Furthering its efforts to help Indian pharmaceutical companies mitigate regulatory scrutiny and increase compliance levels, UL, a global leader in safety science, has entered into an alliance with the Indian Drug Manufacturers’ Association (IDMA). Under this alliance, UL and IDMA will equip the industry with tools and training to enable Indian companies straddle rapid global growth in a highly competitive environment, while navigating complex regulatory issues.
Through this alliance, UL and IDMA are hosting a summit to share best practices and trends in critical areas including GMP (Good Manufacturing Practices), CGMP (Current GMP), GCP (Good Clinical Practices), BiMo (Bio-medical research), Quality System Regulation (QSR), US FDA and regulatory compliance.
In India, UL offers learning and training, especially in the wake of increased scrutiny by global regulators on Indian pharmaceutical companies. UL’s training arm, UL EduNeering has an exclusive partnership with the US FDA and has trained over 36,000 FDA inspectors and investigators. With over 30 years’ experience in providing online learning services to over 400 pharmaceutical clients, in 34 languages across 67 countries, UL EduNeering is committed to bringing top-of-the-line training to pharma and medical device companies, worldwide.
Speaking on this, Dr Kavita Mehrotra, global strategic head, UL EduNeering said, “UL is now bringing that same expertise to Indian life sciences and healthcare companies. UL EduNeering’s on-going commitment is to enable companies meet all their quality, compliance and learning needs. As experience has taught us all in the field of regulatory compliance, compliance does not end with approval but requires an adherence to quality practices on an on-going basis. UL aims at becoming an industry partner for all companies looking to standardize their GMP practices, appropriate documentation and management visibility to training compliance.”
To emphasize this point, Suresh Sugavanam, MD, UL India and South Asia said, “Given the rapid growth curve of the Indian pharmaceutical industry, it is quite natural that the spotlight is on Indian companies’ adherence to good manufacturing practices. We need to look at this increased regulatory scrutiny more as an opportunity for Indian companies. This calls for a universal understanding of GMP guidelines, rightful implementation and fool proof audit processes to ensure consistency. We are already seeing a high level of commitment and drive from the pharmaceutical companies towards establishing robust learning systems, and we hope to gain significant ground towards these goals in the next one year.”
Underlining the need for immediate proactive course of action, IDMA president Veeramani said, “The current spotlight on the industry should not be viewed in isolation, but as a call to action for the entire industry. Companies go wrong not because of lack of intent, but because of lack of information. This is what we’re trying to resolve through our engagement with UL, as they bring a deep understanding of the complexities of various regulations and work closely with the FDA.”