Wake-up call

India runs an unprecedented biological risk, but we are not prepared to successfully deal with. Coronavirus pandemic is a wake-up call, but the Government is too slow to reform and invest satisfactorily in the health and biotechnology sector. It leaves the country too vulnerable to dangers.

India faces three major biological threats: first, diseases caused by a natural mutation in humans, plants, and animals; second, infections arising from human accidents; and third, possible outbreaks occurring due to deliberate weaponisation of dangerous pathogens that affect humans, animals, or crops. These threats seem to be real in the context of our COVID-19 experience that has also been highlighted by a recent working paper of the US-based Carnegie Endowment for International Peace.

The paper is titled 'Biological Risks in India: Perspectives and Analysis' and is authored by Shruti Sharma. India is especially vulnerable 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, the report emphasised.

The way the COVID-19 is being handled in the country exposes the deep fault lines in India's public health infrastructure, including a shortage of healthcare facilities in rural areas, and inefficient disease reporting and surveillance in most states. It necessitates, the country should assess the gaps and divert its resources toward the healthcare sector to prepare itself for both natural and man-made biological emergencies.

There is a further challenge to wisely manage the tradeoffs between regulations to reduce the risks of accidents and attacks on the one hand, and policies that enable government, scientific researchers, and industry to develop and market beneficial applications of biotechnology on the other. This means researchers, business, regulators, media platforms, non-governmental organisations, and voters must strive to educate themselves and their audiences and constituencies about possible threats and about the socially beneficial ways to prevent and manage the situation.

The threats and risks the country is running include the risks of zoonotic infections due to high-density livestock population and a poorly guarded animal-human interface. Poor patient adherence to antibiotic treatment, nontherapeutic use of antibiotics to promote growth in farm animals, self-medication, and illegal over-the-counter access to antibiotics makes antibiotic resistance an emerging health threat that demands immediate policy attention.

India has laboratories with different biosafety levels (BSL). New biosafety guidelines issued by the Department of Biotechnology mentions certification and validation for various levels of safety by the country lacks accredited government or private agencies to certify and validate the lower standard BSL-2 laboratories' compliance with safety rules.

Some experts say that a sudden ban on plastic in India in 2018 has also made it difficult to use autoclavable plastic bags to dispose of laboratory waste. It has complicated the implementation of the proper disinfection protocol to dispose of biomedical waste, posing a serious biosafety hazard.

The paper points towards some unforeseen infection, accidental release of pathogens or other biological materials from designated laboratories, either due to negligence or poor understanding of biosafety protocols among the laboratory workers. Deliberate introduction of genetically engineered organisms for beneficial purposes also might have unintentional harmful consequences.

Disease-causing pathogens are abundantly available in nature. Technologies needed to manipulate them are also becoming easily accessible. Actors with nefarious designs could purposefully weaponise such technologies and naturally occurring pathogens, the paper said. India shares porous borders with most of its neighbouring countries, the possibility of cross-border infections is another major biological threat. In addition to manipulating pathogens affecting human health, invasive pathogens or synthetically crated ones or pest can be used to weaken the agricultural supply chain.

To address safety and security risks, India follows two different approaches — biosafety and biosecurity. Biosafety seeks to protect humans from pathogens while biosecurity protects pathogens from humans. These two concepts complement each other in mitigating different risks. However, there are gaps, and we lack the robust implementation of biosafety protocols. India must be alert to prevent the risks of accidental exposer, intentional theft, or misuse. Biosafety and biosecurity regulations should therefore be revisited because several regulations are not clearly defined and categorised, and they empower different ministries or agencies. Even though India has enacted laws and regulations to protect the country from biological threats, coordination and monitoring of its implementation remain irregular.

We have seen several frightening lapses during the handling of the COVID-19 pandemic. 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 WHO advisories. It is especially noticed in the case of the first category of threats, i.e. diseases emerging from natural sources.

For the second category of threats, i.e. diseases caused by accidents, though India has developed comprehensive biosafety guidelines to monitor the safety of biotechnological research, they are being implemented through many agencies and ministries. The multiplicity of organisations operating under different ministries makes it difficult to ensure implementation of the biosafety guidelines. Moreover, the system often experiences poor coordination between the Centre and the states' regulatory units.

For the third category of biological threats, i.e. threats emerging from intentional sources, India has no specific biosecurity policy or legislation but has a multiplicity of regulations that address threats emerging from different sources. The entities set up under different ministries with inadequate collaboration among them leaves India vulnerable to a variety of foreign threats.

It is to be noted that biosecurity discussions are mostly confined to closed policy circles and rarely involve experts from outside the Government. It leads to poor nationwide biosecurity awareness in the country. Further, we do have regulations relating to 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) that may encode virulent genes. Presently, biosecurity regulations often empower customs officials as the only authority that can check the baggage of incoming passengers. However, most customs officials are inadequately trained to identify specific pests or pathogens.

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 to India and its citizens. India must be prepared in advance.

Views expressed are personal