National Project Implementation Plan - NVBDCP

The quality of Diagnostic Kits on the other hand is governed by ISO standards
(which is a process standard for the manufacturing facilities) and quality
assurance test results concerning quantitative assay, chemical analysis,
sterility, pyrogen content uniformity, microbial limit etc. These are decided on
case to case basis.
The Central Insecticide Board (CIB) under the Ministry of Agriculture is
responsible for ensuring the safety of various insecticides and allied products
such as LLIN. CIB also issues license for use of such products, which are
imported in the country.
In context of quality, there are two major challenges. Firstly, the difference
between the regulatory standards between those set out by the Government of
India and international best practices like WHO GMP. Secondly and more
serious concern is the weak capacity for monitoring the compliance of the
quality standards. A World Bank commissioned study compared the WHO GMP
with that of Indian GMP standards under the revised schedule M and listed the
key differences. The MOHFW has prepared a technical note to guide the drug
inspectors in addressing these deficiencies during the implementation of
revised Schedule M. Familiarization of the drug inspectors identified by states
in the use of these additional technical notes has started by MOHFW through
organizing a series of workshops. For the supplies from other countries with
weaker regulatory regimes, the quality of products also poses considerable
risk.
MOHFW is working on strengthening the revised Schedule M through
introduction of technical notes and training of drug inspectors. Until such time
this process is completed to the satisfaction of the Bank, WHO GMP shall only
be used for all procurement of pharmaceuticals and medical supplies. Predispatch
and post-dispatch inspections shall be conducted to ensure the
adherence to agreed specifications and quality standards. An independent
inspection agency (selected by MOHFW or by procurement agent through
competitive selection procedure) will monitor the quality of pharmaceuticals by
picking up the random samples during the project period and getting these
tested at accredited labs. In addition, five government-owned units (such as
ICMR) will also monitor the quality of drugs and insecticides procured under the
project. World Bank has also hired an expert on pharmaceutical quality to deal
with quality related issues.
Quality assurance of RDTs is of critical importance for maintaining quality of
diagnostics. NVBDCP has prepared draft guidelines based on WHO
recommendations. These will now be reviewed by a WHO consultant, who will
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