Lok Sabha Question No. 88 (STARRED), answered on 2019-02-08
Subject: Multi-Drug Resistant TB
Ministry: HEALTH AND FAMILY WELFARE
Asked by: ANURAG SINGH THAKUR

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 88 TO BE ANSWERED ON THE 8 TH FEBRUARY ,2019 MULTI - DRUG RESISTANT TB

## *88. SHRI ANURAG SINGH THAKUR:

Will  the  Minister  of  HEALTH  AND  FAMILY  WELFARE  be  pleased  to state:

- (a) whether there has been a rise in Multi - Drug Resistant (MDR) TB cases in the country and if so, the details thereof;
- (b) the steps taken to combat AntiBiotic Resistance as a phenome non;
- (c)  the  measures  taken  by  the  Government  for  preventing  drug - resistant  TB through timely intervention and awareness building; and
- (d)  the measures  taken  by  the  Government  to  ensure  that  patients  complet treatment of TB so as to reduce the lost to follow - up rates?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE

## (SHRI JAGAT PRAKASH NADDA)

- (a)to ( d) : A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 88* FOR 8 TH FEBRUARY , 20 19

(a)No, the estimated number of Multi Drug Resistant (MDR)/ Rifampicin Resistant (RR) TB patients has declined from 147000 in 2017 to 135000 for the year 2018 as per the WHO Global TB report 2018. However, the number of MDR patients diagnosed is increasing du expansion of diagnostic facilities and increase in proportion of TB patients being screened for the prese nc of drug resistance.

(b)The Ministry  of Health  and Family Welfare has taken  various  regulatory  measures  to curb the misuse of antibiotics. Details are as under -

Antibiotics are included in Schedule H and H1 of the Drugs and Cosmetics Rules, 19 and are required  to  be  sold  by  retail  only  under  the  prescription  of  a  Registered  M Practitioner. Further in order to regulate the human consumption of antibiotics to re over the counter availability of certain antibiotics, the Drug & Cosmetics Rul es, 1945 have since  been  amended  vide  Gazette  Notification  No  GSR  588  (E)  dated  30.08.2013 incorporating a new, namely, Schedule H1 under the Drugs & Cosmetics Rules containing 4 drugs which include antibiotic drugs, Anti TB drugs and certain habit - formin g drugs. The drugs falling under Schedule H1 are required to be sold in the country with the fol conditions:

o The supply of a drug specified in Schedule H1 shall be recorded in a separate regi the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained fo years and be open for inspection.

o The drug specified in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be with the following words in a box with a red border: 'SCHEDULE H1 DRUG - WARNING:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner.'

The Drugs and Cosmetics Rules were amended by the Ministry of Health and Family Welfare vide Gazette notification G.S.R. 28(E) dated 17.01.2012, to m ake a provision that the container of a medicine for treatment of food producing animals shall be labelled withdrawal period of the drug for the species on which it is intended to be used.

- The Department of Animal Husbandry, Dairying and Fisherie s has issued a circular to all Directors/Commissioners (Animal Husbandry) of all state and UTs vide their letter no. -74/2014 - Trade  Dated  on  03.06.2014  and  directed  for  the  judicious  use  of  antibiotics hormones for the treatment of ailing food produ cing animals and at the same time use of antibiotics and hormones in animal feed should also be stopped. Subsequently DCG (I) also issued an advisory to all States/UTs on 12.09.2014 that use of Antibiotics and Ho in animal feed should also be sto pped.

(c)The Government hastaken following measures to combat drug - resistant TB :

Standards for TB Care in India (STCI), are a set of highest professional standard any health care professional is expected to practice when diagnosing or treating Tuberc losis.

These Standards are implemented in the public sector and expected to be followed by pr sector as well.

- Revised  guidelines  for  Programmatic  Management  of  Drug  Resistant  TB  (PMDT)  is being implemented since Dec'2017.
- To screenall  notified  TB  patients for  presence  of  drug  resistance ,  the  country  has developed a network of 1180 functional CBNAAT sites, 89 Culture and Drug Susceptibili Testing  (C - DST)  laboratories  certified  in  various  technologies. Universal  DST  has  been implemented to ensure early detection of drug resistant  TB cases and appropriate trea
- RNTCP  has  introduced  formulation  of  Fixed  Dosage  Combinations  (FDCs)  for  the management of TB since October 2017 to ensure simultaneous administration all anti drugs which  is  essential  to  prevent  development  of  drug  resistance  during  course treatment.
- Private practitioners are sensitized for rationale and standardised use of Anti - TB drugs, i n collaboration with Indian Medical Association (IMA), the programme is se nsitising private practioners in 1000 IMA branched across the country.
- Newer evidence - based regimens were introduced to improve the treatment outcomes of drug resistance TB patients.
- o The Shorter MDR Regimen for MDR/RR TB patients (9 - 11 months of regimen i nstead of 24  months  of  conventions  regimen).  More  than  15000  MDR  TB  patients  are  initiated  o Shorter MDR TB treatment during 2018.
- o Newer drugs (Bedaquiline) containing regimen has been introduced country -wide under the program and made accessible to all d istricts during 2018. Total 3550 patients initiated o Bedaquiline containing regimen till end of 2018.
- o Newer drugs (Delamanid) containing regimen has been introduced in 7 states based their  capacity,  to  reach  maximum  patients.  More  than  50  MDR  TB  patie nts  initiated  on Delamanid containing regimen.
- Private sector engagement is being promoted to reach out to all patients who are s treatment in the private sector and efforts are being made to provide them all dia treatment and care facilities , including public health action such as counselling, nutritio support, contact tracing etc.

(d)The Governmenthas taken following measures to ensure that patients could complete treatments of TB so that reduce the lost to follow up rates (LFU) :

- Each TB pa tient is linked to a treatment supporter who is responsible for the compl of patient treatment, treatment honorarium based on the type of TB patients is paid purpose.
- Senior Treatment Supervisory (STS) are placed at block level to carry out p atient home visit and patient retrieval
- Various  Information  Technology  (IT)  enabled  interventions  to  monitor  real  ti treatment  adherence  such  as  99  DOTS,  Medication  Event  Reminder  Monitor  System (MERM), etc., are also carried out.
- Programmes has establ ished a call centre which also call the patients tocounsel him/her on completion of treatment and address patient issues .
- Provision  of  patient  education  &  counselling at  the  time  of  diagnosis  and  during  the course of treatment on need of treatment adherence, management of Adverse Drug Reactio (ADRs) has been implemented to improve patient compliance.