NewsVoir | 04 Jun, 2015
With Indian pharmaceutical exports to the United States and other markets showing a marked increase over the last year, government regulatory agencies have started emphasizing the need to ensure consistent quality of drugs manufactured in India. The drugs standardization compliance and regulatory requirements need to be at par with the international regulations, including the US FDA, allowing drug manufacturers to maintain competitive advantage.
To further augment the efforts towards developing a robust compliance and regulatory framework by the drug regulators in India; UL (Underwriters Laboratories), a global safety science organization, has recently signed up as a knowledge partner with the Central Drugs Standard Control Organization (CDSCO) West Zone (comprising the states of Maharashtra, Goa, Gujarat, Madhya Pradesh, Chhattisgarh and UT of Daman & Diu and Silvassa). CDSCO works under the administrative control of Indiaâs Drug Controller General, Directorate General of Health Services: Ministry of Health & Family Welfare.
Under this partnership, UL will help train CDSCOâ Western Zone officials. UL EduNeering, the compliance education and training services business division of UL Life & Health, will lead this initiative. The specially designed online training courses, based on international regulatory guidelines, will empower the CDSCO officers with the appropriate training on good manufacturing practices for pharmaceuticals and medical devices as well as good clinical practices.
UL also will build custom training modules for the CDSCO West Zone that suit the learning needs of their investigators. In the first phase, 10 investigators will be trained on 40 online modules.
âUL's focus on quality is based on the expertise we have garnered from more than a century of testing, certifying products and developing standards. Through this association we will be training CDSCO inspectors across western region on what is essential in the inspection and standardization process. This association is another extension of the MoU, we recently signed with the Gujrat Government. We are happy to see the increase in quality awareness amongst the pharmaceutical industry across the region. We will further continue our focus on the sector and expand our presence with in industry and across regulators, said Suresh Sugavanam, managing director and vice president of UL South Asia.
âUL EduNeering is a leader in providing regulatory and compliance learning solutions to the Life Science industry. Our CFR 21 Part 11 validated platform is used globally by top Pharma and Medical Device companies. We partner with organizations to help them build an effective quality and compliance training program that best suits their needs,â stated Scott Barnard, Vice President, Life Sciences at UL EduNeering. Mr. Barnard went on to say, âUL EduNeering will continue the program throughout the year utilizing a blended approach to learning through continuous improvement and training.â
About UL EduNeering:
UL EduNeering is a division within ULâs Life & Health business. It has an exclusive partnership with the US FDA and provides the technology and content that has been used to train over 36,000 FDA inspectors and investigators globally. With over 30 years of experience in providing learning solutions, UL EduNeering serves over 250 Life Science clients across 67 countries, supporting 34 languages. UL EduNeering is committed to bringing best-of-breed training to Pharma and Medical Device companies worldwide.
UL is a premier global independent safety science company that has championed progress for more than 120 years. Its nearly 11,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain.
For more information about our certification, testing, inspection, advisory and education services, visit http://www.UL.com