Aimed at empowering the central drug regulators with the similar regulatory knowledge as offered to the US FDA officials, the Central Drugs Standard Control Organization (CDSCO) will soon equip its drug inspectors with relevant areas of current Good Manufacturing Practices (cGMP) through an online training module.
The US-based global leader in safety science Underwriters Laboratories (UL) will train around 15 officers from the CDSCO West Zone on critical areas including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), audit-readiness and remedial training. UL offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors till date.
"Drug inspectors in the CDSCO western region require training on relevant areas of GMP and cGMP. The online training module is going to start in a couple of months time," informed an official associated with the development.
UL has recently signed up as a knowledge partner with the CDSCO West Zone. UL EduNeering, the compliance education and training services business division of UL Life & Health, will lead this initiative. 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.
CDSCO West Zone comprises the states of Maharashtra, Goa, Gujarat, Madhya Pradesh, Chhattisgarh and Union Territories of Daman & Diu and Silvassa.
“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 standardisation process. This association is another extension of the MoU, we recently signed with the Gujarat 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 in industry and across regulators,” said Suresh Sugavanam, managing director and vice president of UL South Asia.
Considering the fact that certain Indian companies have got critical global attention due to certain evasions, violations and avoidances during US FDA inspections in the last couple of years, government regulatory agencies have started emphasising the need to ensure consistent quality of drugs manufactured in India. The drugs standardisation compliance and regulatory requirements need to be at par with the international regulations, including the US FDA, allowing drug manufacturers to maintain competitive advantage.
“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 organisations to help them build an effective quality and compliance training programme that best suits their needs,” stated Scott Barnard, vice president, Life Sciences at UL EduNeering.
Out of the 700 courses offered through e-learning mode, 150 courses were also made available in Gujarat FDCA for the state regulators on relevant areas of GMP, GDP and validation protocols.