BIOSPECTRUM | SEPTEMBER 2018 | http://www.biospectrumindia.com l POLICY AND REGULATORY NEWS^9
Global Antibiotic Research
and Development Partnership
(GARDP), the World Health
Organization (WHO) and Indian
Council of Medical Research
(ICMR) recently organised an
event on reducing neonatal and
child mortality by addressing drug
resistance through collaboration,
research, and innovation. More
than 80 researchers from 11
countries met in New
Delhi to kick off an
observational study
to understand
sepsis in
newborns
and current
antibiotic
prescribing
practices.
This is part of
the GARDP’s
broader programme to develop
new and improved antibiotic
treatments for newborns. The
observational study, led by the
GARDP, is benefiting from $
million funding from Bill &
Melinda Gates Foundation to
support study sites in Bangladesh,
India, Kenya, South Africa, and
Uganda. The study will generate
a robust evidence base on how
neonatal sepsis is managed
which can be used as a
basis for evaluating
future interventions
in neonates.
Outcomes of
interest will
include mortality,
antibiotic use,
and duration
of antimicrobial
therapy.The Gujarat Food
and Drug Control
Administration (FDCA)
and bioMerieux India
jointly conducted a
training programme
recently on pharmaceutical
microbiology and
advancement in
pharmaceutical
microbiology to apprise
drug inspectors on
quality control and
microbiological testing
to meet the evolving
challenges of quality and
regulatory compliance
globally. The programme
which focused on the
global perspective in the
context of regulatory
environment and issues
around data integrity
trained around 65 drug
inspectors from the
state of Gujarat. Indian
pharma industry is also
making conscious efforts
to understand what
FDA investigators look
for in a pharmaceutical
product and API facility
due to growing global
regulatory scrutiny.
Besides this, Gujarat
FDCA has developed a
technologically upgraded
lab at Vadodara with
the help of global
microbiological advanced
technology offered by
the French company
bioMerieux India as part
of strategic knowledge
partnership.Gujarat FDCA,
bioMerieux
India conduct
training
programme
India launches viral
hepatitis control programme
Union Minister of Health and Family Welfare JP Nadda recently launched
the National Viral Hepatitis Control Programme to eradicate viral hepatitis
by 2030. The programme was launched to mark the World Hepatitis
Day 2018. On the same
occasion, the minister also
released the Operational
Guidelines for National
Viral Hepatitis Control
Programme; National
Laboratory Guidelines for
Viral Hepatitis Testing;
and National Guidelines for
Diagnosis and Management
of Viral Hepatitis. The
main objectives of the
National Viral Hepatitis
Control Programme aim
to control viral hepatitis in
the country, thus, thereby reducing mortality and morbidity attributed to
it. The key strategies of the programme include preventive interventions
with focus on awareness generation, safe injection practices and socio-
cultural practices.
GARDP, WHO, ICMR to
collaborate for studying sepsis & AMR