Opinion

India needs a policy on synthetic biology

Balakrishna Pisupati | Updated on December 16, 2019 Published on December 16, 2019

Growing interest Today, we can not only create fully synthetic life but also edit the genetic make-up of available life   -  istock

This technology, of developing new life forms, is being pursued by industry despite there being no regulatory framework in place

The prospect that we would no longer need to slaughter animals for meat — it can be grown in labs using plants — seems an exciting green and low carbon footprint route. Burger King is testing this out with its Impossible Whopper in St Luis, US. And, we will not need the vanilla plant to make vanillin nor silk worms to produce silk. We will no longer need a life form to create another life. De novo synthesis of life is now possible.

We not onlycan create fully synthetic life but also edit the genetic composition of available life. This editing can now be done by students and amateurs with readymade kits in their homes and garages.

The power of emerging science is now in the hands of both scientists and the general public. Not just that, we are already making synthetic DNA based on demand. We can synthesise entire chromosomes for an order now.

Will society lead science?

India established the Department of Biotechnology during the late 1980s to harness the emerging science to the benefit of the country. However, there has been a long-standing lack of clarity and consensus among scientists, policymakers, industry, farmers and civil society organisations on how India needs to deal with genetic modification technology in areas like agriculture.

This is a cause of serious concern after decades of work in this area compromising research, investments and decision-making.

With the Department of Biotechnology and Ministry of Agriculture supporting promotion of this science and technology, and the Ministry of Environment, Forests and Climate Change dealing with approval for commercialisation of such new technology, India offers a classical example of how science-policy interface should or should not work.

On the one hand, those who are developing new technology are wary of India’s changing stance on use and protection of their technology while, on the other, the farmers are completely at a loss to comprehend how to increase productivity without having access to technology.

Now, let us focus on a recent development in science — creating life forms de novo. Termed as ‘synthetic biology’, research into developing organisms and products completely new to this world started taking roots decades ago. It was the Craig Venter Institute, US, that created the first artificial life form and called it ‘Synthia’ in 2010. In less than nine years, synthetic biology has caught the imagination of scientists and the industry’s market of $11 billion in 2016 is expected to grow to $100 billion by 2025.

Like any other technology, synthetic biology is an emerging science with possible positive and negative impacts. Countries like India are caught in the dilemma where the industry is pushing ahead with investments in developing organisms and products with almost no regulatory or policy oversight on the technology.

Foresight analysis

Technology foresight, like technology forecasting, is the generation of reasoned statements about the future. Major impacts of foresight belong to knowledge, network creation and promoting public engagement in policy-making. The scope of technology foresight comprises not only technologies and their applications but also public policies and societal challenges.

A conceptual framework for foresight analysis in synthetic biology — for a country like India — would comprise elements of anticipation, inclusion, reflexivity, and responsiveness. Such an approach is perhaps new for India that mostly works on reactive responses both in policy-making and legal framework development.

For example, Japan’s research and development into synthetic biology has been phenomenal during the past few years. In a country where the industry is seen as something orthogonal to academia, synthetic biology is changing the equations.

The foresight assessment of the technology has been carefully drawn, as is in Europe, to bring the elements of real opportunities and virtual problems.

It is surprising to note the number of interventions the private sector is undertaking to focus on product development using synthetic biology in India.

But, as of now there is no consolidated information on who does what, how, for how much, and when the technology will be commercialised with what policy prescriptions.

As many as 196 countries, under the aegis of the UN Convention on Biological Diversity (CBD), have been working for more than four years in providing a global framework to deal with synthetic biology in the context of its impacts on conservation and sustainable use of biological resources.

The results of these discussions, until now, indicate that global policy-making favours treating synthetic biology products and organisms on similar lines as living (read genetically) modified organisms. The definition of what constitutes synthetic biology is also provided for by the CBD.

India is yet to formally come up with its national strategy on synthetic biology — both policy and regulatory. In the absence of India undertaking a proactive approach to this technology, there is ample chance that we will end up having the same, if not more, contentious debates about synthetic biology organisms and products as those on genetically modified organisms.

 

At the minimum, India’s policy and regulatory framework needs to focus on the following: defining what constitutes the science of synthetic biology; what kinds of research and development priorities will be made for public sector; what will be the guidance for private sector in synthetic biology research in the future that considers all relevant policy frameworks, including those in intellectual property rights; and how India will regulate the development and use of this technology, considering issues related to environment and socio-economics.

If there is one thing natural about synthetic biology, it will be the issues that will be in public domain for decisions to be made based on the preparedness or the lack of it to pursue this science in India. The science is real and applications varied.

The writer, the chairperson of FLEDGE, is closely working on global policy issues related to synthetic biology

Published on December 16, 2019
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