Around 100 drug inspectors have been trained as part of the Gujarat Food and Drug Administration (FDCA)'s collaboration with Abbott India to train and equip FDCA officers on medical devices.

As part of strategic partnership for knowledge sharing at the recently concluded Vibrant Gujarat Global Summit (VGGS) - 2017 at Gandhinagar, the initiative has helped drug inspectors in analysing drug samples, devices and auditing manufacturing units.

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.

Gujarat FDCA has also now rolled out 50 new courses on GMP to train another group of drug inspectors in collaboration with US-based Underwriters Laboratories (UL), a global safety consulting and certification company.  Gujarat FDCA had earlier adopted only about 150 relevant courses. UL is offering about 700 such courses of which 125 courses are authored by the US Food and Drug Administration (US FDA).

Such online courses would also help the drug inspectors conduct inspection on the shop floor of a drug facility in an effective way. These courses are as per the training imparted to US FDA inspectors towards increasing compliance in cases related to spurious drugs and faulty medical devices. UL EduNeering, the compliance education and training services business division of UL, is leading this initiative.

Gujarat today boasts of having the highest number of 150 licensed medical device units under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in the entire country. The state earlier had 130 units and added another 20 units recently.

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.