As a step towards equipping regulators on quality control in labs, Merck has recently trained 25 Gujarat Food and Drug Administration (FDCA) officers on Good Lab Practices (GLPs) through a hands on training programme to streamline quality assurance protocols and SOPs in labs.

Around 100 drug inspectors have already been trained on medical devices as part of the Gujarat FDCA's collaboration with Abbott India as part of strategic partnership for knowledge sharing at the Vibrant Gujarat Global Summit (VGGS) - 2017 at Gandhinagar earlier this year. The initiative would further help drug inspectors in analysing drug samples, devices and auditing manufacturing units.

The state drug regulator and bioMérieux, a 115 years old French Company is also going to start training programmes on microbiological testing technologies and applications following an MoU to cater to the regulatory requirements of domestic and export markets.

It is relevant to have rapid monitoring of microorganisms - environmental, spoilage and pathogenic to meet industry needs and of regulators in a big way. To cater to the needs of the pharmaceutical and cosmetic industry, bioMérieux has developed efficient, accurate and rapid methods for detection and enumeration of pathogenic, environmental and public health indicator organisms.   

This MOU will help Gujarat Government, pharma industry in the state, regulators and manufacturers meet expectations for faster, accurate and more cost-effective testing. bioMérieux would be instrumental in setting up a state of the art laboratory for the FDCA in Gujarat for pharma testing on par with global standards.

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 UL.  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.