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‘India has a great potential to become a major player in the bio-pharma innovation process’

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Recently, Professor Meir Pugatch, IPKM Chair University of Maastricht, Professor Frank Lichtenberg from Columbia University and Mike May from Scientific American Worldview presented their empirical studies at the USIBC Convenes Conference. Raelene Kambli speaks to Pugatch, Lichtenberg and May, on how India can become a global leader in the R&D and biopharmaceutical sector while also expanding healthcare access in country

What scope do you see for the Indian life sciences and bio-pharmaceutical sector on the global front?

20160229ep06Professor Meir Perez Pugatch – India holds an outstanding potential to become a regional leader in the field of life-sciences and bio-pharma innovation, especially given the greater government support for biomedical investment and innovation under the Modi administration. The future success of government initiatives such as the ‘National Biotechnology Development Strategy’ could boost India’s capabilities to compete in new fields of bio-pharma innovation.

Yet at the same time significant gaps, which have historically represented a major challenge to innovators seeking to operate in India, should be addressed. For example, looking at the findings of recent Pugatch Consilium research, these gaps and challenges exist in several areas such as India’s IP regime, its clinical research policy environment and regulatory framework. The Modi administration has already shifted its attention to some of these issues. By addressing these aspects and bringing them to the acceptable level of global international standards, India stands to meet its aforementioned potential and benefit greatly from it.

You say that India can become a global top-10 competitor in the life sciences and bio-pharma sector. Can you explain how?

Professor Meir Perez Pugatch – India has a great potential to become a major player in the global pharma arena, not only in the generic front but also in the biopharma innovation process.

Indeed, the recent Biopharmaceutical Investment & Competitiveness (BCI) Survey of 2015, which gauges these ecosystems in a sample of countries, shows that India currently performs well in several areas, not least with regards to its infrastructure and scientific level of research. Yet at the same time the BCI survey also identified four areas of weakness which India should address: 1) regulatory deficiencies and bottlenecks in the approval and review process on innovative products; 2) limited coverage of medicines even with costs driven down; 3) a relatively weak biopharma IP protection, and 4) insufficient collaboration and outputs between public research bodies and private enterprises.

I believe that once India addresses these gaps it will become a much more attractive hub for investment and innovation in 10 years’ time.

How can innovation in the bio-pharma sector help in increasing healthcare access in India?

20160229ep05Mike May – In some cases, innovative medicines require less complicated storage methods and easier delivery methods, such as pills versus injections, and this could take healthcare to more remote areas.

Professor Meir Perez Pugatch – One such prominent way is through clinical research. Pugatch Consilium’s Scaling Global Clinical Trial Activity of 2014 finds that clinical trials provide patients with access to innovative drugs, which may literally revolutionise existing treatments, and often continue beyond the duration of the trial. Clinical trials also provide physicians with experience in cutting-edge and skills, and often involve improvements to infrastructure and health technologies in local communities. Additionally, with costs of the drug itself and associated tests often being borne by the study’s sponsor, clinical trials may lead to savings for healthcare systems, in some cases, the sponsor may continue to provide the treatment at a preferential price.

Conversely, certain regulatory barriers in terms of innovation can also negatively affect access to healthcare. For example, the lack of Regulatory Data Protection for submitted clinical test data, excessive patentability requirements and gaps in predictability and transparency in the criteria and processes governing clinical research outlined in the Drugs and Cosmetics Act all play some part in India’s currently extremely low clinical trial activity and total number of new drug launches.

Tell us about the Scientific American Worldview’s seven years of meta-analysis finds?

Mike May – From 2012-2013, India’s data produced stable outcomes, and then it improved slightly from 2014 to 2015. All BRIC countries, however, need to improve considerably to compete with the current world leaders in innovative biotechnology.

According to your study what’s in store for India?

20160229ep07Professor Frank Lichtenberg – India has made impressive strides in the past 50 years.  In 1960, life expectancy at birth in India was 30 years lower than it was in the US (40 vs. 70).  Today, it is about 13 years lower (66 vs. 79). Thus, India has closed more than half of the life expectancy gap between it and the US. Much of the progress was probably due to the implementation of basic public health measures: better sanitation, environmental regulation, increased childhood vaccination rates, etc. The evidence suggests that to make further substantial progress in population health, the quality of healthcare goods and services must continue to improve. My research has demonstrated that use of new medicines can play an important role in improving the quality of health care, because the quality and efficacy of new medicines tend to be significantly higher than that of older medicines. Indian policymakers should therefore focus their efforts on ensuring that the Indian people have access to recently developed drugs, medical devices, and procedures.

Professor Meir Perez Pugatch – One of our recent researches: Quantifying the Economic Gains of Strengthening India’s Clinical Research Policy Environment has found that by improving its clinical research policy environment to roughly the median level of international best practices, India could increase the number of new clinical trials per year to above 800 and add over ` 600 million in direct monetary transfers and indirect economic gains, with more than 50 per cent of which directed at hospitals, related services and patients. This may be regarded as a conservative estimate. It is possible India could experience even higher levels of investment and economic gains.

What kind of investment is required by India to foster innovation in life sciences?

Professor Meir Perez Pugatch – Essentially, the life sciences and biopharma sector relies equally on public and private investments. India, under the Modi administration, has pushed several government initiatives and policy reforms focused on the life sciences sector which may prove very useful in improving its output.

Looking at the analysis of India’s biopharma ecosystem in the Biopharmaceutical Investment & Competitiveness (BCI) Survey of 2015, the major areas of investment, crucial to foster innovation in India, are its IP regime which suffers from overall ineffectiveness.

With the global markets slowing down currently, do you think that this phenomenon would negatively impact research related to life sciences and the bio-pharmaceutical sector globally?

Mike May – Data in Scientific American Worldview indicate an increase in market capitalisation for public biotechnology companies in many countries over the past two years, and that should actually drive more research.

Professor Meir Perez Pugatch – Naturally, some impact as a ripple-effect can be expected, though to minimal extent. The life sciences and biopharma sector is of the most innovative sectors across all industries, with some 15 per cent of revenues invested in future R&D according to some estimates. While global markets ‘slow-down’ slight decrease FDI inflows and some shifting and reordering of strategies may take place, history suggests that this sector is less sensitive and vulnerable to market trends.

Give us five trends that the world should look for in 2016 where life sciences and the bio-pharma sector is concerned?

Professor Meir Perez Pugatch

Biosimilars: With the impending patent loss of a growing number of biological drugs, the need to address the many issues of biosimilars – e.g. naming, interchange ability, quality assurance and many more – become more pressing. Of equal importance is generic manufacturers’ ability to manufacture biosimilars while maintaining all their properties, a requirement which necessitate much more stringent requirements and modern equipment.

Potential shift in the P&R schemes: The high cost of some innovative treatments had elevated discussions regarding the current pricing and reimbursement schemes, and the potential of new directions which are based on risk-sharing and pay-for-outcome schemes.

Strengthened dialogue between industry and regulators: There is a growing recognition within drug manufacturers and drug regulators alike of the benefits in engaging in collaborative discussions, which may develop into a new, more productive ‘partnership’ between drug regulators and drug manufacturers which maintain international standards.

Healthy ageing: Innovative treatments targeting elderly-specific diseases such as Alzheimer and dementia have long been in the pipeline, yet failure rate was high. As around the world population is rapidly ageing, more effort is directed toward this field, with some result possible in the near future.

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