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UL to train other state regulators after Gujarat FDCA in line with global regulatory practices on GMP
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Shardul Nautiyal, Mumbai
March 26 , 2015
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Aimed at empowering the central and state drug regulators with the
similar regulatory knowledge as that is offered to the US FDA
regulators, the US-based global leader in safety science Underwriters
Laboratories (UL) company will soon collaborate with other state
governments to train and assist the drug regulators.
This is the
next plan of action following the signing of a memorandum of
understanding (MoU) with the Gujarat government to train Gujarat Food
and Drug Control Authority (FDCA) inspectors. UL has already trained 45
officers from the Gujarat FDCA on 22 online courses covering critical
areas including GMP, GCP, audit-readiness and remedial training.
UL
offers about 1,200 courses globally and has trained around 38,000 US
FDA inspectors. UL EduNeering, the compliance education and training
services business division of UL, is leading this initiative.
"There
are about 17 officers in the CDSCO western region which also require
training on GMP for medical devices and clinical research. However, none
of these have been finalised as yet as these are government processes
which need approvals," informed an official. UL is also in discussion
with Goa FDA, which has shown interest in the e-learning training
programme. There are 15 drug inspectors under Goa FDA .
Out of
the 700 courses offered through e-learning mode, 150 courses have been
made available in Gujarat FDCA for the state regulators on relevant
areas of GMP, GDP and validation protocols. There is no monetary
interest associated with offering this online programme as the aim is to
empower the regulators with the similar regulatory knowledge as that is
offered to the US FDA.
Explains Scott Barnard, VP, life
sciences, EduNeering, "As a part of MoU with the Gujarat government, UL
would further provide e-learning courses with different regulatory
topics such as GXP (which includes good manufacturing and laboratory
practices, and clinical research) content to them. A system has also
been provided where regulators can do those courses and track those
completions."
Talking about the training module, Gujarat FDCA
Commissioner Dr H G Koshia said, “Gujarat FDCA is committed to provide
high-quality educational opportunities to its investigators, scientists,
analysts, state and local regulatory officials to meet the challenges
of matching the complex regulatory environment. UL EduNeering’s rich
modules of training programmes that are followed by US FDA would
definitely help our inspectors understand the nuances of global
regulatory requirements and ensure a high degree of quality control for
pharmaceutical manufacturers in Gujarat.”
Last year,
pharmaceutical exports from India to the United States rose 32 per cent
to $4.2 billion. India accounts for about 40 per cent of generic and
over the counter (OTC) products and 10 per cent of finished dosages used
in the US. Explains Dr Kavita Mehrotra, global strategic head, UL
EduNeering, “UL aims at bringing in good manufacturing practices (GMP)
by empowering the regulatory authorities because ultimately not only
does this contribute significantly to patient safety but also influences
the quality of exports of pharmaceuticals and other related products,
thereby accelerating business results as well.”
“UL offers
innovative technologies that prepare companies to have standardised
processes, as well as audit readiness, by adhering to GMP requirements,
so that the best practices exist at every level in the organisation,”
concludes Suresh Sugavanam, managing director , UL India and South Asia.
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