UL has tied up with Gujarat Food and Drug Control Authority to train their inspectors; in talks with CDSCO and other state governments
The US-based UL (Underwriters Laboratories), a global safety consulting and certification company, is likely to collaborate with Central Drugs Standard Control Organisation (CDSCO) and state governments to train and assist the drug regulators and inspectors.
UL EduNeering, the compliance education and training services business division of UL, is leading this initiative. The company has already signed a memorandum of understanding (MoU) with the Gujarat government to train the Gujarat Food and Drug Control Authority (FDCA) inspectors.
Scott Barnard, VP, Life Sciences, EduNeering, said, "We signed the MoU with the Gujarat government during Vibrant Gujarat Summit in January. We are providing them e-learning courses with different regulatory topics such as GXP (which includes good manufacturing and laboratory practices, and clinical research) content to them. We are also be providing a system where they can play those courses and track those completions. We have already trained 45 officers from the Gujarat FDCA on 22 online courses."
UL is offering about 700 courses of which 125 courses are authored by the US Food and Drug Administration (FDA). Since Gujarat has a large number of manufacturing facilities catering to formulations and active pharmaceutical practices (APIs), it has adopted only about 150 relevant courses.
Suresh Sugavanam, vice president and managing director for UL South Asia (India, Bangladesh and Sri Lanka), said, "We will be training FDCA inspectors on what to look for inspection and so on. The Gujarat government took the step in order to ensure that not just their inspectors but the pharma industry can actually be able to take that leap and get to the right kind of regulatory level and maintain it. We have already started the training, and we hope to start the same with other states as well."
Barnard said that 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% of generic and over-the-counter products and 10% of finished dosages used in the US. India also has the most number of US FDA approved manufacturing facilities outside the US.
UL is in discussion with Goa FDCA, which has shown interest to roll out the same training programme that has been extended to Gujarat FDCA. There are 15 drug inspectors under Goa FDCA and it wants to implement the programme for good manufacturing practices for pharma and clinical research, a company official said.
"We are also talking to the CDSCO and we intend to roll out the same programme for the CDSCO-western region. There are about 17 officers in the western region and this would be for GMP for medical devices and clinical research. However, none of these have been finalised as these are government processes which first need to be approved internally," the official said.
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