Taking cognizance of US FDA inspections and the following scrutiny in the last couple of years, government regulatory agencies are now 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.
Aimed at empowering the central drug regulators with the similar regulatory knowledge as offered to the US FDA officials, US-based global leader in safety science 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.
Specially designed customised online training courses, based on international regulatory guidelines, will soon empower the CDSCO West Zone officers with training on GMP for pharmaceuticals and medical devices as well as good clinical practices (GCP).
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. UL has recently signed up as a knowledge partner with the CDSCO West Zone.
CDSCO West Zone comprises the states of Maharashtra, Goa, Gujarat, Madhya Pradesh, Chhattisgarh and Union Territories 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.
“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 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 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.
However, there is no monetary interest associated with offering this online programme as the aim is to empower the regulators with the similar regulatory knowledge as that is offered to the US FDA.
"As part of the MoU with Gujarat government, UL would further provide e-learning courses with different regulatory topics such as GXP (which includes good manufacturing and laboratory practices, and clinical research) to them. A system has also been provided where regulators can do those courses and track those completions", explains Barnard.
Last year, pharmaceutical exports from India to the United States rose 32 per cent to $4.2 billion. India accounts for about 40 per cent of generic and over the counter (OTC) products and 10 per cent of finished dosages used in the US.
Explains Dr Kavita Mehrotra, global strategic head, UL EduNeering, “UL aims at bringing in GMP by empowering the regulatory authorities because ultimately not only does this contribute significantly to patient safety but also influences the quality of exports of pharmaceuticals and other related products, thereby accelerating business results as well.”
Workshops on GMP
The US FDA –CDSCO workshops last year covered relevant topics for Indian regulatory requirements like process validation, enforcements and computer system validation based on out of specific information. The workshops were held in Hyderabad, Goa, Chandigarh and Ahmedabad in May, 2014.
Dr Kavita Mehrotra, Global Strategic Head, UL was one of the attendees at the Goa workshop. The US FDA-CDSCO workshop, she said, was the first step towards having a shared knowledge about GMP and Quality Management Systems. “UL Eduneering will continue to act as a global thought leader in the area of GMP and CGMP, GCP and Learning Management Systems and looks forward to strengthening these ongoing efforts of US FDA to serve the India pharma community.”