India's biotechnology industry appears to be the next biggest business opportunity. Prowess in generics, clinical research trials, bio-processing, bioinformatics and stem cell research is gaining momentum. In an interview with ,Nandita Vijay, Sudhakera Naidu, chairman and managing director, Biovel Lifesciences, deliberated at length on the increasing attention the biotech players grab from the pharma majors and the reasons thereof. Excerpts:
How would you describe the current biotechnology scene in India?
The biotech is an emerging industry. Several pharma majors are now into biotech research and development (R&D) to strengthen their pipelines and are eager to partner or acquire upcoming companies. In human resources front, the government of India is addressing the human resources training within the limited infrastructure. Besides, several new biotech service companies, piloted by scientist entrepreneurs, are on the rise in the country. This move is expected to increase outsourcing opportunities, while reducing time lines.
What according to you are the visible trends in this field?
The biotech industry is dependent on cutting edge innovation to develop new, more effective cures than the chemistry based pharma sector. Biotech drugs like recombinant proteins and monoclonal antibodies have evidently established therapeutic benefit. Companies are looking to develop their expertise in biotech R&D with a focussed small-molecule drug discovery programme to target the disease.
In the process of making sure that the country is ready for the bio-generic versions, lot of companies are investing in building up the infrastructure so that they can manufacture the product. Instead of duplicating the efforts of and investing on facilities, one can invest the similar amount of money into biotech R&D so that in future we can come up with novel drugs. Also, since we are adhering to General Agreement on Tariffs and Trade (GATT), where the intellectual property rights (IP) of the companies will be highly protected, India is making efforts to develop biotech products indigenously.
Union government has slashed the tax levied on pharmaceuticals manufactured in the country by 50 per cent, reduced value added tax and extended tax concessions to the pharma and biotech research companies, which take up outsourced research works. Some of these measures are likely to spur the growth of the contract research and manufacturing services (CRAMS) sector in India.
With India and China competing closely in the area of CRAMS, has Indian firms got any edge over Chinese players to bag more contracts?
Earlier, there was some reluctance to award contracts to Asian biopharma manufacturers because of concerns of IP and regulatory compliance.
Today, Indian firms are expanding and scaling up manufacturing capacities to become global players and the West is increasingly becoming comfortable with the IP, quality, regulatory filings and the infrastructure in India.
Both India and China have large talent pool. The difference is that during an international inspection, there is more transparency in Indian pharma production facility because of visibility of qualified technical science. We believe that we have an edge over China in the area of communication command and open policies. Further, reverse drain expertise which is being employed at many plants puts the regulatory officials at ease in the stringent adherence to quality standards and documentation.
How long can India sustain on expertise and its international regulatory compliant plants when its support infrastructure is becoming a big issue for growth? Please comment.
India can continue to sustain because of its inherent strengths. We have large talent pool who are working abroad and willing to come back given the right working environment. Some of the companies like Biovel have good support infrastructure and those who need the same can always outsource it. Hence, India would be the right destination for CRAMS.
What are the problems in the biotech sector which need to be handled?
India has a large number of schools, which churn out biotechnology graduates. However, most of these institutions do not have the right infrastructure for hands on training. It is a serious issue while hiring candidates. Therefore, giving ample thrust in this area is critical. Also, regulatory mechanism should be further simplified to cut delays and this may be addressed with the proposed single window clearance.
The industry is facing a serious manpower shortage. How do you think this issue can be handled?
People shift from one place of work to another because they get restless primarily because of routine work or more pay at another work place or there is a better boss.
People are restless because there is no challenge and no sense of accomplishment. They do not mind a bit of adversity or discomfort but most people would like to work if there is interesting research. We need to address this because human resource is the key asset in biotech business.
What led you to become a bio entrepreneur? How supportive are union government's polices to nurture entrepreneurial growth?
Biovel is an emerging company with high growth potential. Indian pharma industry has proved that they are capable of becoming world leaders. In fact Cuba and Israel are far ahead of India in biotechnology. India has large manpower pool and this could be an asset with right training coupled with good infrastructure. This is what inspired me to build a successful biotech company.
Union government is highly supportive in terms of funding. The sector received Rs 6500 crore in the 11th plan, of which 25 per cent is allocated for public-private partnerships (PPP). Govt. is trying to streamline the regulatory procedure and working on a single window clearance.
As an entrepreneur, how easy was it for you to garner funds?
Union government has several programmes for funding the industry through Department of Biotechnology (DBT), Council of Scientific and Industrial Research (CSIR) and TDB. Banks like State Bank of India is highly supportive for viable projects. Entrepreneurs with innovative ideas and proof of concept have access to funds as grants, soft loans, term loans and PPP.