Indian and global pharma companies are increasingly looking at collaborative research efforts to drive the drug pipeline. Partnerships like Biocon and Bristol-Myers Squibb (BMS) in the early development of oral insulin Tregopil is a case in point. Recently Lupin’s acquisition of the US-based Gavis Pharma has broadened its research pipeline in generics.
With the Union government reducing the benefits of deductions for research from 150 per cent to 100 per cent from April 1, 2020, the pharma and biotech industry in the country feel that it could impact the funding for research.
Now the government is keen to work with the pharma and biotech industry and make suitable amendments in policies to spur research and ensure a more fuller utilization of the country’s scientific manpower, according to Minister of State for Chemicals and Fertilisers, Hansraj Gangaram Ahir.
The US$30 billion Indian pharmaceuticals industry is the world’s third biggest market by volume with a Compound Annual Growth Rate (CAGR) of 15 per cent over the last five years. It is expected to attain a market size of US$ 50 billion by 2020.
R&D , key driver of growth
R&D is the key driver to growth which enables corporations to achieve core competency and derive economies-of-scale to globalize their operations. Indian companies have started recognizing the importance of R&D and have started spending anything between two per cent and four per cent of their sales for the same. But now the Union Budget 2016 announcement to lower tax benefits on research and development comes as a dampener, opine experts.
Several global drug majors are keen to collaborate with Indian pharma in many areas of research. The scientific acumen and substantial efforts in R&D have led many countries also to ink memorandum of understandings (MoUs) to boost bilateral scientific and technological cooperation and enhance collaboration between the scientists of these nations.
In 2015 it was Scottish Development International, the international arm of Scottish Enterprise, which inked two strategic tie-ups. These included agreements between University of Dundee & Bangalore BioCluster and Scottish Association for Marine Science with Annamalai University & AMET University, respectively, for research in Life Sciences and Marine Biotechnology.
Collaborative projects
The collaborative project partnerships would address India’s critical needs in health, life sciences and biotechnology, said Prof. CNR Rao, National Research Professor Linus Pauling Research Professor & Honorary President Jawaharlal Nehru Centre for Advanced Scientific and chairperson Vision group on Nanotechnology in Karnataka.
Indian researchers cannot be ignored by the western world as we are a critical component of innovation in the global market, said Prof. Rao.
Advanced technologies like high throughput screening, liquid chromatography system allows operators, scientists and laboratory managers to reach new levels of laboratory efficiency. Specifically HTS can accelerate the speed at which compounds can be tested. Another area of investment by R&D centres of pharma and biotech companies is e: R&D which helps to reduce the cost of pre-clinical studies, said KV Venugopalan, president, Waters India.
Pharma companies have also said that investment in technology has transformed the early part of pharmaceutical research and development process. The introduction of e: R&D has enabled use of in-silico technologies to speed up the selection process of drug candidates and increase the overall chances of success.
In order to give a fillip to research and development, Karnataka government is setting up a Centre for Nano and Soft Matter Sciences (CeNS) at Tumkur which will be a Centre of Excellence for nano science, research and development. The establishment of CeNS can have companies using nanotechnology to develop solutions for water purification, drug delivery and healthcare diagnostics. Although the Union government under the Nano Mission funded around Rs.100 crore in 2014 for which the state government provided 14 acres in Tumkuru district, the facility is yet to come up. CeNS will house the Indian Institute of Nano Science & Technology, Nano Incubation Centre supported with the related infrastructure including common facilities.
Phytopharma R&D
Indian pharma industry should look at accelerating its research in new drug development focusing on phytopharmaceuticals. The country has already put in place regulations. As of now 500 investigational new drug applications for botanicals are under review with the USFDA, said Dr. DB Anantha Narayana, member, Indian Pharmacopoeia Commission.
The pharma scientists in the country involved in innovation work in silos without exposure to aspects of regulatory, environmental and entrepreneurial climate that impact their work. It is high time the pharma industry looks at the potential of phytopharmaceuticals. This is where we see the need for working knowledge of regulatory aspects as an essential factor for Indian pharma scientists to successfully develop a drug, he added.
Absence of a dedicated provision in drug regulations to promote innovation in botanical drugs hindered innovation. Many attempts to get such regulations modified did not succeed in India. It was the USFDA which took the lead and announced a guidance to the industry for botanical drugs in 2004 giving the data guidelines.
“If USFDA is looking at as many as 500 applications of this botanical drug category, then Indian pharma industry and its researchers should take advantage and lead the effort. A number of chronic ailments, orphan drug and non-communicable diseases exist where unmet needs of patients offer opportunities for drug development. New drug development has originated in botanicals. It is a known fact that as much as 60 per cent of the new chemical entities have their origin in a lead compound coming from botanicals. For instance Ephedrine, Reserpine, Vincristine and Paclitaxel are just a few notable lead compounds successfully developed from a naturally occurring compound. The traditional knowledge in India along with botanicals from western nations and traditional Chinese medicines offer a plethora of leads, said Dr. Narayana.
“Our country has the unique distinction of vastly documented evidence of such information on drugs in ayurveda accessed from Charak Samitha, Shushrut Samita, Ashtanga Hridaya, Madhava Nidana, Bhava Prakash Nighanttu. These authoritative texts have information on a large number of medicinal plants with therapeutic activity. It was the Central Drug Research Institute (CDRI) which scientifically evaluated many such herbs to assess the product development viability. It took 11 years before Gulgulu tablets were approved as a lipid lowering agent by the DCGI. Today, we do not see Guglip tablets in the market due to sustainability issues for Gulgulu resin as raw material and development of statins which showed better activity than Guglip. Other botanicals listed in the innovation category are Arteether, a compound isolated from Artemisia to treat malaria, Memory Plus, a Brahmi plant extract and Colforesin, an extract from Coleus forskholli used as bronchodilator and to reduce intra ocular pressure in glaucoma. Therefore, it is high time for India now to undertake researches on phytopharmaceuticals, said Dr. Narayana.
Programmes for startups
Centre for Cellular and Molecular Platform (C-CAMP), an initiative by the Department of Biotechnology, government of India is now supporting IIM Ahmedabad’s technology business incubator, Centre for Innovation Incubation and Entrepreneurship (CIIE) which has launched its Healthcare Accelerator 2016 in partnership with The Dasra Girl Alliance.
The three-month long programme is being launched as a part of CIIE’s Bharat Innovation Fund and is backed by C-CAMP and InnoVen Capital. The programme aims to identify potential startups that are embarking on breakthrough routes towards healthcare industry’s advancements, particularly in the areas of medical devices, healthcare IT, and biotech.
According to Salim J. Vali, Vice President (Investments), CIIE there is a wide gap between demand and availability of quality healthcare services and innovative entrepreneurship models will play a key role in realizing quality healthcare for all.
The startups that are trying to fill in the gaps of India’s healthcare industry face stark conditions. At early stages, the startups encounter the critical and inhibiting risks of scarce capital and non-availability of intensive mentoring. This Healthcare Accelerator endeavours to create a positive environment for the start-ups and consequently empower the surrounding ecosystem.
The accelerator programme will offer mentoring and individualized guidance through its program mentors who are industry experts. The programme mentors include eminent experts like Prof. K. V. Ramani and Prof. Piyush Sinha of IIM Ahmedabad.
“Our portfolio of startups with their disruptive enterprise models are bringing equitable healthcare in India. For instance, Forus Health, a CIIE supported enterprise, with its low cost ophthalmic screening device has touched more than a million eyes in rural India and has a potential to prevent 29 million cases of preventive blindness. Our healthcare accelerator is an initiative to provide a platform to nurture such startups,” said Vali.
Azooka Life Sciences, a specialty fluorescent dye company with focus on bringing safe fluorescent stains for application in biological sciences and genomics is now ready with a patent pending food grade nucleic acid gel stain. Known as tinto rang, the nucleic acid gel stain is developed from a plant source. The company claims that it is the safest and fastest stain in the world market. It is seed funded and incubated by the Society for Innovation and Development, Indian Institute of Science, Bengaluru.
“Our focus is to develop safe DNA/RNA fluorescent stains for applications in biological sciences and genomics. tinto rang is the first ever food grade nucleic acid gel stain making it the safest option currently available in the world” said Dr. J Fathima Benazir, co-founder and CEO, azooka life sciences.
According to a Deloitte report, pharma and biotech companies are facing challenges in research and increased competitive pressure. This makes the sector look at ‘open innovation’. It enables companies to overcome many research and market place issues by sourcing innovative ideas and technologies. The industry can exploit complimentary resources and leverage capabilities through collaborations, co-development and joint ventures.