Publication | Legal and regulatory framework for laboratory testing in India: A case study for Covid-19

By Harleen Kaur, Ameya Paleja, and Siddhartha Srivastava.

Testing is central to understanding the spread of the SARS-CoV-2 virus at an individual & population level and designing suitable interventions (Shah, 2020). As of June 23, 2020, India has the fourth-largest number of SARS-CoV-2 cases worldwide. This is despite having conducted only 119 tests per million people. In comparison, the United States and Russia, countries with more cases than India, have conducted 1518 and 2074 tests per million, respectively. While India has somewhat improved its testing rate since the early stages of the SARS-CoV-2 pandemic (21 per million on April 24), we are still unable to test in adequate numbers. In this blog, we study the reasons behind insufficient testing rates in India by reviewing the legal environment for regulating medical testing.

The Indian diagnostics industry is dominated by the private sector. The legal framework for the regulation of private labs is set up under the Clinical Establishments Act, 2010. The issues of non-standardisation of service quality and supplier-induced demands are prevalent in the industry (Competition Commission of India, 2018). Therefore, these labs have been functioning under market-led and self-imposed norms. The government did not depend on this regulatory framework during the SARS-CoV-2 pandemic. Instead, it granted unchecked discretionary power to the Indian Council of Medical Research (ICMR) to regulate the testing strategy. Under the regulatory framework set up by the ICMR, the private lab network is not being utilised optimally for SARS-CoV-2 testing. For instance, the private sector accounts for about 70% of the health care market in India. As of June 22, 2020, only 27% of all labs approved for SARS-CoV-2 testing in India are private labs. In this article, we argue that (i) the private labs are governed by a weak regulatory framework that has allowed market failure to persist in the diagnostics sector in India, and ii) the testing strategy mandated by the ICMR for the SARS-CoV-2 pandemic has led to poor outcomes for the participation of private labs. Hence, there is an immediate requirement for reviewing the powers of ICMR for managing the testing strategy and a long-term requirement for rethinking the present regulatory framework for labs.

Concerns about market failure in the field of medical testing

A market failure occurs when the free market is unable to obtain efficient economic outcomes. Of the four types of market failures, viz, externalities, asymmetric information, market power, and public goods, the diagnostics sector in India is seen to be affected primarily by information asymmetry. Information asymmetry or information inequality occurs when one party, such as a physician, possesses much greater information than the other, a patient (Arrow, 1963). During a pandemic, testing becomes a crucial part of a nation's public health strategy, and hence, the public goods element of market failure also comes into play. For instance, testing data is a public good inasmuch as it is useful to understand the spread of the disease in an area that helps the government to design public health policies, and sharing of such data by the government affects behavioral changes in individuals.

As a result of information asymmetry, the field of medical testing in India faces the recurring issue of quality control and standardisation of services. For instance, practices such as hiring unqualified professionals, using sub-standard equipment, and proxy digital signatures have become prevalent in the industry in the absence of effective regulation. In extreme cases, there have been instances of private labs disbursing 300-400 diagnostic reports within a matter of hours, often without conducting any testing at all.

The free market does not solve the issues of market failure on its own and requires state intervention. This can be done through effective regulation of the market, either by itself or through State coercion. We now study the existing regulatory framework for labs in India and its limitations.

Regulation of diagnostic labs

Healthcare is a state subject under the Indian Constitution. This means that in the usual course of events, states have exclusive powers to make laws concerning different aspects of health care, such as diagnostic laboratories. Article 249 of the Constitution provides exceptional powers to the Union government to make laws on state subjects in the national interest. For such matters, the states retain the power to accept or reject the union law. The Clinical Establishment Act has been passed by the Union government under this provision, and 11 states have enacted it as of now. However, there are two difficulties with the law that have created a gap between aspiration and outcome. First, under our constitutional arrangement, the Clinical Establishments Act is only applicable to those states that choose to adopt it, and only 11 states have adopted this law. Second, the law has serious difficulties in design and implementation.

In the 11 states where the Act is present and implemented, the regulatory function is limited to granting registration to labs and maintaining a register of clinical establishments. The labs interact with the regulatory authority only at the time of registration, when they submit evidence of having complied with the prescribed standards for registration to the regulatory authority. Once a permanent registration is granted, there is no mechanism to review the functioning of the labs or provide grievance redressal to patients under the Act. If a person starts a lab without registration, the maximum punishment under the law is a monetary penalty of rupees five lakhs.

Other than the Clinical Establishments Act, private labs have to comply with the standard regulatory requirements under the state Shops and Establishments Act (relating to hours of work, cleanliness, holidays, etc.) and obtain registration under the provisions of the Biomedical Waste Management Rules, 2016. Additionally, diagnostic kits and reagents used by labs are defined as 'drugs' under the Drugs and Cosmetics Act, 1940, and therefore have to be approved by the Central Drugs Standard Control Organisation (CDSCO).

We see that there is effectively no legal framework for regulating private labs in India. The labs only comply with allied regulatory requirements, such as disposal requirements for biomedical waste and approval of diagnostic kits under the Drugs and Cosmetics Act. Given this regime, two mechanisms, namely accreditation and public procurement, have sought to fill the regulatory void in the diagnostics industry.

Alternative methods of regulation

In the absence of an overarching law that assures the quality of clinical establishments, private labs have turned to voluntary accreditation to establish credibility in the vast diagnostics market. Accreditation of labs is not mandatory in India. The National Accreditation Board for Testing and Calibration Laboratories (NABL), an autonomous body under the Quality Council of India, prescribes accreditation criteria for various kinds of labs. Of the estimated 100,000-110,000 labs present in India, around 4000 have NABL accreditation. Some labs prefer obtaining certifications from international accreditation bodies in addition to obtaining NABL accreditation. Accreditation helps in assuring the quality of labs to the public as well as the government.

The second method to ensure quality standards and avoid market failure is public procurement. The government has dealt with the absence of a regulatory framework in the past by using contractual mandates to avail the services of private labs. The standards expected from these labs are contractually specified by the government while entering into public-private partnership (PPP) agreements for diagnostics. For instance, the union government under the National Health Mission (NHM) has a Free Diagnostics Services Initiative, which contains detailed requirements from diagnostic/pathology labs. NABL accreditation is one of the common requirements for private labs to participate in such government programmes.

To compensate for weak regulation under the Clinical Establishments Act, voluntary accreditation by the NABL and public procurement through PPP agreements have acted as alternative strategies for regulation. These alternatives help in reducing information asymmetry and assuring the quality of services to the public and could have played an important part in the regulation of the labs for SARS-CoV-2. Yet, we find that the government strategy for medical labs for SARS-CoV-2 is based on a command-and-control approach under the ICMR.

Regulation of medical labs for SARS-CoV-2

Under the existing regulatory framework, private labs did not have to follow any criteria or adhere to any standards before starting a new/novel test, such as the SARS-CoV-2 test. This means that patients would have been able to get SARS-CoV-2 tests done in any private lab offering the test using reagents/test kits approved by the CDSCO and having a valid bio-waste and other local licenses.

The lack of a regulatory framework led to confusion regarding the role of private labs in the response to the SARS-CoV-2 pandemic. As a result, the government set up an emergency regulatory framework for the SARS-CoV-2 crisis using provisions of the Epidemic Diseases Act, 1987, and the Disaster Management Act, 2005. Using these laws, it appointed the Indian Council of Medical Research (ICMR) as the apex decision-making body for India's diagnostic testing strategy through the MoHFW (see notifications here and here).

The Epidemics Act authorises the state governments to take exceptional measures and prescribe regulations to contain the spread of a dangerous epidemic disease. It lists a set of basic subjects for which regulations may be made such as travel restrictions, examination and quarantine of suspected cases, and inspections of any ship or vessel leaving or arriving at any port of call. The role of the union government under this law is limited to managing epidemic diseases at ports.

The Disaster Management Act contains an administrative framework for disaster management. Section 6 of the Act sets up the National Disaster Management Authority (NDMA) as a nodal body for disaster management. Any directions issued by the NDMA and the union government must be followed by the Union Ministries, State Governments and State Disaster Management Authorities. The SARS-CoV-2 pandemic has been notified as a disaster under this Act. Under this, the government has passed various directives on different aspects of the SARS-CoV-2 response using the umbrella clauses of this legislation such as section 6(2)(i) (The NDMA may lay down the policies, plans and guidelines for disaster management) and Section 10(2)(l) (The National Executive Committee may lay down guidelines or give directions to union ministries, state governments and state authorities for responding to the disaster) have been invoked to respond to the SARS-CoV-2 crisis.

Using the powers granted to it by the government, the ICMR has placed severe restrictions on private labs to test for SARS-CoV-2. These restrictions include requiring approvals from ICMR for lab facilities, commercial testing kits, and cost-capping for testing. We now study the ICMR decisions on testing strategy in detail to understand its role in the testing outcomes for SARS-CoV-2.

The role of the ICMR

The ICMR has been responsible for the regulation of public labs under a 2012 scheme called the Viral Research and Diagnostic Laboratories (VRDL) network under the MoHFW. The scheme was initiated to increase government capacity for the timely detection of emerging/re-emerging viral diseases. The VRDL labs were exclusively responsible for testing in the initial phase of the SARS-CoV-2 pandemic in India.

The initial advisories issued by the ICMR contained no mention of private labs and focused only on directing public labs to undertake SARS-CoV-2 testing. At the time, some state governments explicitly banned private labs from testing as per their regulations issued under section 2 of the Epidemic Diseases Act, 1897. For instance, the Delhi Epidemic Diseases COVID-19 Regulations, 2020 and the Bihar Epidemic Diseases COVID-19 Regulations, 2020 contain the following provision on testing of potential SARS-CoV-2 cases by private laboratories:

"No private laboratory has been authorised to take samples for COVID-19 in the State. All such samples will be collected as per the guidelines of the Government of India..."

Subsequently, the ICMR issued guidelines for private labs to undertake SARS-CoV-2 testing on March 21, 2020. Since then, the ICMR has been responsible for approving private labs to test for SARS-CoV-2. The ICMR conducts checks on the capability of private labs to test for SARS-CoV-2 and updates the list of approved private labs regularly. It also issues detailed guidelines for other aspects of testing such as procurement of reagents, evaluation of commercial testing kits, etc. In doing so, it has usurped the regulatory functions of existing statutory regulators such as the CDSCO, as well as voluntary bodies like the NABL. For instance, while diagnostic kits for SARS-CoV-2 are considered "drugs" and should be approved by the CDSCO, they also require validation by the ICMR. Similarly, NABL approved private labs are required to get a mandatory clearance from ICMR for SARS-CoV-2 testing. This means that while NABL has accredited 278 labs for RT PCR RNA testing for SARS-CoV-2, the ICMR has approved 258 of these labs for testing as of June 21, 2020. The ICMR does not document the rationale or process of performing these regulatory functions. The Epidemics Act and the Disaster Management Act do not require the ICMR to adhere to minimum standards of accountability, transparency, and public engagement. The invocation of these laws to empower the ICMR means that there is no coherent or intellectually defensible framework for reviewing the ICMR's actions during the pandemic except that the basic rule of law principles are followed by it.

Building state capacity for regulation is a gradual process that requires backing by a comprehensive legal framework (Roy et al, 2018). ICMR was abruptly thrust into a role for which it did not have the required organisational or procedural capacity. Hence, it compensated for the lack of a regulatory framework by issuing strict command and control orders. We see that after being appointed as the government regulator for the testing strategy for SARS-CoV-2, the ICMR barred all private labs from testing unless approved by it. Given that the labs are already approved by NABL, the rationale for re-approval for testing of private labs by ICMR was never shared. Additionally, ICMR started regulation of reagents, test-kits and costs of tests. This has had an adverse impact on the testing outcomes as seen below.

Implications of the regulation of private labs by ICMR

ICMR has been responsible for advising on the SARS-CoV-2 testing strategy for the country. The restrictive policies by the ICMR have led to the inaccessibility of the tests for a vast population. As a result, various courts in India are being involved to challenge such policies.

In April, the Supreme court heard the issue of cost-capping of lab testing for SARS-CoV-2 by ICMR and ordered that the tests shall be free for persons falling under government schemes such as Ayushman Bharat or any other category of economically weaker section of the society as notified by the government. The ICMR cost-cap of INR 4500 per test for private labs was not examined by the court in this petition, but it emphasised on the need for affordable tests to the population.

The Delhi high court reviewed the cost fixed by ICMR for the procurement of rapid testing kits in April. It held that the costs at which ICMR procured the kits had an unduly high profit-margin for the vendors and ordered the cost per kits to be reduced from INR 600 to INR 400. Furthermore, the kits procured by ICMR were later found to be faulty. The court criticised the government and ICMR for low testing of SARS-CoV-2 cases in another order dated June 18, 2020. It ordered the government to review ICMR policies on labs such as the protocol for sample collection, approval of labs, data sharing by labs, and costs per test through an existing government committee.

The Gujarat high court is monitoring the state response to SARS-CoV-2 under a suo-motu writ petition. Under this petition, in an order dated May 29, 2020, the court modified the ICMR guidelines on testing for different categories of patients as it found the patient categories to be non-exhaustive. The court has also decided to review the rationale behind the ICMR SARS-CoV-2 testing strategy.

The ICMR has been criticised for its advisories on the evolving SARS-CoV-2 testing strategy by experts. For instance, its restrictions on the usage of RT-PCR and rapid antigen testing are seen to be unreasonable as the testing capacity has been increasing over time. Additionally, the issue of lack of transparency in sharing testing data and its regulatory procedure makes ICMR decisions difficult to understand and implement.

The ICMR policies regarding the testing strategy for SARS-CoV-2 are restrictive for private labs. This is indicative of a trust-deficit between ICMR and the labs. The ICMR regulatory strategy to reduce this trust-deficit is to micromanage every aspect of testing sought to be done by the private labs. This has led to lower participation of such labs in testing for SARS-CoV-2 and issues of unavailability of tests to the public.

Conclusion

The bulk of the health care services in India are provided by the private sector despite the presence of public health care facilities (Hooda, 2015). Recognising the growth and demand of the private sector, the policy framework in health has gradually shifted from the government providing health care services to being a financier of these services (Patnaik et. al, 2018). Recently, the Indian government conceded before the Supreme Court that the testing capacity of the public sector for SARS-CoV-2 is insufficient.

In this article, we studied the regulatory framework with respect to medical laboratories in India. We find that in the regular course of events, the Clinical Establishment Act, 2010, and the rules thereunder are responsible for such regulation. Issues with the adoption and implementation of this Act leave the sector effectively unregulated. Despite the presence of some alternative methods of regulation, the regulatory gap in the diagnostic sector persists. Therefore, there is a need for a comprehensive law to deal with the market failure of information asymmetry and public goods. However, the enactment of such a law is a long-term deliberative process and should not be attempted in the face of a pandemic.

For SARS-CoV-2 testing, the government has deviated from the existing course of minimal intervention in regulating private labs to regulating every aspect of testing through the ICMR. Government laboratories set up under the VRDL framework were initially the exclusive bodies allowed to test for SARS-CoV-2. While private labs have now been allowed to test for SARS-CoV-2, they are still heavily regulated by the ICMR. The rationale for this approach has not been provided. We believe such an approach is unsuitable for managing the SARS-CoV-2 pandemic. Using the broad powers given to it, the ICMR has reduced the capacity for testing in India by introducing prescriptive testing guidelines, licensing requirements, and cost-capping. This has resulted in non-utilisation of a bulk of the testing capacity for SARS-CoV-2 in India so far. Therefore, we suggest that the power given to the ICMR for SARS-CoV-2 regulation be minimised by specifically disallowing any duplication of regulatory functions already being performed by bodies such as CDSCO and NABL. Further, for the powers delegated to ICMR for regulating the testing strategy, due process requirements such as documenting the rationale, public consultation, sharing of public data should be mandated by the government to increase the accountability of ICMR.

References and further reading:

Arrow, 1963: Kenneth J. Arrow, Uncertainty and the welfare economics of medical care The American Economic Review, December 1963.

Nandraj, 2012: Sunil Nandraj, Unregulated and Unaccountable: Private Health Providers, Economic and Political Weekly, January, 2012.

Srinivasan, 2013: Sandhya Srinivasan, Clinical Establishments Act, 2010 Regulation and the Medical Profession, Economic and Political Weekly, 19 January, 2013.

Hooda, 2015: Shailendra Kumar Hooda, Private Sector in Health Care Delivery Market in India: Structure, Growth and Implications, Institute for Studies in Industrial Development, Working Paper 185, December, 2015.

Patnaik et. al, 2018: Ila Patnaik, Shubho Roy, and Ajay Shah, The rise of government funded health insurance in India, NIPFP Working Paper Series, No. 231, 21 May 2018.

Roy et al, 2018: Shubho Roy, Ajay Shah, B. N. Srikrishna, and Somasekhar Sundaresan, Building State capacity for regulation in India NIPFP Working Paper Series, No. 237, 3 August, 2018.

Competition Commission of India, 2018, Policy Note: Making markets work for affordable health care, Competition Commission of India, October, 2018.

Kelkar and Shah, 2019: Vijay Kelkar and Ajay Shah, In service of the Republic: The Art and Science of Economic Policy, Penguin Allen lane, December 2019.

Shah, 2020: Ajay Shah, More testing: From concept to implementation, The Leap Blog, 06 April, 2020.

Originally published here.

Ameya Paleja is a molecular biologist and science blogger based in Hyderabad. Harleen and Siddhartha are researchers at NIPFP. The authors are thankful to Ajay Shah, Renuka Sane, Amrita Agarwal, Smriti Parsheera, Shubho Roy, Anand Prakash, Arjun Sinha, and three anonymous referees for their valuable comments.

Publication | Can Indian legal framework deal with the COVID-19 pandemic

By Harleen Kaur

The world is dealing with a novel coronavirus outbreak, COVID-19, since December 2019. COVID-19 is an infectious disease caused by a previously unknown coronavirus. The total number of confirmed cases of COVID-19 in India have been increasing since its first case was seen in January.

Multiple methods to respond to the pandemic threat are being utilised in India. Contact tracing, isolation and quarantine are important to prevent the virus from spreading into communities at large. These methods used by the State invariably impinge on the autonomy, liberty and dignity of individuals. We allow these intrusions by the State for it to be able to act in the interest of the population at large. The government actions under pandemics are legitimised through laws. In the present article, I study the legal landscape of the response to the COVID-19 threat with a specific focus on Epidemic Diseases Act, 1897. This law provides wide powers to the states to take action against a dangerous epidemic disease. Recently, there have been calls to update this colonial law as it does not provide guidelines to the states to act to prevent and mitigate epidemics. On the other hand, experts with experience of working within the government seem to believe that the law is appropriate and does not require any changes. To understand the role of this law, I study its application historically and today. I examine whether the recent COVID-19 regulations issued under it are compatible with the standards of reasonable restrictions under the Indian constitution using the test laid down by the Supreme Court on privacy as an example. Finally, I attempt to answer two questions based on the study; a) whether there is there a scope for improvement in current COVID-19 regulations, and b) whether any changes in the Epidemics Diseases Act, 1897 are required.

The elements of COVID-19 response

In case of public health emergencies like the COVID-19, prevention and mitigation is undertaken at a local level while coordination is performed by higher level of the government. The Indian Constitution describes the responsibilities of the governments with respect to subjects related to public health. Public health and Sanitation are the responsibilities of the state government and local government. The union government is responsible for port quarantine, inter-state migration and quarantine.

While public health is a state subject in the Indian constitution, about eight states and union territories in India have a legislation regarding the subject. These laws help the states in defining the administrative, financial and legal framework of action for public health. For instance, the The Tamil Nadu Public Health Act, 1939 sets up public health boards and provide for public health staff in local areas who are responsible for supply of water, drainage, sanitary conveniences etc. In places where laws are absent the basic water and sanitation services are provided directly by a dedicated public health/public engineering department. The state capacity to provide public health services varies considerably among the states in India.

The union government is using various measures to prepare and respond to the COVID-19 pandemic. In January, it had invoked its powers under the Disaster Management Act, 2005 to allow the Ministry of Health to "enhance the preparedness and containment of novel Coronavirus (COVID-19) and the other ancillary matters connected thereto". This would include medical preparedness as well as mass casualty management at hospitals. Notifying the pandemic as a disaster enables the states to use funds from State Disaster Response Fund on COVID-19. The Ministry of Health has also been issuing regular advisories for travel, mass gatherings and healthcare while keeping a tab at global scale of the outbreak. On 11 March, 2020 in a meeting of High Level Group of Ministers, it was decided that all states and union territories should be advised by the Ministry of Health to invoke the provisions of Section 2 of the Epidemic Diseases Act, 1897. This was done with an aim to implement advisories of the Ministry of Health at the union level by the states. Other than the national laws, India is also signatory to the International Health Regulations, 2005 (IHR). These regulations intend to prepare countries for establishing an appropriate public health response to international spread of diseases. The Integrated Disease Surveillance Program (IDSP), is responsible to implement the provisions under the IHR in India. It does so by strengthening disease surveillance for infectious diseases and setting response framework for outbreaks of a disease.

The role of Epidemic Diseases Act, 1897

The Epidemic Diseases Act, 1897 (the law) was enacted in colonial India to enable the states to control spread of diseases. This law was designed to put government machinery into action once there is a considerable threat of a dangerous epidemic disease and not as a code for establishing general public health systems. The provisions of the law seem to be innocuous. It consists of four sections which provide wide powers to the government. The state governments are empowered to regulate dangerous epidemic disease, a term not defined in the law. The union government is empowered to regulate ships or vessels leaving or arriving in India. Disobedience to the regulations is made a punishable offence while providing for immunity to pubic officers for performing functions under the law.

There is much to learn from the way the law was enacted and used by the government historically. SL Polu while describing the history of infectious diseases in India notes that in formulating Epidemics Diseases Act, 1897 and medical strategy to fight epidemics, the government primarily wanted to ensure compliance with the international sanitary conventions, protect trade, and assuage any fears abroad of the potential spread of plague or cholera outside India. (SL Polu (2012)) The epidemics of plague and cholera at that time were treated as a political emergency. David Arnold describes the law as "one of the most draconian pieces of sanitary legislation ever adopted in colonial India." (David Arnold (2000)) The measures under the act which invited Arnold's criticism included compulsory detention of plague suspects, destruction of houses and infected property, physical examination of persons and banning of fairs & pilgrimages. This invited distrust of the Indian communities and resistance towards action taken by the State. As a result, Arnold notes that the colonial government modified its strategy in favor of moderate measures such as creating awareness about sanitation, advocating voluntary measures, and setting up institutions for medical research.

The power of states during a pandemic

Currently, many states including Delhi, Haryana, Karnataka, Maharashtra and Uttar Pradesh have invoked their powers under the 1897 Act for the COVID-19 pandemic. This enables the states to undertake Non-Pharmaceutical Interventions (NPIs) to mitigate the epidemic spread in absence of medicines to treat the disease. These NPIs, so far include closing of educational institutions, malls, schools, gyms, advisories on social distancing as well as regulations regarding home isolation and quarantine. However, some of the regulatory provisions provide extensive powers to government officers. For instance, state regulations such as the Bihar Epidemic Diseases COVID-19 Regulations 2020, Uttar Pradesh Epidemic Diseases COVID-19 Regulations 2020, Delhi Epidemic Diseases COVID-19 Regulations, 2020 authorise officers of the government to admit and isolate a person in case he/she has a history of visit to an area known to be affected by COVID-19 or has been in contact with a symptomatic person. This can be done forcefully, if required. The officers are also given powers of surveillance of individuals as well as private premises. Lockdowns can be issued by the District Magistrate. Further, in order to prevent fake news from being published, prior restraint of free speech is authorised by not allowing anyone to publish information regarding COVID-19 without prior permission of the government.

The current regulations on COVID-19 allow states to practice the coercive actions comparable to those undertaken by the colonial government in the past. These actions have already put restriction on movement, free speech, religion, profession and privacy. The restrictions are legal in as much as they are necessary and proportionate to a legitimate aim. (Supreme Court of India, (2019)) Given the nature of the pandemic which requires extensive state surveillance and usage of force, these must be balanced by corresponding checks on the use of State power. Unless such checks and balances are put in a legal framework, there will be a threat to the individual from the State itself.

As discussed above, the regulations on COVID-19 impact many aspects of fundamental rights of individuals. Herein, I examine the law with respect to the right of privacy. The right to privacy, which includes personal autonomy, liberty and dignity, is a fundamental right in India. However, the right is subject to reasonable restrictions such as in furtherance of public interest. In the Puttaswamy judgment, the court laid down the following tests for limiting the discretion of the State while impinging on the fundamental right to privacy: (Supreme Court of India, (2018))

1. The action must be sanctioned by law
2. The proposed action must be necessary in a democratic society for a legitimate aim
3. The extent of such interference must be proportionate to the need for such interference
4. There must be procedural guarantees against abuse of such interference

The test of legitimate aim is satisfied by the Epidemic Diseases Act, 1897 as its function is to prevent the spread of a dangerous epidemic disease. It is impossible to define specific proportionate regulations for a novel infectious disease in a parent law. Therefore, the law provides for delegated legislative power to the states as an when the situation arises. However, the parent law does not provide for procedural guarantees against abuse of State power of interference with privacy of individuals. For instance, the law does not define or provide guidelines on the meaning of a dangerous epidemic disease. Due to this, the citizens are at risk of both inaction and excessive coercion by the State. In the past, citizens have been forced to petition to courts for directing the State to take action, or to defend themselves against excessive action of the State.

This law can also be used by the State for profiling, mass quarantine and targeting of individuals. Even then, there is legal immunity given to public servants who function under the law. Therefore, the law focuses on public interest while dispensing wih any procedural guarantees for transparency and accountability against abuse of its powers. It is due to these reasons that the Epidemic Diseases Act, 1897 does not pass the tests of reasonable restrictions on the fundamental right of privacy of individuals.

Envisaging immediate fixes

The pandemic of COVID-19 has already reached India and the Epidemics Diseases Act, 1897 does not balance the rights of individuals with the power of the State. The government can, however, still utilise learnings from its own past as well as current practices to make effective regulations.

The problems in the Epidemic Diseases Act, 1897 were apparent since its introduction. In the case of Ram Lall Mistry v RT Greer in 1904, the Calcutta High Court had to decide whether the any action can be instituted against the defendent, a government servant, for destroying the property of the plaintiff. (Calcutta High Court, (1904)) In this case, the plague regulations allowed an officer to destroy the property of individuals, but also mandated them to pay adequate compensation for destruction of the property. Given that the regulations specified the consequence of destruction of property to be adequate compensation, the defendent was held to be personally liable for paying such compensation. The defendent could recover the amount from municipal funds. This case clearly shows that regulations under the Epidemic Diseases Act, 1897 can introduce personal liabilities on the officers of the State while performing their functions. The current COVID-19 regulations need to be modified to introduce similar provisions. For instance, the regulations should increase accountability of the public officers by including elements of rule of law such as; defining notice and consent framework for use of sensitive personal data with a mandatory sunset clause, right to be heard, and absence of immunity against illegal actions done by State representatives.

Modern states use laws, rules and regulations not just for protection of law and order but also for social welfare. The World Health Organisation (WHO) advocates including provisions for protection of individual rights in drafting policies for pandemics. These include transparency, public engagement and social mobilisation. For instance in US, The Health and Human Services Department is responsible for tracking the distribution of federally purchased vaccine, identifying and sharing details about high priority population with stakeholders while maintaining confidentiality of individuals. This is done through developing guidelines on these processes and is legally mandated under the Public Health Services Act.

In India, such provisions are absent. As a result, on COVID-19, the reports suggest that the State power has been exercised for arresting persons spreading fake news on the disease, arresting persons gathering in large numbers despite directives of the government, arresting persons not following home quarantine and sharing publicly the list of suspected patients. Using excessive power without transparency has historically shown a negative impact on the community participation at the time of epidemics. Reports of being forced into unhygeinic quarantine is deepening the distrust between people and the State. 2 persons have already reportedly died due to suicide fearing the disease and many suspected patients have absconded public hospital facilities.

As the science around the novel virus develops, the governments are forced to take immediate public health measures. One way to ensure such measures are accepted in the society is through transparency. The orders/advisories/guidelines under the regulations must be well-reasoned so as to not inadvertently encroach on the life and liberty of individuals. Within India, the states behave differently with respect to transparency. For instance, Kerala has a dedicated daily bulletin with information about latest advisories, statistics about isolation, testing and results at a single place. Delhi does not have such a dedicated bulletin. Information about orders, notifications and minutes of meetings are disaggregated and irregular. On the other hand, information released by Indian Council of Medical Research (ICMR), the nodal body for COVID-19 lab testing is sporadic and does not offer details such as aggregate number of test requests accepted and rejected, time taken for test results or number of healthcare workers tested. The authorities responsible to act on COVID-19 situation in India should follow best practices in the interest of transparency such as; risk communication as seen in Singapore, anonymised details about suspected patient and action taken by states as seen in Kerala, and Tamil Nadu, sharing epidemiological links of cases as seen in South Korea, and providing guidance to employers, as is done in the US .

The need for a legal framework for epidemic preparedness & response

While some immediate fixes in regulatory practices can help the Indian response to COVID-19 threat, structural changes are required in order to balance health security with civil liberties. India has an excessively fragmented landscape for health policy. Epidemic Diseases Act, 1897 is one element of interventions among the multiple agencies that affect the state of public health in India. The limited purpose of the law is to allow states to take extraordinary measures at the time of a dangerous epidemic disease. It does not establish any coordination mechanism between states and the union government at the time of a dangerous epidemic outbreak. The role of the union government is also negligible (such as port quarantine) under this law. However, Article 253 of the Constitution allows the union government to enact a law to give effect to the International Health Regulations, 2005 - which asks for setting up mechanisms to prevent, protect against, control and provide a public health response to international spread of disease. The union government has already been establishing public health surveillance and response mechanism for public health risks and emergencies under its international obligations under IDSP and the National Health Mission (NHM), instead of modernising its legal framework.

A legal framework for infectious diseases in the interest of public health security is essential to increase transparency and accountability of the State towards the public. An example of a national law to give effect to the International Health Regulations, 2005 is seen in Australia. The National Health Security Act 2007 was formed to provide for a national system of public health events of national significance. The union government is empowered to coordinate and consult with states for sharing information and to identify and respond quickly to public health events. The law defines permissible purposes for which state action is appropriate. The citizens are guaranteed confidentiality of information under the law, and detailed consent requirements are laid down for authorisation of use of such information.

Any such law when designed for India, needs to pass the tests of reasonableness as set out by the Supreme Court. This can be achieved by putting procedural guarantees against abuse of power provided to the State as seen above.

Conclusion

The Indian response to COVID-19 has been fragmented. Multiple laws, rules, programmes, regulatory bodies along with national and state level advisories are the components of the response system. One of these laws is the Epidemic Diseases Act, 1897. This colonial law has been a subject of debate as calls for government action grows due to the outbreak. In this article, I attempt to study the role of the Epidemic Diseases Act within the pandemic response. Instead of building a public health framework, the limited purpose of this law is for the states to take special measures in case of outbreak of dangerous epidemic diseases. Within this limited framework, the law gives wide powers to the government to undertake coercive actions against individuals.

Indian states have notified COVID-19 regulations under the law. A study of the provisions of these regulations shows that there are unmitigated powers of surveillance and use of force given to state authorities under them. While such powers are envisaged to be used under the legitimate aim of protecting health of the population, neither the Epidemic Diseases Act nor the regulations under it attempt to describe procedural guarantees against abuse of state coercion.

Using examples of Indian states and past utilisation of the regulations, I attempt to understand what can the states do with their COVID-19 regulations to balance the rights of the individuals with their own power. This is important as emergency public health measures require community trust and participation. Introducing accountability of the government officials & departments while performing their functions under the law and increasing transparency are the two best practices the states can adopt immediately without requirements of changing the Epidemic Diseases Act, 1897.

In order to mandate using such procedural best-practices in the future, a comprehensive legal framework for epidemic preparedness and response is required instead of the the current fragmented response framework through programmes and missions. This is required to increase the accountability of the government to its people. It is imperitive that such a law is passed by the union government while providing states power to utilise their public health framework. This can be done in India under article 253 of the Constitution. The role of such a legal framework to protect the rights of individuals while defining functions, powers and liabilities of government authorities for situations such as epidemics and pandemics.

PS: A shorter version of this article was published in Bar & Bench here.

References and further reading:

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Polu, S. L. Plague and Cholera-The Epidemic versus the Endemic, Infectious Disease in India, 1892-1940 (pp. 50-81). Palgrave Macmillan, London, (2012).

Arnold, D., Science, technology and medicine in colonial India (Vol. 5). Cambridge University Press, (2000).

Rakesh, P. S., The Epidemic Diseases Act of 1897: public health relevance in the current scenario. Indian journal of medical ethics, 1(3), (2016).

Supreme Court of India, Anuradha Bhasin v. Union of India and Ors., Writ Petition (Civil) No. 1031 of 2019.

World Health Organization. Ethical considerations in developing a public health response to pandemic influenza (No. WHO/CDS/EPR/GIP/2007.2). Geneva: World Health Organization, (2007).

Supreme Court of India, Justice K. S. Puttaswamy v. Union of India, Writ Petition (Civil) No. 494 of 2012, decided on 26 September, 2018.

Sivaramakrishnan, K. The return of epidemics and the politics of global-Local health. American journal of public health, 101(6), 1032-1041, (2011).

Gujarat High Court, Devarshi Pragneshbhai Patel v. State of Gujarat, Writ Petition no. 33 of 2015, order dated 26 February, 2015.

Orissa High Court, Gandharva Jena v. State, Criminal Revision no. 233 of 1965, decided on 18 November, 1965.

Calcutta High Court, Ram Lall Mistry v. RT Greer,(1904) ILR 31 Cal 829, decided on 13 June, 1904.

Shah, A et al. Financing common goods for health: a public administration perspective from India. Health Systems & Reform, 1-6, (2019).