National PMDT Scale-up Plan - India - 2011-12 - TBC India

1. Introduction
National Scale up Plan for Programmatic Management of DR TB 2011 - 2012
India has one-fifth of the world’s MDR TB burden. WHO has estimated that 99,000 MDR-TB cases
emerging in India in 2008 – the largest number for any country globally after China. Drug resistant TB
has frequently been encountered in India and its presence has been known virtually from the time first
line anti-tuberculosis drugs were introduced for the treatment of TB. There have been a number of
reports on drug resistance in India, but the studies used non-standardized methodologies and biased
samples, usually from tertiary level care facilities. There is, however, some valid district and state level
information about extent of drug resistance available.
In 2005-06, RNTCP had undertaken state-representative drug resistance surveys in 3 states, which are
conducted according to a standard international protocol, and collect specimens from a populationbased
sample of smear-positive patients diagnosed at RNTCP designated microscopy centers; the
findings are summarized in the table below:
Table 1: State Representative Drug Resistance Surveillance Surveys conducted in India
State (Survey year) Population
MDR among new cases
(95% CI)
8
MDR among previously-
Rx cases (95% CI)
Gujarat (2007-08) 56 million 2.4% 17.4%
Maharashtra (2008) 108 million 2.7% 14.0%
Andhra Pradesh (’09) 86 million 1.8% 11.8%
DRS surveys are on-going in the state of Orissa and the western half of Uttar Pradesh state. The results
from these surveys are expected in early 2010. Additional drug resistance surveys are planned in 2011-
12 in Tamil Nadu (a second State survey) after 10 years) and Rajasthan. Surveys are planned to be
repeated after a gap of 5 years from the initial survey to observe the trends in DR-TB.
India has also reported cases of extensively drug-resistant TB (XDR-TB) to WHO. The state representative
drug-resistance survey of Gujarat state showed, among MDR TB isolates, 3.2% (confidence limits) XDR
prevalence, but also showed a very high prevalence of fluoroquinolone resistance (%); a credible
estimate of the number of fluroquinolone-resistant or XDR-TB cases in the country is not available.
A national level RNTCP DOTS-Plus Committee was established in April 2005, to develop the national
guidelines (policies and procedures) for the programmatic management of drug-resistant tuberculosis
(PMDT) and also suggest periodic modification in the same in light of the current scientific evidence.
The RNTCP PMDT Guidelines (called “DOTS-Plus” guidelines) were first published in March 2006 and are
updated regularly with the latest issued in May 2010. Procurement mechanism for second-line drugs,
including technical specifications, systems for storage, distribution and quality assurance of the drugs,
etc. were developed. Procurement of the required drugs is conducted by the GoI and also by the Global