Following its collaboration with French and US based companies to help its officers train in terms of analysing drug samples and auditing manufacturing units, the Gujarat Food and Drug Administration (FDCA) has now collaborated with Abbott India to train and equip FDCA officers on medical devices and other testing modalities as a part of strategic partnership for knowledge sharing at the recently concluded Vibrant Gujarat Global Summit (VGGS) - 2017 at Gandhinagar.
Gujarat government signed 8 such strategic partnerships with overseas and Indian companies to upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern challenging the regulatory authorities globally and in India.
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.
Other states however have less number of units with 26 in Haryana, 18 in Uttar Pradesh, 17 in Maharashtra, 15 in Tamil Nadu and 10 in Kerala out of the 19 states having medical device manufacturing units.
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.
The Central Drugs Standard Control Organization (CDSCO) released a guidance document on August 7, 2015 to file an application for grant of the license for manufacturing of medical devices in India.
Says Gujarat Food and Drug Control Administration (FDCA) commissioner Dr H G Koshia, “Strategic partnership with Abbott India is a major breakthrough for Gujarat which is leading as a medical device hub in the country having registered the highest number licensed medical device companies. This will help officers to upgrade their knowledge in terms of auditing the units in a scientific manner.”
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.