Enabling India to become a global hub for biopharma manufacturing

ABLE recommends setting up of Rs 5,000 crore biomanufacturing fund. Soft loans, larger SEZs, tax incentives, simplified regulatory framework and a Biosimilars policy -- keys to attain leadership

The Association of Biotech Led Enterprises(ABLE), the voice of the Biotechnology Industry of India, in a meeting held in New Delhi met and submitted a set of suggestions to the Department of Biotechnology (DBT) with the aim to make India a leading global Biopharmaceutical manufacturer and supplier.

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 US, EU and Japan maintain a leadership, with no competition from India or other emerging economies. In 2010, India managed to garner a share of 1.4% of the $138 billion market opportunity. Biosimilars are biopharmaceuticals that are becoming important since 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 reach $1.9 to 2.6 billion by 2015.

India's healthcare outlay in 12th five-year plan is expected to treble from 1% to 3% which may enable 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.

Dr. M.K. Bhan, Secretary, Department of Biotechnology (Government of India) observed that “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 Dr. Panchapagesa Murali, President of ABLE , “As an Industry association it is our duty and responsibility to support Government of India’s efforts in fulfilling its healthcare mandate following which our Executive committee strategized and has come up with a set of recommendations to enable India to become a leader in Biopharmaceutical manufacturing. India has done it before in generics and will do it in Biologics as well.”

Ms. Kiran Mazumdar Shaw, CMD, Biocon and Executive committee member ABLE, expressed

“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 finalizing their guidelines for biosimilars. South Korea is actively expanding its world-class clinical trials and production infrastructure, cultivating bio-specialized 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. We are appreciative of the Indian government asking the Industry for recommendations.”

Among the set of recommendations Dr. Murali said the more important ones are those of Finance (upto Rs.5000 crores biomanufacturing fund for soft loans at 4% to 6% with a 2 year moratorium and 5 year tax holiday from date of commercialization), larger SEZs specifically meant for Biologics, including Biotech drugs under the Free Medicines Scheme being contemplated by the GOI, preference to 100% indigenously manufactured biotech drugs for various government schemes, simplified procedures for obtaining various approvals, including Biotech medicines like Insulin, Mabs and Recombinant proteins in the list of Essential Drugs.