UL Signs a Memorandum of Understanding with Gujarat Government to Train FDCA Inspectors on Audit Regulations

UL to provide robust regulatory and compliance training to government investigators covering critical areas including good manufacturing practices, good clinical practices, audit-readiness and remedial training

New Delhi, Jan 16, 2015:  As a significant step toward demonstrating its commitment to a standardized global understanding of regulatory and compliance training, UL (Underwriters Laboratories), the global leader in safety science, signed a memorandum of understanding (MoU) with the Gujarat government to train Gujarat Food and Drug Control Authority (FDCA) inspectors. UL will be using specially designed online programs in keeping with international regulatory guidelines, to help ensure the quality and safety of pharmaceuticals manufactured in Gujarat. The MOU was signed at a national seminar called “Health for All: Leveraging Technology, Innovations & Enablers,” held during the 7^th Vibrant Gujarat Summit in Gandhinagar, Gujarat Jan. 12.

UL EduNeering, the compliance education and training services business division of UL Life & Health, will lead this initiative. The goal of this effort is to empower the FDCA investigators with the same source of knowledge that is currently accessible to U.S. Federal Drug Administration (USFDA) investigators. In the first phase, training was conducted in December with 45 inspectors from the Gujarat FDCA, and featuring 20 online modules. UL EduNeering will continue training throughout the year utilizing a blended approach to learning through continuous improvement and training .

Last year, pharmaceutical exports from India to the United States rose 32 percent to $4.2 billion. India accounts for about 40 percent of generic and over-the-counter products and 10 percent of finished dosages used in the U.S. Given these numbers, it is not surprising that the Government of India and foreign regulatory agencies are emphasizing the need to ensure consistent quality of the country’s drug products. This move by the government of Gujarat is a step in the strategic direction to bring Indian pharmaceutical standards on par with the USFDA’s and enables India to maintain a competitive advantage.

Notes Dr. Kavita Mehrotra, Global Strategic Head, UL EduNeering, “From a strategic perspective, this is very important, because ultimately, not only does this contribute significantly to patient safety, which is our first priority, but also influences the quality of exports of pharmaceuticals and other related products, thereby accelerating business results as well. Healthy people create healthy economies.”

She added, “UL EduNeering’s ongoing commitment is to bring in expertise to Indian life sciences and healthcare companies. Through this strategic partnership with Gujarat FDCA, for the first time in India, UL aims at bringing in good manufacturing practices (GMP) by empowering the regulatory authorities with the right kind of training which would enable them to guide drug manufacturers in adhering to necessary standards.”

“UL offers innovative technologies that prepare companies to have standardized processes, as well as audit readiness, by adhering to GMP requirements, so that the best practices exist at every level in the organization,” said Suresh Sugavanam, Managing Director , UL India and South Asia. “This strategic partnership with the Gujarat government to train FDCA inspectors is the first in a series of programs with other state government bodies to provide consultation, training and support in the areas of quality and control management,” he added.

Dr. H. G. Koshia, Gujarat FDCA Commissioner, said, “To meet the challenges of matching the complex regulatory environment, Gujarat FDCA is committed to provide high-quality educational opportunities to its investigators, scientists, analysts, state and local regulatory officials. UL EduNeering’s rich modules of training programs that are followed by USFDA 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.” CCI Newswire