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Gujarat FDCA to ink pack with UL under VGGIS 2015, to train regulators on select programmes
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Suja Nair Shirodkar
December 29 , 2014
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Setting yet another milestone, the Gujarat Food and Drug Control
Authority (FDCA) plans to soon collaborate with the US based UL
Eduneering to give hands on training to select a group of inspectors
from the state drug regulatory body on the latest dug regulatory
developments and practices. This collaboration with UL is a first of its
kind initiative taken by any Indian regulator and initially will be
done on pilot basis on select 50 to 60 officials, to be later extended
to all the drug regulators in the state.
Interestingly, this
collaboration will be done under the flagship of the Vibrant Gujarat
Global Investor Summit-2015, so as to empower and train the regulators
from Gujarat to meet the global regulatory challenges in future. The UL
EduNeering which has an exclusive partnership with the US FDA and has
trained over 36,000 US FDA inspectors and investigators, will be
providing online training of US FDA authored regulatory and compliance
points to the Gujarat FDCA inspectors. The training will be done in the
area of current good manufacturing practice (cGMP), good manufacturing
practice (GMP), good laboratory practices (GLP) and audit-readiness and
remedial training.
Dr H G Koshia, commissioner, FDCA pointed out
that as pharma sector being a technology based industry keeps on moving
ahead with technological advancement, it becomes a must for the
regulators too to keep on upgrading and changing the guidelines to meet
the growing challenges.
“More-so-ever, it becomes our the
priority to keep ourselves updated on the latest regulatory changes
adopted world-wide so that it will help us in better understanding of
the international laws and adopt it here when essential. But most
essentially, this kind of training will certainly aid us in guiding the
Indian drug manufacturers to adhere to regulatory standards that are
accepted internationally. As regulators of the state that manufactures
and exports large quality of generic to the regulated market like US, it
becomes our priority to keep a tab with the latest development as
excepted internationally,” Dr Koshiya stressed.
Further speaking
about this course, he elaborated that they have already shortlisted 16
policies or modules that will be taught online by experts from the US to
the selected drug officials to sharpen and enhance their knowledge on
the internationally accepted regulation.
Interestingly, the
Gujarat FDCA decided to go ahead with this pact following a very
elaborate and effective demonstration made by the UL team earlier this
month. Wherein, training was conducted for 45 inspectors from the
Gujarat FDCA with 20 online modules as a part of the curriculum.
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