Having successfully trained 50 drug control officers on Good Manufacturing Practices (GMP) as per the stipulated timelines, the Gujarat Food and Drug Control Authority (FDCA) has 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.
Since Gujarat has over 3,300 manufacturing units located across the state in four large clusters with 5 Special Economic Zones in an area of over 1,500 hectares which caters to formulations and active pharmaceutical ingredients (APIs), 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.
Training which also includes Good Distribution Practices (GDP) and Good Laboratory Practices (GLP) had earlier equipped 45 drug inspectors on 22 online courses through this initiative based on an MoU signed with UL during Vibrant Gujarat Summit in January, 2015.
Done as a part of strategic partnerships for knowledge sharing with foreign companies, the training programme is primarily conducted through an e-learning mode to help drug inspectors get access to world-class training on par with global counterparts. The best part of this initiative is that this has led to increase in detection of spurious drugs and NSQ drugs.
There is no monetary interest associated with offering this online programme as the aim is to empower the central and state drug investigators with the similar regulatory knowledge as that is offered to the US FDA.
The programme is intended for drug inspectors, senior drug inspectors, assistant drug commissioners, deputy drug commissioners and drug commissioners. UL offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors.
Gujarat has become a favoured pharmaceutical hub accounting for nearly 40 per cent of India’s pharma production and 28 per cent of pharma exports. It has also registered a growth of 445 per cent in pharma exports in the past one decade.