Report | Compendium of public–private mix for tuberculosis control in India

 PATH India

Between 2021-2023, I served as an independent consultant for a project that aimed at identifying and documenting the historical role of the private industry in dealing with Tuberculosis in India. It helped me identify various legal and economic levers that can be used to provide essential healthcare solutions at scale. We documented the ongoing efforts in India as case studies focusing on methodology and approach of various public-private partnership solutions, identifying the innovation in these approaches, clarifying the financing and timelines of the solutions, and their attempts at scaling up and sustaining these efforts. 

The report can be accessed here.

Publication | Information about COVID-19 in India

By Natasha Agarwal and Harleen Kaur.

The presence of timely and reliable data enables informed decision-making by government organisations and individuals. When a machine-readable dataset is released on a website, it is non-rival, and thus has characteristics of a public good. There is a case for state financing or production of information. As Carl Malamund says, "Government information is a form of infrastructure, no less important to our modern life than our roads, electrical grid or water systems". Open Data Governance (ODG) are structured datasets produced by government institutions that are released in a machine-readable format. These datasets contain information such as statistics, plans, maps, environmental data, spatial data, materials of agencies, ministries, parliamentary data, budgetary data, and laws.

Governments across the globe have been actively opening their data through national and regional data transparency portals recognising the need for making data available to the public. The process is informed by ODG principles. There are three main reasons for opening government data; increasing transparency, releasing the social and commercial value of the data, and to encourage participatory governance (Attard et al. (2015)). As an example, the COVID-19 pandemic is best controlled through behavioral changes by each individual. To support such changes, the governments need to open their data about the pandemic at an individual and community level.

The ODG principles defining best practices of data sharing include; i) identifying and publishing high-value datasets in a standardised format (such as a directory of medical professionals, tests conducted and results and information about surveillance), ii) adopting open data scheme protocol to share human and machine-readable, non-proprietary format and include universal resource identifier and linked data to provide access,

iii) removing barriers to data access such as requirements of establishing an account, of proving identity, or payments for data access, and iv) making information available in perpetuity by not deleting/changing data permanently.

In this article, we examine the information systems on COVID-19 in India from the viewpoint of these issues in the design of a high performance statistical system.

Data.gov.in and its limitations

In India, an open data policy the National Data Sharing and Accessibility Policy (NDSAP) was announced in 2012 to open government data to the public by following ODG principles.

The policy requires all ministries, departments, subordinate bodies, organisations, and autonomous bodies of the Indian Government to share all publicly generated non-sensitive data in both human-readable and machine-readable formats. The data is disseminated through a common government data platform deployed and managed by the National Informatics Centre (NIC), Ministry of Communications and Information Technology. It mandated that datasets be periodically updated by government agencies along with comprehensive meta-data which enables data discovery and access through departmental portals.

Furthermore, NDSAP requires the Department of Information Technology (DIT) to publish guidelines to implement NDSAP. The implementation guidelines provide details of the data contribution process including; the role and responsibilities of the data controller, approval, publishing process for catalogs and resources, and management of published datasets.

In compliance with NDSAP, India's national data transparency website, data.gov.in was launched in 2012. Accordingly, data.gov.in provides a unified catalog of datasets allowing users to browse the dataset catalog, view the meta-data associated with each dataset, comment on and rank various datasets, download available datasets, submit suggestions and queries on the published dataset, and submit a request for those that are not available yet (Chattapadhyay (2013)).

Despite the comprehensiveness of the policy and the accompanying guidelines, agencies have responded predictably, i.e. they neither comply with NDSAP nor with the implementation guidelines. As a result, data.gov.in contains issues such as the absence of databases, duplicate datasets, lack of follow-up, or meta-data (Agarwal (2016) and Buteau et al. (2015)). The terms 'policy document' and 'guidelines' which are often used in India are ineffective in that they do not constrain the executive. Hence, these documents amount to exhortations that have little impact on the incentives of officials in favour of greater opacity, reduced work, or gaining power through the control of data.

Ministry of Health and Family Welfare (MoHFW) and COVID-19 data

We examine the data in the public domain emanating from MoHFW during the ongoing COVID-19 pandemic. To understand the availability of resources for healthcare, we searched for a directory of healthcare providers (both institutions and individuals). The latest hospital directory available on data.gov.in was for 2016 and the latest data for the number of registered allopathic doctors and dental surgeons was available for the year 2013.

The MoHFW is disseminating limited data on the spread of COVID-19 through the data.gov.in portal. For example, as of 1st June 2020, the data reported under mygov.in (not in data.gov.in) contains information on three variables namely (i) total number of persons infected with COVID-19; (ii) COVID-19 infected persons who have been cured/discharged/migrated; and (iii) COVID-19 infected persons who have died. The state-wise distribution of these three variables is available for a given date "T = Today". This data cannot be downloaded. The meta-data for this information is also not available. On the other hand, the data.gov.in only releases daily factsheets in a pdf format summarising this data.

The dissemination of COVID-19-related data by the MoHFW has problems. It gathers detailed COVID-19-related data from the National Centre for Disease Control (NCDC) (surveillance data from the field) and Indian Council of Medical Research (ICMR) (data through the testing laboratory network), which is not reflected in data.gov.in.

The NCDC, under the Integrated Disease Surveillance Project (IDSP), consists of union, state, and district-level units responsible for the surveillance of infectious diseases in India. Although it releases weekly outbreak reports notifying the status of infectious diseases in India, the reports are available only on its website and not integrated on data.gov.in. On the COVID-19 pandemic, the weekly outbreak report dated 10th-16 February, 2020 was the latest available report under IDSP as of 8 June, 2020.

Similarly, ICMR, the designated body under the National Disaster Management Act to coordinate the testing strategy for COVID-19 has been releasing its data through its website and not through data.gov.in. Through its website, ICMR releases information on two parameters, the total number of samples tested for COVID-19 over time, and in the last 24 hours.

Therefore, data.gov.in is not being utilised by the union government agencies for releasing information. Individuals and researchers interested in the government data on the pandemic have to access information available in different silos according to their skills and knowledge. Moreover, none of the information shared is available in a machine-readable or standardised format. This leads to a weak information base on Covid-19 available to the public and to researchers, which hampers the decision making of individuals on the appropriate care that they should take, and hampers policymaking by government organisations for want of data and research.

Data disseminated by state governments

The union agencies are not the only government source on COVID-19 information. We now study the data dissemination protocols for COVID-19 as followed by the states.

We could not find state data on COVID-19 on the data.gov.in website. As a result, the following information was collected through individual COVID-19 portals set up by the states. Table 1 shows that there is heterogeneity in reporting across states. The information shared by the states is classified into three categories; "state-level", "district-level" and "individual-level".

Table 1: State-level reporting parameters for COVID-19 (As of 9 June, 2020)

	Parameters	Delhi	Kerala	Maharashtra	Gujarat	Karnataka	Madhya Pradesh
State-level data	Total COVID-19 confirmed cases	Y	Y	Y	Y	Y	Y
	Active cases	Y	Y	Y	Y	Y	Y
	Total COVID-19 tests conducted	N	Y	N	Y	Y	N
	Hospitalisation status of positive cases	Y	Y	N	N	Only ICU patients	N
	Isolated/quarantined patients	Y	Y	N	Y	Y	N
	Total recovered patients	Y	Y	Y	Y	Y	Y
	Total deaths	Y	Y	Y	Y	Y	Y
District-level data	Number of people under observation	N	Y	N	N	Y	N
	Number of quarantined/isolated people	N	Y	N	N	Y	N
Individual-level data	Age	N	Y	N	N	N	N
	Gender	N	N	N	N	Y	N
	Comorbidity	N	Y	N	N	N	N

Table 1, placed above, shows the data sharing protocol for COVID-19 in selected states. We may point out a few facts that influence the interpretation of this table:

1. Data as of 10th June, 2020. Sources: Delhi, Kerala, Maharashtra, Gujarat, Karnataka and Madhya Pradesh.

2. Maharashtra, Gujarat, and Karnataka share information about the same parameters at the State and District level. The information depicted here is about parameters in addition to the duplicate information.

3. In the studied states, Gujarat and Delhi inform about the number of patients on ventilators at the state level. However, the information on available hospital beds and ventilators in Delhi is shared under a separate website, https://coronabeds.jantasamvad.org/.

4. District-level information in Kerala is available for patients hospitalised, symptomatic patients hospitalised, the chronology of positive cases, and hotspots. No other states releases data on these parameters.

5. Karnataka is the only state which shared anonymised patient data related to their travel history, district, and location of isolation. It also has a dedicated patient case number for individual patients for whom information is shared.

6. Madhya Pradesh had a dedicated website for individual-level data which was discontinued from 11th May 2020 onwards following the raising of privacy concerns over social media.

We find that in most states, the baseline data includes overall state data about testing rates, persons infected, deaths, and recovery data. However, some states provide additional information such as the number of COVID-19 tests conducted, the number of isolated/quarantined persons, the counts of patients on ventilators, and stable patients. While some states like Maharashtra report data at the district level along with the overall state data, others like Karnataka share information at the individual level. There is a high variation in the type of data shared by the states. For instance, at an individual level, Karnataka reports anonymised information about the demographic details in addition to the baseline data. On the other hand, Madhya Pradesh used to share the name and addresses of the suspected COVID-19 patients to the public while reporting individual-level data. Similarly, Kerala, Maharashtra, and Gujarat report their data at the district level. Kerala reports its surveillance data which is not reported by Maharashtra, and Gujarat. Some states provide daily reports in English, while others do not. For example, Gujarat provides daily reports only in Gujarati.

Most states disseminate data through their COVID-19 websites. However, some resort to reporting through social media. For example, the Maharashtra government website on COVID-19 does not provide information other than that reported in table 1. However, the Maharashtra government has been releasing daily reports providing COVID-19-related information across age, gender, comorbidities amongst other variables through Twitter. While twitter can amplify the transmission of information in a public statistical system, it should not supplant the foundational systems. Data disseminated through a tweet cannot be traced to any government website. Besides, there is inconsistency in the reports shared by the Maharashtra government through twitter. For example, the report dated 22nd April 2020 provides for district-wise distribution of COVID-19 cases in Maharashtra which is not available in the report dated 1st April 2020. The data is a "delete-tweet" away from not being available.

There is also variation in the data sharing format. Most state governments provide data in human-readable formats like pdf. However, some state governments provide some data in machine-readable formats. For example, district-wise data on variables available on dashboard for Gujarat which contains the total number of cases tested for COVID-19, positive cases, patients recovered, people under quarantine, and total deaths can be exported to a csv document. Nevertheless, demographic details of COVID-19 patients or data patients on ventilator/stable, are only available in daily reports in pdf format.

We find that the states do not share their COVID-19 data through the data.gov.in framework. Users have to look for multiple information sources about COVID-19 data to access this data. Within the framework of stand-alone websites providing information, there are two concerns. The first concern is the lack of standardised parameters for information releasing. For instance, few states share the hospitalisation status and the availability of beds which would be useful for the general public in case of emergency. The second concern is the quality of data shared by the states. As discussed, most states share human-readable data and not machine-readable, downloadable data. Meta-data is not available for any state studied making it difficult to interpret. Moreover, the lack of data standardisation makes data non-interoperable. The state-level historical information is unavailable for most states. Therefore, not all data shared by the states is permanent.

Difficulties of CoVID-19 data release seen elsewhere in the world

So far, we have documented variation in what data is being released, and how the same is disseminated, in India. This is a global concern for COVID-19. We map the data reported by selected countries in table 2 below. We find that countries are using two forms of data distribution methods. These are daily updates and dashboards. While daily updates are usually pdf documents, dashboards provide progress of COVID-19 over time. The type of information shared by countries can broadly be classified according to the level of data as "country-level" and "individual-level". Country-level data consists of aggregate information such as the total number of tests conducted, the total number of COVID-19 positive patients, the number of patient hospitalised and deaths, etc. Some countries also share aggregate surveillance data which consists of information about individuals isolated, quarantined, and contact traced. At an individual level, we see a wide variation of data shared by the countries. While India does not provide individual-level data through its Ministry of Health, other countries share demographic information such as age, gender, race/ethnicity, and occupation. A comparison of data disclosed by selected countries is shared in table 2.

Table 2: Country-level data parameters for COVID-19 (As of 10 May, 2020)

Country	Daily updates (DU) or Dashboard (DB)	Total Number of tests conducted	Total Number of COVID-19 +ve patients	Total Number of patients hospitalised	Total Number of deaths	Surveillance data	Individual level data
							Age	Gender	Race/Ethnicity	Occupation
India	DU and DB	Y	Y	N	Y	N	N	N	N	N
USA	DU and DB	Y	Y	N	Y	Y	Y	N	Y	N
UK	DU and DB	Y	Y	N	Y	N	Y	Y	Y	Y
South Korea	DU and DB	Y	Y	N	Y	Y	Y	N	N	N
Singapore	DU and DB	Y	Y	Y	Y	Y	N	N	N	N
Canada	DB	Y	Y	Y	Y	Y	Y	Y	N	N
Australia	DU and DB	Y	Y	Y	Y	Y	Y	Y	N	N

It can be seen from the above table that most countries report testing data (information about the number of tests conducted), and the number of positive cases and deaths. At the national level, India only reports these minimum consistent variables. Some countries report more variables to the public. For instance, the US, South Korea, Singapore, Canada, and Australia report surveillance data in varying details. A few countries like Canada share their database in a downloadable format. This includes information about quarantined and isolated individuals and details about contact tracing and source of infection. Singapore, Canada, and Australia also report data on the number of cases hospitalised. The UK has recently started reporting information about COVID-19 deaths, disaggregated into deaths inside and outside hospitals. Individual-level data such as age, gender, race/ethnicity, and occupation, is visible in some countries, as is the case in some states (though not the union government) in India. The US releases data about age and race, while the UK releases information about age, gender, race, and occupation. South Korea releases age details for only severe cases and Singapore releases individual-level data only in the event of the death of the individual. Canada releases data about age and pre-existing conditions of the individuals and Australia releases information about age and gender.

Therefore, we find that data release for COVID-19 has issues of lack of standardisation and inter-operability globally. In India, the union and state governments have important deficiencies.

Implications for India

India's existing data infrastructure does not meet the demands of a public health emergency. The implications of this are multifaceted. For example, amid the COVID-19 pandemic, the government had to create a Covid19-warriors dashboard that provides information on doctors, nurses, ASHA workers, and others who could be deployed for immediate response. If data.gov.in had worked well, then the government would have had this information already.

Likewise, the problem of inaccurate databases highlighting data discrepancies in reporting COVID-19 infected persons could have been avoided. An available database infrastructure in data.gov.in would have avoided the need for ICMR to evolve its own data-dissemination method in the middle of the COVID19 pandemic. Besides, the problem of collecting, processing, and releasing COVID-19 data with other databases would have been eased. For example, if the existing data infrastructure had data collection and reporting standards across space like district names with their respective codes, then it would not only be easy to collect the data but also facilitate easier collation with other datasets for enabling interoperability.

Conclusion

In the present article, we highlighted one element of the public health response, the issue of data release by the Indian government authorities for COVID-19. We show that the statistical system for disease surveillance dissemination in India is in a need of reform.

The ODG platform in India, data.gov.in, can play an important role in strengthening India's public health data infrastructure. To realise the utility of public data, a data protocol framework with a legally enforceable mandate on the government is required, as is seen in countries like the US. The principles of standardising, anonymising, interoperability, meta-data release, and grievance redressal in the event of non-release should be in this legal framework.

For the union government, a data.gov.in which utilises the sound principles of OGD release could become a better foundation for data release, and thus improve India's response to an epidemic. State and city governments could choose to use the services of data.gov.in or build their own systems. An indicative list of the essential components of such a portal (as seen in NDSAP and ODG principles) are provided below:

1. Standardising data release: Standardisation of reported variables such as reporting unit, disease data, language, individual, and community-level data is required. Elements that go towards this include geotagging and coding of hospitals/labs and the adoption of International Classification of Diseases (ICD) for diagnosis and treatment of diseases.

2. Ensuring privacy: Privacy is a fundamental right in India (Supreme Court of India (2017)). Despite this, states like Madhya Pradesh and Karnataka were seen to be disseminating personally identifiable information of suspected COVID-19 patients. The government would need to adopt various tools at its disposal to protect these rights at an individual and community level. These tools include tagging appropriate data, incorporating principles of Privacy by design (PBD), anonymising and utilising appropriate fiduciary principles (Cavoukian (2011) and Bailey and Goyal (2019)).

3. Interoperability: Facilitating systems interoperability by incorporating common formats, software standards, and semantic interoperability by incorporating e-governance standards so that the meaning of data is not lost across data silos is required (Wright et al. (2010)).

4. Adopting an open data scheme: Legislators need to create the frameworks through which the executive is required to release meta-data, and release data in a machine-readable format.

5. Setting up governance framework: Union, state, and city governments have legitimate authority on how they organise their work, but greater consistency and predictability for API-based access is desirable.

References

Attard et al. (2015): Judie Attard, Fabrizio Orlandi, Simon Scerri, and Sören Auer, A systematic review of open government data initiatives, Government Information Quarterly, 2015.

Chattapadhyay (2013): Sumandro Chattapadhyay, Towards an Expanded and Integrated Open Government Data Agenda for India, IDRC Digital Library

Agarwal (2016): Natasha Agarwal, Open Government Data: An Answer to India's Growth Logjam, SSRN, 16 August, 2016.

Buteau et al. (2015): Sharon Buteau, Aurelie Larquemin and Jyoti Prasad Mukhopadhyay, Open data and applied socio-economic research in india: An overview, IFMR Working Paper, 27 May, 2015.

Supreme Court of India (2017): Justice K.S. Puttaswamy v. Union of India, 2017 (10) SCC 1.

Cavoukian (2011): Ann Cavoukian, Privacy by design: The seven foundational principles, Information and Privacy Commissioner of Ontario, 2011.

Wright et al. (2010): Glover Wright, Pranesh Prakash Sunil Abraham, Nishant Shah, Open government data study: India, The Centre for Internet and Society, 2010.

Bailey and Goyal (2019): Rishab Bailey and Trishee Goyal, Fiduciary relationships as a means to protect privacy: Examining the use of the fiduciary concept in the Draft Personal Data Protection Bill, 2018, Data Governance Network, 2019.

Originally posted here.

Natasha Agarwal is an independent research economist. Harleen Kaur is a researcher at NIPFP. The authors are thankful to Ajay Shah and two anonymous referees for their valuable comments and inputs on the article.

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.

Comments on the National Dental Commission Bill, 2020

Summary of recommendations

This response presents my comments on the Draft National Dental Commission Bill, 2020 (“ NDC Bill”), proposed by the Ministry of Health and Family Welfare. The Bill offers a fairly comprehensive set of provisions for regulating the profession and education relating to Dentistry. However, for the reasons explained in more detail in the response below, the position adopted by the Bill on certain key issues needs to be revisited. These are summarised in the present section:

1. The present bill drops the requirement to regulate the profession and education of Dental Hygienists (DHs) and Dental Mechanists (DMs) from under the domain of the regulator. It is an established fact that the profession of dentistry requires contributions from the DHs and DMs. Therefore, it is recommended that the NDC Bill include provisions for the regulation of DHs and DMs. This may be specified in the functions of the NDC and its Autonomous Boards. Due representation of DHs and DMs may be provided in these Boards.
2. The preamble of the NDC bill should iterate “patient safety” as the objective of the NDC. Patient safety is seen universally as the ultimate goal of a regulator in the field of health services, and a clear ultimate objective of patient safety would enable the NDC to align its regulations for this goal.
3. The definition of the terms dentists and dentistry needs to be modified. This is required to include promotive healthcare as a function of dentists, including only qualified personnel as dentists, as well as including promotive functions and ‘oral health’ as a function of dentistry. The detailed suggestions, as well as the rationale, is provided in the comments below.
4. The definition clause should also include definitions for terms like ‘Oral Health’, ‘Dental Hygienists’, and ‘Dental Mechanics’.
5. The term of the “part-time” members of the NDC board and Autonomous Boards may be increased to be at par with the term of the Chairperson to allow for an uninterrupted functioning of the Board. The Board should be required to record the proceedings of the meetings held by it, and the provision for cases where decision-making occurs without conducting the meetings should be well specified in the NDC Bill.
6. It is recommended that clause 9(6), giving appellate power to the central government over decisions of the Board, should be removed to reduce the risk of conflict of interest and preserve the autonomy of the NDC.
7. The following best principles of regulation should be added to the NDC Bill: 
• The NDC Bill should ensure that the regulation-making process is overseen by the Board to increase accountability of the Board.
• The process of public participation in regulation-making should be standardised and put in the NDC Bill.
• The NDC Bill should provide for strong executive powers, balanced with greater transparency and accountability, to prevent abuse. For instance, the inspection planning guidelines, inspection reports, and action taken reports should be publicly available.
• Judicial & quasi-judicial functions to be performed by the NDC should follow the proportionality principle. For instance, the NDC could develop a graded system of inspection results for dental schools and their effects on a scale from needs no improvement to recommend derecognition. Derecognition should be recommended in extreme cases and should include a transition plan for students.
8. It is recommended that the NDC Bill specify limited or fixed terms of appointment, extendable to a second term for the members of the Dental Advisory Council. It is also recommended that the functions of the Council mandate creating a report on all draft regulations published by the regulator, stating the Council’s views under clause 12.
9. As elections are time-consuming and expensive, as well as the rationale for having part-time members is unclear, it is recommended that the term of all members of Autonomous Boards be made four years to enable the Boards to function without interruptions. 
10. Given that a need has been felt for ensuring regular inspection of existing dental colleges in the past, it is recommended that ongoing quality assurance of established dental colleges be made a function of the DARB.
11. EDRB should be mandated to maintain and make publicly available a live register of students and teachers in dental institutes across the country.
12. It is recommended that the power of the central government, which allows it to disregard the suggestions of the NDC under clause 34 regarding the establishment of colleges and their recognition, be removed from the NDC Bill to ensure autonomy and accountability of the regulator.
13. The provisions requiring the NDC to identify & reward better institutes and develop a graded plan for underperforming dental institutes should be made a part of the NDC Bill.
14. The decision as to whether a question is of policy should be taken jointly by the central government and the regulator. In case of dispute, the power may be kept with the central government with a provision for a written response to the objections by the NDC.
15. The power of the central government to give directions to the NDC and the Autonomous board destroys the independent and autonomous nature of the NDC and should be removed completely.
16. A regulator should be primarily funded through the fees it generates. The NDC Act is silent on the principles through which such fees might be charged by the NDC. The principles include charging fees only to cover expenses and keep adequate reserves; fees to be charged only through regulations; the regulator should clearly explain and demonstrate the proportionality of the fees to the cost to the regulator; and the regulator should break up the fees into different categories.

Preamble

The current preamble states that the purpose of the proposed law is: 

“to provide for a dental education system that improves access to quality and affordable dental education, ensures availability of adequate and high quality dental professionals in all parts of the country; that promotes equitable and universal oral healthcare that encourages community health perspective and makes services of dental professionals accessible to all the citizens; that promotes national health goals; that encourages dental professionals to adopt latest dental research in their work and to contribute to research; that has an objective periodic and transparent assessment of dental institutions and facilitates maintenance of a dental register for India and enforces high ethical standards in all aspects of dental services; that is flexible to adapt to changing needs and has an effective grievance redressal mechanism and for matters connected therewith or incidental thereto” 

The preamble in the current form includes elements of dental education as well as professional regulation, which is an improvement from the earlier preamble of the Dentists Act, 1948, which was focused on regulating the profession of dentistry. 

However, while the preamble of the proposed law lays down the objectives of the National Dental Commission (NDC) in detail, it falls short of recognising the ultimate goal of the NDC, that is, Patient Safety. 

The Dental Council of India is envisaged as an independent regulator of the dental profession and education in India. In 2012, the OECD published its Recommendation of the Council on Regulatory Policy and Governance. The first principle of an independent regulator is the clarity of its role. The principle envisages that an effective regulator must have clear objectives, with clear and linked functions, and the mechanisms to coordinate with other relevant bodies to achieve the desired regulatory outcomes. Clarity of purpose helps the regulator be accountable for their actions to the public.

Universally, patient safety is being seen as the ultimate concern of the regulatory bodies. WHO Safety Curriculum envisages effective regulators with the appropriate legislation, resources, and tools to sanction unsafe clinician behaviour. 

In India, the Report of Financial Sector Legislative Reforms Commission (FSLRC) is seen to be groundbreaking in conceptualising and defining the role of an independent financial regulator. The FSLRC report states that consumer protection in the financial sector (much like patient protection/safety in the medical sector) is a key regulatory component that can help a regulator to initiate preventive and curative activities for the protection of the consumers (or, in the present case, patients). The Commission stated that “As such, the Commission believes that it is essential to place the function of consumer protection at the heart of financial regulation”. 

It is submitted that the draft National Dental Commission Bill, 2020 (NDC Bill) considers patient safety in its objectives in its Preamble. This would make the actions of the proposed NDC accountable to the public. 

Chapter-wise comments 

This section contains comments on select sections of the Bill, arranged in chapter-wise form.

Chapter I Preliminary

The definition of a dentist (Clause 2j) borrows from the definition of dentistry in Clause 2k in the present form. It states that "dentist" means a person who practises dentistry. However, this definition is inadequate and does not exclude persons not trained in the field from practising the profession of dentistry. Borrowing from the example of the definition adopted by the American Dental Association and adding the function of promotive oral health, the proposed definition of dentistry is recommended to be as follows:

“The evaluation, diagnosis, prevention and/or treatment (nonsurgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, maxillofacial area and/or the adjacent and associated structures and their impact on the human body; and the promotion of oral health, provided by a dentist, within the scope of his/her education, training and experience, in accordance with the ethics of the profession and applicable law.”

Definition of dentistry (Clause 2k) should include:

• Measures for promoting dental & oral health
• Measures that include promotive, preventive, and curative healthcare for diseases and conditions affecting public health and population health, such as oral cancer, HIV. 

As the profession of dentistry is closely linked with ‘Oral Health’, its definition should be added to this chapter. For this, it is recommended that the World Health Organisation's definition of Oral Health be adopted. The definition is reproduced below:

“a state of being free from chronic mouth and facial pain, oral and throat cancer, oral infection and sores, periodontal (gum) disease, tooth decay, tooth loss, and other diseases and disorders that limit an individual’s capacity in biting, chewing, smiling, speaking, and psychosocial wellbeing.

The Dentists Act, 1948, included the regulation of DHs and DMs under the Dental Council of India. It is suggested that this framework continues in the NDC Bill, as the DHs and DMs are an important part of the dental professional framework. The definitions of these professions as set out in the Dentists Act, 1948, should be adopted:

“ “dental hygienist” means a person not being a dentist or a medical practitioner, who scales, cleans or polishes teeth, or gives instruction in dental hygiene;” (Section 2(b))

“ “dental mechanic” means a person who makes or repairs denture and dental appliances;”

Chapter II The National Dental Commission

The NDC is proposed to have 30 members under clause 4 of the NDC Bill. This is a significant reduction and a welcome step from the present 95 members in the DCI. 

Twenty-two of these members are part-time members to be appointed for a term of two years. The majority of part-time members are nominated from the Dental Advisory Council by the states and Union Territories under the Act. The maximum term of the Chairperson of the proposed NDC will be four years. Under the proposed structure, the composition of the Board will change significantly in the four-year term of the Chairperson of the NDC, as 22 members will be replaced during the term. FSLRC principles on the appointment conditions on the Board Members state that a fixed term should be applicable for all members, subject to a retirement age for executive members. This is important because it will enable the Board to function without unnecessary interruptions caused by changes in the composition of the Board. Therefore, it is recommended that the duration of part-time members as proposed in the NDC Board be increased to four years, to coincide with the term of the Chairperson under clause 4 of the Bill.

The functioning of the board of regulators should primarily be left to the rules and regulations formed by the regulator. However, in the interest of accountability, certain principles must be laid down to govern the actions of the board. For instance, the NDC Bill prescribes the frequency of meetings of the Board, quorum, and the process of decision making (through voting) under clause 9. The provisions under clauses 6(5)(6) and 6(5)(7) help in reducing the chances of conflict of interest as they require members to put information about their assets in a public forum, as well as disallow members to obtain employment as consultants in private dental colleges for a cooling-off period of two years. This helps in reducing the chances of the members taking advantage of their position earlier. However, provisions in this chapter omit prescribing requirements for recording the proceedings of the meetings held by the Board as well as the provision for making decisions without conducting the meetings. These provisions may be added to the text of the Bill. 

Clause 9 of the Bill deals with meetings and functions of the Board. Under clause 9(6), it is prescribed that a person aggrieved by a decision of the NDC can appeal to the Central Government. This provision is unacceptable on the grounds of causing undue influence of the central government on the functioning of the Board. The central government is one of the stakeholders running dental colleges in India. As such, the provision introduces an element of conflict of interest and, therefore, should be abandoned. It is recommended that clause 9(6), giving appellate power to the central government over decisions of the Board, should be removed in order to reduce the risk of conflict of interest and preserve the autonomy of the NDC. An aggrieved person should be able to approach the courts against any arbitrary and illegal actions taken by the Board. 

Clause 10 of the NDC Bill lays down the powers and functions of the NDC. The NDC is tasked with legislative, executive as well as judicial functions. For instance, the NDC is required to assess the HR and infrastructure requirements in dental health care and lay down policies for the same (legislative), ensure compliance by the State Dental Councils of the guidelines and regulations framed by it (executive), and exercise appellate jurisdiction over autonomous boards (judicial). However, the provisions for accountability from these functions are absent. For instance, the legislative requirements do not include provisions regarding the process to be followed by the NDC to lay down policies which would include describing the scope of the exercise, conducting background research, stakeholders’ interactions, recording reasons for adoption of the policy, assessing alternate mechanisms and costing requirements for the policies, describing methods to execute them as well as the need to update such policies timely.

Including checks and balances is important for the new law, as the DCI had faced challenges in performing its functions. Absence of such provisions in the Dentists Act, 1948, made the DCI complacent, and its inaction went unnoticed for a long time. A CAG performance audit of the DCI observed that while the DCI was supposed to undertake periodic updates of the dental colleges, it had not designed any system to identify institutes for conducting periodic updates. The report also stated that DCI was not performing its basic task of maintaining a National Register of Dentists as required by law. 

.

For this purpose, the following principles of FSLRC are suggested to be included in the NDC Bill:

• The NDC Bill should ensure that the regulation-making process is overseen by the Board to increase accountability of the Board.
• The process of public participation in regulation-making should be standardised and put in the NDC Bill.
• The NDC Bill should provide for strong executive powers, balanced with greater transparency and accountability, to prevent abuse. For instance, the inspection planning guidelines, inspection reports, and action taken reports should be publicly available; and
• Judicial & quasi-judicial functions to be performed by the NDC should follow the proportionality principle. For instance, the NDC could develop a graded system of inspection results for dental schools and their effects on a scale from needs no improvement to recommend derecognition. Derecognition should be recommended in extreme cases and should include a transition plan for students.

Chapter III Dental Advisory Council

The establishment of the Dental Advisory Council (Council) is a welcome step in the regulatory structure of the NDC. The function of the advisory council is to ensure that there is representation from important stakeholders in the decisions taken by the Board. 

While the members of the Council have representation from various states, public and private institutes, etc., the NDC Bill has not specified the term for any of its members. A defined term for the advisory council members will ensure that sufficient continuity and turnover of members is maintained to ensure that members’ expertise remains current. 

The functions of the council are provided in clause 12 and include providing views on the regulatory functions of the NDC. However, providing views on the regulatory functions of the NDC is not mandatory for the council. As providing views on the regulatory functions of the NDC is the only function of the council, it should be mandated to do so.

Therefore, it is recommended that the NDC Bill specify limited or fixed terms of appointment, extendable to a second term for the members of the Dental Advisory Council. It is also recommended that the functions of the Council mandate creating a report on all draft regulations published by the regulator, stating the Council’s views under clause 12.

Chapter V Autonomous Boards

The NDC Bill envisages four autonomous boards under the overall supervision of the NDC. These are: 

(a) The Undergraduate Dental Education Board

(b) The Post-Graduate Dental Education Board

(c) The Dental Assessment and Rating Board; and

(d) The Ethics and Dental Registration Board.

Each of the four boards is set up as an autonomous body and will be comprised of a President, two whole-time members, and two part-time members. The President, full-time members, and one part-time member of the Autonomous Boards are to be chosen based on the recommendations of the Search Committee. The remaining part-time members for each autonomous board are elected by various State Dental Councils. Each Autonomous Board will be empowered to make decisions on all matters about its jurisdiction, and will have complete administrative and financial decision-making powers.

The part-time members of the Autonomous Boards are also eligible for two years of service, as was envisaged in the NDC Board. However, their power is significantly reduced as there are no requirements for a quorum, and decisions of these Boards can take place by a simple majority vote. The role of the part-time members is also crucial because one of these members on all boards is elected from various states. By reducing their term to two years, the NDC Bill shall enable continuous election modes in states. As elections are time-consuming and expensive, as well as the rationale for having part-time members is unclear, it is recommended that the term of all members of Autonomous Boards be made four years to enable the Boards to function without interruptions. 

Just like in the case of the NDC Board, the functioning of the boards should primarily be left to the rules and regulations formed by the regulator. However, in the interest of accountability, certain principles must be laid down to govern the actions of the board. For instance, the NDC Bill prescribes the frequency of meetings of the Board (monthly) and the process of decision making (through voting) under clause 22. However, provisions in this chapter omit prescribing requirements for recording the proceedings of the meetings held by the Board, as well as the provision for making decisions without conducting the meetings. These provisions may be added to the text of the Bill. 

Clause 28 of the NDC Bill specifies requirements for establishing new colleges. However, ongoing quality assurance of more established dental institutes is not considered in the functions of the Dental Accreditation and Ratings Board (DARB). Given that a need has been felt for ensuring regular inspection of existing dental colleges in the past, it is recommended that ongoing quality assurance of established dental colleges be made a function of the DARB.

Clause 31 of the NDC sets down requirements for the Ethics and Dental Register Board (EDRB). The EDRB is required to maintain a list of licensed Dentists practising in India in the National Register for Dentists. However, the NDC Bill has omitted the practice of the DCI in the registration of students and teachers in the public domain. This was necessitated to increase transparency and accountability of the regulator. It is therefore recommended that a live register of students and teachers be maintained and made available publicly by the EDRB in line with the practices followed by the DCI.

Chapter VI Recognition of Dental Qualifications

Clause 34 deals with the recognition of dental qualifications by universities and institutions in India. The Undergraduate & Postgraduate Dental Education Boards are responsible for the recognition. This provision also deals with the quasi-judicial functions of the NDC. Currently, as per the NDC Bill, an appeal against any decision of these Autonomous Boards is to be preferred to the NDC in the first instance. Further, if aggrieved by any decision of the NDC, a final appeal lies to the central government.

Therefore, the central government has final appellate jurisdiction under the NDC Act.

It has been seen in the past that the central government had established dental colleges despite the disapproval of the Dental Council of India without giving appropriate reasoning for such actions. Therefore, there are chances of irregularities by the central government in the present situation as well. It is recommended that the power of the central government to disregard the suggestions of the NDC be removed from the NDC Bill to ensure autonomy and accountability of the regulator

Clause 37 of the NDC Bill deals with the withdrawal of recognition granted to established dental institutes in India. The clause gives powers to the NDC to withdraw the recognition of an institute if the standards prescribed by the autonomous institutes are not met by the institutes. The NDC is also mandated to undertake consultations with the stakeholders before concluding this process. Two considerations seem to be missing from this framework. The first consideration is the introduction of identification and rewarding better institutes, and the second is envisaging a graded response to deteriorating quality of dental institutes. Just like sanctions for poor-performing and non-compliant dental institutes are necessary, there should also be a reward for colleges that perform well. The rewards can be greater autonomy for the institute for performing its functions, in introducing new learning techniques. Similarly, instead of recommending the withdrawal of recognition to underperforming dental institutes, the regulator should be mandated to introduce a method of collaborating with the institute to increase its standards. The regulator should hand-hold such institutions unless they are identified as non-recoverable. However, a graded response from the regulator is necessary, given that the costs of establishing a dental college are exponential as well as derecognition could have negative impacts on the students enrolled in the institute. The provisions requiring the NDC to identify & reward better institutes and develop a graded plan for underperforming dental institutes should be made a part of the NDC Bill.

Chapter VIII Miscellaneous

Clauses 44-46, 53-54 in this chapter deal with the powers of the central government under the NDC Bill. The central government has the power to give directions to the NDC as well as the Autonomous Boards with respect to questions of policy. The decision as to whether a question is one of policy or not is to be taken by the central government itself and will be binding on the commission. The central government will have a supervisory role inasmuch as the NDC would be responsible for submitting its minutes, reports, abstracts of accounts, and other information to it. Similarly, the rules under the NDC will be made by the central government. It has also been given powers to supersede the NDC. 

A regulator is an agent of the government. The government is expected to reasonably oversee the functions of the regulator. However, there is a corresponding risk of encroachment on the powers and functions of a regulator by the government. In order to minimise such a risk, the NDC Bill should assure the autonomy of the Commission while ensuring accountability to the central government. For this, the following is recommended:

1. The decision as to whether a question is of policy should be taken jointly by the central government and the regulator. In case of dispute, the power may be kept with the central government with a provision for a written response to the objections by the NDC.
2. The power of the central government to give directions to the NDC and the Autonomous board destroys the independent and autonomous nature of the NDC and should be removed completely.
3. A regulator should be primarily funded through the fees it generates. The NDC Act is silent on the principles through which such fees might be charged by the NDC. The principles include charging fees only to cover expenses and keep adequate reserves; fees to be charged only through regulations; the regulator should clearly explain and demonstrate the proportionality of the fees to the cost to the regulator, and the regulator should break up the fees into different categories.