Article: Enabling_Policies_to Boost_High_End_R_and_D_in_India
How can India become a hub of pharmaceutical research and development, elaborates Dilip Surana, Chairman & Managing Director, Micro Labs
India currently enjoys a formidable reputation in the global pharmaceutical industry. It is one of the technologically strongest, self-reliant emerging hubs of manufacturing Active Pharmaceutical Ingredients (APIs) and formulations. Many of the Indian companies have attained a global status with their world class, high quality generic drugs. Some have even acquired overseas companies and have graduated to scaling up and rapid capacity expansion. In fact India now is the largest exporter of generic drugs, among other regulated markets.
With over 500 US Food and Drug Administration (FDA) approvals and a number of plants with multiple approvals from regulatory authorities in Canada, Australia, Germany and South Africa, the pharmaceutical industry of India has firmly established its multi-faceted expertise.
But “is India becoming a hub of pharmaceutical Research & Development?” a question that is often asked.
If not in the global stage, is India perceived as a force to reckon with among the BRICS nations?
The answer is that India probably compares well with Brazil and South Africa, but is behind Russia and China in terms of investments and productivity.
There are discernible signs though of India being on its way up in the R&D value chain. From lower-end R&D, India is advancing towards high-end research areas such as bio- informatics, biotechnology, biosimilars and generic biologics.
The R&D era which started in 2005, with the introduction of Product Patent regime, has gathered momentum and has now reached a stage where India has registered over 3500 international patents during 2013–15. This number though small compared to the number of patents registered by countries like US and China, compares favorably with the global trend in terms of growth according to Francis Gurry, WIPO’s director general.
This momentum is likely to gain further strength in view of two trends –
1. Global players are seriously considering R&D offshoring and outsourcing partnership with India due to rising costs and decreasing productivity in their homelands.
2. China is no longer attractive, again due to rising wages and overall operating costs.
Besides, India has its own advantage of a large talent pool: over 3 million postgraduates coming out every year from various streams, pure science and medicine. India’s venerable IT sector and BPO expertise provide a strong platform in clinical data management and pre-clinical research.
Add the fact that India’s wages are still low. This country offers itself as an attractive destination for R&D initiatives of most of the global companies.
Another significant fillip is given by the Government of India in the important “Pharma Vision 2020” document. Prepared by the Department of Pharmaceuticals, it spells out the country’s strategic intent emphatically.
The document provides a road map for making India one of the leading destinations for end-to-end drug discovery and innovations. Through this the government aims to provide support by way of world class infrastructure, internationally competitive scientific manpower for pharma R&D and venture fund for research in the public and private domains.
Further, the Government is embarking on a major multi-billion dollar initiative with 50 percent public funding through a public private partnership (PPP) model to harness India’s innovations capability. The vision is to catapult India into one of the top 5 pharmaceutical innovation hubs by 2020, and target to achieve a global niche with one out of every five to ten drugs discovered worldwide by 2020 originating from India.
The Government has also been taking various policy initiatives for the pharmaceutical sector. These include tax breaks to the pharmaceutical sector and weighted tax deduction at 150% from the R&D expenditure incurred. Steps have also been taken to streamline procedures covering development of new drug molecules, clinical research etc. The Indian government has launched two schemes – New Millennium Indian Technology Leadership initiative and the Drugs and Pharmaceutical Research Programme – specially targeted at drugs and pharmaceutical research.
India’s strengths, combined with the policy thrust by the government augurs well for the country to emerge as a major player in the conventional R&D. This coupled with the fact that India’s vast population, and a heterogeneous patients’ base suffering from myriad diseases raises hopes of India becoming a hot-bed of R&D.
However when it comes to higher end R&D, the road seems to be longer for India in spite of the strides it has made in the emerging fields such as Biotech and Biosimilars, Bio informatics, Stem cell research and Biomedical devices. This is due to certain inherent weaknesses such as inadequate infrastructure, low percentage of capable science graduates who can take up higher end R&D challenges, and the road blocks created by regulatory environment restricting or delaying clinical trials.
In the spheres of Biotech and Biosimilars, private sector companies have made great beginnings and are growing rapidly. Good strides have been made in the area of immunotherapy, vaccines, recombinant DNA technologies, bioprocesses, fermentation based bio-molecules and enzymes, as well as in novel drug delivery techniques and in pharmacogenomics.
The Government too is playing a supportive role in giving a boost to this sector by:
1. Launching the Biotechnology Industry Partnership Programme (BIPP) by the Department of Biotechnology
2. Drafting the Biotechnology Regulatory Act
These steps will stimulate technology research programmes that focus on transformational as well as translational research and development.
Such initiatives as already outlined, have created the developmental and manufacturing capabilities of many biosimilars such as erythropoietin, GCSF and interferon Alpha 2b, plus a number of monoclonal antibiotics, tyrosine kinas inhibitors as well as TNFAlpha inhibitors.
The inherent risks involved in biosimilars and biotechnology products however are the concerns with regards to registrations. These registrations need vast data generation, pre-clinical and clinical studies and, have come in the way of an explosive growth in R&D efforts in this regard, as compared to conventional R&D projects.
Further funding support from the Government will be critical in ensuring continued growth especially during incubation, and of early stage ventures.
Besides, the Indian pharma industry requires a concerted and coordinated collaboration with government, academia and investors.
As emerged in one of the panel discussions during the recently held Pharma India 2016 event “We fragment our academia based on disciplines. We are not building large centres of excellence, so there is not enough critical mass of talent”.
One of the premier institutes, the National Institute for Pharmaceutical Education and Research (NIPER) has already moved in this direction by signing agreements with private sector, aims to accelerate translation of research into development, and is set to become the provider of talent pool, at par with international talents.
Stem cell research in India is moving forward too at a rapid pace because of the combined efforts of universities, hospitals and major research institutes such as CCMB (Centre for Cellular and Molecular Biology), National Centre for Biological Science, National Centres for Cell Sciences and Brain Research.
Here too, while there has been a rapid progress, tangible Government funding is far lower as compared to countries such as the US. Besides, substantial efforts are called for to ease out regulatory road blocks and provide clarity on ethical and moral issues.
Innovations in medical devices and diagnostics offer another opportunity area. India’s low cost advantage can open up many vistas that will encourage preventive healthcare, and enable early and cost effective treatment. This benefit extends beyond domestic market, to emerging global markets.
Since the industry itself is in nascent stage, regulatory and licensing formalities are still required.
As stated by PricewaterhouseCoopers, India’s growing economy coupled with its changing “Epidemiological Profile”, makes it a strong candidate to become a future powerhouse of R&D.
Indian Government’s growing interest in making India a hub of pharmaceutical innovations, coupled with the vibrant industry, IT expertise and availability of large pool of skilled scientists are positive signs for the future of Pharmaceutical Research and Development.
Government policymakers, and all stake holders – industry, academia and investors should however intensify their collaborative efforts which can take India’s R&D capabilities to newer heights.
Infrastructure, availability of world-class talent pool, easing of compulsory licensing and price controls are the major enablers for India to compete globally in the high-end research & development initiatives.
The opinions expressed in this article are the author’s own.