- What is Synthetic biology?
- DIY Bio labs
- Ethical considerations
- Synthetic biology in India
- International scenario of Synthetic biology
India needs a policy on Synthetic Biology
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India established the Department of Biotechnology during the late 1980s to harness the emerging Synthetic biology technology to the benefit of the country. However, there has been a long-standing lack of clarity and consensus among scientists, policymakers, farmers and civil society organisations on how India needs to deal with genetic modification technology in areas like agriculture.
What is Synthetic biology?
- Synthetic biology is a field of science that involves redesigning organisms for useful purposes by engineering them to have new abilities.
- Craig Venter Institute in US created the first artificial life form ‘Synthia’ in 2010.
- Synthetic biology industry’s market of $11 billion in 2016 is expected to grow to $100 billion by 2025.
Redesigning organisms so that they produce a substance, such as a medicine or fuel, or gain a new ability, such as sensing something in the environment, are common goals of synthetic biology projects.
- Synthetic life: Synthetic life more ambitiously aims to recreate life from non-living (abiotic) components. Synthetic life biology attempts to create living organisms (such as bacteria) capable of carrying out important functions, such as detoxifying polluted land and water, Rice modified to produce beta-carotene that prevents vitamin A deficiency or Yeast engineered to produce rose oil as an eco-friendly substitute for real roses.
- Biological computers: An engineered biological system that can perform computer-like operations. They demonstrated that bacteria can be engineered to perform both analog and/or digital computation.
- Biosensors: an engineered organism that is capable of reporting some ambient phenomenon such as the presence of heavy metals or toxins.
- Cell transformation: Cell transformation is used to create biological circuits, which can be manipulated to yield desired outputs. i.e., make antimalarial drug by modifying yeast molecules.
- Space exploration: Synthetic biology could help to produce resources for astronauts from a restricted compounds sent from Earth.
- Access to food – Synthetic biology was viewed initially by the public as a tool to tackle food scarcity. But concerns exist that large corporations could patent developments, create monopolies and leave developing countries dependent on the West.
Application of Synthetic technology using CRISP-Case 9R and Gene Drive
- CRISPR-Cas9 is a unique technology that enables geneticists and medical researchers to edit parts of the genome by removing, adding or altering sections of the DNA sequence.
- It is currently the simplest, most versatile and precise method of genetic manipulation.
DIY Bio labs
- Do-lt-Yourself Biology, also known as “DIY Bio”, the movement of “citizen scientists” interested in synthetic biology experiments has become an international phenomenon over the last decade.
- Often with little prior knowledge of the field, enthusiasts meet in makeshift labs to take crash courses in biotechnology and conduct hands-on experiments Simple protocols found online.
Areas of Concerns
- While the production of small molecules using synthetically biotechnology at small scale is possible, these processes often do not translate well into mass production.
- The number of microbes that are currently in use for the production of synthetic biological materials is only a tiny fraction of the total diversity that exists in Nature.
- Many biological components complicated and unpredictable and lack of clear description. For instance, what are their functions? Will they behave differently under various laboratory conditions?
Leadership and Funding
- International Research Councils are seen to have a key role in this technology. However, there is concern that funding of such technologies could sideline ethical issues. Research Councils have to appoint the right leaders, in the right place and for the right reasons in relation to synthetic biology.
- There is a disconnect for scientists/engineers between the unremarkable nature of their own work and the transformative nature of the field as a whole. This highlights the need for scientists to think more carefully about the significance of their work.
- People expect that some work in synthetic biology will go wrong, so scientists/regulators should not claim to know everything. Scientists need more support in understanding potential impacts and in being more open about early research findings.
- Robust and independent regulation is key; the public did not trust a voluntary or self-regulation system.
- International co-ordination and regulation to control technology development in global markets is a major challenge.
- There is a need for an alternative to the ‘pipeline’ model of innovation where ideas are created in a lab, embedded in products and distributed to consumers. The public should be involved throughout, not just at the end.
- The innovation process needs to be more ‘thoughtful’. Research Council leaders, learned societies and Government should ensure research are informed by social values, not just led by technology.
- Larger and longer investment in Artificial Intelligence and Machine Learning systems to carry out biosystems modeling for Synthetic biology.
- The community needs to support efforts toward creating biosystem modeling and standards. Without standardization, the ability to pool data and models, essential for improving accuracy, will be challenging.
- Ensure that early career researchers are trained in responsible research conduct and ethics as well as being cognizant of existing rules and regulations around Genetic modification and the issue of misuse and harm.
- Coordinate the efforts of academia, government and industry through focused meetings that foster interdisciplinary collaborations.
- Improve platforms for knowledge sharing and recognize the value of failures.
- Scalability needs to be incorporated into the initial design of synthetic biology process by including features, for example, that reduce toxicity of the synthetic molecule in production.
- There has to be a Universal Production System that permits the testing of new bio-synthetic products. This would aid in the identification of optimal production platforms and decrease the need for organism-specific technologies.
- Cell-free environments, interfaced with semiconductors, offer a powerful route for flexible and controllable production systems. For example, nanoparticles made of semiconductor materials can be used to enhance enzyme activity in a cell free environment. (Cell-free system is widely used to study biological reactions that happen within cells, thus reducing the complex interactions typically found when working in a whole cell).
- Scientists, their host institutions and funding bodies should consider whether the research planned on synthetic biology could be misused.
- Synthetic biology is an example of a dual-use technology: it promises numerous beneficial applications, but it can also cause harm.
- Some argues that synthetic biology poses an existential risk. However, counter argument is: ‘Many new technological advances across the decades have met similar concerns, but later proved wrong in most cases. The uncertainty and remote possibility of such risks could hamper the development of useful technology’.
Common ethical questions include:
- Is it morally right to tamper with nature?
- Is one playing God when creating a new life?
- What happens if a synthetic organism accidentally escapes?
- What if an individual misuses synthetic biology and creates a harmful entity (e.g., a biological weapon)?
- Who will have control of and access to the products of synthetic biology?
- Does the patent system allow patents on living organisms? What about parts of organisms, like HIV resistance genes in humans?
- What if a new creation is deserving of moral or legal status?
Most ethical issues associated with synthetic biology are not considered anything new. Similar issues have surfaced for recombinant DNA and genetically modified organism (GMO) technologies.
Synthetic biology in India
- 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.
- A conceptual framework for the potential future implications of synthetic biology, for a country like India, would comprise elements of inclusion and responsiveness of public. Such an approach is perhaps new for India that mostly works on reactive responses both in policy-making and legal framework development.
- Moreover, it is surprising to note the number of interventions the private sector is undertaking to focus on product development using synthetic biology in India.
What India’s Synthetic biology policy should cover?
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.
International scenario of Synthetic biology
- 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 sustainable use of biological resources.
- Although there is no universally agreed upon definition of the term ‘synthetic biology’, the 2016 Conference of the Parties (COP) to the Convention on Biological Diversity defines Synthetic Biology as
“A further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems.”
- Japan’s research and development into synthetic biology has been phenomenal during the past few years.
- The foresight assessment of the technology has been carefully drawn, as is in Europe, to bring the elements of real opportunities and virtual problems.
Synthetic Biology offers innovative approaches for engineering new biological systems or re-designing existing ones for useful purposes.
With the Department of Biotechnology and Ministry of Agriculture supporting promotion of this science and technology, and the Ministry of Environment dealing with approval for commercialisation of such new technology, India offers a classical example of how science-policy interface should or should not work.
However, India is yet to formally come up with its national strategy on synthetic biology. In the absence of such strategy, there is ample chance that India might end up having the same contentious debates about synthetic biology organisms as those on genetically modified organisms.