Association of Biotechnology Led Entrepreneurs (ABLE) has now proposed to the Union government for an overhaul of the current biotechnology regulatory process. It is insisting for a possible regulatory revamp.

In its latest report for the Department of Biotechnology, titled 'Indian Biotechnology: The Roadmap to the Next Decade and Beyond', the Association has called for a single window, efficient, transparent and scientific evidence based regulatory system.

“It is imperative for the government to have a rapid strategy in place because it is  India needs to immediately build a single regulatory authority which is  equipped with trained permanent personnel who comprehend  the ‘science of regulation’ along with supporting critical factors like economic cost and risk benefit analysis,” stated Dr Satya Prakash Dash, former chief operating officer, ABLE and presently senior consultant, Indian Institute of Management-Bangalore (IIM-B).

Dr  Dash who authored the report stated that India has the potential to become a global innovation hub and to be a bioeconomy. Now in order to ensure that India can develop into a biotech break-out nation, it would need to invest Rs. 20 crore (US$4 million) to  establish the a ‘Centre for Biotechnology Policy and Regulatory Sciences’ (CBPRS) on similar lines that of the University of Cambridge’s Institute for Manufacturing (IfM) which brings in business strategy, innovation, regulation, policies and academia-industry-government interactions. CBPRS  should be led by a Biotechnology Leadership Council (BLC) of five industry representatives and five strategic stakeholders that  will take on the  responsibility to implement the Planning Commission recommendations, he said.

Currently the country has a cumbersome regulatory process with multiple agencies that hinder innovation due to several cumulative procedural delays for  biopharma including bioservices and medical device as well as agribiotech segments. The process of biotech innovation is long, arduous and non- linear. The industry is highly regulated with a burden of intense regulation. Regulation and regulatory landscape is associated  with investor’s confidence and impacts  funding and financing landscape. Although  India has a well established regulatory system, now there is an urgent need to overhaul and strengthen it. Moreover,  industry has also shown that when proper support systems exist, scale-up of innovative products are achievable in a desired time-frame like for instance the high quality and affordable vaccines production among other life-saving biotech drugs for cancer and  diabetes, he added.

“Present regulations in the country are archaic and  it is high time we move with the times, said Kiran Majumdar-Shaw, chairperson, Vision Group on Biotechnology and CMD Biocon Limited.

In order to formulate and implement a strategy for the future growth of Indian biotechnology, regulations are needed. There is also need to evolve a road map for  stem cell, synthetic biology, systems biology and molecular assisted breeding and genetically modified food in consultation with the  industry, scientists and other stakeholders as they  are the face behind evidence-based drugs and devices, pointed out Dr Dash.

In the funding arena, under the direction of DBT and BIRAC, new innovative industry oriented schemes have been initiated such as SBIRI, BIPP and now Ignition Grant. These path breaking schemes will be the platforms for catalyzing the transformation of the Indian biotechnology industry into a bioeconomy, Dr Dash added.