As the clinical research industry is expected to grow at a 15.5% CAGR from 2010-2016, the way ahead is strewn with both opportunities and challenges. Quintiles India, the largest biopharma outsourcing services company by revenue, operating in 60 countries, sees opportunities in the data-driven businesses, and challenges in the form of regulatory uncertainties. In a detailed interview with Sohini Das, Quintiles India managing director Anil Raghavan talks about the way ahead. Edited excerpts:
As global healthcare companies are eying the India market, Indian players are vying to spread wings abroad. What kind of business growth do you see in the coming years in the clinical research space?
We expect that our clinical business, which constitutes around 25% of our revenues in India, will continue to show robust growth over the next several years. This growth will be driven by demand from both global and domestic players, as well as from the institutional not for profit segment.
The domestic market is also an emerging opportunity and we have seen considerable traction in this segment over the last year not only to support the global aspirations of Indian players but also to help them derive growth and value from the emerging biosimilar opportunity.
However, the business that we are most optimistic about is our data-driven businesses, which contribute to 75% of our revenues in India. Data services and analytics are the future of transformation of the healthcare landscape.
Are regulatory issues affecting the growth of CROs in India?
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There is no doubt that the uncertainty and lack of clarity in the regulatory environment has impacted the growth of CROs. We are glad that the Government and regulatory authorities are addressing this issue on priority and using a consultative process to seek feedback from various stakeholders to ensure that everyone’s interests are addressed.
However, regulatory changes must be deliberate expression of long term commitment to advancing our national goals and safeguarding patients, rather than a knee jerk reaction to media and other external pressures.
The instability and indecisiveness in policies is raising global concerns about doing medical research in a country where research is a critical public health requirement. The need for medical research in our country to study unique disease profile and find better and more cost effective solutions for the illnesses that inflict our people cannot be underestimated, but we need a more conducive and supportive regulatory environment for this to happen.
What is equally disconcerting is the impact of regulatory uncertainty on local innovation. Trends worldwide have established a positive correlation between growth in overall medical research and domestic drug discovery and innovation. If we want to build a strong culture of innovation and R&D in the biopharma industry in the country, we need to ensure a more conducive regulatory environment for medical research. In the absence of such an environment, the interest in indigenous research and the spirit of innovation will flag.
Conducting clinical trials in India is cheaper compared to developed countries. Comment on the India cost advantage.
While it may be true that India is a relatively low cost market in which to conduct research, cost arbitrage is no longer a key consideration. If this were so, India would be doing far more than the 1.5% global drug development we see being conducted in the country.
The choice of countries in which a study is conducted is established through close collaboration with customers and it is not based merely on cost. It is based on epidemiology and disease prevalence; access to qualified investigators; future commercial plans for the new medicines as well as a host of other factors. Having said that, India has a great advantage in terms of an English-speaking talent pool, trained investigators and a large patient population.
On the recent issue of death during trials, what would you say on the compensation offered to the affected?
Compensation has been a contentious issue in the industry for far too long. In the absence of clear cut guidelines to determine causality and appropriate compensation, various adhoc methods are used to compute compensation and it would therefore be unfair to comment on compensation payouts made thus far.
What the industry needs is a practical and rational framework for determining causality and compensation. Compensation norms need to be applied in a manner that is logical, fair and transparent. The Ministry of Health & Family Welfare has taken a step forward in recommending a method for determining compensation and has invited industry feedback on these guidelines. As an industry leader, we have provided our feedback to the Ministry both as Quintiles and in collaboration with professional industry bodies. We have also participated in review meetings that the Ministry has scheduled on these guidelines and are hopeful that whatever is developed will be in the best interests of all stakeholders, most importantly patients.
What are the key challenges before the industry in India at the moment?
The biggest challenge for us in India is the uncertainty in the regulatory environment. India is losing its edge not because of the direction of regulatory policy but because of the lack of clarity on several issues. The Government and regulatory bodies need to balance requirements resulting from immediate needs and risks with the long term strategic requirements of the country. At the same time, we need a strong ecosystem for the enforcement of regulation so that patient safety and ethics are not compromised at any cost.
Another major challenge is the quality of skilled talent. With the industry growing as it is,institutions need to gear up to provide industry ready talent.