Patent regulations in India have enhanced the growth and profitability opportunities in the drug discovery technologies and development space in India.

According to Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd, "Though drug discovery in India is at a nascent stage, it is gathering momentum at a rapid pace. At the moment most discovery programs are being sourced externally and developed indigenously. The time will soon come when our academic research labs and medical centres will deliver high value innovation and make it a cent percent indigenous effort.

The pharma Industry in India is going through a paradigm shift, from being a generics-focused business to being innovation-driven in its outlook. This transition, pioneered by companies like Dr. Reddy's and Ranbaxy, is seeing an increasing level of activity from other traditionally strong companies such as Glenmark, Orchid, Matrix, Lupin, Torrent and Nicholas Piramal. The success of some of these organizations, including the recent licensing of an in-house compound by Glenmark to pharmaceutical companies across different geographies in the world, has only added to the tempo of growth momentum and interest in drug discovery in India, said, CSN Murthy, COO, Aurigene Discovery Technologies Ltd.

Dr. J Ramachandran, managing director, Gangagen Biotechnologies said, "It is encouraging that there is more interest in drug discovery and not just in pharmaceutical services like outsourcing and marketing. The time required for drug development is long compared to any other product. Therefore, visionary, long term support from the venture community will go a long way to put India on the world pharma map."

Challenges and prospects
"We have at this point a number of gaps like the right mindset, the required pre-clinical expertise and the right clinical experience. Our regulatory infrastructure is not on par with US FDA and EMEA, which is an urgent need if we are to succeed in discovery based drug development," said, Ms. Shaw.

Over the last two decades, the pharmaceutical industry has invested in technologies to increase throughput, decrease costs and provide access to scientific data. But this has not led to much of drug discovery activities by the domestic companies, said Prof. G Padmanabhan, scientist and former director of Indian Institute of Science.

Technical innovation in pharmaceutical manufacturing has been relatively slow compared to drug research and this has led to companies failing to address their focus on drug discovery, noted RS Iyer, pharma consultant.

Some of the fore-most challenges faced by the domestic industry are in terms of lack of experience. A truly integrated drug discovery effort requires expertise and investment in different areas of science, including genomics and proteomics (for new target identification), biology (from expression of targets to assay of drug candidates), medicinal chemistry (as different from synthetic organic or process chemistry), in vivo biology, pharmacology and clinical development, according to Murthy.

India is strong in chemistry but not in medicinal chemistry, which is the key for drug development. There is a great need for skilled medicinal chemists and scientists for preclinical development (pharmcokinetics, drug metabolism, formulation science etc), said Dr. Ramachandran.

Investments in discovery and development are huge for infrastructure and the time frame required to commercialize new intellectual property (IP) molecule. It is still difficult for Indian companies to take on the burden of frequent failures.

The country has not yet put into place innovative-driven intellectual personnel. There is a mind-set required to move to an 'IP-led' regime. It needs time and training in the art and skill of negotiating and protecting patents, noted Murthy.

Advanced technology platforms
The availability of state-of-the-art basic technology platforms, required to accelerate the pace of drug discovery has not taken place in India as in US and Europe. Companies like Pfizer, Bristol Myers Squibb, GlaxoSmithKline, Novartis, Organon, AstraZeneca and Merck have made the necessary advances in terms of technology. Such developments are not there in India. The main reasons for this are lack of access to high quality research labs in the Universities, low access to risk capital and poor experience in development of cutting-edge science, according to the industry experts.

There is a need for wider application of standardized technologies, such as micro-fluidics, which can help scientists' move faster and share better-quality data across therapeutic areas or between R&D groups, pointed out Prof. Padmanabhan.

Companies like Waters Millipore, Pall Corporation, Agilent Technologies, Sartorius have installed technologies to increase the speed of drug discovery in pharma companies but a lot more needs to be done, going by the huge gaps in R&D pipelines and lack of late-stage compounds, said scientists from the National Centre for Biological Sciences (NCBS).

Advantage India
Pharmaceutical industry in India has access to high-quality chemistry resources and a large talent pool in biology and pharmacology. In addition, naïve population and low costs are proving to favour Indian pharma sector to take on drug discovery and development, according to experts.

There is also access to a reverse brain skill pool of scientists of Indian origin engaged in discovery in pharma and biotech in the US and Europe to bring in the critical mass required to train a larger number personnel here. "All this is expected to eventually result in a cost-effectiveness of drug discovery activities to the extent of cost savings of 60 to 75 per cent. In development activities it will reflect 45 to 50 per cent cost saving, said Murthy.

Emerging trends
Companies like Ranbaxy, Dr. Reddys, Lupin, Torrent, Biocon and AstraZeneca India have forayed into the drug discovery space. There many Indian companies like Aurigene, Advinus, Jubilant Biosys, Rheoscience, which are engaged in contract research for many drug discovery efforts for multinational companies globally.