India is fast emerging as a major force in the global pharma research and development (R&D) landscape.
A considerably large talent pool across diverse areas of science, technology and management, along with robust academic and research infrastructure and a progressive policy environment is spurring a lot of basic and industrial R&D activity in the country and increasingly making it a top choice among global corporations for off-shoring their R&D needs, said Dr. A Didar Singh Secretary General Federation of Indian Chambers of Commerce and Industry (Ficci) in a recent report.
According to Prof. Eric S Lander, one of the principal leaders of the Human Genome Project, who was in India recently for a series of lectures, “Advances in genetic research pave the way for latest therapy options for cancer and psychiatry health particularly schizophrenia . The big setback in genetic research globally came in with the slashing of grants to the tune of 25 per cent for National Institute for Health, USA. This stalled the pace of development. But the positive outcome was the scientific talent which led to development of research with the existing human genome data. India has a huge scientific talent which is being maximized by the pharma global bio pharma majors in the US. The country now needs to gear up because the allocation for research and development is not growing and stagnated at 0.8 per cent of the GDP as compared to the US which is 2.8 per cent and China is 1.8 per cent."
India is slowly gaining recognition as a preferred destination for research and creation of intellectual property. Indian pharmaceutical companies have been investing a considerable part of their total revenue in R&D projects to stay ahead of the competition. Statistics show that investments in R&D in India have grown from Rs 347 crore (US $52.5 million) in 2000 to Rs 4,276 crore (US $646.5 million) in 2010. Out of this, domestic companies account for nearly 80 per cent, while the remaining 20 per cent investment comes from foreign companies. It is the result of pharma outsourcing to the Indian market that the pharmaceutical sector has grown at a CAGR of 62 per cent over an eight-year period., said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd and Director, Research, Venus Medicine Research Centre.
R&D is the key to survival because the business world runs on the survival of the fittest theory. In a rising cut-throat competitive environment with ever-rising pressure on margins of generic products, a shift to research is the only option to keep up the growth momentum. However, the current regulatory framework is a matter of concern for a majority of the Indian pharma companies.
Besides, slowdown in clinical R&D and patent processes and delayed regulatory approvals are forcing many Indian pharma companies to think of shifting their operations to South-East Asia. The government must create a healthy environment for research, especially with respect to funding by venture capitalists, private equities etc. It should encourage industry-academia collaboration in low-cost research. This will not only bring the industry and academia closer, but will also result in the creation of an efficient talent pool and give a fillip to low-cost research, which will ultimately benefit the industry, she added.
The big research discoveries
Indian Institute of Science (IISc) has now developed a novel shock wave induced drug delivery patch that will replace the painful injections and stall needle stick injuries. The patch developed with hydro collide material is designed to hold on active molecules like vaccines, insulin and antibiotics. The pre-clinical studies are complete and now the institute is set to scout for bio pharma industry partners to take the research to human trials and technology transfer for commercialization thereafter.
The research is carried by IISc’s departments of aerospace engineering and the department of microbiology and cell biology. A number of methodologies to generate shock waves of requisite strength have been designed and indigenously built in the Laboratory for Hypersonic and Shockwave Research (LHSR) in IISc.
“This is an unusual kind of experiment with shock waves which is commonly associated with aerospace engineering. In fact, shock waves appear in nature, whenever different elements in a fluid, approach one another with a velocity larger than the local speed of sound. LHSR is among the best in the world and there are only seven countries globally that have such a facility. There are 35 PhDs working on varied technologies and drug delivery device is one such research. Utilizing shock waves to increase the pressure and temperature in a propagating medium, enabled the development of shock wave assisted non-intrusive needle-less drug delivery system, gene gun, cell transformation device at our lab, said Dr. Gopalan Jagadeesh, chairman, centre for excellence, Hypersonics and Professor, department of Aerospace Engineering.
“We understand enough about shock waves. Now this needle - free drug delivery device for vaccines and other injectable drugs is a land mark discover. The technology is patented in the US and India,” he added.
The effectiveness of shock wave technologies, can be a non-invasive treatment modality for diabetic foot wounds and vaccine delivery among others. The drug delivery is targeted and accurate into the Langerhans cells which are present in all layers of the epidermis, making it cost- effective, he said.
Dr. Jagadeesh is also the Founder Director of Super-Wave Technology Pvt. Ltd., an initiative with equity participation from IISc to commercialize his discoveries related to industrial applications of shock waves. "Now it becomes very easy to ink pacts with the bio pharma industry to upscale this technology finding. There is also an Ethics Committee within the IIsc to co-ordinate once an bio-pharma industry partner is identified", he said.
Another big advantage of the shock wave induced drug delivery is the positive outcome of both in-vivo and in-vitro studies which provides ample indication that we are on the right track, said Dr. Jagadeesh.
According to Dr. Dipshikha Chakravorthy, associate professor, department of microbiology and cell biology, IISc the shock wave induced drug delivery patch is a significant development. With the rise in metabolic disorders like diabetes, this is seen as the way forward to replace injections and draw blood for diagnostic tests.
Indian bio-pharma R&D: Current scene
As compared to the western countries, Indian R&D costs are much lesser , which is an attractive reason for many multi-nationals to outsource projects to the country. The country is a huge source of promising research talent , which is driving contract research efforts. From Syngene a Biocon subsidiary to GVK Bio Sciences and Anthem Biosciences, companies are chipping in their efforts to prove excellence and time line deliveries.
The Indian R&D spend is mostly done by the corporates. Companies like Sun, Ranbaxy, Glenmark, Dr Reddy’s Laboratories, Cadilla, Lupin are among the topmost spenders in R&D. Most large local pharma companies spend anywhere between 3-10 per cent of their revenues on R&D. However, most of the expenditure on research is aimed to help them in their generics business rather than creating new drug molecules, said Prashant Nagre, CEO, Fermenta Biotech Ltd. in an earlier email interaction with Pharmabiz.
The acquisition of Ranbaxy by Sun is seen to be a the most positive for the latter’s abbreviated new drug applications (ANDAs) and first-to-file opportunities, said a pharma analyst.
There is also an alarming trend which is the closure of existing R&D centres . Three R&D centres of multinational companies have been shut down in Karnataka and have been shifted to their global headquarters, thanks largely to the global slowdown, slashing budgets for research and disappearance of blockbuster drugs. The centres are Accelrys, a subsidiary of Pharmacopeia Inc., Actavis and UK’s AstraZeneca Avishkar research and development unit.
While pharma experts view such moves as a serious blow to the Indian research acumen, others opined that partnerships with small research outfits for multinational companies (MNCs) is the future strategy. The key reasons for these shut-downs are global slowdown, slashing budgets for research, disappearance of blockbuster drugs, drying up of the drug pipeline primarily because of shift from treatment to prevention, linear phase of research giving way to out licensing and the emergence of a large potential for R&D outsourcing, said R&D personnel who were earlier employed in MNCs.
Current market dynamics are creating a platform for the emergence of scientist-entrepreneur driven integrated small research. MNCs are viewing the skills and scientific talent available in such small research companies like Connexious Life Sciences or a Gangagen Biotechnologies which are scientist-entrepreneur driven, said corporate heads who did not want to be named.
“There is also a dip in the research investment made by MNCs which does not present a very encouraging picture. These MNCs traditionally have never been large spenders on R&D in India,” said the Fermenta Biotech chief.
Last year, Biocon and the U.S.-based CytoSorbents Corporation expanded the scope of their strategic partnership for CytoSorbents’ CytoSorb cytokine reduction therapy to treat patients experiencing severe whole body inflammation, often called a Systemic Inflammatory Response Syndrome (SIRS). The Indian biotech major partnered with CytoSorbents in 2013 to launch CytoSorb, a ‘first-in-class’ therapy to treat sepsis, the over-active immune response to a serious infection. It has also created a dedicated sales force that is solely focused on promoting CytoSorb across cities in India.
Issues needed to be sorted out
India needs to strengthen its intellectual property regime. The country has witnessed a landmark judgement wherein the Supreme Court quashed the patent permission for cancer drug Gleevac manufactured by the Swiss pharma major Novartis . The outcome has benefited domestic drug manufacturers like Cipla Ltd and Natco Pharma Ltd, which already sell generic Glivec in India at around one-tenth of the price of the branded drug.
In another move , the Indian Patent Office went on to simplify the method of analysing the applications of pharma companies. In November 2014, a clause in the draft rules, mandating the use of generic names of pharmaceutical substances to check whether discovery claims made in a drug patent application were already known or not, has been dropped in the final rules by Indian Patent Office.
“We view this as a positive development. This would not just save time but also make the process of ‘prior art search’ more efficient and accurate. Though it is convenient to perform prior art search using generic name of the drug ,yet it leads to several discrepancies especially when the invention related to drug, which is a derivative of a known compound, said Bindu Sharma (Patent Attorney) and CEO, Origiin IP Solutions LLP, Bengaluru.