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Shardul Nautiyal, Mumbai January 31 , 2018
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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