The Gujarat Food and Drug Control Authority (FDCA) has shortlisted another 50 drug control officers to help get them training on Good Manufacturing Practices (GMP) for medical devices and 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.

Training also includes Good Distribution Practices (GDP) and Good Laboratory Practices (GLP).

Gujarat FDCA has already trained 45 drug inspectors on 22 online courses through this initiative based on an MoU signed with UL during Vibrant Gujarat Summit in January, 2015. UL EduNeering, the compliance education and training services business division of UL, is leading this initiative.

Says Gujarat FDCA Commissioner Dr HG Koshia, “The programme is primarily done through an e-learning mode with exams conducted at stipulated timelines. The best part of this initiative is that this has led to increase in detection of cases related to counterfeit drugs, spurious drugs and Not-of-Standard Quality (NSQ) drugs. As many as 11,000 samples were collected last year which were sent for testing to the government testing lab at Vadodara.”

He further added that the online course would also help the drug inspectors conduct inspection on the shop floor of a drug facility in an effective way.

UL is offering about 700 courses of which 125 courses are authored by the US Food and Drug Administration (FDA). Since Gujarat has over 3000 manufacturing facilities catering to formulations and active pharmaceutical practices (APIs), it has adopted only about 150 relevant courses.

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.

India accounts for about 40 per cent of generic and over-the-counter products and 10 per cent of finished dosages used in the US. India also has the most number of US FDA approved manufacturing facilities outside the US.

Other state drug controllers have also shown interest to roll out the same training programme that has been extended to Gujarat FDCA.