For any endeavor to take root and thrive, a support system which nurtures it and helps it blossom is critical. India’s Biotechnology scientific and industrial organizations have always found an exemplary enabler in the Department of Biotechnology (DBT). By providing specialized skills, and financial and regulatory support, the DBT has strengthened the bedrock on which the Indian Biotech sector has built a global, disruptive industry – one that is well on its way to fulfilling its life-changing promise. It is fitting that we reflect on the DBT’s contribution and examine its role in the coming years as we celebrate its silver jubilee.
Over these 25 years, the development of the DBT has mirrored the emergence of Biotechnology in India, matching every inflection in its journey from a nascent sector to a sunrise industry. When I began my own entrepreneurial journey in 1978, sowing the seeds of the country’s first biotechnology company, the DBT was not in existence. Up until the mid 1980s, I was a loner, pursuing critical R&D while needing to import every research consumable, constrained by red tape and inadequate infrastructure. However, as I built Biocon step by painful step, the sector was evolving in India around me and the business environment was becoming more biotechnology-friendly.
Recognizing the need to support Biotechnology in India, the government set up a 'National Biotechnology Board' in 1982 with Dr S Ramachandran as member secretary with a mandate to identify areas of priority development areas. As the need for a separate Department grew, the government established the Department of Biotechnology in 1986 with Dr. S. Ramachandran as founder secretary. As a pioneer in the industry, I was privileged to be invited to the DBT’s launch. The focus in this phase – through Dr. S. Ramachandran’s nearly seven-year-long tenure – was on creating an academic ecosystem for Biotechnology and thereby start generating the required human capital to support this emerging sector through a number of Departments of Biotechnology at select universities – including Anna University, Madurai Kamaraj University, Jawaharlal Nehru University, MS University, CCMB, and IMTECH Chandigarh. The DBT was also focusing on helping the sector overcome the type of challenges faced by Biocon during its formative years – the dire need for infrastructure for both research and development and manufacturing, along with a facilitating regulatory environment.
By the 1990s, the sector started growing in depth and scope; several enzyme companies sprung up across the country and a cluster effect was seen in Bangalore which soon became India’s pre-eminent biotech city. Localization was the start of a new phase for the sector, speeding up the Indian biotechnology industry. As the industry grew, DBT’s focus expanded to include the building of industry-academic linkages that were critical to enhancing the sector’s value. The phase, which spanned Dr. Manju Sharma’s nine-year stint as DBT secretary – saw the birth of Hyderabad start-up Shantha Biotech and Bharat Biotech which developed India’s vaccine sector based on seed technology developed at CCMB and IISc.
India has now become a Biotechnology hot spot with the promise of becoming a high-value, low-cost innovator in bio-therapeutics. The West, hit by high drug development costs, a drying pipeline and patent expiration, is looking to us for innovative therapies, research and licensing alliances to leverage symbiotic advantages, and expansion into emerging markets. We have entered a new phase in Biotechnology and, as a result, the DBT is now focusing on building global scale and enabling India's stature as a global hub for vaccines, biosimilars and research services.
The immense support the DBT has given Indian Biotechnology is the result of close collaboration between all key stakeholders – individuals who have understood the potential of Biotechnology and are committed to promoting it in our country as a science and as an industry. However, going forward, the DBT needs to take several steps if India is to realize its true potential in biotechnology. These include addressing the following requirements:
• Promote innovation: R&D must be given top priority for India must add value through product innovation
• Streamline regulations: India has multiple regulatory bodies which cause confusion. We need to act now to write enabling regulations and enhance mutual recognition between international regulators.
• Establish strong industry-academia linkages: A systematic exchange of knowledge between academics and industry can help bolster the sector.
• Enhance fiscal support: With venture capital firms adopting a low-risk funding mentality, innovative funding is the need of the hour.
The DBT has been a strong supporter of the Biotech industry. Through funding initiatives such as BIPP (Biotechnology Industry Partnership Program), SBIRI (Small Business Innovation Research Initiative), and NMITLI (New Millennium Innovation Technology Leadership Initiative), it has helped lay the foundation for the sector. Having already made its mark in Biotechnology, India has the potential to become a global leader. However, the DBT, scientific community and industry will need to work together and evolve policies and methodologies that augment R&D as well as the skill base to take Indian Biotechnology to the next level.