Aimed at empowering the central and state drug regulators with the similar regulatory knowledge as that is offered to the US FDA regulators, the US-based global leader in safety science Underwriters Laboratories (UL) company will soon collaborate with other state governments to train and assist the drug regulators.
This is the next plan of action following the signing of a memorandum of understanding (MoU) with the Gujarat government to train Gujarat Food and Drug Control Authority (FDCA) inspectors. UL has already trained 45 officers from the Gujarat FDCA on 22 online courses covering critical areas including GMP, GCP, audit-readiness and remedial training.
UL offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors. UL EduNeering, the compliance education and training services business division of UL, is leading this initiative.
"There are about 17 officers in the CDSCO western region which also require training on GMP for medical devices and clinical research. However, none of these have been finalised as yet as these are government processes which need approvals," informed an official. UL is also in discussion with Goa FDA, which has shown interest in the e-learning training programme. There are 15 drug inspectors under Goa FDA .
Out of the 700 courses offered through e-learning mode, 150 courses have been made available in Gujarat FDCA for the state regulators on relevant areas of GMP, GDP and validation protocols. There is no monetary interest associated with offering this online programme as the aim is to empower the regulators with the similar regulatory knowledge as that is offered to the US FDA.
Explains Scott Barnard, VP, life sciences, EduNeering, "As a part of MoU with the Gujarat government, UL would further provide e-learning courses with different regulatory topics such as GXP (which includes good manufacturing and laboratory practices, and clinical research) content to them. A system has also been provided where regulators can do those courses and track those completions."
Talking about the training module, Gujarat FDCA Commissioner Dr H G Koshia said, “Gujarat FDCA is committed to provide high-quality educational opportunities to its investigators, scientists, analysts, state and local regulatory officials to meet the challenges of matching the complex regulatory environment. UL EduNeering’s rich modules of training programmes that are followed by US FDA would definitely help our inspectors understand the nuances of global regulatory requirements and ensure a high degree of quality control for pharmaceutical manufacturers in Gujarat.”
Last year, pharmaceutical exports from India to the United States rose 32 per cent to $4.2 billion. India accounts for about 40 per cent of generic and over the counter (OTC) products and 10 per cent of finished dosages used in the US. Explains Dr Kavita Mehrotra, global strategic head, UL EduNeering, “UL aims at bringing in good manufacturing practices (GMP) by empowering the regulatory authorities because ultimately not only does this contribute significantly to patient safety but also influences the quality of exports of pharmaceuticals and other related products, thereby accelerating business results as well.”
“UL offers innovative technologies that prepare companies to have standardised processes, as well as audit readiness, by adhering to GMP requirements, so that the best practices exist at every level in the organisation,” concludes Suresh Sugavanam, managing director , UL India and South Asia.