Shambhavi Naik is a Research Fellow with Takshashila’s Technology and Policy programme.
Shambhavi has a Ph.D in Cancer Biology from University of Leicester, UK and over 3 years of experience as a PostDoctoral Fellow at NCBS and InStem, Bangalore. She has a PGP in Public Policy from the Takshashila Institution. Shambhavi’s research covers India’s policies in areas of emerging technologies, with a focus on healthcare and higher education. Shambhavi tweets at @TheNaikMic
Gene Editing Tech Needs Enabling Policies to Be Useful in India
The Wire; 31 May 2018: All emerging technologies need certain policies to ensure their outcomes are in line with the spirit of their promises.
Livemint; 07 Mar 2018: India’s current regulatory architecture needs to be restructured to optimize trial approval time while addressing safety requirements
Pragati; 11 Dec 2018: Indian regulation will have to make a decision to either toe the line on gene editing or turn to options that could address its huge healthcare problem.
Nature India; 29 Nov 2018: In the backdrop of genetic modification experiments in China, India needs to set up guidelines to promote ethical research in India
Pragati; 02 May 2018: Genetically modified mosquitoes are being prepared to tackle regular mosquitoes. But we need to proceed with caution.
Time for India to Set up a Framework to Use Gene-Editing Tech in Its Farms
The Wire; 25 Aug 2018: If India classifies genetic editing as gene modification, we will be signalling our unwillingness to participate in the genetic editing race, whose winner will clearly hold the key to development in the 21st century.
Pragati; 13 Nov 2018: Early detection and a robust healthcare infrastructure are necessary preparation for biological warfare. And guess what — we need those anyway.
Firstpost: India remains vulnerable to disease outbreaks—natural or intentional—and should invest in biodefence capabilities.
Institute for Defence Studies and Analyses CBW Magazine, January-June 2019, Volume 12, Cover Story, Issue 2.
DNA Technology Bill 2018:
Firstpost: The Bill is a potpourri of good intentions—but aims at governing too much
Caution on DNA Bill: raise awareness first
Deccan Herald; 26 Oct 2018: To instill confidence in the technology, ease its implementation and ensure protection of people’s rights, perhaps a staggered approach would be beneficial than the all-out approach suggested in the Bill.
Nipah outbreak in India:
Pragati; 28 May 2018: A short essay on the information coming out of Kerala in the midst of the Nipah outbreak.
Business Standard; 24 Aug 2018: The lessons from Nipah are clear – we need quick and efficient diagnosis to contain infectious diseases
Policies affecting Indian science researchers:
IndiaBioscience; 07 Sep 2018: Postdoctoral fellows form the mainstay of research activities in many parts of the world, yet are curiously under-utilized and under-funded in Indian institutes. In this article, we examine possible causes and propose solutions to India’s persistent problems with retaining and attracting quality postdoctoral talent.
IndiaBioscience; 18 Feb 2019: Megha and Shambhavi Naik discuss the implications of a recent memo from DST incentivizing publication and patents by doctoral research scholars through a monetary reward.
Policies affecting agriculture:
Pragati; 14 Aug 2018: India should look at the merger between Monsanto and Bayer as an opportunity, not a problem.
Firstpost: Should laws protect the intellectual property of companies in particular cases where the breeder is also the end buyer?
Pragati; 14 Feb 2018: India lacks Scientific Temper. It is up to our scientists to change this through dialogue and discussion. If they do not engage with society at large, they do a disservice to science.
Panacea for Cancer:
Executive summary: Gene editing offers many benefits. They range from basic research that can enhance the scientific understanding of gene functions to practical applications like improved healthcare and agricultural production. At the same time, like other developing technologies, gene editing is not without its limitations and problems.
Guided by a few core principles, this discussion document develops a framework to analyse gene editing technologies. The paper explores three broad categories, corresponding to the stage of development of the technology: Fundamental R&D, Commercial R&D and Commercialisation. Each of these groups requires a different governance principle. This idea is used to develop a three-level framework, as set out below.
a. “Laboratory” Stage (Fundamental R&D) – Compliance with Standards.
Research organisations free to conduct lab experiments as long as they adhere to scientific standards and protocols for different technologies. Government to set standards in collaboration with research and industry groups.
b. “Trial” Stage (Commercial R&D) – Subject to Approval.
Clinical/open field trials on a demonstrated product cannot be carried out without prior approval. The approval will be granted by an agency based on standards set by the government in collaboration with research and industry groups.
c. “Public Release” Stage (Commercialisation) – Verification of Safety.
Product can be sold on the market only after government has independently verified that the product meets safety and disclosure standards.
A vital feature of this framework is that there is no absolute moratorium on any technology. Instead, it provides for safety checks at each stage which become increasingly rigorous as the technology/application gets closer to being released to the public. Its primary goal is to ensure that the regulatory environment is conducive to scientific progress. As such, the framework would allow India to harness the benefits of gene editing while keeping risks in check.
The implementation of such a framework, which separately regulates laboratories, trials and public releases of gene editing technologies could take many forms. One such form would be the creation of independent accreditation firms that would implement safety standards at the Laboratory Stage and approve the trials of gene editing research. These safety standards as well as the parameters on which approvals are granted would implement standards set by a Gene Editing Authority. This authority would also be in charge of setting safety protocols for laboratories and regulating the public release of gene edited products. This framework allows timely approvals while still keeping risks in check. However, a detailed discussion of implementation pathways is left for future work.
Executive Summary: This Blue Paper was prepared as a result of a roundtable discussion organised by the Takshashila Institution on 15 December 2017, based on the Discussion Document: A Framework for Governing Gene Editing.
The discussion document developed an analytical framework to differentiate gene editing technologies into three broad categories. Each of these categories corresponds to the stage of development of the technology: Fundamental R&D, Commercial R&D and Commercialisation. Each group requires a different governance principle; the document thus envisages a three-level framework to govern all types of gene editing technologies.
The roundtable discussion was convened to dissect the discussion document within the specific context of human gene editing. There is a need to have a clear regulatory position on this type of gene editing in order to hinder malfeasance as well as reduce India’s significant disease burden. This will only happen if there is an environment that is conducive to research that still effectively addresses all the risks. The discussion, which was chaired by Dr. Vijay Chandru, ranged from what protocols and standards should be followed by researchers to what exceptions should be given to treatments for orphan diseases.
The Blue Paper highlights the recommendations of all participants at the roundtable discussion, which was chaired by Dr. Vijay Chandru.
Executive summary: Gene drives are being explored for alleviating vector-borne infectious diseases however, the risks of employing them need to be understood. This Slidedoc assesses the potential use of gene drives in India by performing a stage-wise risk assessment of deploying gene drive.
Gene drive mosquitoes are an application of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology. The application is to develop mosquitoes that decrease the incidence of mosquito-borne diseases.
Research into gene drives should be promoted however, there are risks associated with their potential use in India. Given the nature of the technology, it is recommended that robust monitoring mechanisms for disease incidence, mosquito burden and ecological impact be implemented before deploying these mosquitoes.
Data driven decisions on identifying the type of gene drive and deployment locations will ensure effective use of the technology.
Gene editing, synthetic biology, and improved delivery systems have reinvigorated the attention to biological weapons. Furthermore, the Biological Weapons Convention has repeatedly failed to agree to a verification mechanism, giving rise to suspicions that state actors may still be experimenting with biological weapons. Further, non-state actors have also dabbled with biological weapons, with isolated reports of incidences in recent decades.
This discussion document assesses three major impacts of new technologies on biological weapons. Firstly, increased access to scientific methods, resources and reduced barriers to scientific expertise has led to the proliferation of bioweapons to non-state actors. Secondly, advanced knowledge of biology and programmable-delivery weapons has converted biological weapons from a weapon of mass destruction to a covert targeted weapon of tactical importance. Finally, in light of these developments, existing preventive measures have become inadequate to curb the threat of biological warfare.
This discussion document recommends:
Ep 84: From Academia to Entrepreneurship with Dr Vijay Chandru
Ep 61: The Many Indian Genomes with Dr K Thangaraj
Ep 24: Editing our Genes with Madhav Chandavarkar
Puliyabaazi: Ep 36: ज़िन्दगी की चाबी A hindi podcast on the history of genetics and the future therapeutic uses of gene editing.