India is home to a robust and growing biotechnology industry because of the country's increasing premium on innovation. Maintaining
and sustaining this sector, however, requires active support from government, policymakers, academia, the financial community,
Biotechnology promises solutions to many of the global challenges faced by the world, and industry leaders in India recognize
the myriad benefits of further developing a robust biotechnology sector within the country. Policies to encourage biotechnology
investment and development will produce a significant return on investment by creating high-skill, high-wage jobs and bringing
innovations to market.
Last Fall, the Biotechnology Industry Organization (BIO)and the Association of Biotechnology Led Enterprises (ABLE) hosted
the inaugural BIO India International Partnering Conference in Hyderabad, to bring together biotechnology and pharmaceutical
companies from North America, Europe, and Asia to explore business opportunities within India's emerging biotechnology sector.
Leading companies and industry experts from India and around the world attended the conference as did many investment industries.
There is significant global competition engaging the biotech sector globally and it was clear at the conference that many
multinational biotechnology and pharmaceutical firms have set their sights on India. They are eagerly entering into resaerch
and development partnerships as well as licensing and distribution agreements with Indian companies.
But questions remain. Will India, for example, establish the regulatory system, public policies, and incentives it needs to
encourage and support innovation?
Discussions at the 2010 BIO India meeting highlighted the need for a concerted effort to develop a comprehensive regulatory
framework for the approval of biologics in India, including the approval of biosimilars. For example, the Indian government
must set approval criteria for biologics and biosimilars that protect patient safety and preserve incentives to innovate. Well-crafted pathways for the approval of these drugs will lower costs by increasing competition
and promote further biomedical research and development. BIO has created a list of principles on biosimilars which is available
BIO recognizes the efforts of the Indian government to streamline the various authorities impacting the nation's biotechnology
sector and we applaud the open channel of communication between the Department of Biotechnology and the Drugs Controller General
of India. These efforts, in conjunction with the Indian government's willingness to hear from various stakeholders, will be
useful in shaping India's regulatory framework which, in turn, will generate investment interest in biotechnology. The Indian
government also is working on economic programs to bolster its established biotech clusters, and the National Institute of
Public Finance is drafting a plan to establish a venture capital-type fund to finance drug-discovery projects across the country.
India's biotechnology industry holds the potential for boundless growth. Global biotech companies will continue investing
in India as long as India continues investing in biotechnology. BIO stands ready and committed to working with biotechnology
leaders in India to deliver on the enormous promise and potential of their biotech sector.
Of note, BIO India will be held Sept. 21–22 in Hyderabad.
Alan Eisenberg is the executive vice-president of Emerging Companies and Business Development for the Biotechnology Industry Organization