NOVEMBER 10, 2017
Video Address: Critical Importance of Global Traceability in the Experience Economy
The first session of the second day at Pharma CXO Summit 2017 was on ‘Critical Importance of Global Traceability in the Experience Economy’. A global pharma expert, Dr Ajaz S Hussain, Founder Insight, Advice & Solutions, LLC and former Deputy Director of Pharmaceutical Science, US FDA, spoke to the audience at the event through a video address. He emphasised that we are in an age of experience and meeting patients’ expectations is going to be paramount. He explained that the need for experience is growing exponentially but our ability to provide assurance is not growing at the same pace. Dr Hussain also gave insights on how serialisation will help improve patient experience in times of outcome-based pricing and help the industry avail manifold benefits and accelerated growth. He advised the pharma industry veterans to have an open mind towards serialisation and devise their strategies for its adoption with care.
OPEN Serialization Standard Released: Why it’s needed and why you should join?
Marcel de Grutter, Executive Director, OPEN-SCS and Liaison Regulatory & Government Affairs, Abbott, an OPEN-SCS expert, gave an understanding on the vision and scope of these standards and explained how they offer manifold benefits to streamline and improve the supply chain, aid in GAMP-compliant change and
lifecycle management, spur innovation, improve quality and performance etc. He also informed how global companies are already part of this initiative and urged the rest of them to follow suit to increase their competitiveness in the global arena.
He strongly recommended serialisation for countries like India and opined that it will help improve quality processes. He also advised training people to use electronic systems to ensure easy implementation. He mentioned that quality will be a huige determinant of success in times to come and Indian pharma companies could use serialisation as an oppurtunity to increase exports. In his presentation, he also explained the criticality of a standard data exchange specification for healthcare packaging serialisation.
He also shared achievements and milestones of various packaging serialisation specification 1.0 use cases which his company has already implemented such as PSS 1.0 and 2.0 deliverables and agile GMAP development process of PSS. He said that with implementation of serialisation, companies can also train their people to apply GAMP.
Serialisation: 2017 & Beyond
Jean Pierre Allard, CTO, OPTEL Group made a presentation on the impact of serialisation in the pharma industry. He revealed that recorded incidences of counterfeiting in 2014 stood at 2177. Cautioning that counterfeiting is not a myth but a reality, he also said that this number does not represent the real number of counterfeit and this could be tip of the iceberg! He informed that in the world, 15,000 packaging lines need serialisation and stressed on the point that unless we do something on a urgent basis, an unprecedented dilemma is on its way. On the plus side, he said that India is one of the country which has started its serialisation journey.
He also spoke on how serialisation mandates are being adopted in countries across the world and gave an overview on the laws in different developed markets such as the US and the EU. He also laid emphasis on the need to comply with these laws.
He also spoke on the global regulations already implemented in India, China, South Korea, Turkey and Argentina. He also said that serialisation is here to stay and each company needs to create to blueprint for embracing serialisation. He also spoke on OPTEL’s readiness and ability to be a great partner to pharma companies in their efforts to adopt serialisation processes.
Valedictory Address: Made in India, Export to the World
Dr Sanjit Singh Lamba, MD, Eisai Pharmaceuticals India, in his valedictory address, spoke on Make in India, Export to the World. He also briefed the audience on the journey of Eisai Pharma and shared the key learnings of the company while dealing with different markets globally. He said that after the success of Eisai in India we have seen a number of investments coming from major Japanese pharma companies coming to India.
He also highlighted the various challenges faced by the Indian pharma companies. He pointed out that on one side we talk about being the ‘Pharmacy of the World’ and on the other side we are faced with issues of infrastructure, compliance and regulation. However, he also said that with technology adoption, the industry is undergoing a huge change since the in past 10 years.
Speaking on exports, he said, “The major challenge is the quality issue that is affecting the reliability. We are doing a lot more on that, for instance, serialisation to ensure that we have full control on our supply chain.”
He also advised, “We need to have continuous investment in technologies and people.” Thus it was a very befitting conclusion to two days of knowledge sharing at Pharma CXO Summit 2017.
Panel Discussion: The Serialisation Journey in India
The last panel discussion at Pharma CXO Summit 2017 was on The Serialization Journey in India. The panel discussion was moderated by SM Mudda,
Director – Global Strategy (Technical), Micro Labs. Prabir Das, VP, Mylan Laboratories; Shivaji Chakraborty, Assistant General Manager, Packaging
Development, Fresenius Kabi Oncology; and Vardhaman Jain, Marksans Pharma were the panelists. The discussion began with a very important question: Why there has been a reluctance to accept serialisation? Lack of understanding about technology and its potential, high initial cost of implementation were some of the major reasons which emerged as the answer to the question.
The discussion also touched upon varied topics ranging from India’s standing in the global pharma industry, rising threat of counterfeit medicines, and global track and trace regulations, to India’s regulations for the export market, as well as serialisation compliance and challenges and more.
Das informed that serialisation is the most discussed topic in the pharma industry these days. He also spoke on the basic challenges faced in packaging. One of them is accommodating the additional barcode which is relatively smaller to our conventional barcode. He said that at various levels of packaging, we face different challenges. Elaborating on them he said, there are no harmonised standards across the globe which can be easily integrated in a common system. It is a challenge for the packaging industry to keep evolving complying with the new regulations coming up in different countries.
Speaking on operational challenges faced in serialisation, Chakraborty said, “Serialisation looks simple but its not that simple. The few challenges which is very common in the industry is integration with the existing packaging line. It is really difficult keeping in mind the Indian scenario. Most of the lines are old and their speed is very low and changing to updated machinery involves cost. In India, we have unskilled, untrained manpower in the packaging line so handling the new equipment is a big challenge for them. Accommodating text on small cartons is a challenge for automation. We are still working on to deal with challenges.”
Jain elaborated on how the barcodes need to be integrated in the quality system. He said, “The complexity is very high. However, today, people understand that track and trace is not required only for the DAVA portal but also falls under the FDA enforcement, US as well as EU.”
Concluding the panel discussion, Mudda said, “It is a difficult journey and there is a long way to go before we standardise the requirements globally to find workable solutions. We should be looking forward to better solutions and compliance.”
Glimpses of Pharma CXO Summit 2017