Biotechnology is a fast-growing sector
India must take proactive steps to strengthen and streamline its biotech regulatory apparatus
Entrepreneurs have to see failure as the beginning and the middle
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Biotechnology is a fast-growing sector. It offers vast scope for incubation, innovation and entrepreneurship. India’s indigenous biotechnology sector has risen swiftly in current years, with the country’s biopharmaceuticals industry leading the charge. By 2020, the sector in India is likely to reach $100 billion levels with the present annual growth rate of around 20%. Across the country, more than 350 companies are working in various sub-sectors of biotechnology such as biopharmaceuticals, agriculture, industrial biotechnology, bio-services and bioinformatics.
While the biotechnology sector has attracted many investors and entrepreneurs alike but as creating self-sustaining profitable companies, the old models of the biotechnology have not been very successful. Long development cycles and underestimation of risk have resulted in the destruction of capital and assets for a biotech firm. Most companies focused on achieving milestones specific to product development, financing and strategic alliances whilst losing the sight of what could be the end goal of a business venture: profit.
Even though each new wave of start-ups appears to improve on the past, biotech companies consistently overestimate their projected revenues and underestimate the time to breakeven. However, given increasing private investment in R&D and impetus by recent policy reforms, there is an immense potential for growth, especially in segments such as biopharmaceuticals, bioservices, and agriculture.
Despite the biotechnology industry’s rapid emergence in India, critical gaps remain as obstacles for development. The key factor that would help the sector to live up to the promise it holds and achieve long-term sustainable growth on a global scale would be innovative research. However, Indian companies lack the experience to successfully launch new molecules globally and the funds to make huge investments required for innovative research strengths of multinationals.
It is crucial for companies to march forward with high risk but promising profitable products rather than bow down under pressure from short-term investors.
The issues of intellectual property have constituted the main deterrent for the growth of the Indian biotechnology industry. After the Patent Amendments Act in 2005, Indian patent laws have a few obscure issues such as the patentability of new use of a known substance remains to be fully settled. The major implementation of foreign ventures investing in the Indian Biotechnology sector also remains in disdain. Foreign venture capitalists are wary of insufficient patent protection and access to patent litigation in India.
The regulatory framework is still developing and is a multiplicity of bureaucratic organizations and processes. Many pharmaceutical firms avoid India because their drugs can be transformed into domestic generic equivalents by Indian scientists without legal repercussions.
Also, skilled labour receives a poor rating because of the brain drain from the best universities. Many of the best-educated scientists in India leave for the United States and Europe to receive much higher salaries than are available in India.
Despite more advanced research base in India, major developments in the biotechnology companies have occurred in the developed countries due to strong and persistent government funding, favorable policies, availability of venture capital and an entrepreneurial workforce. In India, the expertise required for manufacturing biological innovation is vastly different and not yet available within the Indian bio-pharma industry. The most interesting challenge ahead is to understand and implement the requirements, minimize the go-to-market time for products and to attain a sustainable competitive advantage globally.
The policy framework and the right module to keep a biotech start-up ahead of all these crises lies in a simple business concept that covers the following bases:
- The company must efficiently develop viable products.
- The company’s intellectual property must be defensible and other patents cannot block the path of your company’s product commercialisation.
- There must be a clear and visionary business model or strategy for generating a significant profit.
- The company should be wise enough to target a large and rapidly growing global market.
- The management should be capable enough and have shrewd skills to implement the business plan.
Entrepreneurship in biotechnology does not include only high-value Input but its focus on High Percentage of Yield. Furthermore, biotechnology research demands a well-furnished lab, with all proper facilities on a basic level A sound regulatory environment and a flourishing domestic biotech sector, in turn, would help India build a foundation to emerge as a more prominent voice in international conversations about biotech-related issues.
India must take proactive steps to strengthen and streamline its biotech regulatory apparatus; support the commercialization of biotech advances; and foster an inclusive domestic dialogue to build greater public knowledge about biotechnology, appropriate norms, and baseline practices.
Entrepreneurs have to see failure as the beginning and the middle, but never entertain it as an end. Stepping out of the comfort zone and experiencing new things is the best way to learn. You can research, plan, and educate yourself, but the only true way to improve is to put yourself or your business out there and learn from what you experience.
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