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Abbott India, Gujarat FDCA collaborate to train new drug inspectors on auditing medical device facility

Shardul Nautiyal, Mumbai
Tuesday, January 2, 2018, 08:00 Hrs  [IST]

Abbott will give hands-on training to around 62 newly recruited drug inspectors on auditing a medical device manufacturing facility as part of the Gujarat Food and Drug Administration (FDCA)'s collaboration with Abbott India.

Around 100 inspectors have already been trained as part of the collaboration, which has immensely helped Gujarat FDCA inspectors considering the fact that Gujarat has the maximum number of licensed medical device units under Central Licensing Approval Authority (CLAA) scheme.

Gujarat today boasts of having the highest number of 200 plus licensed medical device units under CLAA scheme as against a total 284 medical device units in the entire country.

CLAA scheme was formed to oversee the regulatory activities related to grant of manufacturing license for hi- tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.  

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.

“As part of strategic partnership for knowledge sharing, the initiative has helped drug inspectors in understanding the effective analysis which can be properly done for a medical device vis-a-vis a drug sample,” says Gujarat FDCA Commissioner Dr H G Koshia..

Gujarat government had signed eight such strategic partnerships with overseas and Indian companies to upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern of the regulatory authorities globally and in India.

Done as a part of strategic partnerships for knowledge sharing with foreign companies, Gujarat FDCA did a similar kind of exercise of training 50 drug inspectors to detect faulty medical devices and sub-standard drugs in line with the training imparted to US FDA inspectors through a collaboration with US-based Underwriters Laboratories (UL), a global safety consulting and certification company. UL EduNeering, the compliance education and training services business division of UL, led this initiative.


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