The state biotechnology coordination committees SBCCs of each Indian state rely on other state bodies, such as pollution control boards and health authorities, to inspect, investigate, and take punitive action in cases of unsafe biotech activities. They monitor research institutions and companies engaged in the genetic manipulation of microorganisms, plants, or animals to examine whether they are following stipulated safety regulations and the conditions tied to GEAC approvals for field and clinical trials.
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They also do post-release monitoring of GM products for a period of at least three to five years to avoid unforeseen risks. District-level committees do similar work within their respective jurisdictions, visiting biotech installations and regularly submitting reports to SBCCs or the GEAC. Likewise, when it comes to biosimilars, state drug regulatory bodies exercise wide-ranging powers.
Regulatory bodies need to coordinate effectively among themselves and must be aware of innovations happening in the biotech space early on, so that appropriate regulatory adjustments can be made in a manner conducive to both innovation and safety. Unfortunately, the current Indian regulatory system is characterized by divided roles and responsibilities based on the diverse applications of biotechnology rather than integrated, coordinated action within a holistic, well-tailored ecosystem.
There was overwhelming evidence of this issue in a report of the Committee on Agriculture headed by Basudeb Acharia. As a result, Indian biotech firms seeking to establish themselves in rapidly advancing sectors are too often hamstrung by bureaucratic delays and poorly defined regulatory processes.
As observed by the expert committee constituted by the Ministry of Health and Family Welfare in , the CDSCO has been plagued by a lack of functional and financial autonomy, poor infrastructure, and the adequate manpower to perform its role as the central drug approval body. Similarly, the pharmacovigilance machinery to inspect the safety of already approved drugs, mostly through state regulatory bodies, is in need of technical and skill upgrades.
On top of these barriers, incomplete and sometimes skewed societal understandings of biotechnology and its consequences have contributed to a contentious political atmosphere in India that is often not supportive of the biotech industry. Since agriculture comes under the jurisdiction of states in India, state governments wield significant influence over trials and the commercial cultivation of GM crops.
Bt cotton, approved for commercial cultivation in , remains to date the only crop to receive such approval. The polarization of views and opinions around biotechnology has left little room for healthy and balanced appraisals.
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As a consequence, states long refused to even offer a regulatory pathway for testing other GM crops. But after seven years, the status of Bt eggplant still stands where it was left in , and the GEAC has provided no clear path for securing approval. Recent developments indicate that GM mustard may also be headed in the same direction. A public interest litigation case initiated before the Supreme Court of India by an anti-GM campaigner has delayed approval from the GEAC, which was inclined to approve commercial cultivation of the crop.
Examples abound, including the granting of patents pertaining to the healing properties of turmeric and the fungicidal properties of the neem plant, in the United States and the EU respectively. Consequently, this act has painted India as unfriendly toward scientific innovation in the biotech space and even compelled some Indian biotechnology companies to relocate abroad.
Unless India seeks ways to address the problems plaguing its biotech sphere, growth in this sector will likely continue running into sizable roadblocks. A flourishing Indian biotech sector supported by a sound regulatory environment and a supportive political atmosphere, in turn, would help New Delhi build a foundation to become a more prominent voice in global governance discussions pertaining to biotechnology.
One promising step would be for New Delhi to strive to create a legal and financial ecosystem that will nurture innovation and growth while limiting regulatory hold-ups. India needs a proper balance between strategic research, product planning, and the liberalization of regulatory frameworks to support biotech growth. To improve bureaucratic outcomes, New Delhi must strengthen its regulatory capacity.
The best solution may be to establish an independent or statutory body with the authority to regulate biotech research as well as the transporting and importing of biotech products. In the absence of such a sweeping overhaul, the government should at least augment the capacities of and facilitate greater coordination among existing institutional bodies like the RCGM, GEAC, and DCGI so as to minimize bureaucratic delays. Mashelkar, proposed one possible solution when it recommended the creation of an independent National Biotechnology Regulatory Authority NBRA , which would offer a single professionally managed mechanism for the various clearance processes across different verticals in the biotech industry.
As of now, both these ideas remain unimplemented. There was even a parliamentary bill initiated to create such an entity in , which subsequently lapsed. India also needs strong legal and regulatory frameworks to address emerging critical issues arising from new innovations in the biotech space, such as big data analytics. The bioinformatics boom is a function of technological advances in genomics, cloud computing, data analytics, artificial intelligence, and machine learning. At its core is the availability of significant data tranches coupled with analytic capabilities.
Structural regulatory reforms would likely be more impactful if they are accompanied and complemented by broader societal input on issues related to biotechnology. India needs a more expansive domestic discourse on a range of issues that affect biotech governance—from the ethics of deploying new technologies to flexible efforts to adopt to the changing balance of influence on biotech issues among states and nonstate actors.
New Delhi needs to draw in the biotech industry as well as the legal and strategic communities to strengthen interactions with the bureaucratic and political classes to cope with the extraordinary challenges and opportunities that biotechnology is ushering in.
A comprehensive domestic discourse involving a wide range of stakeholders would enable India to chart a path to obtain the greatest possible benefits from these developments in a sustainable and legal manner. A committee on the biotech economy, constituted by the Department of Biotechnology, and comprising researchers, policymakers, industry players, and members of civil society, must be created to enhance synergies and make central- and state-level policies and regulations both coherent and consistent.
A bioeconomy information system and observatory, along the lines of a three-year experiment in the EU, 98 may also be established to regularly evaluate research and innovation, the interactions between policies and actors, and market competition across biotech verticals and update strategies accordingly. The exchange of ideas and information is imperative for ensuring that biotech research and development is carried out in a sustainable manner. Additional outreach efforts such as national biotech conferences should be held regularly to discuss advances in modern biotechnology and regulatory hurdles to researching and commercializing such advances.
It is only through ongoing regular dialogues with multiple stakeholders including bioethicists, lawyers, industry players, and researchers that efficient regulatory mechanisms compliant with good manufacturing practices can be formed. This, in turn, could present new avenues for contract research and manufacturing services, which could spark further growth in the bioservices sector.
More energetic public outreach on issues related to biotechnology is also vital. The emphasis must be on communicating about biotechnology with the general public in comprehensible terms. Conducting public awareness campaigns in print and electronic media as well as modifying school curricula may be the initial steps toward making public discourse on biotech issues science-based rather than emotionally driven; this may eventually help lessen public opposition to biotech and the political pressure this can cause.
Aspects of global governance pertaining to biotechnology have become particularly salient as the rapid pace of innovation in India and around the world has also heightened the global challenges that such advances pose. The issue of how to regulate biotechnology globally came to the fore in the s and, over the years, this has given rise to a number of international legal instruments. These instruments broadly deal with three distinct sets of challenges: the protection of genetic resources and biodiversity, the regulation of biological weapons, and the management of international trade in GM products.
Broadly speaking, there have been a few successes especially in the case of biological weapons , but elements of this patchwork of legal instruments suffer from three major shortcomings. Existing legal instruments have not included adequate enforcement provisions to protect the interests of developing countries. While the Nagoya Protocol, a supplementary agreement to the Convention on Biological Diversity, does address the issue of fair and equitable sharing of benefits from products developed through genetic manipulation, it has not been as effective as one would hope.
Consequently, while biotechnology can help states move toward achieving economic and environmental sustainability in a globalizing world, there is a fear that a few multinational firms in technologically rich states will enjoy a disproportionate degree of power over access to food and other critical resources. The outsized control of vital biotech innovations by such companies has been a source of significant tension in developing countries, including India.
When coupled with the continued commercialization of vital genetic and biological resources of the developing world, this reality has two major implications for global politics: If the world comes to increasingly rely on seeds and technologies developed and controlled by such companies, the food security achieved in much of the developing world, including India, after immense struggles and investments could be undermined. The second area where global governance must be improved relates to the security dimensions of biotechnology, which existing legal mechanisms may not be in a position to deal with comprehensively.
In a worst-case scenario, advances in biotechnology, genetics, and genomics could theoretically result in a new form of militarized eugenics, whereby certain individuals, or a small section of people carrying a certain genetic strain, could be specifically targeted. Furthermore, the falling costs of bioengineering using technologies like CRISPR may level the playing field between states and nonstate actors to a degree.
If such technologies were to get into the hands of extremist or terrorist groups, the nature and scale of potential harm would be almost unimaginable. The security dilemmas posed by the potential weaponization of biotechnology have already caught the attention of the United States; James Clapper, then U. Traditionally, India has taken a hard stance against biological weapons; however, it remains to be seen how New Delhi might react to the possible developments discussed here. Third, the ability of existing multilateral legal instruments to respond to rapidly emerging biotech-related ethical dilemmas is unproven.
Take for example, the recent creation of a pig embryo injected with human stem cells that, when fully developed, will be able to grow organs containing human cells.
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But the creation of a part-human, part-animal creature throws up a number of fundamental ethical and regulatory questions that cannot be answered by the existing regime. Similar questions are being raised by advances in gene-editing technologies; this may facilitate the genetic modification of embryos, which could eventually lead to the birth of so-called designer babies, in effect allowing people to artificially enhance their capabilities.
These issues of gene editing directly relate to the existing technology gap between a handful of rich nations and the rest of the world. If, for example, gene editing is used to enhance the capabilities of citizens in countries that have the technical and financial resources to do so, then actual biologicaldifferences could arise between the citizens of these countries and the rest of humanity.
Reconciling these issues under existing international agreements would be very difficult, and the only means of addressing this challenge is likely to provide for new ways of consensus building among relevant actors. The inadequacies in these current international frameworks underscore the need for a new set of global conversations that not only take into account the evolving issues likely to be faced in the future but also address the leading questions of today.
Beyond traditional actors like states, the stakeholders in these new conversations must include pharmaceutical companies, universities, research laboratories, and nongovernmental organizations from both developing and developed countries, along with proprietors of traditional knowledge, including indigenous peoples. Such a multi-stakeholder model would mean acknowledging the diversity of issues present in this field and would allow everyone who has a stake in the outcome of such global discussions to have a voice at the table.
The multi-stakeholder model that internet governance is moving toward could possibly be emulated for the case of biotechnology. Given these pressing concerns, India has an urgent interest in shaping new potential global regimes pertaining to biotechnology. As a global biodiversity hotspot, and as a potential beneficiary of these technologies, India must actively engage in shaping governance regimes that account for its interests.
These interests primarily include protecting indigenous bioresources and related knowledge, equitably sharing technological know-how, and preventing these technologies from falling into the wrong hands. And, as previously mentioned, India must also focus on providing a stable and open domestic ecosystem for biotech innovations. Yet, over the last few years, some have begun attempting to correct this orientation, as India has started instead presenting itself as a responsible power seeking to contribute to and manage the global order.
To this end, beyond the aforementioned ways that India could seek to improve its domestic regulatory environment and convene a comprehensive domestic dialogue on biotechnology, there are other steps that India can take on the international stage to improve its position on issues related to biotechnology. For instance, India can try to leverage its position as a major developing country to advocate for a more equitable worldwide distribution of the technical knowledge and potential gains of biotechnology.
With the global biotech industry currently focused on accelerating productivity, collaboration is a plausible way forward for countries faced with resource constraints.
1 Biotechnology: Old and New
With an abundance of high-quality, low-cost, technical human capital and a relatively advanced commercial biotech sector, India could conceivably become a partner of choice for stakeholders from developed and developing countries alike. The task is to foster an environment that encourages India to continuously improve its domestic strengths in collaboration with others and use that strength to shape global rules of the road. One issue to keep in mind here is that such international collaboration should not provide an impetus for bio-piracy or the undue transfer of genetic resources outside the country.
India has, in the past, been subject to instances of bio-piracy, including infamous examples involving Basmati rice and turmeric. Despite its limitations, the TKDL could potentially be at the front lines of ensuring that genetic research collaboration does not take place on terms that are detrimental to India, and therefore the Indian government should consider giving it greater support. These problems at least partially stem from a lack of clear biotech-related definitions in international mechanisms for protecting IP. A further issue is that these IP protections have expired.
Tellingly, Article 27 3 , which deals with the patentability of microorganisms, was introduced with a short shelf life, and its terms were supposed to come up for review only four years after TRIPS came into effect. That this review never happened indicates strong differences over this issue and the need for clarity as to when renewed negotiations should commence in earnest. After all, bilateralism between countries that own technology in this space and other countries that do not could accentuate the division between technological haves and have-nots, whereas a multilateral approach would allow developing countries to exercise greater collective negotiating power and perhaps level the diplomatic playing field considerably.
The treatment of data being gleaned from the field of bioinformatics and the intersection of biotechnology and big data would also benefit from having global standards, which India could help shape. There is currently no global framework for vital matters such as nondiscriminatory deep-learning algorithms; privacy-by-design architecture; or norms for data acquisition, storage, distribution, and analysis. Leadership in this arena would help guarantee beneficial, data-driven solutions while hopefully safeguarding against truant actors who may be tempted to handle genetic data irresponsibly.
It may take a great deal of time to improve global standards on various aspects of biotech and the prospects for success are uncertain. In the meantime, India can also do more on its own to spur domestic innovation as a way to reduce its dependence on biotech materials from other countries. For instance, Radhakrishna Pillai, the director of the Rajiv Gandhi Center for Biotechnology, observes that basic biotech research in India still depends almost exclusively on imports of molecular biological enzymes, monoclonal antibodies, cell lines, serums, experimental animals, and key reagents.
This dependence is expensive and considerably slows the pace of innovation and research in India. To overcome this limitation, Pillai recommends that the Indian government invest in developing the necessary infrastructure, along with seed capital and tax breaks, to push scientific researchers out of their comfort zones and spur them to develop their own domestic business ventures. As for the threat of biological weapons, India is party to the BWC and has stated that it has no intention of developing such weapons.
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The United States, however, presumably fearful of international interference with its own biological defense program, seemingly scuttled these talks and the additional protocol. With formal efforts to strengthen and update the BWC effectively stalled, India must not shy away from studying the possible implications of the weaponization of new developments—including CRISPR and gene editing. These advances, by their very nature, are dual-use and cannot be easily equated with more easily distinguishable weaponized applications, such as anthrax. There are potential military and strategic benefits that can be derived from these technologies that may not fall afoul of existing international norms, and India should actively undertake and encourage research on these particular technical aspects until new norms specifically dealing with these developments are adopted.
In all of these areas, it is therefore necessary for an honest and open global conversation to take place on recent developments in this biotech sector among a wide range of stakeholders. A consensus-based approach to the global governance of biotech that is equitable, just, and fair may emerge out of such a conversation.
Any such global regimes would need to be necessarily open to further changes, while ensuring that safeguards exist against the potential misuse of these technologies. Biotechnology is among a handful of technologies, along with artificial intelligence and quantum computing, that will likely redefine human society in the twenty-first century.
The avenues it will continue to open up, both positive and negative, are staggering. If India is to become a leading power in the coming decades, it is imperative that it begin to grasp the immense possibilities and implications of recent developments in biotechnology. Mayekar et al. Sammut and Daniel S. Ghosh Berlin: Springer, , 1, Department of Agriculture Foreign Agricultural Service, 5, February 9, statement of James R.
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