Innovations in the Biotech and Pharma Industries in India

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Case Details:

Case Code : BREP014
Case Length : 15 Pages
Period : 1978 - 2004
Pub Date : 2005
Teaching Note : Available
Organization : -
Industry : Biotech and Pharmaceutical
Countries : India

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This case study was compiled from published sources, and is intended to be used as a basis for class discussion. It is not intended to illustrate either effective or ineffective handling of a management situation. Nor is it a primary information source.

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"The potential for Indian BioPharma segment is huge. With the implementation of WTO and patents regime in 2005, Indian companies would not be able to do backward engineering of the drugs, so they are focusing on in-house R&D. The growth prospects are bright as many contract research organizations are coming up. Besides, a large number of foreign pharma companies are setting up their R&D divisions here."

- Dr. S D Ravetkar, Senior director, Serum Institute of India.¹

"The trend seems to be that more and more pharma companies are diversifying into the biotech sector. It would be prudent to have a synergy between the pharma and biotech companies to avoid cannibalization and killing of effective products."

- Dr Krishna M Ella, chairman and managing director of the Hyderabad-based Bharat Biotech International Limited (BBIL).²

Introduction

Biotechnology is an emerging sector in India. It accounted for just 2 percent of the global biotechnology market in 2003. However, it is estimated to grow exponentially over the next five years, with an expected global market share of 10 percent.

India has been leveraging its strong information technology (IT) base, human expertise and low cost research and development (R&D), to establish and strengthen its presence in the global biotechnology market. Biotechnology is believed to be the next major driver of growth in India, after Information Technology in the 1990s. The Government of India (GoI) has taken special initiatives to promote India's biotech industry.

Innovation Case Studies | Case Study in Management, Operations, Strategies, Innovation Case Studies, Case Studies

The GoI has more than doubled the biotech research Plan outlay, from Rs 6.22 billion in the Ninth Plan (1997-2002) to Rs 14.5 billion in the 10th Plan (2002-2007). Apart from funding, the GoI has eased the regulatory framework by approving genetically modified crops³ and recombinant-DNA products (rDNA)⁴; as well as ethical stem cell research⁵.

In 2002, the GoI made changes to the Patents Amendments Act (second amendments). These changes were intended towards making Indian patents comparable to WTO and TRIPS. Inventions relating to the method of treatment of plants are to be made patentable.

Patent protection has been made available for micro organisms; earlier, all life forms were excluded from patent protection. The term of a patent is 7 years for food and drugs, and 14 years for others. The government intends to make changes in the terms of patents in order to bring them in line with the TRIPS agreement, in which the term is set at 20 years from the date of application for a patent.

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1] Rolly Dureha, "BioPharma longs for scientists",' www.biospectrumindia.com, February 12, 2004.

2] Joe C Mathew, "'It's wise to have a synergy between pharma and biotech companies to avoid cannibalization", Pharmabiz.com, April 23, 2002.

3] Genetically Modified Crops are cultivated from genetically modified plants. A genetically modified plant is one that contains a gene or genes which have been introduced artificially into the plant's genetic makeup using biotechnology techniques. Plants are genetically modified for various reasons such as, to reduce the harmful effect of pesticides and herbicides, to make food stay fresher for longer, to develop resistance to pests, to increase yield of the crop, and to experiment with taste and quality.

4] Recombinant DNA technology is a set of biotechnology techniques used to genetically modify or engineer plants and organisms to produce various types of products such as food and vaccines.

5] Stem cells are unspecialized cells that renew themselves for long periods through cell division. They have the potential to develop into many different cell types in the body. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. Research on stem cells is advancing knowledge about how an organism develops from a single cell and how healthy cells replace damaged cells in adult organisms. Research is being conducted to develop treatments and cures for certain diseases and medical conditions. This kind of research is possible because under certain physiologic or experimental conditions, stem cells can be induced to become cells with the desired special functions. For example, stem cells can be induced to become the insulin producing cells of the pancreas; in order to treat diabetes.