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Category Archives: Human Genetic Engineering
It felt as if humanity had crossed an important line: In China, a scientist named He Jiankui announced on Monday that twins had been born in November with a gene that he had edited when they were embryos.
But in some ways this news is not new at all. A few genetically modified people already walk among us.
In the mid-1990s, fertility doctors in New Jersey got an idea for how to help women have children. They suspected that some women struggled to become pregnant because of defective material in their eggs.
To rejuvenate them, the doctors drew off some of the jellylike filling in eggs donated by healthy women and injected it into the eggs of their patients before performing in vitro fertilization.
The researchers did not ask the Food and Drug Administration for permission to try out the procedure. Only after their patients started having healthy children did they share the news that it seemed to work. Once the word got around, would-be parents streamed into clinics to try the procedure themselves.
But other people reacted with shock rather than excitement. Our cells generate fuel in miniature factories called mitochondria. And each mitochondrion carries its own small set of genes. The New Jersey fertility doctors might have created children with the DNA of three people, not two.
It turned out that this was indeed the case. The doctors discovered that some of the children carried mitochondrial DNA from the donors in addition to their parents. In their 2001 report on this discovery, they called it the first case of human germ-line genetic modification resulting in normal healthy children. The germ line is a lineage of cells that gives rise to a new person.
The F.D.A. was not pleased. It sent the clinics letters demanding that they apply to test the method as if it was a new experimental drug. Those bureaucratic hurdles were so daunting that the clinics stopped injecting eggs.
By then, perhaps a dozen children had been born with a mixture of DNA. Maybe there are more no one knows for sure.
The New Jersey doctors later tracked down some of these children and didnt find anything unusual about their health as teenagers. Meanwhile, some biologists had realized that a variation on their procedure might be able to do something else: prevent diseases that are otherwise incurable.
Like the DNA in our chromosomes, the DNA in our mitochondria can mutate. Mutations can cause symptoms ranging from blindness to early death, and women pass them down to their children. An estimated one in 5,000 people suffer from a mitochondrial disease, and for a vast majority, there are no effective treatments. Scientists wondered if they could erase these diseases by swapping mitochondria.
The procedure they envisioned began with taking a patients chromosomes out of one of her eggs. Next, they got an egg from a healthy donor and removed her chromosomes as well. Finally, they inserted the patients chromosomes into the donor egg and fertilized it with sperm.
Tests of this so-called mitochondrial replacement therapy, carried out on mice and monkeys, offered encouraging results. But when scientists approached the United States government about trying it out on human eggs, they got shut down.
It wasnt just the possible medical risks that worried people. Many saw it as an affront to human dignity.
It is a macabre form of eugenic human cloning, declared a Nebraska congressman, Jeff Fortenberry, at a hearing in 2014.
Two years later a provision was mysteriously slipped into a congressional budget bill that barred the F.D.A. from even considering mitochondrial replacement therapy. So researchers went underground.
In 2016, an American fertility doctor named John Zhang announced that he had gone to Mexico to quietly carry out the procedure on a woman from Jordan with a neurological disease called Leigh syndrome. She gave birth to a boy who appeared healthy. But she and her husband had no interest in letting scientists track the health of their child. We know nothing more of his fate.
This history echoed loudly this week, when Dr. He, an assistant professor at the Southern University of Science and Technology in Shenzhen, told the world that he had made gene-edited babies by altering the DNA of human embryos with a new technology called Crispr.
He cut out a small portion of DNA from a gene called CCR5. People who are missing this chunk of genetic material appear to be resistant to infections with H.I.V. Dr. He reasoned that genetically modified babies would resist the virus, too.
On Sunday, MIT Technology Review broke the news, followed by a lengthy story by The Associated Press. Dr. He posted a series of triumphant videos online, and on Wednesday, he went to a major gene-editing conference in Hong Kong to show slides with some details of his work.
Like the New Jersey fertility doctors before him, Dr. He was roundly condemned for his secretive recklessness. The organizers of the Hong Kong meeting issued a statement Thursday calling the birth of the twins irresponsible. They said Dr. He had designed the study poorly, and they labeled his ethical considerations a failure. Some scientists who watched Dr. He's talk wondered if he might have actually removed the wrong chunk of the CCR5 gene. The Chinese government called the procedure illegal and opened an investigation.
I got in touch with Glenn Cohen, a professor at Harvard Law School who studies reproductive technologies, to ask him to guess what happens next. His forecast sounded like a repeat of the mitochondrial replacement story.
My sense of what will happen is that across the world there will be strong regulatory action, Professor Cohen told me. He predicted a blanket ban of the technology. People are scared, and when they are scared they make decisions that are not so subtle.
On Wednesday, the commissioner of the F.D.A., Scott Gottlieb, appeared to give some credence to Professor Cohens prediction. In an interview with BioCentury, he criticized the scientific community for failing to stop Dr. He and warned of potential regulations and laws that could be far more restrictive than they might otherwise be if there were more confidence that the community was able to self-impose appropriate standards.
That would be a shame. There may be times when editing human embryos would make medical sense. Last year, the National Academy of Sciences and the National Academy of Medicine issued detailed guidelines about what sort of cases might qualify. While they didnt point to any particular disease, they argued that it should be considered only when no other treatment could allow parents to have a healthy child.
Fortunately, history offers us a different path. We need only look at what happened to mitochondrial replacement therapy in Britain.
When British scientists raised the idea of using the procedure on human eggs, the country conducted a serious, open conversation about the pros and cons. The health department conducted a long investigation. Parliament held a public debate. And in 2015 it passed a law approving the procedure.
The British government wasnt creating a medical Wild West, where doctors were free to use the procedure whenever they wanted. Clinics had to get a license from Britains Human Fertilization and Embryology Authority, which would monitor the procedures and track the children throughout their lives to check for unexpected side effects.
This February the authority announced that it was for the first time approving the use of mitochondrial replacement therapy on two women at a fertility clinic in Newcastle. On Thursday, a representative at the authority declined to say whether children had yet been born as a result.
Its only natural for the world to focus its attention on the two babies born in China. But these babies in Britain deserve our attention, too. We can choose which ones represent the future.
Carl Zimmer writes the Matter column for The New York Times and is the author of She Has Her Mothers Laugh: The Powers, Perversions, and Potential of Heredity.
Spatial Genomics & Transcriptomics Market Demand is Expanding at a Stellar Pace in the Years to Follow – BioSpace
The demand within the global spatial genomics and transcriptomics market is expanding at a stellar pace in the years to follow. Advancements in molecular biology have paved the way for revenue inflow into the global spatial genomics and transcriptomics market. The need for studying genetic patterns in humans, animals, and plants has generated new opportunities for market expansion, Genetic engineering has emerged as a robust domain within nascent biological sciences, creating room for experimentation and analysis. The applications of genomics in molecular biology and genetic studies has given a thrust to market expansion.
In this custom review, TMR Research delves into the extrinsic and intrinsic trends that are shaping the growth graph of the global spatial genomics and transcriptomics market. The domain of biological sciences has encapsulated new technologies for studying sizes, compositions, and archetypes of human genes. This is playing a vital role in driving sales across the global spatial genomics and transcriptomics market. This review also assesses the impact of advancements in genetic engineering to decode market growth.
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Spatial Genomics & Transcriptomics Market: Notable Developments
Spatial Genomics & Transcriptomics Market: Growth Drivers
The high incidence of genetic disorders has probed the medical industry to invest in new technologies for genetic engineering and gene transfer studies. Several medical centers and research units are investing in the study of dyslexia, downs syndrome, and other genetic inconsistencies. This has created fresh avenues for growth across the global spatial genomics and transcriptomics market. In addition to this, the use of next-generation genetic studies for understanding genetic disorders has also given a thrust to market expansion.
The importance of microbiology in genetic studies has created a boatload of opportunities for growth and expansion across the global spatial genomics and transcriptomics market. The use of spatial genomics to understand the structure and composition of genes has enabled the inflow of fresh revenues into the global market. Besides, the use of genetic studies in the domain of veterinary care has also generated humongous opportunities for market expansion. The study of human and animal genes often goes hand-in-hand for the purpose of core research and analysis.
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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 Indias 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 threatseither alone or togetherwill 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 Indias 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.
To address safety and security risks, India follows two different approachesbiosafety 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:
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:
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 threatsdiseases emerging from natural sourcesIndia has invested in a public health infrastructure and has various laws and guidelines that drive preparedness and response to naturally occurring disease outbreaks. However, Indias response to the avian influenza, Nipah virus disease, and COVID-19 has exposed the countrys 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 threatsdiseases caused by accidentIndia 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 threatsthreats emerging from intentional sourcesIndia 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.
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:
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 threatsby 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 vaccinemaking 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 functionsgenomicsenables 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 functionalitiesfor 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.
This paper is divided into five sections. The first section describes how different stakeholders perceive and think about the possible benefits of biotechnology and the factors that could prevent these benefits from being realized. Based on interviews and informal conversations with leading government officials, scientists, academicians, and private-sector experts, as well as insights gleaned from workshops, roundtable discussions, and extensive literature review, the paper highlights Indias vulnerability to three major categories of biological risks:
Based on these perspectives, the paper argues that societies need to create a healthy balance between innovation, commerce, and regulation to ensure safety and security. This means researchers, businesses, regulators, media platforms, nongovernmental organizations, and voters must strive to educate themselves and their audiences or constituencies about possible threats from biotechnology and about the socially beneficial ways to prevent and manage them so that this technology can be used to enhance social welfare.
Next, the paper focuses on the first category of risk, which is probably the largest biological danger if multiplying the probability of occurrence with the consequences of occurrence. And, because naturally occurring sources of infectious disease in human beings and animals will occur, even if human-made ones do not, this paper, through brief case studies, explores Indias plans and capacity to detect and mitigate biothreats once they have dispersed into the larger environment and human population. Assessing the gaps in Indias response to disease outbreaks, this section of the paper suggests that New Delhi must create, fund, and deploy capabilities to detect, mitigate, and eventually prevent naturally occurring outbreaks. Most, if not all, of the policies and capabilities needed to respond to natural outbreaks would be vital also in responding to biological attacks and accidents, which is an argument for prioritizing them.
The third and fourth sections elaborate on how India seeks to protect against infections arising from accidental or deliberate release of pathogens through biosafety and biosecurity regulations, respectively.
While biosafety is the protection of humans from pathogens, biosecurity is the protection of pathogens from humans.15 Though these two concepts and practices reflect diverse scenarios and mitigate different risks, the paper argues that they share a common goal of keeping biological materials and the world safe and secure.
The final section of the paper identifies areas where stakeholders can work together and proposes a new nodal organization called the Office of Biological Threats Preparedness and Response (BTPR), operating under the National Disaster Management Authority (NDMA), to strengthen Indias capacity to tackle biological threats. Whether or not the office is set up, this section proposes other recommendations to strengthen Indias public health infrastructure, necessary to tackle both natural and manmade biological threats.
Emerging technologies can provide immense and widespread public health benefits by enabling the global scientific community to improve diagnostics and treatments of diseases that afflict human beings, animals, and plants. The benefits of some methods and new biotechnologies sometimes entail risks such as the accidental spilling of pathogens from the labs or the deliberate misuse of technology to create more dangerous pathogens. Other types of research may come with risks that are commensurate to the potential large-scale benefits they could provide. For example, to evaluate the effectiveness of current and future public health interventions, scientists in the United States have re-created the Spanish flu virus, the pathogen responsible for the worlds deadliest pandemic to date.16 To develop better vaccines and cancer therapeutics, Canadian researchers have synthetically reconstructed an infectious horsepox, a close relative of smallpox.17 Gain-of-function experiments, which increase transmissibility or virulence of pathogens, if undertaken with extreme care, can develop better vaccines by enhancing the pathogenicity of potential pandemic pathogens, such as coronaviruses, in laboratories in order to test new ways to kill or slow them.18
While such research promotes scientific understanding and provides tools to design medical countermeasures to reduce global disease burden, experts in India understandably worry that wide applications of dual-use technologies and decreasing barriers to access them raise safety and security concerns.
Given Indias geographical placement and history of infectious disease outbreaks, there are three major concerns that exist under this category:
India lies within the distribution zone of disease vectors, such as Aedes aegypti, a mosquito that carries and transmits viruses. India is therefore prone to mosquito-borne diseases such as dengue fever, malaria, Japanese encephalitis, and chikungunya virus disease. The vulnerability to vector-borne diseases is exacerbated by its tropical climate and annual monsoon season.19
Additionally, several scientific and academic experts in India stress that among a myriad of different diseases, viral infectionsespecially the ones that jump from animals to humans, called zoonotic diseaseshave the potential to cause devastation in India.20 Scientific experts further suggest that smaller genomes, higher replication speed, and greater transmission rates make it easier for certain pathogens, especially viral pathogens, to cause infections. Moreover, the high density of livestock and the difficult-to-regulate interface between human and animal populations make India more vulnerable to contagious viral zoonotic diseases. West Nile, avian influenza, swine flu, SARS, Middle East respiratory syndrome (MERS), Ebola virus disease, Nipah virus disease, and COVID-19 are examples of such zoonotic diseases. This is compounded by the unhygienic maintenance and breeding of livestock for human consumption.
Some industry and scientific experts in India emphasize that viral infections lead to secondary bacterial infections. Increasing rates of antibiotic resistance, a subset of antimicrobial resistance, is an emerging health trend in the country.21 Human pathogens frequently isolated from infections in patients and hospital sources have been growing more resistant to commonly used broad-spectrum antibiotics. Major contributors to this growing problem include poor patient adherence to antibiotic treatment, nontherapeutic use of antibiotics for growth promotion in farm animals, self-medication, and illegal over-the-counter access to antibiotics.
There are four major biosafety threats in India:
Several scientific, academic, and industry experts stress that personnel in some of the laboratories might have a poor understanding of the prescribed laboratory procedures and/or may be inadequately trained to follow them. This can result in ignorant mishandling of pathogens, cross-contamination of samples, inadequate oversight in a laboratory, or uncontrolled experiments.22
Several scientists in India note that by improperly handling a live attenuated strain of virus that is being used to develop a vaccine, for example, laboratory personnel could unintentionally make the pathogen more virulent. This could either lead to an unforeseen infection of the personnel or their local communities, or even a pandemic.
These risks are not unique to India. In 2001 in Australia, for example, scientists hoping to render a mouse infertile instead accidentally created a lethal mousepox virus.23 In the Soviet Union in 1979, anthrax spores were accidentally released from a Soviet military microbiology facility, causing livestock deaths and a few human fatalities.24 Almost seventy-five scientists from the U.S. Centers for Disease Control and Prevention (CDC) were exposed to anthrax because researchers failed to kill the bacteria and accidentally shipped live strains to other CDC labs that were not equipped to handle them.25 In another incident involving the CDC, a scientist cross-contaminated a benign strain of bird flu virus with a deadly bird flu strain, causing unintentional death of chickens, though it did not result in any human infection.26 These episodes demonstrate why layers of safety procedures and physical protection are necessary. Reviewing some of them, a few scientific and industry experts in India highlight that the absence of mechanisms to certify that all relevant laboratories are actually implementing safety standards for facilities, personnel training, and operations might lead to similar accidents in India in the future.
Moreover, multiple laboratories with different BSLs have been set up by the network established under the Indian Council of Medical Research (ICMR) across the country to deal with pathogens relevant to public health.27 Although a Department of Biotechnology (DBT) memorandum has introduced an application form to make certification and validation of BSL-3 and BSL-4 labs by the Review Committee on Genetic Manipulation mandatory,28 experts in India worry about the lack of national guidelines and absence of any accredited government or private agency for the certification and validation of BSL-2 labs, which are widely distributed all over the country.29 This is important because some of the BSL-2 labs sometimes work with biorisk group 3 pathogens, thereby raising safety concerns. Based on the objective of the laboratory, certification includes physical inspection of the facility to ensure that the building and infrastructure meet the design criteria and the basic requirements of protecting people and the environment from infectious agents. Validation, on the other hand, is necessary to review that the prescribed processes and procedures are followed within the laboratory. This includes having standard operating protocols and a training record of personnel in the laboratory. Certification and validation, according to experts, is necessary to ensure basic minimum standards are promoted and implemented to avoid unintentional exposure to high-risk pathogens.30 Scientists also emphasize that without proper disinfection, disposal of biomedical waste, including animals used for clinical and drug trials, is another serious biosafety hazard that might have ramifications for public health.31 Large numbers of coronavirus patients all over the world have produced garbage contaminated with bodily fluids and other infectious material. Maharashtra, a state in central India, for example, observed maximum coronavirus cases in the country, generating an average of 1,500 kilograms of coronavirus-contaminated waste per day. According to civic bodies in the state, improper segregation of waste and inadequate equipment provided to garbage collectors increased the risk of transmission.32
In addition to the biosafety of laboratory operations, participants in this project have also expressed concern about safety outside the laboratory. Genetically engineered organisms could be introduced for purposes such as mosquito control, agriculture, environmental remediation, biofuels, and medications. These experiments or applications, according to some experts in India, raise the possibility of unintentional interaction with naturally occurring organisms, which if not adequately addressed and monitored, could lead to unintended consequences. Despite these concerns, some scientists emphasize the importance of genetically engineered organisms in reducing Indias vector-borne disease burden.33
The four major biosecurity threats relevant to the Indian context are:
Most experts in India acknowledge the value of biotechnology applications to improve the yield and nutritional quality of crops and to boost their resistance to diseases and drought.34 Naturally evolving pests and plant pathogens may be extremely invasive and costly to Indian agriculture. They can reduce crop production as well as negatively influence international trade. For example, the European Union in 2014 temporarily banned the import of Alphonso mangoes and a few vegetables from India after the consignment was found to be contaminated by pestsa potential threat to the unions salad crop industry and to Indian agricultural exports.35 Similarly, accidental introduction of blight-causing fungus from Asia led to the loss of American chestnut trees in the eastern United States.36
Some experts in India therefore worry that actors with nefarious intentions might deliberately release naturally occurring invasive pathogens or synthetically create pathogens or pests to target the agricultural supply chain.37 Individuals, businesses, terrorists, or hostile states could seek to bypass or break rules for a variety of reasons. Some might seek profit from more productive crops or livestock. Terrorists could seek to create panic and distrust within the society by introducing or claiming to introduce infectious disease into livestock. An enemy state could seek to impair military responses, paralyze government functioning, and decimate the economy.
Several experts in India also worry that nefarious actors could release naturally occurring known pathogens that have the capacity to cause widespread harm, such as anthrax or coronavirus. To influence election results in the U.S. state of Oregon, the Rajneesh group deliberately contaminated salad with the naturally occurring Salmonella bacteria, to reduce voter turnout on election day,38 and the Bacillus anthracis bacteria strain, isolated from an infected cow in Texas decades earlier, was used for the anthrax attack in 2001 that targeted prominent U.S. senators and media outlets, infecting seventeen Americans and killing five individuals.39 These real-world examples point to the fact that the development of biological weapons does not necessarily require genetic engineering.
More sophisticated malicious actorsboth inside and outside the labcould take advantage of genomic data that is now online and new and inexpensive synthetic biology tools to engineer deadly pathogens in a lab. Even for the information that is not available publicly, these actors can compromise the information system to gain unauthorized access to confidential genomic information. Thus, as one former government official emphasized, access to a pathogens culture is no longer a precondition to develop biological weapons.40 Custom-made genes can now be ordered online to produce drugs, vaccines, or other disease therapies. For example, do-it-yourself biologists, a group of amateurs who conduct biotechnology research outside a formal institutional setup, teamed up online to create coronavirus test kits and vaccines.41 Even though do-it-yourself biologists are independent researchers not linked to formal institutions, India does not have any policy to regulate them, thereby raising both safety and security concerns.42 Moreover, synthetic biology allows actors to develop pathogens from scratch in the lab. Large strands of deoxyribonucleic acid (DNA) can be created artificially, with the cost of DNA synthesis dropping from a dollar to less than ten cents per base pair in the last decade.43 Actors with nefarious intentions could order custom-made DNA strands online to create dangerous pathogens with enhanced virulence, transmissibility, and/or resistance to therapeutic interventions.
Individuals and groups have demonstrated intentions to get involved in such activities. A senior biodefense researcher in the United States was believed to have mailed anthraxobtained from a government labin letters that killed five people and infected seventeen others in 2001.44 A laboratory technician in the United States was charged in 1998 for stockpiling plague and anthrax and conspiring to use it as a weapon.45 Al-Qaeda reportedly made repeated attempts to acquire biological weapons,46 and operatives from the self-proclaimed Islamic State are known to have accessed information to weaponize pathogens.47 It is reasonable to assume that other such cases have been intercepted by various countries intelligence and security services without publicity.
Although advances in biosciences and technology can help contain and eradicate naturally occurring outbreaks, experts in India worry that since pathogens responsible for such infections are freely available in nature and the tools and technologies needed to manipulate them are easily accessible, developments in technology can lead to purposeful weaponization of such diseases. Not all pathogens have this versatile nature, and it requires tacit knowledge to weaponize them; for this reason, some government officials believe that it is more difficult than it might seem for an adversary to create and/or steal a bioagent with bioweapon potential and use it in devastating ways.
As pathogens do not respect national borders, some experts emphasize that they can be intentionally or unintentionally carried across borders. India shares porous borders with most of its neighboring states, so it is vulnerable and needs to secure its frontiers as much as possible and check travel and trade to prevent the proliferation of biological weapons.48 Recently, the director general of the police in Jammu and Kashmir claimed that Pakistan is pushing coronavirus-positive militants into Kashmir to spread the disease throughout the valley.49 Although the government in Pakistan has rebutted this claim, it indicates Indias vulnerability to cross-border infections.50
Discussions of biological risk naturally focus on the dangers of human action or inaction, purposeful or accidental. This is because human actions are controllable in ways that natural mutations of organisms are not. Human beings also fear losing things they already have more than they fear not gaining things in the future.51 From the perspective of societal well-being, then, some stakeholders in India see potential risks in restricting or burdening research, development, and applications of bioscience and technology without adequate evidence that the social benefits of such restrictions outweigh both their direct and opportunity costs. The two major areas that have faced strong public resistance in India are vaccines and genetically modified food/crops.
The World Health Organization (WHO) notes that fear of vaccine side effects has led to vaccine hesitancy.52 Although there is no organized antivaccination campaign, resistance to vaccines prevails in some parts of India, as concluded by a study that was commissioned after the reemergence of eradicated vaccine-preventable diseases such as diphtheria. The main reasons behind this growing trend are often the lack of trust in the government, fear of safety and efficacy of vaccines influenced by rumors, and poor communication regarding the benefits of vaccines.53 For example, resistance to the polio vaccine in some parts of North India was spurred by religious suspicions that the immunization drive was part of the governments agenda to control the high birth rate among the Muslim population. Similar resistance was observed with the human papillomavirus vaccine after rumors connected the vaccination to death among girls.54 Although dubious information is mostly spread by people with little or no scientific background, virus conspiracy theories are sometimes spurred by discredited researchers, as observed during the coronavirus pandemic.55 Such uncorroborated rumors regarding vaccines can sometimes jeopardize public health efforts to fight vaccine-preventable infectious diseases.
Similarly, people in India are more alarmed by the possibility that modifying plant genetics will accidentally reduce harvests or raise the costs of seeds for farmers than they are by the possibility that prohibiting such modifications will deprive them of faster growth in the future.
Experts have highlighted that no restrictions exist for plants or other organisms modified through traditional techniques. They added that traditional biotechnology techniques such as selective breeding, hybridization, and fermentation have been used to modify living plants for improved yield or enhanced nutritional value. In addition to producing the desired product, these traditional breeding techniques can lead to random mutations. With improvements in knowledge about the role of individual plant genes, modern biotechnology techniques can be used to edit the specific gene to produce a desired variety, thereby reducing the possibility of off-target effects.56
Despite widely documented economic, health, and environmental benefits of genetically modified crops, public backlash against these varieties, irrespective of their validity, has created a difficult political atmosphere in India where stringent measures have been developed to restrict transgenic research, field trials, and commercial product release.
Some Indian experts have witnessed mixed and varied reactions from the public and the government, depending on the product in question. They believe that it is not the technology but the way the product is perceived by the public that affects whether a product receives government backing. The primary example they used to highlight this was the contrasting treatment of genetically modified cotton and brinjal. The former is a cash crop widely accepted and in use, while the latter, a food crop, is still facing resistance to its introduction to the market.57
To address public concerns regarding biotechnology-derived products, the Indian government adopted a multilayered regulatory system to examine the safety of biotechnology products before their commercialization. However, the hierarchical setup is often plagued by coordination issues between various bodies at different levels. Bureaucratic delays in approving products sometimes lead to regulatory uncertainties. As a result, the private sector and the venture-capitalist community limit their investment in the biotechnology sector, constricting the scope of research in India.
First and foremost, it is important for India to periodically update the three categories of risks mentioned above. Once risk cataloging is complete, the next step is to identify and assess regulations that deal with each of these different categories of risk. For the first categorydiseases occurring because of natural mutationsit is important to understand the functioning of Indias public health infrastructure to identify gaps and limitations in the existing system. For risks emerging either from lab accidents or deliberate release, it is important to evaluate existing regulations against recent developments in biotechnology. Next, it is important to identify stakeholders that would be involved in dealing with each of these categories of risks. In addition to assessing regulations and identifying stakeholders, it is imperative for India to invest in scientific communication strategies to build a bridge between the scientific community and Indian society. This would help in fighting misinformation and would also help address public resistance to biotechnology-derived products, thereby spurring innovation.
As discussed above, biothreats can emerge from natural events, human accident, and/or malicious human action. This chapter focuses on Indias capacity to tackle the first category of riskthe ones emerging from natural sources.
In case of any disease outbreak, the central government issues specific notifications and guidelines to control and monitor the disease and has in several instances set up new ad hoc response committees. Like any naturally occurring biological disaster, accidental release or intentional attack also affects a countrys health infrastructure. Case studies of Indias responses to naturally occurring outbreaks can foster understanding of the health infrastructure.
To assess Indias capacity to handle human-induced biological threats, it is important to understand Indias responses to naturally occurring infections. The five case studies discussed in this section highlight Indias response toward agricultural infestations, such as the recently observed locust attacks; diseases that affect animals and have not yet infected humans, such as avian influenza; and zoonotic infections that have jumped from animals to humans, such as the Kyasanur Forest Disease (KFD), Nipah virus disease, and more recently COVID-19.
In 1957, India adopted an interdisciplinary approach to tackle an outbreak of KFD, a tick-borne viral hemorrhagic fever. The disease, commonly called the monkey fever, primarily infects primates and spreads to humans through ticks. The Rockefeller Foundation extended financial and technical support, including laboratory facilities to investigate the disease outbreak. Scientific expertise was provided by researchers at the National Institute of Virology, a lab set up by the Rockefeller Foundation (now under the ICMR). In addition, WHO supported an ornithologist who started the Bird Migration Project under the Bombay Natural History Society, which traces the origins and transmission of KFD.58
Epidemiological investigation of KFD was one of the early successful examples of the multidisciplinary approach needed to tackle zoonotic infections.59 However, no detailed studies have been carried out on any zoonotic pathogen in India, including the KFD virus, especially after the Rockefeller Foundation pulled its support in the 1970s.60 Even though most experts in India speculate that the next pandemic may also move from animals to humans, India has developed a more reactive approach to disease outbreaks rather than developing measures to prevent such infections. Independent ministries that are responsible for agriculture, animal husbandry, environment, and public health often work in silos and do not coordinate with each other. This leads to inadequate information sharing, which results in a weak surveillance mechanism needed for timely diagnosis of zoonotic infections.
It is therefore important to break the silos, develop robust coordination mechanisms for better information sharing, and develop a strong disease surveillance mechanism for early detection of diseases.
A high-density poultry population combined with the illegal movement of poultry and poultry products makes India vulnerable to avian influenza, a viral disease that affects both wild and domestic birds alike but very rarely infects humans. India has so far reported avian influenza, commonly called bird flu, almost every year, starting from 2005 until 2015. Fresh cases were again reported in 2020. Although state governments have been successful in minimizing human infections so far, the response strategy mostly involves the mass culling of birds, as is done in other Asian nations. This policy response, however, entails huge financial cost for farmers and the poultry industry in general, without appropriate compensation. Most of these bird flu cases are restricted to rural areas; as a consequence, the lack of awareness along with the huge financial burden on farmers sometimes lead to underreporting of cases.61 It is therefore important to strengthen Indias disease surveillance mechanism that monitors and reports diseases in animals. Early detection of diseases in animals might help contain the spread of zoonotic infections, one of the major biological threats in India.
Nipah, a zoonotic virus that moved from bats to humans, killed seventeen people in the southwestern state of Kerala in 2018. Keralas State Surveillance Unit of the Integrated Disease Surveillance Programme (IDSP), an initiative led by the Ministry of Health and Family Welfare (MOHFW), reported the Nipah outbreak to the Central State Surveillance Unit of the IDSP. The Manipal Centre for Virus Research (now Manipal Institute of Virology [MIV]) at the Manipal Academy of Higher Education confirmed the Nipah outbreak, which was later reconfirmed by the National Institute of Virology in Pune.62
Following the confirmation of the outbreak, a multidisciplinary team from the National Centre for Disease Control (NCDC) was sent to Kerala to work locally with the state government to investigate and respond to the infection. The team was headed by the director of NCDC, with representatives from the National Institute of Virology; All India Institute of Medical Sciences; Ram Manohar Lohia Hospital; the Department of Animal Husbandry, Dairy, and Fisheries; and the Division of Emergency Medical Relief. This team was sent to support the local authorities to train medical personnel to detect and isolate active cases, trace their contacts, provide treatment, discard hospital waste, and safely dispose of the deceased. NCDC also activated the Strategic Health Operations Centre to monitor the outbreak and issue daily situation reports. In addition, WHO also provided support in terms of technical materials and guidance on the Nipah virus to both the MOHFW and the state health authorities. These coordinated and collaborative efforts of the central and the state government, along with WHOs technical support, led to an effective containment of the outbreak.63
Despite the successful containment of the outbreak, the central government determined that the lab that detected Nipah was underqualified, so it was dropped from a central list of virus research and diagnostic labs in 2019. The Ministry of Home Affairs (MHA) suspended the labs account under the 2010 Foreign Contribution Regulation Act (FCRA), which regulates foreign donations based on national security implications, for collaborating with the U.S. CDC for its research on the Nipah virus. Some government officials noted that the lab was being used to map the Nipah virus, which can be used to develop a vaccine, the intellectual property right of which will not be with India. Importantly, understanding how the human body reacted to the virus will also produce a more virulent form of virus for biological warfare.64 The laboratory, however, issued a clarification, emphasizing that the CDC was only involved in training to detect Nipah and was never involved in the actual Nipah investigation. Detection of the outbreak was exclusively funded and carried out in close collaboration with the ICMR. Samples for virus isolation were transferred to the National Institute of Virology. The statement issued by the laboratory further clarified that the research at MIV was not connected to any vaccine development and no intellectual property right was generated or transferred.65 Given that government bodies at the central level were aware of the research, including MIVs capacity to detect Nipah, the Health Ministrys sudden allegation and withdrawal of the labs FCRA license undermines the capacity of the lab and creates disincentives for other labs.
Not only does it undermine the potential of private labs, it also threatens prospects for global cooperation needed to tackle biothreats. Because biological threats, especially infectious diseases, are transnational in nature and cannot be tackled individually by national governments, international cooperation is both necessary and important in all facets of disease controlprevention, detection, warning, response, and the development of drugs and vaccines. While commercial considerations and debates around intellectual property are important, Indias biosecurity policy should foster global cooperation to advance knowledge and strengthen infrastructure to tackle biological threats.
Contrary to previous locust infestations that were localized to the northwestern states of Rajasthan and Gujarat, a latest locust attack that started in April 2020, much ahead of the normal July to October interval, damaged crops in the states of Gujarat, Madhya Pradesh, Maharashtra, Rajasthan, and Uttar Pradesh. Because winter crops were harvested and monsoon crops were yet to be sown, locusts in search of fodder moved deeper into India, affecting new states. Moreover, strong westerly winds from the Cyclone Amphan in the Bay of Bengal also influenced their widespread movement.66 Pandemic-induced economic slowdown made it difficult for the Indian government to tackle the invasion in a timely manner.
Locusts are transboundary pests that damage crops and threaten food security. Repeated locust infestations in India led to the 1939 establishment of Locust Warning Organisation, which in 1946 was integrated with the Directorate of Plant Protection Quarantine and Storage under the Ministry of Agriculture and Farmers Welfare.67 To combat the locust invasion, the organization worked closely with the MHA, Ministry of Civil Aviation, Ministry of External Affairs (MEA), Ministry of Defence, Ministry of Communications, relevant state departments, and other pertinent stakeholders, including farmers. At an international level, the Locust Warning Organisation coordinated with the Food and Agricultural Organization, a United Nations body that performs monitoring of possible locust outbreaks and issues timely warnings.68
Some states noted this locust invasion as mid-season adversity under the government-sponsored crop insurance program known as Pradhan Mantri Fasal Bima Yojana, which processes insurance claims for farmers losses.69 Although part of the claim is disbursed based on a joint survey conducted by the concerned insurance company and the state government, the remaining payment depends on the result of crop-cutting experiments that map damage from locusts at a village level. However, the methodology to conduct such experiments is skewed and depends on random selection of any four fields in the village. Because locusts do not affect all fields uniformly, random sampling sometimes does injustice to farmers, thereby causing financial strain.70 Moreover, pesticides used to limit the spread of locusts also adversely impact food crops, causing further financial troubles for the farmers.71
Given the impact of locusts on food security and agricultural supply chain, scientists all over the world are trying to genetically engineer locusts to control their spread.72 However, these experiments raise security concerns because the same techniques can be used to modify locusts or other insects in ways that would make it harder to control them.73 For example, scientific experts have raised concerns around the U.S. Insect Allies program that uses insects to spread viruses to create genetically engineered crops. While the program intends to develop healthier crops, some bioethicists and scientists believe that this technology poses serious safety and security risks.74 It is therefore important to strengthen Indias capacity to prevent, detect, and respond to natural infestations to better prepare for man-made invasions.
India observed its first few COVID-19 cases almost a month after Chinese authorities officially reported the coronavirus outbreak to the WHO. The first three cases were reported in Kerala from January 30 to February 3, 2020, among students who came back from Wuhan, the Chinese city where the initial outbreak took place.75 Because health is a state subject in India, the Kerala government declared COVID-19 a state disaster as soon as it reported its third case. A multidisciplinary state response team was composed of experts in epidemiology, community medicine, infectious diseases, pediatrics, drug control, and food safety. This team was supported by other state-level teams to enhance the surveillance of the outbreak, train medical personnel, and strengthen the states public health infrastructure. In addition to the state response team, rapid response teams were also constituted at the district level to facilitate micro-level planning.76
A month later, in the first week of March, India witnessed a sudden spike in the number of coronavirus cases across the country. Recognizing the severity of the situation, the Prime Ministers Office (PMO) took charge. The response was guided by a team of more than thirty health experts and scientists who worked relentlessly to fight the contagion. This team was divided into two groupsone comprising health professionals and the other consisting of researchers from the ICMR and secretaries from the DBT, the Department of Science and Technology (DST), the Council of Scientific and Industrial Research (CSIR), and the Defence Research and Development Organisation.77Based on their recommendations, the government imposed severe travel restrictions to limit cross-border movement of people. In addition, all states and union territories were advised to invoke section 2 of the Epidemic Diseases Act of 1897 (EDA), which allowed them to take preventive measures to contain the spread of coronavirus in their respective states.
While measures taken by most states and union territories moved in the right direction, lack of uniformity across multiple states led to complications and impediments. To overcome this, the Indian government declared COVID-19 a notified disaster under the 2005 Disaster Management Act.78 As a result, Prime Minister Narendra Modi, who is also the chairperson of the NDMA, announced a nationwide lockdown, starting from late March through May 2020. Most states followed the central governments guidelines and directives to tackle the pandemic, but some states did not comply with the central government-issued advisories. This was caused by ambiguity in the constitutional structure, where health is classified as a state subject and disaster management, though not explicitly stated, falls under the concurrent list. While only state governments have the power to create laws for subjects falling under the state list, both central and state governments have powers over subjects mentioned in the concurrent list, with the centers decisions prevailing in case of differences. Because the central government declared COVID-19 a disaster, it gave both central and state governments the authority to draft rules and regulations to tackle the pandemic, with the central government playing an upper hand. Some states, however, argued that because health is a state subject, the states should have more flexibility in tackling the pandemic. This ambiguous nature of center-state relations complicated Indias fight to contain the pandemic.79
Recognizing the need to ramp up domestic capacity to strengthen Indias response to COVID-19, a task force was set up under DST with representatives from CSIR, DBT, DST, and ICMR; the Ministry of Electronics and Information Technology; Atal Innovation Mission; the Ministry of Micro, Small, and Medium Enterprises; Startup India; and the All India Council for Technical Education. This group tried to identify startups with market-ready solutions to develop affordable testing kits and to scale up manufacturing of equipment supplies such as masks, protective gear, sanitizers, ventilators, and respirators. The task force was also constituted to identify data-mapping solutions to develop an effective surveillance for coronavirus in India.80 Taking lessons from other countries, India also developed a contact-tracing app, called Aarogya Setu, to detect, trace, and isolate people who came in contact with COVID-19 patients.
Although the government took strict measures to implement social distancing, the country did not have adequate capacity to handle the pandemic.81 Personal protective equipment (PPE) for frontline medical workers was not easily accessible. Respirators, ventilators, and other equipment required to set up isolation wards were available in limited quantity. Diagnostic kits were also not available in sufficient quantity. In addition, the former Indian Health Secretary Preeti Sudan wrote a letter during the coronavirus pandemic stating that India needs to hire epidemiologists on a war footing because they are a critical element in the effective management of the pandemics like COVID-19.82 Hiring epidemiologists and microbiologists in the middle of the coronavirus pandemic indicates the shortage of trained personnel in India to fight the disease.83 Moreover, an academic expert in India highlighted that most scientific institutions in India prefer to recruit personnel who have received their degrees from abroad rather than hiring people who have been trained locally and have a better understanding of the Indian scientific and administrative environment. Such hires unfortunately lack an initial vision about the crisis from an Indian perspective and take time to adjust to the local system, which creates a longer lag phase and loss of valuable time, a crucial element during health emergencies.84
The above case studies clearly underscore Indias reactive approach toward infectious disease outbreaks. Rather than using the time between two outbreaks to develop national legislation to tackle infectious diseases, India mostly relies on ad hoc notifications and guidelines. Invoking the 2005 Disaster Management Act to tackle the COVID-19 crisis when this enactment is not geared toward handling epidemics in the first place highlights the poor state of Indias preparedness in combating infectious diseases.85
Complicating matters further, the Modi government reconstituted the NDMA and downsized it. The vice-chairman post was downgraded from Union Cabinet Minister to Cabinet Secretary, and members ranks were changed from Union Minister of State to Union Secretary of the Union government. According to the former vice chairman of the NDMA, this has weakened the organization, and there will be difficulty in coordination with the states in this regard. If a Vice-Chairman of Cabinet Minister status goes to a state, he will be meeting the Chief Minister more easily than somebody of Cabinet Secretary level. These are issues with protocol also.86
Capabilities, like the ones discussed in the previous section for tackling threats that naturally occur, would also be required to deal with human-induced outbreaks resulting from safety or security lapses. However, Indias responses to naturally occurring disease threats have exposed its poor disease surveillance network, inadequate coordination between ministries needed to prevent zoonotic infections, lack of a nationwide policy on biological disasters, rickety public health infrastructure, and minimal investment in research, all of which will be elaborated below.
For rapid surveillance and response to disease outbreaks, the NCDC, under the Indian MOHFW, set up an IDSP. The IDSP is a decentralized surveillance system that establishes surveillance committees at the central, state, and district level (see figure 1). The state surveillance committee is set up under the secretary of health; the district surveillance committee is under the chairmanship of the district collector or district magistrate. Information is relayed from the district unit to the state unit to the central surveillance unit on a weekly basis using an IDSP portal. This weekly data gives insights on the disease trends and the seasonality of infections. In addition to these surveillance units, IDSP has also established multidisciplinary rapid response teams at the district level for early detection and containment of infectious disease outbreaks.87
Some public health experts in India have, however, raised serious concerns about the infrastructure and the human resource capabilities needed to accurately detect and report an outbreak. In addition to the IDSP, the Indian Health Ministry, under the National Health Mission, runs several other disease surveillance programs such as the National Vector-Borne Disease Control Programme, Revised National Tuberculosis Programme, and National Leprosy Eradication Programme.88 Moreover, there are additional surveillance programs such as the National Polio Surveillance Project (NPSP) that run beyond the ones included under the mission. These organizations sometimes collect data for the same disease, but often not with similar standards and practice. For example, both IDSP and NPSP record data for polio incidences in India. They use differing case definitions with little or no coordination (and often bureaucratic turf battles), which leads to different disease numbers being reported under different programs.89
Moreover, all these surveillance programs only mandate a few institutions, mostly government affiliated, to report disease outbreaks. This makes it difficult for organizations excluded from this network to report diseases. Limited involvement of private labs and practitioners in the disease reporting network leads to severe underreporting of disease outbreaks.90
In addition to disease surveillance programs that gather information on human infections, India runs parallel surveillance programs that collect data for livestock diseases. The National Animal Disease Reporting System, a computerized network set up under the Department of Animal Husbandry, Dairy, and Fisheries (within the Ministry of Fisheries, Animal Husbandry, and Dairying), collects and collates animal health information at the block, district, and state level.91 The National Animal Disease Referral Expert System is another web-based interactive livestock disease database that operates under the Indian Council of Agricultural Research, a body under the Ministry of Agriculture and Farmers Welfare.92
These multiple disease surveillance programs, set up under different ministries, work in silos and sometimes collect data for the same disease with different standards. This leads to the collection of redundant data, resulting in a convoluted, uncoordinated, and ineffective disease-mapping mechanism.
Indias response to biological disasters, both natural and man-made, is specified under the nonlegally binding guidelines for managing biological disasters, issued by the NDMA in 2008. The guidelines have clearly outlined the role of separate ministries in the wake of biological emergencies. MOHFW is responsible for handling naturally occurring biological disasters. The MHA is in charge of events arising through bioterrorism; the Ministry of Defence is responsible for events related to biological warfare; and the Ministry of Agriculture and Farmers Welfare has been put in charge of animal health and events related to agroterrorism. In addition, the guidelines mention the role of the community, medical care professionals, public health personnel, and veterinary professionals in preventing, responding, and mitigating the impact of any biological emergency.
Although the guidelines mentioned that the EDA should be repealed and a national-level policy for biological disaster should be framed, there is still no formal legislation for biological disasters. Because of the absence of a nationwide policy, many states have developed their own public health legislations to deal with disease outbreaks.93
The NCDC and the Directorate General of Health Services jointly prepared a 2017 public health bill, which was introduced in the parliament as the first step toward a formal legislation. The 2017 bill, which is now lapsed, was an attempt to replace the archaic 1897 EDA. Unlike the EDA, this proposed bill clearly defined an epidemic and identified thirty-five epidemic-prone diseases and thirty-six bioterrorism agents, high-priority pathogens that pose public health risk.94
This bill, however, has certain issues: it is more reactive than proactive, the measures included in the bill are insufficient and lack clarity, and it does not address the balance between public health and human rights.
Even though the NDMAs 2008 guidelines for biological disasters mention preventive options such as immunization of first responders or stockpiling of medical countermeasures, the new public health bill is not comprehensive enough and does not cover any prophylactic procedures. It only specifies scientific and containment measures that must be followed once the outbreak has happened. Key themes such as disease surveillance and identification of disease hotspots, development of vaccines, establishment of fully equipped hospitals, training for medical professionals, and coordination and collaboration among scientists and the biomedical industry appear to be missing in this proposed legislation. Besides this, the bill has not addressed the human resource component needed to contain disease outbreaks. For example, training of public health professionals, epidemiologists, and other frontline workers seem to be notably absent from the bill. Moreover, it fails to address budgetary challenges needed to create a robust public health infrastructure that is capable of tackling epidemics, bioterrorism, and biological disasters.
Although the bill empowers local governments to take measures to contain various diseases, it does not clearly explain the organizational structure that will operate in case of an emergency. Even though the bill mentions both natural and man-made biological threats, it has not clarified whether the setup would be operational under the guidelines issued by the NDMA or if a new authority will be established under the newly proposed bill.
In addition, some experts emphasize that the bill violates basic human rights and gives enormous powers to medical officers to inspect any location, isolate patients, limit their movement, conduct medical investigations, and treat them irrespective of their consent.95 To get a glimpse of what these powers might look like, consider a 2017 example where the Tamil Nadu state health department, under the Tamil Nadu Public Health Act of 1939, tried to make the measles-rubella vaccination mandatory for all children under the age of 15 without parental consent.96 Privacy concerns were also raised during the coronavirus pandemic when the Indian government deployed the Aarogya Setu contact-tracing app, meant to detect, isolate, and treat contacts of COVID-19-patients. Anyone using any public transport had to have the app installed on their phone, although it was not mandatory to download the app otherwise. Some data experts in India raised apprehensions regarding the privacy and consent framework of the app.97 The public health bill, if it is enacted, would need to be modified to include measures to prepare for a biological emergency and introduce provisions that balance public health and human rights.
Even though the MOHFW in 2016 conceded that Indias public expenditure on health as a percentage of gross domestic product (GDP) is far lower than countries classified as poorest in the world,98 the latest financial budget has increased the expenditure only marginally from 1.5 percent to 1.6 percent of the GDP.99 According to a few public health professionals, the Indian governments plan to increase its public health expenditure to 2.5 percent of GDP by 2025 looks disappointing when the global average will be about 6 percent.100
Given Indias minimal investment in public health, the coronavirus pandemic exposed the bleak reality that India only has 8.5 beds and eight physicians per million people, with even lower numbers reported in rural areas.101 Although the WHO recommends a ratio of 1 doctor to 1,000 people, a recent study showed that India only has one government doctor per 10,819 people and one nurse per 483 patients, highlighting a deficit of 600,000 doctors and almost 2 million nurses.102
On top of this personnel deficit, healthcare workers tested positive for coronavirus, owing to the lack of protective health supplies such as masks, gloves, and gowns. The lack of healthcare workers and shortage of PPE kits both seem to have jeopardized Indias efforts to respond to the coronavirus disease. To divert all available public health resources to combat the pandemic, most hospitals in India closed their outpatient departments, thereby creating a huge problem for non-COVID-19 patients. As India has limited beds and facilities, several reports noted that patients with surgical procedures, routine checkups, and follow-up visits were deferred to avoid extra hospitalizations.103 Some states also halted immunization and reproductive health outreach to free up community healthcare workers for COVID-19-related surveillance and contact tracing. As a senior official in the Health Ministry reportedly noted, India, with its high disease burden, would fare best by avoiding a situation like the Democratic Republic of the Congo was in after the Ebola crisis, where more people died of tuberculosis, malaria, and measles than from Ebola.104
Indias research and development spending fluctuates between 0.7 to 0.9 percent of its GDP, much lower than other countries like Brazil (1.3 percent), Canada (1.6 percent), the United Kingdom (1.7 percent), China (2.1 percent), France (2.2 percent), the United States (2.8 percent), Germany (3 percent), Japan (3.2 percent), South Korea (4.5 percent), and Israel (4.6 percent).105 Among various scientific departments, the Department of Health Research, set up under the MOHFW, received only seven crore rupees for the development of tools and technologies needed to combat disease outbreaks such as the new coronavirus. Furthermore, the departments apex research organization, the ICMR, which is responsible for setting up diagnostic laboratories across India, has always faced budgetary constraints. In 2016, the then director general of ICMR reported that although ICMR had asked for 10,000 crores for a five-year plan from 2012 to 2017, only 50 percent of the amount was sanctioned.106 Similar reports highlighted that in 2020, when ICMR budgeted 2,300 crores for operations, it was allocated 1,795 crores.107 This mismatch between demanded and allocated funds, along with minimal investment in research to set up diagnostic labs, could be one of the many factors that contributed to Indias abysmally low testing numbers toward the beginning of the coronavirus pandemic. Because the research pipeline is not adequately developed, the country also struggled to ramp up domestic production of diagnostic kits. Several experts noted that this budget crunch might be detrimental to research and might impact innovation in public health.108
Repeated outbreaks of infectious diseases along with a huge burden of noncommunicable diseases should be a warning for policymakers in India to invest more in public health, build capacity to face a biological emergency, strengthen its disease surveillance mechanism, enhance interministerial collaboration to avoid bureaucratic bottlenecks, and spend time to develop a strategy to respond to disease outbreaks (see box 1).
The following are a set of recommendations for tackling diseases that emerge from natural sources:
To deal with the second category of risks (that is, risks emerging from human accidents), India has developed a series of biosafety guidelines and related rules and adherences to monitor and address the safety of research and its applications.
Biosafety seeks to keep laboratory workers and the surrounding environment physically safe from any unintentional exposure to dangerous or genetically engineered organisms. Personal protection such as laboratory coveralls and PPE to avoid accidental contact with blood, body fluids, and other potentially infectious material is necessary to ensure the safety of lab workers. Facility design and training to ensure safe handling of samples is important to reduce the possibilities of unintentional release of any organism into the environment.
Biosafety regulations and practices in India generally have three aims:
Indias 1989 Rules for Manufacture, Use/Import/Export, and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells (commonly called Rules 1989), notified under the 1986 Environment Protection Act, focuses on maintaining biosafety for all biotechnological experiments. These rules are supported by a series of guidelines issued by the DBT.109 These separate guidelines take into consideration the rapid pace of biotechnological advancements and the need to strengthen oversight for those involved in biotechnology research.
Under Rules 1989, DBT created the Review Committee on Genetic Manipulation (RCGM) to monitor the safety-related aspects of ongoing research projects or activities involving hazardous organisms. The RCGM includes representatives of DBT, the ICMR, the Indian Council of Agricultural Research, the Council of Scientific and Industrial Research, and other experts in their individual capacity. RCGM may appoint subgroups to assist RCGM on matters related to risk assessment and in reviewing existing and preparing new guidelines.110
CollPlant to Supply rhCollagen to STEMCELL Technologies for Use in a Broad Range of Cell Culture Applications – PRNewswire
REHOVOT, Israel and VANCOUVER, BC, Dec. 10, 2020 /PRNewswire/ -- CollPlant (NASDAQ: CLGN), a regenerative medicine company, and STEMCELL Technologies, Canada's largest privately owned biotechnology company, which develops cell culture media, cell separation systems, instruments, and other reagents for life sciences research, today jointly announced they have entered into aproduct manufacturing and supply agreement. CollPlant will sell its proprietary recombinant human Type I collagen (rhCollagen), the world's first plant-based rhCollagen, to STEMCELL Technologies, which will incorporate CollPlant's product into cell culture media kits.
The recently signed agreement follows the companies' established business relationship, which started in 2014 when STEMCELL began purchasing and incorporating CollPlant's rhCollagen into some of its cell culture expansion and differentiation media kits. To date, hundreds of companies, as well as research and academic institutes, have used these kits for research and development projects. STEMCELL will distribute the kits globally for use in the regenerative medicine research market.
"Incorporation of rhCollagen into STEMCELL's cell culture applications sold to researchers worldwide is designed to help advance the science in a broad range of dynamic fields including stem cells, immunology, cancer, regenerative medicine, and cellular therapy. We are happy to have entered into this agreement with STEMCELL, which, as Canada's largest biotechnology company, is very well positioned to make rhCollagen-containing cell culture kits widely available in the market," stated Yehiel Tal, Chief Executive Officer of CollPlant. "The cell culture market is just one example of the vast potential of our rhCollagen platform technology in life science applications. We continuously evaluate new fields in which CollPlant's products and technologies have the potential to enable breakthroughs that improve patients' lives."
Dr. Sharon Louis, STEMCELL's Senior Vice President of Research and Development noted that "STEMCELL is pleased to utilize CollPlant's animal component free rhCollagen to promote cell attachment in several products that support the culture of diverse human progenitor cell types. The quality and animal component-free composition of CollPlant's rhCollagen is what first brought this product to STEMCELL's attention, and the robust performance rhCollagen provides with a variety of STEMCELL media is what we want to be able to provide to our customers. Upon entering into this agreement, STEMCELL and CollPlant will together provide high-quality reagents that will be used to further our understanding in life sciences and potentiate regenerative medicine research."
About STEMCELL Technologies
STEMCELL Technologies is Canada's largest biotechnology company. Based in Vancouver, STEMCELL supports life sciences research around the world with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, and educational resources that are used by scientists advancing the stem cell, immunology, cancer, regenerative medicine, microbiology, and cellular therapy fields.
Find more information at http://www.stemcell.com
About CollPlant Biotechnologies
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant's proprietary plant based genetic engineering technology.
Our products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing, and, we believe, are ushering in a new era in regenerative and aesthetic medicine.
Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. In October 2018, we entered into a licensing agreement with United Therapeutics, whereby United Therapeutics is using CollPlant's BioInks in the manufacture of 3D bioprinted lungs for transplant in humans.Recently, the parties announced the expansion of the collaboration with the exercise by United Therapeutics of its option to cover a second lifesaving organ, human kidneys.
Safe Harbor for Forward-Looking Statements
This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the CollPlant's history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; CollPlant's expectations regarding the timing and cost of commencing clinical trials; regulatory action with respect to rhCollagen-based products, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the CollPlant's rhCollagen-based BioInk; CollPlant's ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third-party distributors and resellers; CollPlant's reliance on third parties to conduct some aspects of its product manufacturing; the scope of protection CollPlant is able to establish and maintain for intellectual property rights and the company's ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the company operates; projected capital expenditures and liquidity; changes in the company's strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F, filed with the SEC, and in other filings that CollPlant has made. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and CollPlant does not undertake, and specifically disclaims, any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Eran RotemDeputy CEO & CFOTel: + 972-73-2325600[emailprotected]
Contact at STEMCELL: Luba Metlitskaia Vice President, Business Development & Licensing [emailprotected]
Its no secret that the United States government has played a huge role in the creation of major technological and medical breakthroughs over the past few hundred years, but did you know that its responsible for many of the devices and products that many people use every day?
If youve ever used a GPS system, you have the Defense Departments research to thank. What about your smartphone? Although the government didnt directly fund the exact phone you own, NASA, the National Science Foundation (NSF), and the CIA were integral in creating crucial elements of todays smartphonessuch as microchips and touch screens. Even the internet, which makes reading this story possible, began as the Advanced Research Projects Agency Network (ARPANET), a computer network first made by the U.S. Defense Advanced Research Projects Agency (DARPA).
Perhaps one of the most consequential fieldsthat hasbenefited most crucially from government support is that of medicine. Many vaccines that prevent millions of Americans from contracting preventable diseasesfrom the common flu to Haemophilus influenzae type Bwere funded and developed with support from the National Institutes of Health (NIH). More recently, the federal initiative Operation Warp Speed was established to facilitate the manufacture and distribution of the coronavirus vaccines.
However, government research and funding have been integral to so many inventions, big and small, that it can be hard to find a starting point when learning about which ones can be credited to various supporting agencies. Stacker compiled information about government-funded creations using a combination of news, scientific, and government reports. The inventions on this list encompass a wide variety of areas, including technology, agriculture, medicine, aviation, and others.
From the beginnings of the civilian aviation industry in 1925 to a recent COVID-19 vaccine breakthrough in 2020, read on to learn about 50 inventions you might not know were funded by the U.S. government.
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The rapid progression of science and technology is converging with societal, economic, environmental and geopolitical shifts in ways that alter our future. As a result, people everywhere are focused on the future of X, where X increasingly represents every domain.
It is not surprising then to see the future of sports impacted by this convergence. There is no doubt that the future of sports and running in particular is changing. Tata Consultancy Services (TCS) launched #ThisRun, a new worldwide community for runners, reinforcing its long-standing commitment to global marathon and running partnership platforms. In support of this initiative, TCS conducted This Run Tech Survey, which captured runners views of technology and its role in the sport now and in the future. It provides a glimpse into the minds of a broad spectrum of runners, giving us foresight to see across horizons. With it, we can envision the future of running and explore how it may impact societal wellness.
Every analysis of future scenarios now includes the impact of COVID-19, and running is no exception. Our survey indicates that running has sparked more enjoyment and importance in the pandemic-filled lives of people. In fact, 67 percent of respondents said that running during the pandemic has been especially important in their life. With stress and depression amplified, running has reduced some of those worries. While the pandemic has been one key motivator, technology adoption represents another. Currently, running technology is used to track fundamental metrics such as pace, distance and time. The focus is primarily on individual runners connecting, capturing and leveraging data and technologies to improve their experience and performance. The survey indicates that runners are interested in practical uses of running-based technologies, with respondents interested in injury prevention (59 percent), runner performance (58 percent) and nutrition/hydration (58 percent).
Popular technology includes smart watches, distance tracking apps and heart-rate monitors. Our survey highlights several other technologies embraced by both avid and casual runners. The early adopter nature of runners creates a virtuous cycle, where technologies are adopted at a faster rate, thus accelerating product innovation and product demand. COVID-19 has amplified this virtuous cycle, as it has in many different domains. As the cycle continues, a broader lens illuminates the potential role that technology will play in the future of running (or any sport). Imagine how we might maximize performance through wearables, game technology, AI coaching, VR tracking, gene doping, neuro-coaching and, ultimately, brain-to-brain communication.
If we pull back our lens even further and envision the future athlete, we can see the total reimagination of sports. We are likely to experience a complete blurring of boundaries between technology and the athlete. Exoskeletons, implants, artificial body parts or human-machine convergence could alter the athlete and therefore the sports themselves. Does this lead to enhanced leagues versus natural leagues? What happens if genetic engineering enables the creation of super athletes or genetic screening allows us to pick only the best children for participation in sports? It is not far-fetched to imagine leagues where robots compete against each other. Now, go even broader. These early indicators from our survey portend a world that is to come. As we look to this future, does the survey provide signals that help envision that future? Two key signals include the environment and wellness.
Our survey found that avid runners are more likely to be motivated by green technology specifically the carbon footprint of races (59 percent of avid runners would be more interested in participating in a carbon-neutral or zero-carbon-footprint race).
From a wellness perspective, a connected health platform emerges to improve the health of athletes and humans more broadly. This connectedness ultimately drives a wellness ecosystem that accrues value to the collective. The ecosystem evolves to support individual needs, while athletes contribute to collective intelligence on wellness. This enables wellness that permeates every aspect of our lives.
Were now able to monitor our health at the cellular level and our environment through the smart home; we enjoy 3D-printed food that meets our individual nutritional needs; our clothing regulates our body temperature based on our internal and ambient temperature; injuries are healed through smart bandages and rapid cell regeneration; and all of our health and wellness data is integrated into an AI-powered dashboard. These metrics improve overall health and wellness, contributing to the extension of healthy lives.
In this era of genomics, precision medicine and rejuvenation biotechnology, extending our healthy lives is not only possible but likely. Life scientists believe that the first person to live to 200 has already been born. When I look at innovation in the health domain and the rapid progression experienced in the last two decades, I see the possibilities. Catalysts like pandemics have always served as both obstacles and accelerants. In the area of health, it is the latter. Imagine the extended athletic careers these advancements may enable. When viewed through the lens of the athlete, a broader view of our emerging future materializes. Enjoy the journey!
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