India is emerging as a force to reckon with in the global pharmaceutical arena. The Indian pharmaceutical industry is globally ranked as world's second-largest by volume and is likely to lead the manufacturing sector of India.  As per BioSpectrum—ABLE Biotech Industry Survey report 2010, India's biotech industry clocked a 17 per cent growth with revenues of Rs14, 199 cr in the 2009-10 financial year over the previous fiscal. Biopharma was the biggest contributor generating 60 per cent of the industry's growth at Rs.8, 829 crore, followed by bio-services at Rs.2, 639 crore and bio-agri at Rs.1, 936 crore.  Top 20 biotech companies contributed 52% of the total revenue and these companies grew at an average growth rate of over 22%.  The Indian Government’s Department of Biotechnology also expects annual sales of the biotech sector to cross US$ 25 billion by 2015.

Biotechnology is an umbrella term that covers a wide spectrum of scientific applications used in many sectors. The national and international biotechnology industry is now at the beginning of a technology curve whose upside potential appears limitless. The Indian government is embracing biotechnology as the next driver of innovation and economic growth. Biotechnology has made phenomenal success in India in almost all the sectors primarily in healthcare.

Biological products include a wide range of products such as vaccines, blood and blood components, allergenic, gene therapy, tissues and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources - human, animal, or micro-organism - and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available

“Biopharmaceuticals” are biological medicinal products that are developed by means of some biotechnology practices such as recombinant DNA, controlled gene transfer/expression, and monoclonal antibody production. Biopharmaceuticals are emerging global healthcare products, that act as panacea for many serious and life-threatening illnesses.

The Indian biopharmaceutical sector is today offering stiff competition to its global competitors and is poised to excel in this area. The biopharma market consists primarily of vaccines, therapeutic drugs, insulin, animal biologicals, statins and diagnostics. The vaccine market continues to drive the growth of the biopharma segment and growing in the range of 10-13 per cent in the next five  years. The market clearly shifts to combination vaccines such as pentavalent vaccines and comprise a largest component. It’s worth mentioning that the vaccine segment such as human as well as animal vaccines accounted for 50-60 per cent of the total bioPharma market.

India's ‘similar biologics’ (biosimilars) market is at a nascent stage but has considerable commercial potential. It is expected to reach around $580 million by 2012 and about 50 Indian biosimilars have already reached the country's markets and some being sold in the unregulated markets as well. Biosimilars are similar, but not identical, to already registered biological medicinal products in terms of quality, safety and efficacy. Unlike the more common "small molecule" drugs, biosimilars generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. Verification of the similarity of biosimilars to innovator medicines remains a key challenge.

The inventive skill and efficiency of the private sector has to the success and resilience of the biotech sector. Stiff competition among multiple domestic manufacturers, and the need to balance between doing innovative R&D and delivering affordable quality products  have turned India into a top bio-pharma producer particularly in vaccine.

The collaborations and public-private partnerships in the biotech industry are on the rise. DBT and other organizations have pro-actively taken up a number of initiatives in creating trained human resource, institutional infrastructure has taken initiatives such as Small Business Innovation Research Initiative (SBIRI) and the Bill & Melinda Gates Foundation are some of the examples of collaborations between government and industry. According to some reports,DBT has also tied up with UK-based Wellcome Trust  to enhance cutting-edge biomedical research in India. PPP will be the catalyst for affordable solutions to the pressing national needs of health care sector and at the same time it must be competitive enough to take advantage of the lucrative international markets

Regulatory framework
The DCGI is responsible for approvals of preclinical and clinical trials, new drug applications, and the importation of drugs from abroad for all biologics. In the case of biological products however, additional approvals are required. Once the proposal is made through Institutional Bio Safety Committee (IBSC), the Review Committee on Genetic Manipulation (RCGM) under the Department of Biotechnology (DBT) examines the pre-clinical data and recommends the application to the DCGI for human clinical trials on the basis of pre-clinical data. The Recombinant Drug Advisory Committee (RDAC) under the DCGI approves the protocol and recommends conducting of human clinical trials. For marketing license, a new drug approval application is to be filed before the DCGI. Yet another committee, the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forest (MoEF) examines information on containment facilities and data on clinical trials in respect of recombinant pharma products (LMOs) and accords environmental clearance.

To streamline the regulatory process, step - wise procedures (five protocols) are recommended. The mandate of the task force was to review the current framework and recommend a transparent and streamlined regulatory mechanism and process for the use of living Modified Organisms (LMOs) in the pharmaceutical industry during the various stages of R & D, testing, manufacture and import of LMOs as drugs.

Biotechnology Regulatory Authority of India Bill 2010 has been proposed to introduce single-window mechanism and received the Cabinet approval seeks to create a new body to regulate research, manufacture, import and use of products of modern biotechnology

Biologics, biopharmaceuticals and recombinant therapeutics promise potentially cheaper alternatives but at the same time, it needs to be ensured that the quality, safety and efficacy of such products are not compromised. In view of the above, the following “Guidelines for Preclinical Evaluation of Similar Biologics” have been developed to provide guidance to applicants for generating data for approval of similar biologics and regulations for evaluating the submissions. Now comments on the guidelines are invited by DBT to incorporate important observations made by the stake-holders and organize workshop on the guideline. Another guideline is expected from DCGI on clinical studies and both the guidelines will have a synchronic effect for approval of similar biologics.

In view of the above facts it is clear that India is the next big destination for international biotechnology companies. With the right kind of funding and collaborations between the government, domestic and foreign companies, the industry is set to grow tremendously in the coming years. India is now shifting its focus to the most promising industry of the future, biotechnology. The  large pool of scientific talent and regulatory framework that has come up  for recombinant pharma, biologics and similar biologics will strengthen the approval procedures to pave way for quality biopharmaceutical products and a vibrant biopharmaceutical sector. India thus presents a huge market opportunity and is well positioned to emerge as a significant player in the global biotech arena.