The Association of Biotech Led Enterprises(ABLE), the voice of the biotechnology industry in India, has urged for a series of reforms to propel the sector in the next phase of its growth. The important one among them includes the ones pertaining to finance — upto Rs 5,000 crore biomanufacturing fund for soft loans at 4-6 per cent with a two-year moratorium and five-year tax holiday from date of commercialisation; larger SEZs specifically meant for biologics, including biotech drugs under the ‘free medicines scheme’ being contemplated by the Government of India; preference to 100 per cent indigenously manufactured biotech drugs for various government schemes; simplified procedures for obtaining various approvals, including biotech medicines like Insulin, Mabs (monoclonal antibodies) and recombinant proteins in the list of essential drugs.
According to ABLE, statistics reveal that India has already gained recognition as one of the leading suppliers of generics. India produces and exports $11 billion worth of generics to a large number of countries. But, in biopharmaceuticals, developed nations like the US, EU and Japan maintain leadership with no competition from India or other emerging economies.
In 2010, India managed to garner a share of 1.4 per cent of the $138 billion market opportunity. Biosimilars are biopharmaceuticals that are becoming important as they are similar versions of the important patented innovator drugs like Herceptin and Enbrel, patents of which are due to expire shortly. Global sales of biosimilars is expected to be in the range of $1.9 billion to $2.6 billion by 2015.
India’s healthcare outlay in 12th Five-Year Plan is expected to treble from 1 per cent to 3 per cent which may enable for free drugs for some chronic diseases like diabetes, cardio-vascular diseases, cancer and immune-mediated diseases. Most therapy solutions in these disease areas are provided by biopharmaceuticals. In South Korea, India and Brazil, biosimilars are seen as a key macroeconomic driver of growth, attracting foreign capital by creating manufacturing and R&D centres of excellence.
M K Bhan, Secretary, Department of Biotechnology (Government of India), observed: “India has the potential to be a world-class player in biomanufacturing, enablers for which would be fiscal and regulatory policies that would need to be followed by robust action and demand generation efforts.”
According to Panchapagesa Murali, President of ABLE, “As an Industry association it is our duty and responsibility to support Gove-rnment of India’s efforts in ful-filling its healthcare mandate following which our executive com-mittee strategised and has come up with a set of recommendati-ons to enable India to become a leader in biopharmaceutical man-ufacturing. India has done it earlier in generics and will do it in biologics as well.”
Kiran Mazumdar Shaw, CMD, Biocon, and executive committee member, ABLE, said, “Biomanufacturing is a capital-intensive activity where infrastructure costs are high. Biosimilars is an opportunity that India cannot afford to miss. Many countries like Korea, Malaysia, Singapore, Turkey, Taiwan, Turkey and Argentina are finalising their guidelines for biosimilars. South Korea is actively expanding its world-class clinical trials and production infr-astructure, cultivating bio-specialised manpower, building R&D, legal and system support strategies. India too should come out with its biosimilar policy and encourage biomanufacturing in a big way.”
