SHRUTI SHARMA
Infectious diseases such as COVID-19, the disease caused by the novel coronavirus; severe acute respiratory syndrome (SARS); Middle East respiratory syndrome (MERS); and the diseases caused by the Ebola, Nipah, and Zika viruses have exposed countries’ susceptibility to naturally occurring biological threats. Even though scientists from multiple countries concluded that the virus responsible for the coronavirus pandemic shifted naturally from an animal source to a human host,1 the international community should not ignore the possibility of pathogens escaping accidentally from research labs and threats of deliberate manipulation to create more dangerous bioweapons.
India is especially vulnerable to such infections because of its geographical position, large population, low healthcare spending, minimal expenditure on research that benefits public health, weak coordination between central and state health authorities, limited involvement of private actors, poor awareness of biosecurity, and the rickety state of public health infrastructure. Most recently, COVID-19 has revealed the deep fault lines in India’s public health infrastructure, including a shortage of healthcare workers, lack of trained epidemiologists, scarcity of medical equipment, poor access to healthcare facilities in rural areas, and inefficient disease reporting and surveillance in most states. The pandemic should therefore be a wake-up call for India to assess gaps in its public health infrastructure and divert its resources toward the healthcare sector to prepare itself for both natural and man-made biological emergencies.
Like any country, India faces three major biological threats: naturally occurring infections in humans or animals, or agricultural infestations; infections arising from accidental release of pathogens into the environment; and possible outbreaks caused by deliberate weaponization of dangerous pathogens that affect humans, animals, or crops. These threats—either alone or together—will force India to strengthen its capacity to detect and respond to them.
Shruti Sharma is a research analyst with the Technology and International Affairs Program at the Carnegie Endowment for International Peace. She works primarily on the safety, security, and ethical implications of emerging biotechnologies.
In all of this, there is a further challenge to wisely manage the trade offs between regulations to reduce the risks of accidents and attacks, on the one hand, and on the other, policies that enable government, scientific researchers, and industry to develop and market beneficial applications of biotechnology. Breakthroughs in biotechnology will be necessary to treat or vaccinate people against naturally occurring diseases as well as to detect and counter potential human-made threats and their consequences. This means researchers, businesses, regulators, media platforms, nongovernmental organizations, and voters must strive to educate themselves and their audiences or constituencies about possible threats and about the socially beneficial ways to prevent and manage them.
This paper addresses these varied challenges faced by India. It is based on interviews and informal conversations with leading government officials, scientists, academicians, and private-sector experts, as well as insights from workshops, roundtable discussions, and extensive literature review. Given India’s vulnerability to infectious disease outbreaks, the goal is to provide all stakeholders and the Indian public with an understanding of the biological risks facing India and the existing policies and involvement of various agencies working to enhance safety, security, and responses to threats. The paper further provides a brief assessment of how these policies are being implemented today and the scope of enhanced and better implementation in the future. The aim is to highlight the vital roles that bioscience, technology, and industry can play to advance the well being of Indian citizens while reducing risks of natural or human-induced afflictions.
THREATS AND RISKS
Naturally Occurring Infections
Given India’s climate conditions, the country is vulnerable to vector-borne diseases such as malaria and dengue fever, among others.
A high-density livestock population and a poorly guarded animal-human interface make India susceptible to zoonotic infections such as avian influenza, commonly called bird flu; pig influenza, commonly called swine flu; Nipah virus disease; and coronavirus diseases, such as COVID-19.
Poor patient adherence to antibiotic treatment, nontherapeutic use of antibiotics to promote growth in farm animals, self-medication, and illegal over-the-counter access to antibiotics makes antibiotic resistance an emerging health threat that demands immediate policy attention.
Safety Concerns
India has multiple laboratories with different biosafety levels (BSLs) set up across the country. Although new biosafety guidelines issued by the Department of Biotechnology (DBT) mention certification and validation for the higher-standard BSL-3 and BSL-4 labs, the country lacks accredited government or private agencies to certify and validate the lower-standard BSL-2 laboratories’ compliance with safety rules.
In interviews, some scientific experts emphasized that the sudden ban on plastic in India in 2018 has made it difficult to use autoclavable plastic bags to dispose of laboratory waste. This has complicated the implementation of the proper disinfection protocol to dispose of biomedical waste, posing a serious biosafety hazard.
Unforeseen infection of laboratory personnel or the accidental release of pathogens or other biological materials from designated laboratories, either due to negligence or poor understanding of biosafety protocols among laboratory workers.
Deliberate introduction of genetically engineered organisms for beneficial purposes might have unintentional harmful consequences.
Security Concerns
Disease-causing pathogens are abundantly available in nature. Technologies needed to manipulate them are becoming more easily accessible. Actors with nefarious designs could purposefully weaponize such technologies and naturally occurring pathogens.
India is vulnerable to zoonotic diseases. Naturally occurring zoonotic pathogens can be manipulated in the lab to enhance their virulence, transmissibility, and/or resistance to therapeutic interventions.
Because India shares porous borders with most of its neighboring states, the possibility of cross-border infections is another major biological threat.
In addition to manipulating pathogens that affect human health, bad actors could release naturally occurring invasive pathogens or synthetically created pathogens or pests to weaken the agricultural supply chain.
SAFETY AND SECURITY REGULATIONS AND POLICIES
To address safety and security risks, India follows two different approaches—biosafety and biosecurity. Biosafety seeks to protect humans from pathogens while biosecurity protects pathogens from humans.2 Though these two concepts and practices reflect diverse scenarios and mitigate different risks, they complement each other. Robust implementation of biosafety protocols, in addition to reducing the risk of accidental exposure, limits risks of intentional theft or misuse.8
Biosafety regulations in India are defined under the 1986 Environment Protection Act, with implementation broadly distributed between the Ministry of Science and Technology and the Ministry of Environment, Forest, and Climate Change (MOEFCC). These regulations have three aims:
To prevent biological materials from escaping designated places in laboratories
To prevent laboratory workers from unintentional exposure
To prevent unintended consequences when genetically modified organisms are released purposefully into the environment
Like biosafety, biosecurity regulations in India, although not clearly defined and categorized, empower different ministries or agencies that are responsible for sectors usually associated with human health, food safety, agriculture, livestock, and the environment. As no uniform definition of biosecurity exists globally, the concept differs across human, animal, and plant health sectors. Biosecurity for public health often refers to “the protection of microbiological assets from theft, loss or diversion, which could lead to the inappropriate use of these agents to cause public health harm.”4 However, because biosecurity for plant and animal health entails protecting biological resources from foreign or invasive species,5 regulations in India are broad enough to cover four major aims:
To prevent unauthorized or ill-conceived release of naturally occurring biological agents
To prevent cross-border entry and movement of dangerous pests and pathogens
To prevent theft or acquisition of sensitive research, organisms, and information for nonlegitimate use
To prevent weaponization of pathogens by both state and nonstate actors
IMPLEMENTATION
Even though India has enacted laws and regulations to protect the country from biological threats, the coordination and monitoring of their implementation remains irregular.
For the first category of biological threats—diseases emerging from natural sources—India has invested in a public health infrastructure and has various laws and guidelines that drive preparedness and response to naturally occurring disease outbreaks. However, India’s response to the avian influenza, Nipah virus disease, and COVID-19 has exposed the country’s rickety public health infrastructure, poor disease surveillance network, inadequate coordination between ministries to prevent zoonotic infections, absence of a national policy on biological disasters, and dismal investment in scientific research. Rather than using the time between outbreaks to develop national guidelines to tackle infectious diseases, India mostly relies on ad hoc notifications and guidelines, along with World Health Organization (WHO) advisories.
For the second category of threats—diseases caused by accident—India has developed comprehensive biosafety guidelines to monitor the safety of biotechnological research. Although implementation of biosafety guidelines falls under the ambit of the Ministry of Science and Technology and MOEFCC, researchers often work in labs supported by the Indian Council of Medical Research (ICMR) and the Indian Council of Agricultural Research, which are research bodies set up under the Ministry of Health and Family Welfare (MOHFW) and the Ministry of Agriculture and Farmers’ Welfare. The multiplicity of organizations operating under different ministries makes it difficult to ensure implementation of biosafety guidelines across the country. Moreover, the system often experiences poor coordination between center and state regulatory units. In addition, some experts interviewed during the project note that while scientists or researchers perform all necessary safety tests before approaching the regulatory authorities, the approval agencies, perhaps influenced by activist groups, perform additional safety tests that delay the clearance of such products.6 Whether such additional tests are necessary or not is often disputed.
For the third category of biological threats—threats emerging from intentional sources—India has no specific biosecurity policy or legislation but has a multiplicity of regulations that address threats emerging from different sources. However, entities set up under different ministries with inadequate collaboration among them leaves India vulnerable to a variety of foreign threats. While security agencies, such as the National Security Council Secretariat, are responsible for investigating a security threat, response to an event is often coordinated by civilian ministries.7 Because threats emerging from biological sources have a technical component, security agencies often include experts from other government departments, such as the Defence Research and Development Organisation, for their scientific inputs. Some experts, however, highlight that biosecurity discussions are mostly confined to closed policy circles and rarely involve experts from outside the government, leading to poor nationwide biosecurity awareness in India. Further, most regulations cover the export and import of pests and pathogens but do not adequately cover commercially ordered (mostly through e-commerce platforms) deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequences that may encode virulent genes. At present, biosecurity regulations often empower customs officials as the only authority that can check the baggage of incoming passengers. But most customs officials are inadequately trained to identify specific pests or pathogens. In addition, there seems to be no systematic assessment of vulnerabilities in the existing system nor development plans and methodologies to build a sustainable, functional, and well-equipped system to counter biothreats.
Beyond the need to prevent outbreaks caused by safety and security lapses, any system must also be able to respond to threats whether they occur through human action (and inaction) or through natural processes. Although security agencies require time to investigate if an outbreak is natural or man-made, the mitigation strategy to tackle the threat must be prepared in advance and implemented immediately after detection of an outbreak.
MAJOR RECOMMENDATIONS
As the spread of infectious diseases is a long-term, continuous, and evolving threat, India may need an agency specifically responsible for preventing and managing biological threats. India could consider investing in an agency that can coordinate policy responses for any biological emergency. A full-time Office of Biological Threats Preparedness and Response (BTPR) under the National Disaster Management Authority (NDMA) is being suggested as an alternative. This paper sketched out this idea to stimulate further dialogue among interested stakeholders. This office could focus on naturally occurring diseases, threats emerging from laboratory accidents, and deliberate weaponization of diseases. Because India has numerous organizations that sometimes perform overlapping roles with limited or no coordination with each other, the office could become a nodal agency that brings together experts from different ministries, representatives from the private sector, and experts from the academic and scientific community.
Whether or not a new office is set up, it is important for India to review domestic measures needed to predict, prevent, and respond to both natural and man-made biological threats. These measures include:
Periodic training of healthcare workers on nursing practices, safe handling of samples, decontamination procedures, and proper disposal of biomedical waste;
Strengthening cooperation between central and state health authorities;
Introducing clearer and stronger incentives for personnel to identify and report disease outbreaks among plants, animals, and humans to strengthen the disease surveillance network;
Aggregating data obtained from different disease surveillance programs that collect data on plant, animal, and human health to detect outbreaks in a timely manner;
Developing common disease reporting standards to harmonize data collection from all organizations reporting disease outbreaks;
Creating an epidemiological model for diseases through collaboration between government, scientists, academicians, industry, epidemiologists, and data scientists;
Implementing capacity-building measures, such as engaging with local donors to mobilize resources needed to ramp up public health infrastructure, increasing funding to research bodies, introducing incentives to invest in biotechnology research, and fostering collaboration between the scientific and the policy community, which should all be encouraged to strengthen India’s preparedness for biological threats;
Conducting surprise on-site inspections by members of the government-led Review Committee on Genetic Manipulation (RCGM), the Genetic Engineering Appraisal Committee (GEAC), and state regulatory authorities to ensure rigorous monitoring of biotechnological research;
Harmonization of application protocols and introduction of standard evaluation forms for researchers applying for approvals to commercialize biotechnology-derived products;
Introducing mandatory certification and validation for BSL-2 labs that sometimes work with high-risk pathogens;
Developing a formal biosecurity policy that encompasses threats emerging from different sectors such as plant health, animal health, and public health to avoid any overlaps or coordination issues;
Conducting specific training sessions for customs officials to identify specific pests or pathogens that might pose a risk to India’s national security;
Introducing simulation exercises to develop standard operating protocols that can be implemented during the time of a crisis, like inexpensive tabletop exercises that can help generate awareness among relevant agencies and can be useful for monitoring, assessing, and strengthening the capabilities of emergency policies, plans, and procedures.
INTRODUCTION
Outbreaks of life-threatening infectious diseases such as the Ebola virus disease in West Africa, the Zika virus disease in South America, severe acute respiratory syndrome (SARS) in China, and the Nipah virus disease in India are not only limited to the region but frequently put people all over the world at risk. Most recently, COVID-19, the disease caused by the novel coronavirus, originated in China in late 2019 and rapidly evolved into a global pandemic, clearly demonstrating the harm infectious diseases can cause to the world economy and health security.
Natural processes of mutation and transmission caused these threats to human society. Human beings could create similar or even more dangerous threats—by accident or on purpose. Such accidents happened, for example, in 2003 when a Singaporean researcher acquired SARS from inadvertent cross-contamination of viral samples.8 In 2004, the accidental release of the SARS virus from a Chinese laboratory infected nine people, one of whom died.9 In 2014, a researcher working in a lab in India was accidentally infected with buffalopox virus,10 and in 2019 more than 3,000 brucellosis cases were detected in China due to contaminated exhaust from a brucellosis vaccine–making company.11 Going further back in history, during World War II, Japan deliberately used pathogens to spread plague, anthrax, typhoid, cholera, and other diseases among Chinese military and civilians.12 The United States and the Soviet Union developed major biological weapons programs during the Cold War,13 which Russia, then part of the Soviet Union, continued illegally even after it signed the Biological Weapons Convention in 1972.14 Yet, if societies and governments overreact and impose ill-conceived regulations to control these risks, they would defeat themselves by depriving the world of the great benefits that bioscience and technology can provide. The study of genes and their functions—genomics—enables researchers to understand the genetic causes of human, animal, and plant maladies. Synthetic biology and gene-editing tools such as the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) and CRISPR associated protein 9 (Cas9) can be used to modify genes to fix maladies and to create new functionalities—for good or ill, as discussed below. Bioscience and technology together are needed to produce vaccines that prevent the spread of infectious diseases such as COVID-19 and medicines that treat people who could not be vaccinated. New biotechnologies also promise to advance prevention and treatment of other human afflictions and to boost agricultural productivity and sustainable development.
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