Pulse

To get India’s clinical research sector live and kicking, again

RACHEL CHU MEIR PEREZ PUGATCH | Updated on January 16, 2018

Clinical reserch in India needs a booster dose

MEIR PEREZ PUGATCH

RACHEL CHU

If India is to realise its potential, it needs a stable regulatory environment of international standards

Five years ago India was on track to becoming a global leader in clinical research. Its strong foundation in manufacturing and contract research, large and relatively low-cost market, and a diverse population attracted trial sponsors from near and far. But in 2013, this burgeoning sector was brought to a near standstill with a disruptive overhaul of the clinical research regulatory framework.

Onerous trial approval procedures out of sync with international standards as well as ambiguous rules for trial-related injuries compounded existing gaps in quality control, creating highly burdensome and unpredictable conditions. Between 2013 and 2015, the volume of clinical trials conducted in India plummeted by half (some put it as high as 90 per cent) squeezing availability of new, life-saving treatments and prompting capital flight from this research sector.

Today, India still punches below its weight in clinical research, experiencing only around a tenth of the average rate of clinical trial activity among the remaining BRIC (Brazil,Russia, India, China) economies (when standardised by population). India’s extremely low clinical trial activity directly affects its share in the global distribution of biopharmaceutical research and development (R&D) directed foreign direct investment.

Predictable environment

India’s experience over the past five years is a poignant case for the importance of a robust and predictable environment for biomedical R&D. And this will play a significant role in catching the attention of biomedical innovators as they decide where to invest.

Indeed, in the Biopharmaceutical Competitiveness and Investment (BCI) Survey, an executive opinion survey that rates countries’ attractiveness for biomedical investment, a stable regulatory framework aligned with international standards and conditions that support innovation across the board are what characterise the most competitive economies worldwide, large or small. For its part, while India performs on a par with other emerging markets in terms of its overall biomedical competitiveness it could, and should, be much stronger.

To its credit, the Government has recognised this and already begun taking concrete steps to clarify rules, raise standards and create a more balanced system for governing clinical research. These include easing processing of trial applications and closing certain loopholes in quality control. However, other, crucial aspects remain largely unaddressed in terms of bringing the review system and quality parameters for trial and manufacturing sites in line with global standards.

Empirical data suggest that these and related policy reforms are a worthwhile endeavour for India. A number of studies show that improvements to the policy environment and addressing outstanding concerns could result in considerable gains across the Indian public health system and economy — both in the short and long term.

Big gains ahead

Our own modelling estimates that even small advances in the above areas could increase India’s number of new clinical trials per year to above 800 and add over $600 million in direct monetary transfers and indirect economic gains. These transfers first translate into greater early access to cutting-edge medical therapies (which may be patients’ last resort for treatment), improvements to hospital infrastructure and training for healthcare professionals, as well as savings on high-cost drugs.

They also entail greater investment from multinational biopharmaceutical companies, which could include sponsoring the most advanced early phase trials (a particular area for growth in India), and a boon for the local clinical research industry.

The conditions are ripe for a revival of clinical research in India — and the important benefits for patients and the wider economy that come with it. The onus is now on policymakers to go the distance to deliver a comprehensive reform, dedicate a consistent flow of resources and ensure implementation on the ground.

Rachel Chu is Partner, Pugatch Consilium; Meir Pugatch is Professor (intellectual property, innovation and entrepreneurship), University of Maastricht and Managing Director, Pugatch Consilium. Views expressed are personal

Published on December 23, 2016

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