CDSCO west zone partners with UL to train inspectors on audit regulations
(NewsVoir); 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 India’s Drug Controller General, Directorate General of Health Services: Ministry of Health & Family Welfare.
Under this partnership, UL will help train CDSCO’ 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.
“UL'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.
“UL 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,” stated Scott Barnard, Vice President, Life Sciences at UL EduNeering. Mr. Barnard went on to say, “UL EduNeering will continue the program throughout the year utilizing a blended approach to learning through continuous improvement and training.”