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Gene Editing Tech Needs Enabling Policies to Be Useful in India

Gene Editing Tech Needs Enabling Policies to Be Useful in India

Representation of a helicoid strand of DNA. Credit: rafaelzajczewski/pixabay

Gene sequencing has enabled scientists to decipher how genes govern many characteristics of living organisms and empowered them to alter them genes to express some characteristics over others. For the first time, we can explore ways to correct defects in haemoglobin that lead to thalassemia before the affliction even kicks in. And this is just one application.

Obviously this is a powerful tool that can reshape the way society deals many issues of healthcare, food scarcity and the environment. Bill Gates, co-chair of the foundation named for him and his wife, Melinda, has written about gene editing’s potential to save lives and improve standards of living. His applications of choice include increasing crop productivity and engineering mosquitoes to eliminate malaria. At the same time, he also calls for more attention towards the policies undergirding the use of this technique.

A lesson from the past

All emerging technologies need enabling policies to ensure their outcomes are in line with the spirit of their promises. Like gene editing, vaccines were a breakthrough technology that doctors and scientists worked on through the 20th century. Today, vaccination is so successful that only clean drinking water rivals it in the ability to save lives. Vaccination has significantly impacted healthcare in India; the fight against polio exemplifies the sort of partnerships and data-driven policies needed to press healthcare tech into the service of society.

India’s anti-polio drive had been initiated by the Rotary Club, the Government of India and a clutch of funding agencies. The Centre ran the National Polio Surveillance Project (NPSP) jointly with the WHO. Data from the NPSP had shown that the contemporary trivalent vaccine was ineffective in Indian children, so officials subsequently adopted a newer bivalent vaccine. Funding from the WHO was used to procure the vaccine locally instead of buying it from international vendors.

The Government of India continues to organise the drive with the support of the Rotary Club, the WHO and UNICEF. It also organises two national immunisation days every year to create awareness and immunise nearly 172 million children. Camps are set up all over the country, with health volunteers running door-to-door campaigns, including those on trains to ensure children on the move are also covered. Mop-up teams then visit localities to confirm all children have been immunised.

The result of this enormous exercise: India was declared polio-free, with no wild poliovirus incidence having been reported since 2011.

This is a very good example of a bit of breakthrough technology, political will and data-driven policies coming together to create societal benefits. It also illustrates what it takes to tackle such problems: understanding the nature of the issue, responding with a specific strategy, creating awareness and monitoring outcomes. The story has a simple moral: technology may hold amazing potential but to deliver on that, it needs to be backed by agile policies. And this applies to gene editing as well.

Gene editing tech is still limited in India, so we will have to rely on solutions developed in other countries for domestic problems. These solutions may be expensive and also not entirely suitable for our specific needs. The government needs to improve infrastructure and access to funds, and spur innovation in this niche, and tie them together with well-defined policies to regulate its use. Moreover, the various applications of this tech have different potential benefits and risks associated with them, so a one ‘policy fits all’ approach won’t work.

Genetic diseases and vector control

A study published in September 2017 reported that 5% of children born in India have a genetic defect and recommended that translation research be mooted to find solutions. India’s current regulatory architecture is ambiguous, with different departments bearing overlapping responsibilities vis-á-vis reviewing research proposals. Such a setup delays research and decreases risk-taking behaviour in scientists and funding agencies. The US and (unsurprisingly) China have already taken the lead on this front.

First, India needs to reform its regulatory structure to expedite approvals and make it easier to conduct research. A consequent risk is that biohackers and quacks could exploit vulnerable people by providing unscientific or untested solutions. So regulations will have to balance the need for local solutions against the threat of pseudoscientific remedies, such as by designing time-bound approval systems and including relevant experts when reviewing proposed research.

We consulted with various stakeholders, including clinicians, scientists, patient-group representatives and lawyers, to design a pyramidal structure for smooth regulation of human applications. The framework proposes creating national-level working groups to lay down guidelines and local accreditation agencies to accelerate their implementation. Finally, it categorises research based on ethical and scientific considerations to ensure basic research can be promoted and translational research be regulated transparently.

Another potential application is the control of vector-borne diseases such as malaria and dengue. Conventional methods like fogging have not worked, and we need to try more innovative solutions to exert vector-control. One option is genetically modified mosquitoes. These mosquitoes have inheritable genetic modifications that either lead to loss of viability or render them incapable of hosting the disease-causing pathogen. A British company named Oxitec and the Tata Institute of Genetics and Society are currently conducting research in India on this subject.

However, unlike other genetically modified organisms, there is no mechanism to recall these mosquitoes once they have been deployed in the environment. There are also significant scientific risks associated with engineering the mosquitoes and their effective deployment is contingent on the availability of accurate disease data. As a result, an effective policy that would apply to this avatar of the technology should ensure proper mitigation measures are in place.

These are just two examples of gene editing’s potential to transform our future. It’s evident that all such applications together can drive India’s economic growth over the next decade to new heights. Moreover, the tech’s potential can only increase as we learn more about genes and associated molecular tools. However, if gene editing is to be just as transformative as the polio vaccine was, it will need to be supported by responsive policies, particularly at this early stage, that promote research as well as ensure applications are safe and well-tested. Risks associated with the technology can only be mitigated by setting high thresholds of acceptability, not by banning. Responsible use of gene editing could be just the remedy for some of India’s problems and – to quote Gates – it would be a tragedy to pass up on the chance.

Shambhavi Naik is a research analyst at the Takshashila Institution. She has a PhD in cancer biology from the University of Leicester.

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