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National Project Implementation Plan - NVBDCP

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5.2 Other Issues<br />

5.2.1 Therapeutic Efficacy<br />

A standard protocol for therapeutic efficacy will be used based on WHO<br />

recommendation and at least 15 studies will be undertaken every year.<br />

The <strong>National</strong> Institute of Malaria Research Centre (NIMR) will have overall<br />

responsibility for implementing this activity which involves finalization of<br />

protocols, recruitment and training of staff, assuring the quality, complete<br />

the data and organizing annual consultation and feedback. NIMR will also be<br />

responsible for recruitment of Research Officers on contract for the units<br />

located with the Regional Directors of ROHFW where no post of Research<br />

Officer is in position. The 13 therapeutic team under <strong>NVBDCP</strong> located at<br />

Regional Offices will work in close co-ordination with the NIMR. An MOU<br />

shall be signed with NIMR for effective utilization of manpower that exists in<br />

Regional Offices.<br />

5.2.2 Pharmaco -Vigilance<br />

This activity will be introduced first time in the programme. NIMR will also<br />

undertake this activity along with therapeutic study. At national level, NIMR<br />

will have a advisory group supported by a full time Consultant<br />

(Pharmacologist) who will help in developing protocol, site selection training<br />

etc. At the operational side pharmaco- vigilance programme shall be linked<br />

with sentinel surveillance and facilities that treat severe malaria cases. By<br />

September 2008, NIMR will submit detailed protocol to <strong>NVBDCP</strong> which will<br />

include reporting formats. The protocol shall be shared with experts and the<br />

World Bank.<br />

5.2.3 Quality Assurance of RDTs and Other Commodities<br />

The quality assurance of microscopy, diagnostics and drugs are critical for<br />

the programme to ensure that end users are getting benefit of tested<br />

products. <strong>NVBDCP</strong> will request WHO to provide Consultant for further work<br />

on this issue with NIMR and submit a detailed protocol for development of<br />

SOPs for implementation at field level. The Consultant with the help of NIMR<br />

and <strong>NVBDCP</strong> will develop protocol by December 2008. Quality assurance of<br />

RDK supplied under the programme in the field will start from January 2009<br />

by NIMR and the batch testing will start from April 2009 by when the new<br />

laboratories of NIMR are expected to be ready. <strong>NVBDCP</strong> has already<br />

requested NIMR to undertake external quality assurance of microscopy and<br />

quality panels are being prepared by the NIMR. To sustain the activity,<br />

<strong>NVBDCP</strong> will also hire the services of accredited laboratories for testing the<br />

samples drawn from field.<br />

5.2.4 Insecticide Resistance Monitoring<br />

The project will undertake insecticide resistance monitoring in the country<br />

to know the susceptibility status of vectors to insecticide in use under<br />

Indoor residual spray. This will help the programme to switch over to next<br />

effective insecticide for killing of vector population and inter- alia reduction<br />

in human vector contact. Some of the states like Gujarat, Maharastra,<br />

Tamilnadu, Karnataka, and Andhra Pradesh has well established<br />

entomological set up. However, in project states, entomologist and<br />

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