India being a very large country with at least seven distinct climatic zones has one of the largest and most varied sets of marine organisms. There is also ambient temperature in most parts of the country. It is just what living organisms need for their activities that result in a biotechnological product. In this way, India has got natural advantage over most of the countries in this word to develop biotechnological products.
Another very important point is that, in India labour and infrastructure costs are, perhaps, lower than anywhere else. So, developing and manufacturing biotechnological products/drugs and doing research on biotechnological therapeutics in India, has got a very wide and large scope. India has already established the infrastructure which is basically required for such type of research and development to take place.
The factors that make India a suitable place for developing biotechnological tools for therapeutics:
● Rich biodiversity
● Well-developed base industries
● Excellent network of research laboratories
● Trained manpower and knowledge base
Issues in pharmaceutical biotechnology/therapeutics
It is important to state that, it is not always advantageous to have variety in terms of different climates in different regions with diversity for microorganism etc. to develop in the area of biotechnology. In the case of pharmaceutical biotechnology, the drug targets for the population across the country are different. The effects of drugs and adverse effects of drugs (ADRs) are different in different populations. These characteristics vary due to different genetic make up of the individuals, which in turn depends on the geographical and environmental differences. The drugs which are developed for one population might work in different manners for others. Similarly, due to these reasons, the drugs developed in other countries than in India, might not be as potential and effective in Indian population. So, Indian scientists have got the responsibility to develop their own tools for their target populations. In these cases even the targets of the drugs, for example the microbes, are also genetically different during the treatment of a particular disease.
Aim of pharma, biotech industry
The aim of pharmaceutical industry is to provide specific medicines having least side effects with great potency to the population at an economic price. This goal can be achieved by using biotechnology and bioinformatics tools. Indians are doing biotechnology since long by developing methods and products like arishtas, yoghurt and many other ayurvedic formulations and therapies. But these things were developed on the basis of long time experiences and the effect of the formulations in small local populations. In modern biotechnology, we first of all develop the in-depth understanding of the disease/ the specific targets and the mode of drug (to be discovered) action and then use that knowledge to develop specific drugs with a faster pace.
Modern biomedical tools
In India, biotechnological tools like in vitro fertilisation (IVF) etc. are becoming very popular for the couples without kids. Now, even couples from foreign countries are arriving India to get IVF done by the skilled hands at cheaper prices. People are becoming very open for blood, organ or tissue transplantation and India is even becoming popular for organ transplantation all over the world. And because of all this, the field of "medical tourism" has started growing very well in India. The organ and tissues which have been used for the purposes are either donated and also they have been developed by using new biotechnological tools like stem cell research etc.
However, the darker side of the picture is that the poor people are being utilised for all these purposes even without knowing their consequences. The ethics and regulatory issues have to be looked upon very carefully for all these matters.
Stem cell research
Stem cell research has also started in India and several institutes (ACTREC, Navi Mumbai etc) and companies (Reliance Life Sciences, Mumbai etc) are involved in this area. Research in this area is oriented in two directions: cancer research and developing organs/tissue for transplantation. Because of the low cost factor, India has been looked upon for Stem cell research as well.
Nano-bio bond in India
Nanotechnology has grown very fast in India. Many institutes (IITs, BARC Mumbai, NML Jamshedpur and TIFR Mumbai etc.) and companies are working in this area. Biotechnology has joined hands with nanotechnology in many areas like: gene delivery in case of gene therapy or delivery of drugs at a site of action (infection/cancer) etc. So, the research in this area is mainly oriented towards cancer treatment, cosmetics, formulation development and drug delivery etc.
With special concern to Indian scenario, it is imperative to quote that scientist are now getting proofs that the formulations which are used as bhasmas in ayurveda have got nanoparticulate material. It is possible that although having the heavy metal content they are being used in ayurveda because of their unique nano size and the way they work and behave differently from the heavy metals. To validate Indian products for their use in therapeutics throughout the world, it required to characterise them to prove there efficacy, safety, toxicity and efficiency for and during the treatment.
There are chances that our ancient herbal formulations with some genetic modifications (genetically modified herbs) can be used more efficiently and potentially without putting lesser efforts than developing entirely new drugs.
India's strength in biotech research and development (R&D) is spread into areas like:
● Genetic engineering
● DNA technologies
● New drug delivery systems
● Rational drug design
● Stem cell research
● Bioinformatics
Govt initiatives & motivations
Government of India is providing enormous funding in the area of biotechnology. Government agencies like Department of Biotechnology (DBT), Department of Science and Technology (DST), Indian Council of Medical Research (ICMR) and Council of Scientific and Industrial Research (CSIR) are encouraging biotechnological programmes, which can lead to develop more specific drugs by involving the biotechnology with fewer side effects. Government of India is also encouraging collaboration with other countries like Germany, US and China by funding the collaborative projects between the countries. Beside this, government is also providing funds for those companies who are interested in joining hands with the academic institutes for doing research in pharmaceuticals and other areas.
Contract research in biotech
Most of the Indian pharma companies were not having biotechnological research centres earlier. Several of them have already started biotech research and many of them give their project on contract basis to the academic institutes and other government or private institutes.
India has the bright brains and skilled hands in the world, and hence the potential to do research for even other countries. Indians are already doing very well in the sector of information technology, bioinformatics and clinical research. Now we are into developing the drugs (biotechnological drugs) and are engaged in drug manufacturing and researching for other countries. Being a big hub for bioinformatics, it is advantageous for biotech sector to work on developing new drugs on the basis of the known genetics and genomics of the population. Many multinational companies are now coming to India for these kinds of services at a lower price with best results.
Products in market & pipeline
There are two different areas in which the research for pharma in biotechnological area is going on. They are vaccines and other biotechnological drugs, and pharmacogenomics research, which has already been started in India. The main aim of this kind of research is to design, population or person specific drugs to avoid the side effects, ADRs and to reduce the cost of the drug development
The drugs which are already available from the biotechnology sector are vaccines, monoclonal antibodies, recombinant interlukins, interferons, recombinant insulin and recombinant growth factors. Besides these scientists are also planning to develop targeted therapy to avoid the side effects causes by unspecific delivery of the drugs to the normal healthy sites. This kind of research can actually increase the quality of life for the patient suffering from disease like cancer. In most of the cases, this kind of therapy includes immunotechnology, nanotechnology and pharmaceutics and general principles of pharmacology.
While companies like Virchow Biotech (VIRKINASE- recombinant Streptokinase), ClinInvent Research (r-human Erythropoietin), Shasun Chemicals & Drugs (r-Streptokinase), Emcure Biotech (r-Mutant Tissue plasminogen Activator (TNK-t- PA) and r-GM-CSF), Serum Institute of India (r-erythropoietin, r-G-CSF and PEG-G-CSF) and Reliance Life Sciences (r-human interferon alpha 2b (Reliferon)) have received approval for conducting clinical trails, Biocon received GEAC's approval to conduct large-scale process optimisation studies (R&D purpose only) of oral insulin IN -105 precursor, for the production of oral formulation of recombinant human insulin.
The top ten biotech companies of India - Biocon, Serum Institute of India, Panacea Biotec, Nicholas Piramal, Wockhadrt Limited, GlaxoSmithKline, Bharat Serum, Krebs Biochemicals and Industries Limited and Zydus Cadila - have broken new grounds and given new products and technologies to the world. Indian biotech firms are known for their capability to produce vaccines. India is producing vaccines even for other countries as well.
Vaccines edge
● Indian firms are estimated to supply 90 per cent
of global demand for the measles vaccine, in the near future
● Pune-based Serum Institute is believed to be the world's largest manufacturer of DPT vaccines
● Indian Immunologicals operates the world's second largest plant for veterinary vaccines and is also the world's largest manufacturer of the vaccine against foot and mouth disease
"As a sunrise industry, the biotechnology sector's growth is on track to achieve the target of $5 billion (Rs 200 billion) by 2010. With about 30 per cent year-on-year growth, the sector's revenue increased to $3 billion (Rs 120 billion) for fiscal 2008. About 50 per cent ($1.5 billion) of the total revenue is generated from exports, with Bangalore again driving the growth," said M K Bhan, secretary, biotechnology department.
The Indian biotech industry today encompasses 325 companies, with Biocon, Serum Institute of India and Panacea Biotec contributing about 27 per cent of revenues. In the case of investments, Bangalore accounted for 12 of the 24 biotech firms set up in the last fiscal (FY 2008). Top five biotech firms such as Serum, Biocon, Shantha, Wockhardt and Panacea accounted for a third of the total pie. Revenue from research activities touched $500 million.
India has progressed a lot in the pharmaceutical biotechnology sector and still there is large scope to grow as now MNCs are coming to India for biotech research. In combination with biomedical and bioinformatics and clinical research, biotechnology can do wonders to relieve the pain of human kind and improve the quality of life of the patients. Also, this sector is contributing to a very large extant to the country's economy.
(The authors are with School of Pharmacy and Technology Management, SVKM's NMIMS University, Mumbai)