Indian Drug Manufacturers' Association (IDMA) and global safety science company UL today entered into an alliance for providing tools and training to domestic companies to mitigate regulatory scrutiny and to meet the increased compliance levels.
The alliance will also help companies to navigate complex regulatory issues, IDMA said in a statement.
"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 are 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," said IDMA President Veeramani.
UL will offer learning and training to companies, especially in the wake of increased scrutiny by global regulators on Indian pharmaceutical companies.
"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 them," Suresh Sugavanam, managing director, UL India and South Asia said.
"This calls for a universal understanding of good manufacturing practices (GMP) guidelines, rightful implementation and fool proof audit processes to ensure consistency," he said.
The company's global strategic head, Kavita Mehrotra said, "UL aims at becoming an industry partner for all companies looking to standardise their GMP practices, appropriate documentation and management visibility to training compliance."
UL and IDMA are also hosting a summit here 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.
