For 75 years, even before India attained independence, the Council of Scientific and Industrial Research (CSIR) carried out research and innovation through its chain of laboratories (labs) in India and has made significant contributions to the national economy. Upholding the CSIR point of view and approach will allow science and technology to serve society more effectively and provide investment opportunities for business.
CSIR Contributions: A Brief History
Since the 1950s, CSIR has contributed effectively whenever there was a challenge that science could address, contributing to the national cause. For instance, during the early phases after independence due to foreign exchange limitations, we needed technologies that could give India an edge through import substitution. There were several technological innovations made then that still have a great relevance as export products, such as the indelible ink that is still used in Indian elections. Another instance is that of the first Indian milk-based baby food from buffalo milk, a seemingly small yet a major contribution economically and socially. Similarly, India’s first indigenous tractor was designed by a CSIR lab.
In the 1970s, a major thrust was provided to Indian drugs manufacturers through the availability of pharmaceutical process patents. This has enabled India to become a major generic drugs producer in the world. Thus, through its concerted contributions in affordable health, chemicals and pesticides, farm sector etc., CSIR labs were able to create innovative solutions to national problems that earlier required imports at a heavy cost to our fledgeling economy.
In the 1970s, a major thrust was provided to Indian drugs manufacturers through the availability of pharmaceutical process patents. This has enabled India to become a major generic drugs producer in the world.
For several years, as mentioned above, many opportunities came up for smarter process development to obtain process patents for low-cost advantages, mainly for entities that were not IPR protected. The Patents Act 1970, which gave a lot of freedom for Indian companies to “bypass” the international patent regime was, by and large, immensely good for India. It benefited other poor countries as well, but it was not necessarily received very well internationally as it worked against the patentee companies in the western countries. After the General Agreement on Tariffs and Trade (GATT), World Trade Organisation (WTO), and the other global changes that came in the 1990s, all these arrangements came under stress.
As we moved into the 1990s, the challenge was to get a foothold within the great Globalisation Game through industrial production of innovative products and services, preferably backed by our own patents and copyrights. At the time, even primary awareness of these challenges and opportunities needed to be engendered. CSIR pioneered a national awareness movement on Intellectual Property and within a few years, it became the number-one patent holder amongst all Indian R&D organisations.1
Some of the early post liberalisation battles that CSIR very visibly fought in the international arena were centred around protecting Indian intellectual property rights (IPR), especially those originating from traditional knowledge. For instance, CSIR created IPR for the beneficial effects of spices such as turmeric, medicinal plants such as neem and other therapeutic plants. CSIR also set up a traditional knowledge database to constantly monitor infringements of Indian traditional innovation. Many countries in Africa and across Asia which have a rich base of traditional knowledge in various arenas were sensitised to the fact that traditional knowledge could be utilised in a responsible manner with due credit given to the societies of origin. Of course, it is also incumbent upon countries such as India and China to use their traditional medicinal knowledge for the masses.
Many decades of capability-building and advanced scientific research have enabled CSIR to occupy the upstream end of innovation with high-quality international publications and awards for international patents. But how do we efficiently commercialise all this scientific wealth for the benefit of our masses and for exports? The current challenge is not the early stage of the innovation process, but the ‘downstream’ steps of successful commercialisation and adoption- i.e., taking innovation from lab to market.
How do we efficiently commercialise all this scientific wealth for the benefit of our masses and for exports? The current challenge is not the early stage of the innovation process, but the ‘downstream’ steps of successful commercialisation and adoption- i.e., taking innovation from lab to market.
From Lab to Market
Over time, labs in CSIR successfully handled aerospace, biotechnology, defence/strategic sector needs, as well as pharmaceuticals. Indeed, historically, much of the innovation in cost-effective processes useful to industry, particularly to the generic pharma industry, are results of R&D from CSIR laboratories. The opportunity today for CSIR is to link with the industry and transform its process development capabilities by using cutting edge technology in product development.
The ‘downstream’ stage of converting innovation into products requires a synergy not only with industry, but also requires a huge amount of investment in the early stage of innovation i.e. post-laboratory basic work. Central to this is also the requirement of a change in the mindset of the scientists themselves. In the last two or three years, the focus of CSIR has not only been on start-ups and spin-offs from our laboratories, but also on creating synergy to convert the ‘patent mass’ and knowledge base into high-class products and services of use to the industry.
The opportunity today for CSIR is to link with the industry and transform its process development capabilities by using cutting edge technology in product development.
How does one begin to do that? Incidentally, a lot of our patent wealth comes from a solid base of fundamental and target oriented-science. CSIR is in the 75th position among the top R&D organisations in the world today (and 9th among 1200 world R&D organisations in the Public Sector space globally).2 The achievement must be seen not only in terms of high-quality publications and patents, but also in terms of technological visibility and contributions centred on industry and public sector space. Despite this great progress, a challenge remaining to be overcome is utilising the rich knowledge base of National R&D labs into products and services on scales commensurate with our national needs.
An example of such a success is the CSIR Lucknow and AIML drugs Ltd. collaboration which launched a traditional-knowledge based medicine two years ago. This product is an extract of 6 herbal medicines and is very effective to fight Type II Diabetes. Market inputs and clinical studies show that it turns out to be a blockbuster and it is competing with some of the best modern drugs like Metformin. The labs are currently doing a double-blind clinical trial, the results of which will be out soon. The limited clinical trials according to the so-called AYUSH route that were done three years ago also showed marked benefits to patients. This is an example that one needs to emulate to get scientifically validated products from traditional knowledge.
Another very recent contribution from CSIR in collaboration with the Department of Biotechnology is the development of microbial blight resistant, diabetic friendly, low glycemic rice strains. Their production is already deployed across several lakh hectares in Andhra Pradesh. In the area of medicinal and aromatic plants, similarly, new varieties have been developed and given to the farmers for cultivation.
This shows clearly that our CSIR national laboratories are fundamentally fit to do the early part of the value chain research which involves generating knowledge, filing valuable patents, creating prototypes and demonstration of early stage technology. This is no mean achievement. In recent times, there is a sort of clamour in reaching a stage where support for so-called frugal innovation, including ‘jugaad innovation,’ can be realised. Although such slogans are attractive, half-baked and ’miracle’ technologies are not very easy to take to the market. Even if they reach the market, they do not survive. To ensure quality in the long run and establish trustworthy brands both nationally and internationally, one needs a synergy between the national labs, innovators and downstream processes that engender the investment, care and convergence required to take these technologies to market in successful business models. Successive rounds of investments (both private and public) will help reap the full benefits of our scientific efforts and capability.
To ensure quality in the long run and establish trustworthy brands both nationally and internationally, one needs a synergy between the national labs, innovators and downstream processes that engender the investment, care and convergence required to take these technologies to market in successful business models.
This is indeed the widest gap that we see today on the R&D horizon. It requires not only focused attention from scientists, technocrats and policy makers but also rather large investments. When China decided to cultivate and build up the tech-to-market value chain, especially the downstream steps, it put in huge amounts of investment. In India, we are depending more on the private sector now to fill the gap. Thankfully, the private sector is willing to bet on reliable technologies and innovations. For that, our national labs and its scientific teams need to develop high credibility. Wherever that has happened, such as in the pharmaceuticals arena, the private sector has put in a lot of interest and investment. And the results are there for all to behold!
There has been an effort to realign and reorient the CSIR labs, and hopefully other national labs, into a model where the facilities, the personnel and the knowledge base synergises around technological development. The effort helps to maximise the returns on the national investment, and to not leave our IPR unutilised. In the last couple of years, CSIR has focussed intensively on developing dependable and tested technologies that will have a high probability to succeed in the hands of the industrial risk-taker. At the same time, CSIR has become acutely aware that the convergence of the national labs and the large amount of investment that the nation has put into it over decades, has to be made available to the innovators looking for support to create successful outcomes from small-scale industrial units.
It is well known that when one takes a new technology with long term nurturing, such as a new lead molecule in the pharma sector, the ‘downstream’ processes sometimes requires orders of magnitude of the initial R&D investment than that which goes into the early ideation and Proof of Concept (PoC) stages. Now, this is a dilemma and a challenge that needs to be addressed seriously. A lot of focus has been put into early stage innovation in the past years, which is very good. But it requires more inputs at the early stages where technological outcomes interface with the industry. Fortunately, serious academicians- people who have in the past been focused on publication-oriented knowledge generation – have begun participating in and contributing to the tech-to-market process.
From Tech to Market: the Indian Pharma Industry Case
CSIR now has a portfolio of about 3000 patents and is actively auditing and sharpening them to convert this knowledge base into useful technologies. To cite an example, a generic product like Hepatitis B vaccine and Streptokinase (an affordable clot buster) were taken up and commercialised to create great socio-economic benefits. The initial smart process oriented generic technology developed for Natural and Recombinant versions of Streptokinase by a CSIR laboratory (CSIR-IMTECH) was transformed into smarter internationally competitive clot busters which were licensed out in high-value deals. Therefore, building up on a knowledge base from process development to product development with high IPR value, and thereby creating globally competitive products, is the new game that CSIR focuses on, today.
We see a synergy where young students in the colleges like the IITs and even in regional engineering colleges are turning their attention to the potential of riding the innovation wave. But, how do you fill that gap where the innovation, once standardised and shown as a PoC, is taken to the market? That chasm is very big and we need to focus on filling that, more so in the non-IT technological arena. This is a task that remains to be encouraged and fostered to create the value from our science and patents knowledge base of the last several decades.
We see a synergy where young students in the colleges like the IITs and even in regional engineering colleges are turning their attention to the potential of riding the innovation wave.
Be that as it may, the Indian pharma industry has grown up to be one of the best in the world with a lot of money to invest. It is remarkable that a new mindset change is slowly coming about. But the regulatory regime of taking new drug molecules, the risk involved and indeed the whole philosophy of taking big risks by Indian companies is somewhat low. Although there is a positive change that is coming about, albeit slowly.
What is the role that R&D experts in the laboratories can take on in the changed scenario? They should continue to generate early stage breakthroughs which in turn generate a whole pipeline of prospective new lead molecules, which has also been a great challenge so far. Not because of the international weakness, but because the focus of the scientific intellects has been towards early stage discovery and enough attention has not been put in downstream, close-to-the-market steps.
The fact that this scenario is changing is laudable. But early-stage handholding and a few good success stories are required, as success begets more success. Our success in bio-generics came almost after two decades of hard work, collaboration between industries, academia and R&D labs and the appropriate regulatory and policy guidelines in place. Even here, there is great potential for national labs in partnering with their ground state innovation at the pre-commercialisation stage with the other stakeholders down the line.
Innovations funds and support systems like the Biotechnology Industry Research Assistance Council (BIRAC) have been doing a good job for spin-offs. Hence, one lesson is that if one takes selected technologies with promise, whether from the so called ‘frugal’ space or the relatively new IPR from the national labs, through an intensive merit peer-reviewed process, it could become a model with great societal value. The peer-review process must allow industry participation and optimal utilisation of publicly supported technology development platforms.
It needs to be said that even if one involves industry with attractive patent portfolios, the credibility factor of the scientific group still comes into their decision-making. Today, our industry would much rather take up a ready to use B-class technology from abroad for, say, an electric auto mobile. But for pharma one would need very high levels of innovation which needs to be nurtured for at least 5 to 7 years before one is pretty sure that the risk associated with it is substantively decreased. Who is going to invest in that? There is, therefore, a great opportunity for national labs to align all the required ‘unit operations’ from the patenting stage onwards as well and not just stopping at the patenting stage. There is also a great challenge for the drugs regulatory system to fast-track such national innovation projects. It is, indeed, possible to develop world class pharma products through smart alignment at much reduced costs than what is currently required in the West.
Building CSIR’s Value
What are the platforms needed to build these support systems? CSIR has just begun an innovation fund of about Rs 400 crores with their own external earnings. CSIR has decided that half of this innovation fund will focus onto society-oriented technology development, particularly the downstream steps, where venture capital is not easily available, and the industry is not ready to put in investments at an early stage.
This is very important in generating the ‘proof of the pudding’. If national labs and organisations like the Honey Bee network, which are grounded well with the grassroots innovators, allow the industry to get a ringside view and offer viable licensing options, that would actually lead to businesses paying attention and participating. Industry would want to invest where there is a risk minimisation.
CSIR has decided that half of this innovation fund will focus onto society-oriented technology development, particularly the downstream steps, where venture capital is not easily available, and the industry is not ready to put in investments at an early stage.
CSIR has been creating in its history tremendous value for India. A few years ago, we conducted an economic value estimation of six CSIR technologies including the Streptokinase clot busters, affordable water filters, vitrified tiles and indigenous tractors which were successful commercial technologies in the last two decades. The total societal contribution in economic value terms of these six technologies, according to 2011-2012 figures, was upwards of Rs 30,000 crores! This finding indicates that societal value– not necessarily the value produced through the commercial royalty channel but created out of technologies and their societal impact– is a major national contribution. So, when we talk about patents and technologies coming out of national laboratories, we need to focus on their role in nation building and evaluate their societal contribution as opposed to merely the monetary value created for the industry.
Edited by Ram Mohan Chitta