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Gujarat FDCA discusses training schedule with Abbott India, BioMérieux as part of strategic partnership
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Shardul Nautiyal, Mumbai
January 31 , 2018
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The Gujarat Food and Drug Control Administration (FDCA) is in talks with
US-based medical device company Abbott India and French company
BioMérieux to train Gujarat FDCA inspectors on global regulatory
requirements and standards concerning medical devices and drug quality.
Having
trained around 100 inspectors as part of the collaboration, Abbott
India will give training to another 62 drug inspectors on auditing a
medical device manufacturing facility.
“The training is very much
required as the maximum number of licensed medical device units under
Central Licensing Approval Authority (CLAA) scheme are in Gujarat and
FDCA has also recently given approvals for setting up close to 80 new
drug formulation units in the state which also requires microbiological
testing facility and know-how,” says Gujarat FDCA Commissioner Dr H G
Koshia.
Gujarat today boasts of having the highest number of 200
plus licensed medical device units under CLAA scheme as against a total
of 284 medical device units in the entire country. CLAA scheme was
formed to oversee regulatory activities related to grant of
manufacturing license for hi- tech medical devices in India.
The
devices currently regulated under CLAA scheme include cardiac stents,
drug eluting stents, catheters, intra ocular lenses, I.V. Cannula, bone
cements, heart valves, scalp vein set, orthopaedic implants and internal
prosthetic replacements.
He further adds, “We have spoken to
French company BioMérieux on fixing up a training schedule to help drug
inspectors check contamination in medicines imported and exported and
also set up a rapid microbiological testing lab in the state for the
purpose”.
The rapid microbiological testing lab will be set up by
Gujarat Medical Services Corporation Limited (GMSCL) with assistance
from BioMérieux based on an MoU with Gujarat FDCA for knowledge sharing
on microbiological testing technologies for the pharmaceutical sector.
The
partnership will also offer knowledge, services and products to
up-grade microbiological technology which includes media preparation,
quality testing for media -growth promotion testing, environmental
monitoring, active and passive air sampling, sterility testing of raw
material, in process testing and end product testing for filterable and
non filterable products.
Gujarat government had signed eight
such strategic partnerships with overseas and Indian companies last year
to upgrade the knowledge of the Gujarat FDCA officers on relevant areas
of concern of the regulatory authorities globally and in India.
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