet office, local schools and colleges, local police station, and local
health centers and also in all the RNTCP selected clinics, drug stores etc.).

2.

Social punishment : the defaulters will be supported with adequate counseling and reward etc. to
bring them back to treatment. On failure, when a defaulters name will displayed openly at all the
places as mentioned above with a note that the person has been doing harmful activities for the
society he or she will be under pressure in the community to observe the directions from the treating
authority. As a bi-product, there will be good social awareness in turn and it will be easy to mobilize
mass support in favor of the campaign.

3.

Involvement of NGOs : it will mostly be restricted to ensure adherence and monitoring for which it will
be paid from a different department (viz. HR ministry) but RNTCP and both RNTCP and HRM shall
have the right to monitor the activities of the NGOs. Local feedback facility has to be developed to
ensure assistance and surveillance on the NGOs. Any NGO willing to treat TB or do something
beyond the stipulated activities in anti-TB campaign have to have RNTCP certification. Any institute
having existing anti-TB activities (as institutes like Ramakrishna Mission, Ranchi that is running a TB
hospital effectively for a long time) shall be allowed with RNTCP certification and all possible logistic
assistance.

4.

Data keeping : a mega software can be prepared with the help of the experts that will enable all the
activities to be uploaded with provisions for verification, monitoring, emergency actions, decisions
regarding punishment, and continuous operational appraisal and research. A system of continuous
and effective back up has to be evolved at the central and local level. Data keeping shall be a must for
both the public and private sectors.

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Anti TB-Campaign
CLASSIFICATION OF CASES AND PROPOSED TREATMENT RE

GIMEN :

The background : TB is a global challenge and the rising prevalence of MRD TB is going to be a global
threat. With the existing variable but essentially very high level of initial resistance to different antitubercular drugs, and our experience of rising prevalence of the MDR disease, we feel that some
rethinking on the classification and the recommended treatment regimens is necessary. We
appreciate that there are some conceptual and logistic problems related to the existing RNTCP
categorization of the disease and the recommended therapy and they need to be addressed. To our mind,
it is the right time to try so with positive intellectual feedback, appropriate pilot studies, and consensus
formation. We feel again that bare classification and recommendation of treatment is not enough to
enforce or implement a treatment regimen successfully. To us, there shall be rooms to guide in difficulties
and there should be adequate flexibilities when a situation demands. To us again, especially in face of
rising prevalence of resistance to the anti TB drugs by the bug, the concept of de-escalation of therapy with
the appropriate use of culture sensitivity tests (whenever possible) should be the approach especially
when there is relapse or treatment failure.
For the time being, the members agree that, by and large, the RNTCP guideline has to be followed
although they feel that the RNTCP categorization of patients and treating them accordingly needs
modification, and deviations may be allowed in selected situations through the decision of a board meeting
or consensus of opinions (at least by two experts) in an individual case whenever necessary.
Although the consensus group appreciates its limitations of formulating a treatment regimen right now, it
wishes to forward the proposal of an alternate regimen (as given below) to the Govt. and the RNTCP
to consider it for a pilot study. Similar other regimens may also be formed on consensus for pilot study
again. To us, it is easy to say that one needs evidence to make or formulate a regimen, but it is actually very
difficult to find or generate the evidence overnight where the mycobacteria appears more smart than us by
way of becoming resistant to different drugs. Therefore, even if there is serious effort to generate evidence,
it will take a long time and meanwhile the situation may turn further difficult to tackle. Therefore, the
consensus body feels that there should be efforts to make pilot studies with one or two regimens for
different categories of patients alongside simultaneous appropriate research to generate the necessary
evidence and in the process the best possible PPM should be encouraged.
The consensus group further wishes a widespread discussion and a systematic review of these issues in
private, public and PPM to finally come out with an acceptable solution and it feels that the present draft
may go a long way in this direction.
The proposed new classification :
?
Group 1 : Tuberculosis first time in life without h/o exposure to possible MDR patient or situations:
?
Group 2 : Relapse and treatment failure cases
a)

relapse cases : when a patient relapses after a complete or incomplete treatment

b)

treatment failure cases : when there is no response to a good regimen of treatment given for at
least 3 months
We have omitted the discussion with defaulter group to make the grouping simple

?
Group 3 : Extra-pulmonary tuberculosis
?
Group 4 : TB in immunocompromised host: (HIV disease, patients on chemotherapy, patients with
immunosuppression from other causes and patients on immunosuppressive dose of steroid)
?
Group 5 : TB in special situations as CRF, Chronic liver disease, pregnancy, others including
tuberculosis in children**, diabetes mellitus***,
and ATD toxicities ***. (group 4 and 5 may be
clubbed together)

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?
Group 6 :
a)

relapse after treatment of group 2 patients and

b)

relapse after treatment of MDR tuberculosis

* There should not be, in general, any room for the treatment for latent tuberculosis at present.
Alongside, any single drug chemoprophylaxis in a high prevalent society as ours (with high prevalence of
initial resistance to the first line drugs) is not recommended. If the situation demands, the prophylactic
regimen needs to be decided on consensus. The consensus members feel that full anti-tuberculosis
treatment can be offered as per the treatment regimen of the proposed group 1 for any situation where the
prophylaxis is deemed necessary. Such a decision, however, has to be taken through a meeting / board
with the presence of at least one / two level 2 TB treating physicians.
** A draft has to be prepared on consensus for the diagnosis and treatment of tuberculosis in children. This
is an important but neglected area especially in Indian scenario. The members have observed that
probably because of the fear of toxicity, ethambutol is avoided and there is lethargy in using pyrazinamide.
As a result, in many occasions, the treatment ends up with two drugs as INH and rifampicin. It is also
observed that anti TB drugs have been prescribed in children even for non-specific reasons without
evidence of the disease; the members propose RNTCP to take into view the opinion of the pediatric
associations and form an uniform, acceptable, and evidence based (as far as possible) criteria for the
diagnosis and treatment of tuberculosis in children. Experts may be identified from the pediatricians also to
help the treatment of doubtful and difficult situations.
*** With progressively higher prevalence and incidence of diabetes along with demand of insulin in many
occasions and for other difficulties of treatment. We feel that the co presence of diabetes with TB needs
special mention and guidance. Similarly, anti-tubercular drug toxicities often pose problem to treat the
disease; we feel that they too need special attention. Separate treatment guideline may be formed on
consensus in these two important areas.
**** Quinolones need to be regarded as first line equivalent drug and it should be preserved for the
treatment of resistant disease and in intolerance to first line drugs.
Recommended regimen of treatment for the patients according to the alternate classification :
Group 1 : Tuberculosis first time in life without h/o exposure to possible MDR patient or situations :
6 RHEZ
?
An injectable (viz. streptomycin) or a quinolone may substitute any one or two particular agent in case
of resistance or toxicity. The regimen should be changed upon availability of the culture sensitivity
report, if sent. In cavitary disease extra care must be sought for isolation of the patient for at least 2
weeks. Any modification needs to be done on consultation with a level 2 doctor and this has to be
notified properly.
One level 2 doctor should preferably be involved to decide the initial regimen
Group 2 : Relapse and treatment failure cases
2a) Relapse case
6RHEZ 3 HRE
?
Sputum (preferably paired samples) must be sent for mycobacterial culture and sensitivity before
starting treatment and the regimen should be changed subsequently according to the culture
sensitivity report.
?
The sensitivity tests should be sought for at least nine (R, H, E, Z, Sm, Kana, Ciprofloxacin,

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ethionamide and cycloserine) and if necessary for more drugs.
?
The treating physician has to bring the previous treatment history (in details) and take into account the
co morbid factors (medical and social) into account to decide the regimen and also to make the
appropriate strategy to ensure DOTS.
?
The treatment has to be on daily regimen and, if necessary, the patient has to be admitted.
?
A quinolone or an injectable (strepto/ kana/ amika) may substitute any particular agent in case of
known resistance or toxicity.
?
Any modification in the treatment has to be notified.
One level 2 doctors must be involved to decide the initial regimen
2b) Treatment failure cases :
6RHEZQ SM/ Kana and ethionamide 6 RHE+Z/Q and ethionamide
?
Sputum (preferably paired samples ) must be sent for mycobacterial culture and sensitivity and the
regimen should be changed according to the culture sensitivity report.
?
The sensitivity tests should be sought for at least nine (R, H, E, Z, Sm, Kana, cipro, ethionamide and
cycloserine) and if necessary for more drugs.
?
The treating physician has to bring the previous treatment history (in details) and take into account the
co morbid factors (medical and social) into account to decide the regimen and also to make the
appropriate strategy to ensure DOTS.
?
The treatment has to be on daily regimen and, if necessary, the patient has to be admitted.
?
A quinolone or an injectable (strepto/ kana/ amika) may substitute any particular agent in case of
known resistance or toxicity.
?
Any modification in the treatment has to be notified
?
The patients should be isolated till they turn smear negative.
To start the treatment as MDR TB and modify/ deescalate the treatment after 6 to 8 weeks upon the
availability of the culture sensitivity report should be the protocol in this group of patients. The
treatment of MDR disease may be done as per the existing RNTCP guideline.
One or preferably two level 2 doctors must be involved to decide the initial regimen
Group 3 : Extra-pulmonary tuberculosis : should be treated on individual merit to a large extent upon
consultation with at least one (preferably more) level 2 doctor/ doctors. The duration of treatment will vary
in each type according to the degree of response; pericardial, meningeal, and bone TB should be treated
for prolonged period. Particularly for CNS tuberculosis, pyrazinamide has to be continued for the full length
of therapy since the CNS penetration of the drug is good. Consultation / collaboration of a specific
subspecialty expert (cardiologist, orthopedician, etc.) shall have to be done whenever felt necessary.
RHEZ may be started and continued for prolonged duration as per the discretion of the physician
concerned in consultation with level 2 or 3 specialist. The treatment should be stopped on satisfaction of
the treating physician as cure is achieved and in the process level 2 or 3 doctors may be consulted in any
doubt / difficulty.
Group 4 : TB in immunocompromised host :
?
If there is no risk factor or suspicion of drug resistance: the patients should be treated as group I
?
If there is risk factor of drug resistance: the patient should be treated as MDR-TB keeping R and H and
changing the regimen subsequently according to the CS report.

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?
Concomitant treatment of the immunocompromised state has to be done.
?
Involvement of appropriate sub-specialty doctors will be done as per the demand of the situation
One (preferably more) level 2 doctors must be involved to decide the initial regimen, follow up
schedule, duration of the treatment in collaboration with an expert from the required sub-specialty.
Group 5 : TB in special situations as CRF, Chronic liver disease, diabetes, pregnancy, others : the
regimen has to be decided by level 2 doctors on consensus and the treatment should be done as per the
existing RNTCP guideline with or without modification. A draft need to be to be prepared with experts upon
consensus. One (preferably more) level 2 doctors must be involved to decide the initial regimen, follow
ups, duration of the treatment in collaboration with an expert from the required sub-specialty.
Group 6 : Relapse after a) category 2 treatment and b) MDR tuberculosis : to individualize the regimen
using multiple drugs not used earlier; the treatment should be done through by board formation including
more than one level 2 and level 3 doctors.
+ The Government is proposed to mark quinolones for tuberculosis treatment and not meant for routine
general use as an antibiotic with immediate effect. The drug needs to be preserved for treatment of
resistant TB only.
** Indications of steroid with dose and duration shall be specified.

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Group

Details

Regimen

Involvement of experts

Tuberculosis first 6RHEZ or One level 2 doctor should preferably be

involved to decide the initial regimen
time in life without 3RHEZ
h/o exposure to
possible
MDR 5RHE
patient or situations
(Group 2 patients) :

Relapse case

6RHEZ

Isolation Admission

3 HRE
2b

Treatment failure
cases

Extra-pulmonary
tuberculosis

6RHEZQ one or preferably two level 2 doctors

SM/Kana must be involved
and
ethionami
de
6
RHE+Z/Q
and
ethionami
de

An injectable or a quinolone may substitute

any particular agent in case of resistance or
toxicity. The regimen should be changed
upon availability of the culture sensitivity
report, if sent. In cavitary disease extra care
must be sought for isolation of the patient
for at least 2 weeks. Any modification
needs to be done on consultation with a 2nd
level (level 2) doctor and this has to be
notified properly.

yes, when
sick and
home
isolation
not
possible

One level 2 doctors must be involved to yes for 2

decide the initial regimen
weeks
yes, till
they turn
sputum
negative

Comments

yes, when
sick and
home
isolation
not
possible

Sputum (x 2) must be sent for

mycobacterial culture and sensitivity and
the regimen should be changed according
to the culture sensitivity report.
The sensitivity tests should be sought for at
least eight ( R,H,E, Z, Sm, Kana, Cipro,
ehionamide) and if necessary for more
drugs.
The treating physician has to bring the
previous treatment history in details and
also to take into account the co morbid
factors (medical and social) in to account to
decide the regimen and make the
appropriate strategy to ensure directly
observed therapy.
The treatment has to be on daily regimen
and, if necessary, the patient has to be
admitted.
a quinolone or an injectable (strepto/ kana/
amika) may substitute any particular agent
in case of known resistance or toxicity.
any modification in the treatment has to
be notified

consultation with at least one (preferably

more) level 2 doctor/ doctors is
recommended

yes, when should be treated on individual merit to a

large extent. The duration of treatment will
required

TB in
immunocompromis
ed host

One (preferably more) level 2 doctors

yes for 2
must be involved to decide the initial
weeks
regimen, follow ups, duration of the
treatment in collaboration with an expert
from the required sub-specialty.

yes, when no risk factor or suspicion of drug

resistance: start as Category 1
required

TB in special
situations as CRF,
Chronic liver
disease, diabetes,
pregnancy, others

One (preferably more) level 2 doctors

must be involved to decide the initial
regimen, follow ups, duration of the
treatment in collaboration with an expert
from the required sub-specialty.

yes, when to be decided by level 2 doctors as per

consensus should be done as per the
sick

Relapse after a) Gr.

2 treatment and b)
MDRTB

the treatment should be done through by yes till

board formation including more than
sputum
negative
one level 2 and level 3 doctors.

yes

vary in each type according to the degree of

response; pericardial, meningeal, and bone
TB should be treated for prolonged period.
Consultation / collabotation of a specific
subspeciality
expert (cardiologist,
orthopedician, etc.) shall have to be done
whenever felt necessary

risk factor of drug resistance : start as MDR

keeping RH and change the regimen
subsequently according to the CS report.
concomitant
treatment
of the
immunocompromised state
involvement of appropriate sub-specialty
doctors will be done as per the demand of
the situation

existing RNTCP guideline with or without

modification. A draft need to be to be
prepared with experts upon consensus.
the treatment should be done through by
board formation including more than one
level 2 and level 3 doctors.

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Anti TB-Campaign
ISSUE OF REFERRING A PATIENT : WHEN?
We understand that treatment of TB is not an easy job and, therefore, we have proposed to specify the TB
treating doctors officially. By virtue of widespread observation of DTCD and MD (pulmonary medicine)
curriculum in different universities, and a lot of MBBS doctors with inclination and vast experience in
treating TB, the country has a very good human resource for making level 2 and level 3 TB treating
physicians. However, they are to be trained for adhering to an uniform course of action and offer collective
response to a particular situation (opinion pool of two or more TB treating doctors).
A certificate course may be opened to train interested doctors to make them capable of joining the anti-TB
campaign.
We feel that there should be a laid down guidelines for seeking referrals in treating TB. This, to our mind, will
help to reduce defaulters and treatment failures.
Consultation recommended as :
a)

b)

c)

mandatory
1.

tuberculosis in special situations

2.

tuberculosis in HIV co-infection

3.

any relapse and treatment failure case

4.

any suspected drug resistant disease

5.

non lymph-node extra-pulmonary tuberculosis

6.

no response/ no response to chemotherapy for 2 months

7.

H/O contact with drug resistant tuberculosis

8.

any untoward ATD toxicity

9.

suspected NTM infection

optional and recommended

1.

lymph-node tuberculosis

2.

poor response to chemotherapy for over one month

3.

no strong evidence for TB but it seems necessary for EATD trial

4.

h/o family member dying of tuberculosis

5.

H/o successful anti-tuberculosis therapy in past

6.

tuberculosis in children

optional
1.

tuberculosis in HCW

2.

tuberculosis in hostels/ camps/ confinements

3.

suspected cases of PUO from tuberculosis

There can be debate / discussion on the points jotted down as above and many of them needs elaboration
(like what are the untoward effects of ATD or what are the situations to suspect NTM). These all may be
addressed in a revised version of the draft in future.

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Anti TB-Campaign
WHAT ARE THE PROBLEMS FOR THE PRIMARY CARE PHYSICIANS?
This is an issue of immediate operational research. We have to know the problems categorically to
implement the anti-TB campaign more effectively. This important area should not be overlooked and
should be addressed with a strong zeal. We have tried to innumerate a few to initiate awareness and
actions.
?
Problem to access the existing knowledge base
?
Problem to access the RNTCP facilities
?
Problem to come out from the old mindset (a few are charted below)
a)

chest x-ray is enough to diagnose tuberculosis.

b)

that Mantoux test can diagnose TB

c)

that immunological tests are good to start ATD

d)

the PCR based testes are confirmatory

e)

the poor access to TB culture

f)

costly and the latest tests are the better ones

g)

any fever over 2 weeks is likely TB

h)

any shadow persisting in X-rays and not resolving to antibiotics merits ATD

i)

one can prescribe any regimen he or she wishes

j)

fixed dose regimens are all cure; do not bother for any dose adjustment

k)

pyridoxine is not essential in treating with INH containing regimen

l)

one can add a single drug to the failing regimen

m) there is no problem to start nd

2 line drugs without evidence of resistance
n)

there is no need to refer a patient to RNTCP

o)

there is no need to refer a patient to experts

?
Problem to access to evaluate TB properly
a)

evaluation with less useful tests (serology/ QFT G)

b)

poor access to TB culture

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Anti TB-Campaign
WHAT IS EXPECTED FROM THE GOVERNMENT ?
The Government needs to act as a facilitator for the treatment and control of TB. Infact, to our opinion, a little
modification in the policy will help in a long way to fight TB in our country. With the advent and assess to
modern information technology, the job appears possible without much difficulty. We have broadly
outlined the expectations from the Govt. and have also given an outline of the modus operandi. There is
room for significant modification and improvisation of the draft based on consensus and operational
research.
General expectations :
?
The state shall declare the TB as a state of emergency and all the TB cases shall have to be notified with
RNTCP.
?
The state shall accept the principles of treatment officially and will endorse all treatments matching the
principles.
?
The right of treating TB has to be withdrawn from everyone and the TB treating doctors shall have to be
identified and fixed for the purpose. They should be trained appropriately for performing the job.
RNTCP may take the charge of training with the help of different individuals, institutes and professional
bodies as API, IMA etc. Any modification of treatment has to come through the specified experts and to
be notified again.
?
The OTC availability of ATD has to be stopped and the drugs should be dispensed through the RNTCP
centers or selected and licensed drug stores.
?
TB PCR and serological tests should be restricted for research purpose and to the use by experts only
in very selected situations.
?
The RNTCP centers should be more in number.
?
AFB detection centers (smear and culture-sensitivity) shall be increased sharply under RNTC. More
number of accredited laboratories are to be set up at least one in each rural medical college and
preferably one in each district headquarters. If this is not possible selected private centers shall be
recognized as reference laboratories for the purpose (as a firm step in PPM). Any sample tested in
these labs on order by the selected TB treating doctors will be financially reimbursed by the RNTCP.
The RNTCP shall monitor the quality and performances of the labs.
?
Arrangements are to be done so that non govt. care givers and recipients find some easy and effective
accessibility to administration.
?
All Govt. policies, actions, allocations, expenditures, and resources should be available to access by
any body on internet on request and all databases should be available online.
?
All the actions at micro (individual) level to macro level should be entered in a mega-software
programme and all collected data has to appear within 3 (three) days of collection so that anybody on
request should be allowed to access the data.
?
There should be a provision of interaction online with registration of grievances, suggestions and any
knowledge input.
?
There should be an independent and autonomous operational research cell funded by RNTCP. One or
more NGOs may be entrusted for the activities independently and under co-ordination by the said
research cell.
?
The sanitaria should be modernized to admit MDR & XDR TB cases.
?
To implement the anti-TB campaign in a PPM the efforts should start from the top with steps to

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Anti TB-Campaign
a) identify the resource persons from private sector along with that from public sector; make a mix for
uniform strategic activities.
b) identify the treating physicians: specialists should be marked for referral in specific situation.
c) identify the institutions that will cater to anti TB campaign by way of providing the necessary
infrastructure facilities for AFB culture etc.
d) identify the modes of operation for TB detection and treatment effectively.
?
To identify and recognition of TB treating doctors the proposed mode of selection may be considered :
a) through the involvement of the resource persons in action of selection.
b) to take into account the qualification / training / inclination.
c) arrange a basic training and make new members with willing physicians.

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