H Erik Heemskerk , Brand Director, Pharma Portfolio, UBM Live , in an e-mail interview with AD Pradeep Kumar gives an overview of the Indian pharma industry and dwells on the significance of the CPhI India 2013 event. Heemskerk who had joined UBM as Brand Director Pharma in June 2013 ,is responsible for growing the industry leading global pharma events,conferences and digital products through organic growth and by leveraging new opportunities.
As CPhI India, one of the largest and most comprehensive pharmaceutical industry events in South Asia is unfolding in Mumbai,what are your comments on the growing role of India pharmaceutical industry in the global context?
The Indian pharmaceutical market is growing at 13 per cent annually, twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. In January-July 2013 the Indian pharma sector received close to 40 per cent of all Abbreviated New Drug Approvals (ANDA) from the US Food and Drug Administration (FDA). To accelerate this trend Indian pharma companies are making high investments to ensure absorption of modern procedures and practices for further operational efficiency.
Further, R&D in India is advancing, with investments having grown from US$ 52.5 million in 2000 to US$ 646.5 million in 2010, clearly presenting great opportunities for all international pharmaceutical companies to explore and benefit from. As one of the strongest emerging markets in the global pharma industry, India is fast becoming a pivotal player within the pharmaceutical sector and CPhI and P-MEC India, along with co-located events ICSE and BioPh enables the industry to meet under one roof to conduct business which will shape the market not only now but in years to come.
Compared to other CPhI events, how attractive is India as a platform for the pharmaceutical sector?
All of our CPhI events offer the industry an ideal platform to invest in growing markets and they have been specifically selected to provide global opportunities to enhance the market. India is a very attractive platform for the pharmaceutical sector, having seen manufacturing innovation and development technologies rise- particularly thanks to the explosion in generics production.
Further, over the last three years exports have grown at over 21.5 per cent (CAGR), now accounting for over $13 billion in annual sales. India has reaffirmed its commitment globally trying to lower the cost of medicines through its development expertise, clearly showcasing the country’s ideal position within the pharmaceutical sector and highlighting the benefits that CPhI and P-MEC India and co-located events provide for companies who want to take advantage of the unique position that the Indian marketplace holds.
As quality has become a major issue, what should the Indian regulators as well as companies do to improve quality management system and documentation in the context of the current global regulatory environment?
Although India has had minor regulatory setbacks, overall quality remains high and India is committed to ensuring that high quality is maintained. This is evident throughout the country, where there are 546 US FDA approved company sites (second only to the US), 23 companies holding 1100 authorisations with UK's MHRA and 166 companies with CEPs (Certificates of Suitability) from EDQM . So the country is a strong example setter for regulatory compliance. As with any other country, it is necessary to ensure that audits are carried out and constantly monitored to both improve and ensure quality management systems.
To what extent do you feel the US austerity measures will impact the Indian pharma sector?
The US austerity measures are likely to have a positive impact on the Indian pharma sector. As healthcare spending has seen a substantial reduction , companies will look to reduce revenue spending, possibly by outsourcing to India – as is an evident trend in the current marketplace – where manufacturing costs are significantly lower.
Overall, the industry has benefited from a rise in generics and, more recently, supergenerics (where much R&D spend in India is currently being invested). India is a clear leader in this sector, with the generics and supergenerics likely to grow hugely across the entire industry- further facilitating the country’s position as a manufacturing innovation hub. CPhI and P-MEC India, for example, are the foremost pharmaceutical events that bring pharmaceutical suppliers and buyers together to drive the industry and overcome such austere measures.
To what extent do you feel that the fee hike by the US Food and Drug Authority (FDA) for drug master filings (dossier for APIs) will impact drug exports to the US?
Overall, there will be limited impact on drug exports to the US- the fee hike will affect all countries so the playing field will largely remain the same. Outside of the US, India has the largest amount of FDA approved sites reiterating the huge importance for India to raise and maintain standards- it is for this reason why India has filed so many more DMFs than anywhere else in recent times. The country is increasingly looking to adhere to Western standards whilst also reducing the costs of manufacturing which will enable India to offer a unique proposition within the global pharma market. Every year at CPhI and P-MEC India, we witness solid partnerships being built between Indian and American companies and this year will be no different, showcasing that India’s valued exportation market is likely to be unaffected by the fee hike.
What are your comments on the recent trend of multinational companies setting up green field projects in India?
The trend is unsurprising as Indian pharma is such an innovative and dynamic growing market where international companies will look to invest. As these companies get bigger, the internal market will become more competitive, increasing standards and driving the industry.
It has been predicted by the Economist Intelligence Unit (EUI) that India’s pharma sector will double by 2016 to US$29 billion – an annual growth rate of 13 per cent – clearly displaying that there has never been a better time to invest in the Indian pharma market, hence the influx of multinational investment.
It is likely that we will see this trend remain for the foreseeable future, particularly as companies progressively shift their business models to adopt outsourcing, with India the prime destination to accommodate this. Consequently, it is clear that selling to the right contacts will be key to continued success meaning attending CPhI, P-MEC, ICSE and BioPh India has never been more important.
What are the novel features this year compared to other years?
This year, P-MEC India retains its strength and has expanded to adopt an additional hall (hall 7), which will attract more pharmaceutical machinery, technology and packaging exhibitors to the event, highlighting the growing role that this sector has and providing more business leads than ever before.
Furthermore, our mobile app which we launched last year will be available on all mobile devices with an internet connection, helping our attendees to navigate their way around the event, drive traffic to stands and stay up to date with schedules and speaker events.
Finally, ahead of this year’s event, the UBM India Pharma awards will be taking place on December 2, honouring and celebrating excellence and showcasing the crème de la crème of the Indian pharmaceutical industry. During this celebratory evening, there will be a panel discussion on “Moving up the Global Pharma Value Chain” designed to inform and educate those present at the ceremony. Nine awards will be given this year, including Excellence in Contract research and ‘Excellence in Packaging Development’. There will also be a lifetime achievement award, honouring a key player for their long-standing commitment to the shaping of the pharmaceutical industry.
How have the co-located events progressed during these years?
CPhI India’s co-location with events P-MEC, ICSE and BioPh highly reflects current industry trends. The pharmaceutical machinery and equipment market in India is significantly growing and as such P-MEC India has rapidly expanded at the event, providing unprecedented insight into the equipment and machinery sector and highlighting the latest innovations and trends in the market.