UL, a global independent safety science company providing testing, inspection, certification and advisory services, recently signed an MoU with Pharmexcil to be the Council’s knowledge sharing partner and subject matter expert. Peeyush Gupta, Director, Sales and Marketing, South Asia – UL, shares more details about the alliance and its objectives, in an exclusive interview with Lakshmipriya Nair
What does the recent partnership between UL – Pharmaceutical Export Promotion Council of India (Pharmexcil) entail?
With Pharmexcil, we signed an MoU on September 23, 2016. This is a knowledge sharing partnership under which we would support the Pharmexcil members and help them find solutions to their various requirements. Under this partnership, we plan to do a series of workshops and events partnering with the pharma industry in India over 2017 and beyond. These workshops would comprise technical sessions wherein we will understand the challenges faced by the industry and address these challenges. We will also have consultative sessions wherein experts from UL as well as regulators and representatives of leading pharma companies will address the participants to work together and create a strong compliance and performance framework in India. At a higher level, with this partnership we intend to ensure that the pharmaceutical industry in India achieves greater heights of growth.
What are the three important goals that this partnership aims to achieve?
The three important goals of this partnership is to:
- Provide knowledge to the Indian pharma industry in terms of global regulations and global compliance
- Understand the challenges faced by the pharma industry and address them effectively
- To develop long-term, lasting solutions for the Indian pharma industry so that it looks beyond just compliance to business performance and business excellence
How will it help the pharma players up their game?
The Indian pharma industry is going through a high-growth phase. More than 40 per cent of generic drugs sold in the US are manufactured in India. We continue to see high growth in the exports to the US market as well as other global markets. However, this kind of growth comes with its inherent challenges in terms of quality as well as compliance and in terms of meeting both customer as well as regulatory needs. We, at UL, with over three decades’ experience of helping lifesciences companies bring to the table a level of global expertise that can help the industry find solutions to some of the challenges that they are facing at this point of time.
Can you elaborate on the services provided by UL for the pharma industry?
We operate on a partnership model. We work with clients and try to find solutions to their needs. Right from market access needs – if they are accessing certain markets what are the regulatory needs in those countries, right upto their training requirements whether they are on CGMP, data integrity, good clinical practices, validations, SOPs etc, we have a suite of courses that help clients understand their needs. More than that, we work with the clients to offer them relevant solutions customised to suit their needs.
Tell us more about the courses offered by UL? Who are your clients?
We have designed and implemented several courses to facilitate training and learning for pharma companies in India. We have over 700 e-learning courses. These courses are addressed for people at different levels in the pharma organisations, right from the workers to the senior management. We have advisory frameworks where we work with clients on a periodic basis and establish long-term associations to understand their needs and develop solutions for the issues they face. We have worked with a lot of leading pharma companies in India.
Are these courses accreditated/ recognised by any industry/ regulatory body?
Well, it is a very interesting story. We were one of the pioneers or one of the first organisations to be qualified by the FDA in the US to train their staff. So, these courses were jointly developed by UL and the FDA in the US. Now, for more than decade, we have been working with the US FDA and partnering with them to develop these courses which as used to train the FDA auditors. Leveraging on that experience, we have these courses in our course library which not only look at the requirements from a US FDA standpoint but also from a global regulatory standpoint whether its is the MHRA in the UK or regulatory bodies in China or Japan etc. These courses basically help clients to understand regulatory frameworks in different countries across the world.
Tell us about the agreement you have signed with the Gujarat government to train their FDCA inspectors on regulatory compliance.
We have signed an agreement sometime last year. Since then we have trained around 40 inspectors of the FDCA in two or three sessions. We have trained them on different aspects of good manufacturing practices and good clinical practices.
What are the learnings you have gained from your presence in the Indian market that can be incorporated in the partnership with Pharmexcil?
We have been in the Indian market for some time and we have been trying to understand how we can leverage the global experience but provide solutions tailored to the local needs. We understand that there are specific areas where the Indian pharma industry is facing challenges such as data integrity, corrective and preventive action, inspection readiness, facing audits. So, in fact, a lot of the solutions that we are working on revolves around the understanding that we have about the challenges faced by the Indian pharma industry. So, we are becoming more local now, trying to understand the local needs and provide local solutions.
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