Lessons from the COVID-19 vaccine procurement of 2021

by Charmi Mehta and Susan Thomas

Introduction

The recent announcement on procurement and project management shows a heightened policy interest in improving how government contracts with private parties for projects. However, several problems in public procurement in recent times have been in the procurement of goods. The most visible were the failures in vaccine procurement in the first half of 2021.

In the middle of 2020, at the time of the first pandemic lock-down, Serum Institute ("SII"), an Indian firm, had been gearing up to manufacture the Astrazeneca vaccine (a.k.a. Covishield). The union government placed advance orders with SII and Bharat Biotech in January 2021 for doses that would cover 0.6% of the population with two doses. Deployment of Covishield began in the UK on 4 January 2021 and the first vaccination took place in India on 16 January 2021. The union government's vaccination program was the only one available in the country, and it was delivering about 2 million doses a day in April and May 2021. The surge of the disease raised questions about the efficacy of this program. The union government changed course with a press release on 19 April 2021 through which state governments could also work on vaccination if they desired and the procurement could be done directly from global suppliers and manufacturers (Agarwal and Shah, 2021).

It was a difficult time to buy vaccines. The Union government had a unique power to indemnify an overseas vaccine producer against legal liability, without which no overseas firm was willing to sell into India. Sub-national governments did not have this power, and were thus not able to purchase from firms like Moderna or Pfizer. Some global firms refused to transact with sub-national governments.

A certain set of state/city governments started on the process of procuring vaccines directly, in an attempt to do better on managing the disease within their states. Tenders to procure COVID-19 vaccines were published by 14 para-statal agencies. Of these, five were successful in attracting bids. Vaccine purchase by states largely ended by June, when the union government declared on 6 June 2021 that it would buy 75% of the total vaccines manufactured in India, and supply vaccines to states.

From a research perspective, this was a natural experiment where multiple state governments tried to solve the identical problem at dates that were just a few days apart. While the union government had negotiated contracts for vaccine purchase, the state governments chose to engage in open, competitive, global tendering. We hand-collected a data-set by breaking down published tender documents, and extracting fields that gave us insights into the procurer details, details of the bidding process including tender timelines, eligibility criteria for bidders, quantities to be procured and quality/storage requirements, procurement price constraints, payment features, delivery schedules and locations.

We do not observe whether a state government actually purchased vaccine or not. Information in the public domain stops at observation of responses to tenders.

This dataset gives us an opportunity to see differences in purchasing strategy and to look back at these experiences, in order to obtain insights on many questions: What kinds of states tried to buy vaccines? What were the features of their attempts? What states appeared to fare better? What lessons can we draw, from this episode, for better government contracting, in an emergency and in normal times?

We find that existing contracting processes have significant flexibility, particularly when procuring in emergency situations. The tenders published had flexibility of awarding contracts at prices away from the default L1, as well as in choosing efficient delivery schedules and locations. These were evident across all the tenders we studied. But this flexibility was not sufficient to attract bids for the tenders. Instead, what appeared to matter was the speed to tender and speed to award. Further, this was the first episode of direct procurement by state governments. The lack of prior experience and standing in the global vaccine market place was the essence of low state capacity.

What is the legal framework governing vaccine procurement in India?

I. Procurement of vaccines In India, there is a legal framework for the procurement of drugs, but not one to directly procure vaccines (Kaur et al, 2021). In the National Vaccine Policy (2011), Section 6.4 states the following on vaccine procurement:

1. All UIP (Universal Immunisation Programme) vaccines are purchased at the central level for distribution to the states.
2. While the UIP vaccines are purchased by the central government from indigenous sources, Oral Polio Vaccines (OPV) for mass immunization campaigns as well as Japanese Encephalitis (JE) vaccine is procured through other mechanisms. OPV immunization was conducted as part of a World Bank, WHO and UNICEF joint campaign that sought to eradicate polio in India (World Bank 2014). Likewise, the JE immunization programme was coordinated by WHO, UNICEF and PATH, who negotiated vaccine supplies from China (PATH 2019).
3. There are three takeaways about the Indian vaccine procurement from this: (1) Vaccines are usually procured only by the Union Government; State Governments do not routinely procure vaccines. (2) The Union Government usually procured vaccines solely from domestic suppliers. (3) The Union had additional support from international agencies for both vaccines that are globally tendered.

II. Procurement in emergency situations Several provisions in the Manual of Procurement of Goods (2017) ease competition requirements in an emergency cases.

1. There is a relaxation of the requirement to procure solely from domestic sources. Conditions for Global Tender Enquiries are listed in Section 4.3 and 4.4 of the Manual as `Where Goods of required specifications/quality are not available within the country and alternatives available in the country are not suitable for the purpose; in case of non-existence of a local branch of the global principal of the manufacturer/vendors/contractors;or Requirement for compliance to specific international standards in technical specifications; or the absence of a sufficient number of competent domestic bidders likely to comply with the required technical specifications, and in case of suspected cartel formation among indigenous bidders.'

2. There is also a relaxation in using L1 tendering as the sole mode of tendering. The Manual states that `Limited Tender Enquiry procedures should be default mode of procurement when the estimated value of procurement is between Rs. 2.5 lakh to Rs. 25 lakh.'

3. Section 4.7 of the manual permits single tender enquiries in case a situation of emergency warrants goods/services to be procured from a particular supplier. 'In case of emergency procurement, facility of withdrawing requisite advance cash amount and its subsequent accountal may also be considered', whilst procuring through a direct contract. In case of emergency, the purchaser may purchase the same item through ad hoc contract with a new supplier.

4. In all these cases, there is a greater onus on the procuring entity to ensure that value-for-money is ensured.

Observations about the vaccine procurement by states

Who procured?

Of the 33 states and union territories in the country, 14 published tenders between May to June. The others were either unresponsive to the situation or concluded that purchase was infeasible. As an example, the Punjab Government approached manufacturers but Moderna refused to contract with them. Punjab was not one of the states that put out a tender for vaccines.

What was the buying organisation?

Eleven out of 14 tenders were issued by independent medical services agencies, and three were issued by government ministries/departments. The literature suggests that organisational efficiency is often better in independent agencies as compared to ministries or departments, owing to their internal capacity, audit mechanisms and higher accountability mandates. Three out of the five tenders that received responses were issued by independent agencies/societies/corporations in charge of medical services procurement for the state. However, most of the states that did not receive bids procured through independent agencies.

Who received bids?

Of the 14 that published tenders, Karnataka, Odisha, MCGM, Maharashtra and Rajasthan received bids. Andhra Pradesh, Delhi, Haryana, Kerala, Madhya Pradesh, Tamil Nadu, Telengana, Uttar Pradesh and Uttarakhand did not receive any bids.

Did tender timelines matter?

The figures show the tender timelines as the number of days from the starting date of 19 April to the 23 June 2021 (which is the day after the Uttar Pradesh closed its tender on 22 June). The coloured portion of the time line shows the period from when the tender was published to when it was closed. Figure 1 shows the states that received bids, and Figure 2 shows the states that received no bids.

Figure 1: States that received bids

Figure 2: States that did not receive bids

 

From the starting date of 19 April, most states took 25-30 days to issue tenders. Uttar Pradesh and MCGM published tenders within 12 days, while Madhya Pradesh, Haryana and Delhi took more than 30 days. Uttar Pradesh kept the process going for the longest period, i.e. 34 days. In contrast, MCGM and Maharashtra closed within 6-8 days. The Maharashtra state tender was issued the day the MCGM tender first closed.

There is considerable variation in tender timelines. For example, Odisha had a 21-day tender open period and received responses, while Delhi had a 10-day tender period but did not receive responses. But from Table 1, we see that the average values of the timelines are different for the two samples. For example, on average, the states that did not receive bids took 4 days more to publish the tender compared to those that did receive bids. The difference is larger for the days that the tender remained open. States that did not receive bids kept the bids open for almost two weeks longer on average than those who did receive bids. In a period of great supply shortage, speed in closing the tenders appear to be more attractive to bidders.

Table 1: Comparison of timelines

	Received bids	Did not receive bids
Median days to start	25	29
Average days to start	25.4	29.9
Median days of tender being open	8	21
Average days of tender being open	10.2	19.22
Median number of corrigenda	1	1
Average number of corrigenda	1.1	1.2
Average quantity (million single doses)	25.6	17.6

Our research in government contracting has revealed the common procedure of weak preparatory work followed by numerous corrections to the tender documents, termed corrigenda (Roy and Sharma, 2021). There were corrigenda to some of the vaccine tenders. However, the number of corrigenda to a tender does not serve to differentiate between states that received bids or not. The median number of corrigenda issued across both sets is 1.

Finally, we compared the average quantity tendered for, and the states that received bids had a larger quantity requirement on average than those that did not receive bids.

Did payment terms matter?

The problem of payment delays in public procurement is significant (Mannivanan and Zaveri 2021). This has adverse effects on the perception of participating bidders and the cost of doing business with the government. We know from public reports that the Union Government was paying an advance to manufacturers are part of its negotiated contracting approach. However, most of the 14 tenders did not have advance payment, other than Odisha (which did receive bids) and Tamil Nadu (which did not).

Was there flexibility in the tendering process?

Rigidity in tendering processes such as adherence to L1 (lowest price bid) awards is often cited as leading to constrained optimisation for procuring entities. In contrast, the tenders for COVID-19 vaccines showed flexibility in the procurement process, from awarding contracts to bids beyond L1 to allowing for significant differences in tender parameters such as quantity, delivery, and who can bid. We find the procurers were empowered to empanel a larger number of suppliers to distribute their total requirement amongst bidders.

Was there expertise to design complex, non-standard tenders?

A reading of the tenders suggest a mechanical replication of standard drug procurement tender. In certain cases, tenders contained text referring to drugs rather than vaccines. So while there were specific areas where there was considerable expertise deployed (such as the variation in delivery schedules where manufacturers were required to submit a schedule of delivery and there was a clearly stated preference for the soonest supply), such lapses suggest that greater state capacity needs to be developed to handle complex goods procurement. In a simplistic view, standard tender templates that minimise ground-level discretion are favoured, e.g. as a pre-requisite for international funding agencies (World Bank 2021). However, there is no escape from deep rooted capabilities in contracting for every contracting organisation; mechanical use of templates is unlikely to work well.

In summary, our analysis finds some covariates that differentiate the states that were able to attract bids for the supply of the vaccine. What stands out is the speed to tender and to have a short tender period. In our data-set, we see a minimum time taken of 20 days for the most speedy tender issuance. While procuring entities must take adequate time to ensure value for money on contracts, lengthy tender cycles also tend to discourage bidders who must lock-in capital and resources in the anticipation of an award (National Audit Office 2007). Even in India, the Manual of Procurement of Goods 2017 prescribes a period of 30-45 days for tender processing, as delays in finalising procurement deprive the public of the intended benefits and results in lost revenues and cost over-run. If speed to issue tenders is important for procurement efficiency, then it is important that procurers must have the capacity to do so.

Conclusion

In this article, we have looked at a moment of sharp change in the rhythm of government contracting in India. At the height of the second wave of the pandemic, there was a rush of vaccine purchase by at least 14 Indian sub-national government organisations, within days of each other. Only five of these got bids. Within weeks after, sub-national governments stopped trying to buy vaccines.

We have documented the numerous constraints these organisations faced. Contrary to popular perception about the rigidity enforced by procurement laws and rules in India, our examination of different tender documents reveal that there was significant variation across tenders. There were important constraints in the form of private firms who were skeptical about dealing with Indian government organisations. Private firms are not confident about timely payments. Some overseas vaccine sellers required an indemnity which could only be issued by the union government. Some overseas firms refused to deal with sub-national governments.

The main finding of this article is that even when presented with supreme urgency and the highest prioritisation of the political leadership, it was often not possible to successfully buy vaccines. Given that vaccine procurement has always been undertaken by the union government, state governments were permitted to procure a commodity that they had scarce experience in doing, and in a market where they had no previous experience or credibility. Fire-fighting and "mission mode" works poorly. There is need to develop state capacity in calm times before they being asked to perform in an emergency (Kelkar and Shah 2019). State capacity can only arise slowly. A stable team of policy practitioners needs to engage in a given fixed activity (e.g. vaccine purchase from the global market) repeatedly. An ongoing relationship needs to be established with dozens of private firms. There needs to be continuing and repeated interactions through which learning takes place, and further, gets encoded into purchase manuals and document templates. Once such a framework is in place for many years, it would become possible to readily purchase vaccines in a given government organisation. If such a framework is not in place, episodic government contracting in a crisis management mode is unlikely to succeed.

References

Amrita Agarwal and Ajay Shah, An important change of course by policy in Indian Covid-19 vaccination, The Leap Blog, 20 April 2021.

Matt Apuzzo and Selam Gebrekidan, Governments Sign Secret Vaccine Deals. Here’s What They Hide, New York Times, January 2021.

Centre for Vaccine Innovation and Access, Indias leadership in the fight against Japanese encephalitis, PATH India, 2019.

Chartered Institute of Public Finance and Accountancy, Good Governance in the Public Sector, 2013.

Ruchika Chitravanshi and Sohini Das, Covid-19 vaccination: Govt books 440 million doses with 30% advance, Business Standard, June 2021.

Department of Expenditure, Ministry of Finance, Manual of Procurement of Goods 2017, Government of India, 2017.

Atul Dev, COVID-19: ‘Panic’ among India health workers over PPE shortages, Al Jazeera, March 2020.

Harleen Kaur, Ajay Shah and Siddhartha Srivastava, How elements of the Indian state purchase drugs, xKDR Working Paper 5, August 2021.

Vijay Kelkar and Ajay Shah, In Service of the Republic, Penguin Random House India Private Limited, 2019.

Pavithra Manivannan and Bhargavi Zaveri, How large is the payment delays problem in Indian public procurement?, The LEAP Blog, March 2021.

Ministry of Health, Family and Welfare, National Vaccine Policy Government of India, 2011.

Ministry of Health and Family Welfare, Revised Guidelines, Government of India, May 2021.

Ministry of Statistics and Programme Implementation, Government of India, 2021.

Atri Mukherjee, Regional Inequality in Foreign Direct Investment Flows to India: The Problem and the Prospects, Reserve Bank of India, 2011.

National Audit Office, Improving the PFI process, Office of the Comptroller and Auditor-General, National Audit Office, United Kingdom, 2007.

Press Information Bureau, Government of India announces a Liberalised and Accelerated Phase 3 Strategy of Covid-19 Vaccination from 1st May, Ministry of Health and Family Welfare, Government of India, April 2021.

Vikram Rajan, A Polio-Free India Is One of the Biggest Achievements in Global Health, World Bank, 2014.

Shubho Roy and Anjali Sharma, What ails public procurement: an analysis of tender modifications in the pre-award process, The Leap Blog, November, 2020.

Arup Roychoudhary, Centre should share some financial burden of states' vaccine procurement, Moneycontrol, May 2021.

Pankaj Shah, Uttar Pradesh amends global vaccine tender, Pfizer, Moderna can now bid, Times of India, May 2021.

The Hindu, Moderna refuses to sell vaccines directly to Punjab, 23 May 2021.

World Bank, World Bank PPP - Legal Resource Centre, 2021.

xKDR Forum, Government vaccine procurement, August 2021.

Acknowledgements:

Charmi Mehta is a researcher at xKDR Forum and Chennai Mathematical Institute and Susan Thomas is a researcher at xKDR Forum and a Research Professor of Business at Jindal Global University. We thank Diya Uday and Bhargavi Zaveri-Shah for their enthusiastic support and intellectual inputs into the design of the tender dataset, and Harsith Ravichandran for research and data assistance.

Distribution of self-reported health in India: The role of income and geography

by Ila Patnaik, Renuka Sane, Ajay Shah and S. V. Subramaniam.

In health research, we study the causes and consequences of health at the individual level. This requires measurement of the health status of individuals. One simple path lies in asking a person: "Are you feeling well today?". This `self-reported health' (SRH) is a measure that is easy to implement, and has limitations in that psychological factors are present. A significant global literature has emerged, which draws on this measure to explore the causes and consequences of health.

The CMIE CPHS is an important new dataset which has longitudinal data for about 170,000 households, measured three times a year. They measure SRH for each individual in each wave. This measurement of SRH, alongside a rich array of household characteristics, makes possible many interesting research projects. In a new paper, Distribution of self-reported health in India: The role of income and geography, we discern some new facts and phenomena about health in India, through this data.

We use data for calendar 2018 and 2019, which works out to 3.5 million observation of a person in a wave. These years were chosen in order to obtain a baseline description of health in India, while avoiding the pandemic of 2020 and the possible impact of demonetisation in 2017.

What do we find? On average, ill health is observed in 3.25% of the records. On average, people in India are unwell for about 12 days a year. There is a U-shaped curve in age, with higher ill health rates for the young and the old.

We get a nice map of the variation of the ill-health rate across the country. This is interesting, in and of itself, as it shows us something about health care requirements. However, some of this variation reflects geographical heterogeneity in income and age structure.

We estimate logit models which explore correlations between standard socio-economic measures and the ill-health rate. The important sources of variation turn out to be age, income and location.

We then focus on an approximately modal person. Model-based predictions for the ill-health probability are constructed for this individual. This yields a map of the predicted ill-health rate --  

 

This shows the variation of ill-health in the 102 `homogeneous regions' (HRs), after controlling for income, age structure and other standard socioeconomic characteristics. It is an interesting and new map. These results do not conform with the standard stereotypes of north vs. south. Epidemiological research is required in understanding what is at work in each of the difficult HRs. Major gains in the health of the people could potentially be obtained by focusing on these hot spots and finding the right public health interventions.

We then ask: are rich people healthier than poor people? As the rich fare better on nutrition, housing quality, knowledge and access to health care, we expect there would be such a correlation. This is indeed the case in the overall aggregate data. However, there is strong geographical variation in this correlation. Ill health and poverty are positively correlated in only half of the country. There are even HRs where the relationship is reverse -- where poor people report better health than the rich. Further, the two maps (the map of ill health of the modal person, and the map of the places where ill health is not positively correlated with income) show different patterns. They are distinct phenomena that invite further exploration.

Incentive compatibility and state-level regulation in Indian drug quality

by Harleen Kaur, Shubho Roy, Ajay Shah and Siddhartha Srivastava.

The Indian pharmaceutical market is the third largest in the world by volume of drugs sold and is dominated by local players that produce branded generics at low prices. Existing government estimates suggest that 3.16% of drugs at retail pharmacies and 10.02% of the drugs at government pharmacies are not of standard quality. Independent surveys hint at higher estimates of inadequate quality. While India is a powerhouse of drugs export, foreign drug regulators routinely classify Indian origin drugs as not of standard quality. This problem has been around for a while. Reports of the Comptroller and Auditor General of India (CAG) and Parliamentary Committees have repeatedly highlighted the problems and poor regulatory capacity.

There is a need for better policy pathways to address these problems. In this article, we argue that an incentive problem inhibits the existing regulatory structure. The present law is set up in such a way, that it may be in the interest of the regulator to not carefully monitor the manufacture of pharmaceuticals. Unlike other areas where a statutory regulator is responsible for the safety of an industry, the legislative system of for the pharmaceutical sector does not create a body dedicated to ensuring that medicines are safe and up to standards. Alongside this, there are long-standing problems with regulators in India, where laws create arbitrary power, and the feedback loops of accountability mechanisms do not create a striving for improved state capacity. Certain solutions flow directly from this reasoning.

The current system

Unlike the working of the market economy in most goods and services, market discipline through consumers in the field of pharmaceuticals is limited; there is market failure caused by asymmetric problem. The user (usually the patient) does not have the skills or experience to know if a pill actually contains the claimed active ingredient. When (say) a pen does not work, this is evident to a consumer. However, it is very difficult for an individual patient or even a doctor to know if a drug is substandard. When medication fails to cure the patient, this could be because of three different possibilities -- a wrong diagnosis, or the patient just did not respond to the correct drug, or a problem with drug quality. This induces an identification problem, so there is no feedback loop when a substandard drug is purchased. Similarly, when a patient does get better, a lot of the time, this would have happened through the working of the human body and is helped by a placebo effect. Here also, there are no feedback loops based on quality signals.

The consequences of inadequate quality can be grave: substandard medication can even cause the death of a patient. And even if a patient dies, it is extremely difficult to establish (after the fact) that the medication was defective.

As with most other countries, India has a law that creates a government apparatus for approval and manufacture of medicines in the country: the Drugs and Cosmetics Act, 1940 (DC Act). This divides the functions of regulation between the union government and state governments. The union government is responsible for the approval of new drugs, regulation of drug imports, and laying down standards for drugs, cosmetics, diagnostics and devices. State governments are responsible for licensing and monitoring manufacturers for drug quality and initiating legal action against offenders.

The parliamentary law does not separate the regulatory duties between the union and state governments. The primary legislation allows the union government to appoint licensing authorities (S. 33 of the Act). Under this authority, the union government has delegated licensing functions to state governments (Rule 59 under the Act).

What was the text of the law which generated this separation? Section 33 of the legislation empowers the union government to appoint the 'licensing authority' for the manufacturing and sale of drugs and the union government has used this power to anoint the state government using subordinate legislation (See rule 59 of the DC Rules). As a result of this delegation, State governments (through their State Drug Regulatory Agencies) are responsible for licensing pharmaceutical manufacturing facilities and inspecting them.

Misplaced incentives under the law

The present arrangement of delegating inspection of manufacturing facilities to the state government, however, has problematic implications. In a unified national market, where goods flow across state borders seamlessly, pharmaceutical manufacturing factories do not limit their sales to one state. Many firms are harnessing the economies of scale that come from producing for the entire country or even the global market from a few very large manufacturing plants. Small states like Himachal Pradesh and Goa contribute disproportionately to India's total pharmaceutical production.

This unification of markets creates a problem of incentives for the state governments where these plants are located. These states benefit from the tax revenue, jobs and licensing fees that these large plants bring to the state. If the state government is vigilant and runs a tight inspection regime, it risks discouraging pharmaceutical companies from setting up plants in their state. Companies may engage in jurisdiction-shopping, taking the tax base and manufacturing jobs to states with a lax regulatory regime. On the other hand the welfare costs associated with a poor regime -- the adverse impacts on the health of users -- is not borne by the state exclusively, but by the entire country. If the state has a small population (e.g. Goa or Himachal Pradesh) and the medicine is not commonly used, the failure of the regulatory regime may be invisible to the voters of the state. Therefore, it is not in the interest of a state government to run an efficient inspection regime.

Another dimension in the incentive problems of state governments lies in the cost and complexity of regulation. State governments are being asked to spend on manpower, testing facilities and institutional capacity for regulation, while the benefits of regulation are enjoyed by customers all over India.

This incentive problem leads to a race to the bottom with states competing on laxity of regulation. As an example, while a single database for providing information about substandard drugs to the public exists, only five state regulators provide such information through this database.

Finally, even if a drug manufactured in one state is found to be substandard by a regulatory agency in another state, it is difficult to organise enforcement actions that cut across state borders.

Additionally, the separation of roles between state and union is not clear and leads to confusion about who is actually responsible for inspecting manufacturing facilities. For instance, under the DC Act, drug inspectors are responsible for inspecting manufacturing sites and detecting substandard medicines (Sections 22, 23). However drug inspectors can be appointed by both the central and state governments (Section 21), and function under the control/directions of an officer appointed by the relevant government (Rule 50).

Crucially, the DC Act and Rules do not clarify the instances in which the drug inspectors are to be appointed by the central government and when they are to be appointed by the state government. Neither do they outline a scheme of accountability wherein the quality enforcement actions of the drug inspectors can be scrutinised or audited by either a state or central body.

This results in a quality enforcement framework where there is no clear statutory body responsible for the failure in drug quality at the central or state level and therefore no incentive for individual drug inspectors to investigate and prosecute quality violations adequately. Both levels of the governments may consider the other responsible for the failure to inspect a facility.

Solutions proposed in the prevailing literature

There are broadly two schools of thought on how to reform the problem of drug quality in India. The first set of arguments favour the creation of a new central regulatory authority (Pharmaceutical Enquiry Committee (1954), Drug Policy (1994), Mashelkar Committee Report (2003)). The second set of arguments suggest that the existing State Drug Regulatory Authorities (SDRAs) be strengthened for better implementation of drug quality regulation (Hathi Committee Report (1975), Department-related Parliamentary Standing Committee on Health and Family Welfare 59th Report on the Functioning of CDSCO (2012)).

Does the solution to the problems of drug quality in India lie in building a single agency at the union government and giving it high powers to investigate and punish? In thinking about the federal architecture of the Republic, there is merit in the separation envisaged in the 1940 Act. It is difficult for the union government to build an operational capability in any field, which is effective all across the country. The Constitution of India is imbued with federalism: India is not a unitary country ruled from New Delhi, but a union of states. The Constitution envisages a limited role for the union government: the establishment of standards for quality of goods to be transported from one State to another (See Entry 51 of List I of Schedule 7 of the Constitution).

Multiple legislative attempts have been made so far to create a centralised drug authority along the lines of these recommendations but without much success. In all these instances, the bills have been opposed by state manufacturers associations and state drug regulators. But going beyond these political economy constraints, there are concerns about this pathway to policy design. Simplistic centralisation, drawing on the existing text of the DC Act, will be problematic both on the grounds that decentralisation is a valuable approach and on the grounds that the present Act has flaws on incentive compatibility. The proposals for reform have not analyzed the incentive problems and ambiguity created by the 1940 legislation. The regulatory framework for pharmaceuticals in India suffers from multiple failures which need to be addressed, over and beyond the question of decentralisation. For example, you can check the inspection dates and reports of all drug manufacturing plants in the U.S (here), but we do not know when Indian manufacturing plants are inspected. There is no obligation on either the state or union governments to regularly inspect manufacturing plants, and the DC Act is the site where such obligations need to be imposed upon state agencies.

One possibility lies in reversing the focus of state-level agencies from factories to consumers of their state. E.g. if a factory makes drugs in Goa which are sold in Maharashtra, their quality characteristics would be the responsibility of the Maharashtra drugs regulator. Such a drugs regulator would achieve greater alignment with the interests of consumers in Maharashtra, and have a reduced conflict of interest with jobs and prosperity. However, there are difficulties in establishing the powers of the Maharashtra drugs regulator over a factory in Goa. There are also dangers of creating barriers to inter-state commerce.

How to reshape incentives

Better working of regulators. An extensive body of knowledge has developed in India, in the last decade, on the working of regulators and regulation. This literature has argued that the path to high state capacity in regulation lies in: Clarity of purpose, the role/composition/working of the board, formal processes for legislative/executive/judicial functions which are written into the law, reporting and accountability mechanisms, the budget process, and low powers of investigation and punishment (FSLRC 2015, Roy et. al. 2019, Kelkar and Shah 2019). This knowledge needs to be brought into a deeper transformation of the DC Act.

Transparency reforms that reshape incentives. A low cost intervention could be based on reputation costs and can usefully be placed at the level of the union government. There are multiple channels through which drug testing is taking place in India today. Whenever a drug is found to be substandard, the union government should obtain this information and upload that information to a publicly available repository along with the name of the manufacturer and the state in which it was manufactured. This will impose a cost on states which are lax on inspecting manufacturing facilities. The public will come to associate drugs from that state to be of poor quality and avoid them. Pharmaceutical firms will then face a market based penalty if they locate manufacturing facilities in states with lax regulatory regimes. On the other hand, states which set up good regulatory regimes will benefit from the positive publicity. Pharmaceutical manufacturers would gain respectability and may even command a price premium by locating their manufacturing facilities in states with a reputation for high inspection standards. Consequently, such states would gain from licensing fees, revenue, and jobs by establishing a good regulatory regime. Therefore, with a modest work program at the union government, naming and shaming bad actors and their state level regulators, we can reverse the incentive problem and create a virtuous cycle instead of the present race to the bottom.

Greater transparency would also kick off market discipline. Households would become more aware of quality characteristics associated with the brand names of various drugs and that would kick off greater pricing power in the hands of higher quality drugs. This process would, however, be curtailed by the extant system of price controls for drugs.

Conclusion

The current regulatory framework does not adequately define the objective, functions or powers of the de-facto regulators, the CDSCO and the SDRAs in the primary law or rules thereunder. This leads to creation of unaccountable regulators that have misaligned incentives. In this article, we have shown elements of a drug regulatory regime that are consistent with the federal vision of the Republic, and can effectively reshape the incentives of state level regulators. The union should be responsible for national public goods : drug quality standards, cGMP standards, randomised testing on a national scale, and release of this testing data. The laws that create state level regulators need to draw on modern Indian thinking about how regulators should be constructed. Put together, these reforms will modify the incentives of state level regulators. 

References and further reading

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

National Drug Survey Report, 2016: Ministry of Health and Family Welfare, Survey of extent of problems of spurious and not of standard quality drugs in the Country, 2014-16, Ministry of Health and Family Welfare.

Government of India, 2012: Department-related parliamentary standing committee on health and family welfare, 59th report on the functioning of the Central Drugs Standard Control Organisation (CDSCO) Rajya Sabha Secretariat, May 2012.

CAG, 2007 Report No. 20 of 2007 for the perriod ended March 2006 - Performance audit of Procurement of medicines and medical equipment Comptroller and Auditor General, 2007.

Khan et al. 2016: AN Khan, RK Khar and Malairaman Udayabanu, Quality and affordability of amoxicillin generic products: A patient concern Indian Journal of Pharmacy and Pharmaceutical Sciences, 2016.

Stanton et al, 2014: Cynthia Stanton et al, Accessibility and potency of uterotonic drugs purchased by simulated clients in four districts in India BMC Pregnancy and Childbirth, 2014.

Thakur and Reddy, 2016: Dinesh S. Thakur and Prashant Reddy T, A report on fixing India's broken drug regulatory framework Spicy-IP, June 2016.

Singh et al, 2020: Prachi Singh, Shamika Ravi and David Dam, Medicines in India: Accessibility, Affordability and Quality Brookings India, March 2020.

Krishnan, 2020: KP Krishnan, The three tiers of government in public health The Leap Blog, August 2020.

MoHFW, 2017: Ministry of Health and Family Welfare, Department of Health and Family Welfare, Notification G.S.R. 1337(E), CDSCO, Oct 2017.

Drugs Enquiry Committee, 1930-31: Government of India, Report of the Drugs Enquiry Committee, 1930-31.

Pharmaceutical Enquiry Committee, 1954: Ministry of Commerce and Industry, Report of the pharmaceutical enquiry committee,1954.

Hathi Committee, 1975: Ministry of Petroleum and Chemicals, Report of the Committee on Drugs and Pharmaceutical Industry, 1975.

Drug Policy, 1986: Government of India, Measures for Rationalisation, Quality Control and Growth of Drugs and; Pharmaceutical Industry In India, 1986.

Drug Policy, 1994: Government of India, Modification in Drug Policy, 1986, 1994.

FSLRC, Indian Financial Code, version 1.1, Ministry of Finance, 2015.

Vijay Kelkar and Ajay Shah, In Service of the Republic: The art and science of economic policy, Penguin Allen Lane, 2019.

Mashelkar Committee, 2003: Ministry of Health and Family Welfare, Report of the expert committee on a comprehensive examination of drug regulatory issues, including the problem of spurious drugs, 2003.

Shubho Roy, Ajay Shah, B. N. Srikrishna and Somasekhar Sundaresan, Building State capacity for regulation in India in "Regulation in India: Design, Capacity, Performance" edited by Devesh Kapur and Madhav Khosla. Oxford: Hart Publishing, April 2019.

Task force under the Chairmanship of Dr. Pronab Sen, 2005: Government of India, Task Force to Explore Options other than Price Control for Achieving the Objective of Making Available Life-saving Drugs at Reasonable Prices, 2005.

Jeffery and Santhosh M.R., 2009: Roger Jeffery and Santhosh M.R., Architecture of Drug Regulation in India - What are the Barriers to Regulatory Reform?, 2009.

 

The authors acknowledge the support of Thakur Foundation in this work, and valuable conversations with Dinesh Thakur and Prashant Reddy. All errors are ours.

Vaccination in India: how will demand change when persons above age 18 are eligible?

by Renuka Sane and Ajay Shah.

1. On 16 January 2021, the union government's vaccination program started with eligibility limited to frontline workers. On 1 March 2021, eligibility was extended to a) those above the age of 60, and b) for those above the age of 45 with comorbidities. This was further opened up to everyone above the age of 45 from 1 April 2021. On 20 April 2021, the union government announced that from 1 May 2021 the minimum age of a person that is able to obtain a vaccine will go down from 45 to 18.
2. It is useful to juxtapose this recent expansion, from age 45+ to age 18+, against the structure of the population, and envision the magnitudes involved.
   
3. The last available census in India was in 2011. It is likely that the age structure of the Indian population has changed since then. We use the CMIE Consumer Pyramids household survey data to get the following age structure, based on an estimated population of 1.4 billion for late 2020:

   Age group	Population
   0-17	344 million (SE: 8 million)
   18-44	622 million (SE: 18 million)
   45-59	321 million (SE: 9.5 million)
   60+	125 million (SE: 4.7 million)

4. On 26 April 2021, 142 million vaccine doses have gone out. Of these 119.6 million persons have got one dose, and 22.5 million have got both doses. However, of the 142 million doses, about 11.2 million doses have been to persons below age 40. In the eligible population of 45+, a little less than 5% have received both the doses, while a little less than 27% have received the first dose. There is considerable room to go, in completing the work of vaccinating persons above age 45.
5. The union government was pushing out approximately 2.3 million doses in the eligible population per day. This translates to 5.1 doses per 1000 eligible persons per day. This reflects a combination of distribution capabilities, vaccine hesitancy and supply constraints.
   
6. Opening up the vaccination to those above age 18 has meant that the magnitude of the eligible population has gone up from 446 million to 1.06 billion. If we subtract the already vaccinated, we end up with an eligible population of 926 million.
7. The eligible population has roughly doubled. To preserve the erstwhile run rate per unit eligible population, the number of doses/day would need to roughly double. In late April, there were anecdotal reports of shortages, where eligible persons were turned away at vaccination centres. Looking forward, this may become a bigger problem with the expansion of eligibility.
8. If all else is held intact, then, there will be a larger mismatch between demand and the ability of the union-government led system to push out doses. There are two pathways to not hold all else intact. On one hand, there is the need to shift from a union government led system to something that is a self-organising system, with energy from many persons. On the other hand, there is a need to rethink vaccination protocols. For example, if a person has antibodies, perhaps one dose suffices.
   

An important change of course by policy in Indian Covid-19 vaccination

by Amrita Agarwal and Ajay Shah.

Strategy for Covid-19 and vaccination

A global race took place on building vaccines for Sars-Cov-2. By late 2020, it became clear that vaccine development was progressing rather well.

With the vaccines in sight, the standard economics knowledge about vaccination came into play. Each vaccinated person reduces the possibility of spread of the disease. While the individual who gets a vaccine is gaining protection, that individual is also imposing a positive externality upon the population. There is a market failure -- a positive externality -- as an individual would tend to under-spend on buying a vaccine. There is a case for state financing, to augment personal expenditure on personal protection, to tip more people over into vaccination. The end goal of vaccination is not to vaccinate everyone, but to change the disease dynamics by achieving herd immunity.

A debate took place in India in 2020 about two alternative pathways to roll out vaccines, on a significant scale.

On one hand was the vision of a centrally planned program, where the government would control everything, and the citizenry would obediently wait for their turn. This involved (a) Using the coercive power of the state to block any vaccination activities in India other than the union government, and (b) Organising a nationwide vaccination program at the union government. This was similar to the vaccination efforts prevalent in many other countries.

An alternative approach involved recognising that in India, state capacity is limited. A centrally planned effort was likely to work out poorly. It was better to harness all the energy available in the country to do more vaccination -- whether it was at a state government, city government, club, association, educational campus, private non-health firm, health care firms, etc. This involved (a) Not using the coercive power of the state to block any other energy in vaccination, alongside (b) Some work on vaccination by state organisations in order to address market failure. An example of this perspective is in an article from 30 November, and this talk, at an NCAER event on 29 December 2020. Shruti Rajagopalan, Mihir Sharma, Naushad Forbes were some of the thinkers who wrote on this.

In the event, decision makers in government chose the first path. There were difficulties [8 March, 5 April]. Using data for 19 April 2021, the New York Times tracker shows India at rank 62 in the world, with 1.2% of the population fully vaccinated, in roughly the league of Malaysia (rank 61) at 1.4% or Bangladesh (rank 64) at 1.0%.

At present, the union government is able to push out 3.5 million doses a day. Looking forward, the rate achieved (by the unreconstructed union government program) is likely to go down:

1. It is likely that the process design used, in any centrally planned union government program, would work for one (hopefully modal) use case, but peter out once we reach out beyond this zone.
2. The present vaccine production for the Indian market [SII, Bharat Biotech] is below the required 100 million doses a month.

By this reasoning, the present run rate, of 3.5 million doses a day, may not be sustainable. If we are to get to half the Indian people fully vaccinated in the coming four months, this requires about 10 million doses a day or 300 million doses a month. We need to get up to 10 million doses/day and we face difficulties in maintaining the present rate of 3.5 million doses/day.

An important change in course

On 19 April, the union government has announced an important change in course. The nature of state coercion will now change as follows:

1. Indian vaccine makers are forced to sell half their output to the union government, at an unspecified price, the remaining half being available for sale to state governments and private persons in India (at a price that must be publicly disclosed),
2. Private firms which perform vaccination services are forced to publicly announce the price at which these services are provided,
3. All providers of vaccination services are forced to supply data to the union government's CoWin IT system, and
4. Private persons and state governments are free to import vaccines.

This is important progress. The union government has stepped back from blocking every other energy in the country in vaccination. State governments, and private persons, will be able to buy/import vaccines and run vaccination programs. Vaccine makers remain in the grip of central planning in the new world, but it is a step forward when half of their output can be sold to state governments and private persons at market-based prices.

Implications

The 19 April decisions harness energy in thousands of organisations all across the country. Some state governments and many private organisations will now be able to embark on vaccination efforts. Each of them would tailor their process designs for local conditions and the practical problems as seen by them. The sum total of resourcing and energy that would go into vaccination, in India, would go up. This would improve the overall progress in conquering the pandemic.

The private sector will surprise us with innovation in business models, billing arrangements, etc. Perhaps some firms will find it easier to deliver the one-dose J&J vaccine in difficult locations. Perhaps telecom companies will call their vast subscriber base and sell vaccination services. Private firms know how to segment the users into a large number of categories, and devise strategies for each of them. This is what a union government, which solves for one use case, is ill suited for.

In the short run, it is hard for SII to drastically change its production. Import of vaccines holds the key. In the world market for vaccines, a buyer asks for a price quotation at a certain quantity. These prices are on the decline. Vaccine supply in India will go up through imports.

There are some concerns about the AZ vaccine with younger persons and particularly with young women. Availability of mRNA vaccines in India would help address the needs of these users.

If India were an AZ vaccine monoculture, there is greater vulnerability to a new strain that is able to breakthrough. The self-organising system will bring diverse vaccines to play into the Indian populace, and generate greater pandemic security.

The second wave will not be the last one. Existing vaccine makers will regularly make booster doses through which people will become safe against new variants. Covid-19 is only one among many infectious diseases which call for sustained large-scale adult vaccination programs. The work done this year, flowing from the 19 April decisions, will matter not just in conquering the second wave. Thousands of organisations in India need to view this as a sustained activity. As an example, it would make sense for every large employer to organise quarterly vaccination camps for their employees and their family members, through which an array of adult vaccines are regularly delivered.

Improvements required in the policy framework

The pathway to elicit better production by private firms does not lie in coercing them with quantity restrictions or dictating terms on issues such as price. Such coercion will bring out reduced output by Indian manufacturers. We learned, in the 1960s and 1970s, that it is impossible for a state organisation to go inside the firm, and discuss elements of the cost function with the firm. It is not the job of the state to be a financial service provider for a firm. There should be market-based engagement with vaccine producers, that is free of coercion, and couched in the language of prices, quantities and foreign competition.

Some vaccines are distinctly less efficacious and/or more dangerous than others. The union government can play a useful role by wielding its coercive power to limit the vaccines that are permitted for use in India to the class of vaccines which have achieved approval in an advanced economy such as the US, UK, Japan or Germany.

The use of coercive power by the union government, to harvest data through CoWin, raises concerns given the absence of legal protections against state access to the data. State surveillance is particularly harmful when it comes to health data, so enhanced state legibility will have unintended consequences. This program of capturing data will exacerbate vaccine hesitancy.

The decisions of 19 April are important and will get India up from 3.5 million doses a day. It is, however, likely that we will not get up to 10 million doses a day. It is useful to think about two distinct problems on the demand side:

The rich

If protecting a family of five costs Rs.5,000 to Rs.10,000, many individuals / employers will spend this much. While a positive externality influences the decision making, the decision will be correct as long as the personal gains from protection exceed the price of the vaccine.

The poor

Many poor families will balk at this magnitude of expenditure. This is where market failure bites, in generating the wrong decision because there is a gap between the gains to society as a whole vs. the gains for the individual. State governments and the union government need to step into this breach. Vaccine vouchers are the precise instrument through which this market failure can be addressed.

Conclusion

Central planning has worked well for Covid-19 vaccination in countries like the US and the UK. These countries intelligently used private sector energy [example] as opposed to many varieties of coercion. But central planning works poorly under conditions of low state capacity. It is better to harness the energy of the self-organising system.

The 19 April announcements make important progress in stepping back from a centrally planned system, in increasing freedom, and in harnessing the power of the self-organising system.

The role of the state lies in addressing market failure. There is a need to use the coercive power of the state to require that vaccines used in India must have achieved approval in an advanced country. Poor people will make better decisions when nudged towards vaccination through the tool of vouchers.

The market for Covid-19 vaccines and the tipping point to herd immunity

by Ajay Shah.

Many firms are developing Covid-19 vaccines. Enormous resources have to be deployed, up front, to develop a vaccine and to build manufacturing capacity. It is likely that many vaccines will get through to approval in mature regulatory regimes. Not all vaccines will work identically for all situations, e.g. some vaccines may work better for an elderly person than others.

It is commonly assumed that the global market size for a Covid-19 vaccine is about 6 billion people. In this article, we argue that this might not be the case. Let's think about the situation in the market once one or more vaccine reaches the market.

The buyers perspective before vaccine sales have commenced

The private gain for an individual from buying a vaccine are shaped by the probability of getting sick when leading an unconstrained life. This is shaped by the extent to which Covid-19 has burned through the communities that the person plans to engage with. As an example, in the slums of Bombay or Delhi, herd immunity has set in. A person living there knows that few people in her circles are now getting sick, and she feels relatively safe. Well known factors such as age and co-morbidities will also shape the threat perception of each person. Therefore, for her, the gains from a vaccine are relatively modest, and the willingness to pay is small.

In each city of the world, there is a different numerical value for the attack rate (the fraction of people who are infectious) and the extent of immunity. The state of the epidemic in Pune is different from that in Bombay. As time passes, each city is inching towards herd immunity, and the passage of time thus diminishes interest in paying for a vaccine. Vaccine IP and manufacturing facilities are wasting assets.

It it were possible to develop a combination of tests that add up to an `immunity passport', then the price of this test and the odds of coming out positive would shape the demand function for the vaccine.

Progress on immunisation and herd immunity

Into this world, let us imagine that the sale of multiple vaccines commences. At first, there would be a rush of demand and high prices. As immunisation progresses, the attack rate would go down and the gains from buying the vaccine would further go down. In places like Bombay and Delhi, where a considerable proportion of the population has already been exposed to the disease, when a modest fraction of the population is vaccinated, this could tip the population over into herd immunity, and the disease could die down.

In such a world, vaccine makers face the prospect of a short hot market. At first, vaccine demand will be high and the factories will not be able to keep pace. Competition will come about and that will exert pressure on prices. In a city like Bombay, with about 20 million people, after (say) 5 million persons buy the vaccine, this may significantly change the threat perception in the eyes of the average individual. Vaccine demand would then decline.

Under such numerical values, the market potential in Bombay is not roughly \$50 $\times$ 20 million people or \$1 billion, but perhaps more like \$25 $\times$ 5 million people or about \$125 million.

All of this reduced revenue potential will go to the first few firms that get 5 million doses into the Bombay market. Competition would exert downward pressure on the price, demand would tail off as herd immunity sets in, and there would be a price crash. The late comers would flood the market with output but would obtain low revenues in return.

The vaccine demand collapse in a simple model and in the real world

We have always known that a vaccine is not just a private good; there is a positive externality. The novel idea of this article is about tipping points.

Consider a simple model in which herd immunity is achieved at 60%. Suppose 50% of the population is already immune and knows it. The first 10% that gets the vaccine tip the system over to $R_0<1$ and then the fires start dying out. Once the fires start dying out, the attack rate goes down, the threat perception changes, and the incentive for private people to buy the vaccine drops a lot. Under these conditions, the positive externality imposed by vaccine purchase by the early vaccine buyers, upon the overall system, is particularly large.

A key factor that drives behaviour in this model is that when a person is immune, she knows it and then has no incentive to buy a vaccine. In the real world, people don't know whether they are immune, and would be more inclined to buy a vaccine just to be safe. In the limit, the veil of ignorance is complete, nobody is able to assess the threat, and everyone wants to buy a vaccine.

In the real world, the veil of ignorance is not complete. At every place, people do have a personal judgement about the threat level based on the extent to which their friends and family are getting sick (or not) per month. Age and co-morbidities will also shape vaccine demand. As a general principle, it is always wise to think that humans are sentient optimising creatures. Individuals have a noisy estimator of the threat that they face and this will shape their willingness to pay for a vaccine.

Wall street tells Main street what to do

These problems feed into the thought process of private firms and shape the commitments of capital to the problems of vaccine development and manufacturing when faced with a novel epidemic. 

Numerous vaccines are under development. The process of vaccine approval is necessarily slow. At present, we generally think that over time, one by one, many of these vaccines will get through to the market. By the reasoning of this article, the first few will get through, within a few months the market will collapse, and all funding will be yanked for other projects. This will be a bit reminiscent of how funding for vaccines against Sars-Cov-1 was abruptly yanked when the funders realised that Sars-Cov-1 had reached $R_0<1$.

The numerical values used here (e.g. 60% for herd immunity, 5 million immunised in Bombay to tip over into herd immunity, $50, etc.) are of course purely illustrative. To translate these ideas into practical calculations requires data on the extent to which immunity has come about. In many places worldwide, there are good estimates of the persons who have antibodies, but there is more to immunity than measured antibodies. In India, the information available about the state of the disease in (say) Bombay is rather poor.

If we take this dynamics of the vaccine market seriously, vaccine makers have an incentive to create such datasets. Alongside the construction of such datasets, there is a need for derivatives trading on underlyings such as the fraction of Bombay residents who have antibodies.

The argument of this article is a special case of the long-standing problems of incentives for vaccine development. An effective pathway for state intervention, and philanthropic capital, lies in offering contracts for R&D and manufacturing which change the incentives of private persons to engage in these activities.

Implications

To the extent that this reasoning is correct, individuals will at first face a vaccine market with high prices and shortages. For many individuals, particularly for low-risk persons, there is a tradeoff between paying more to get the vaccine early versus paying less to get it late or even to not get vaccinated if the pandemic has subsided.

For firms with a vaccine under development, this article paints a winner-takes-all scenario, where the first few vendors who get output on scale will capture all the revenue. To the extent that this reasoning is correct, plodding along to the finish line late will induce low revenues.

For policy makers and philanthropic capital, it is important to avoid a `coronavirus winter', a collapse in coronavirus research of the kind which happened after the SARS epidemic achieved $R_0<1$. There is enormous knowledge, and capable teams, which has been created by the early gold rush of building vaccines against SARS-Cov-2. This knowledge should not be lost. As an example, it would be nice if research groups will publish research papers and release code before they put out the lights. We need to think of the sustainable frameworks, where we achieve a new normal of high R&D into pathogens that can trigger pandemics.

The three tiers of government in public health

by K. P. Krishnan.

The Covid-19 pandemic has provided us with fresh insights on health policy in India. One key element of this thinking lies in a careful understanding of what elements of public health are best done at the city/district level, at the state level or at the union government. The Constitution of India has allocated the tasks in some detail. Considerable policy research work is now required, to bring life to the Constitutional scheme, based on a first principles understanding of the work that is required in public health, drawing on our experiences of 2020.

Market failure in health policy

There are great insights that can be obtained in the field of health policy by applying the toolkit of market failure. It is best to define the task of government as addressing market failure, and market failure comes in four categories: concentration of market power, presence of positive or negative externalities, presence of information asymmetry, and the need to provide public goods. There is a neat split in the field of health: public health is about public goods and externalities, while health care may contain market power and asymmetric information.

Public goods are a compelling example where the government is central, and the things that are not done by the government are hard to achieve through purely private initiatives other than pure philanthropy. Knowledge is the ultimate public good -- once a research paper is released on a website it is non-rival and non-excludable -- and we need public funding for research. When one person coughs and communicates Covid-19 to another, this is a negative externality, and there is some role for the government in reducing this externality. The main task of health policy thinking lies in analysing the landscape of public health, identifying the market failures (public goods and externalities), defining the tasks of the government, and finding a path to achieving state capacity on these functions.

Where should each function be placed?

Once we have a picture of the various functions which have to be performed in public health, we come to the question of the best place where it should be performed: the union government or the state government or the local government. The famous `Subsidiarity principle' of public economics asserts that every function should be placed at the lowest level of government where it can possibly be performed.

As an example, Amy Harman and Farah Stockman have an article in the New York Times which describes the treatment of travellers from China into the US. The federal government (which we in India call the union government) is the right agency to track flights and obtain lists of passengers. After this, there is a handover of information, that person x flew in from China, to the local government where that person resides. At this point, the local government is the one best equipped to work on contact tracing, testing, and isolation. This is an optimal allocation of the two tasks. It is hard for a local government to keep track of who flew in from China. It is hard for the union government to manage front line staff in a city or a district.

It is interesting and important to think about the elements of a public health system, and to think about the optimal placement of each of these elements, between the union, state and local governments. However, we do not engage in policy thinking on a tabula rasa. We do policy thinking in India where the Constitution of India has a well-developed point of view on these questions, and amendments to the Constitution on this aspect are rare. Hence, our puzzle in thinking about public health in India lies in taking full cognisance of the Constitutional scheme and best adapting it for our present understanding.

Health in the Indian Constitution

The distribution of subjects in the Constitution is reasonably elaborate. It sets up a division of labour between different levels of government, viz, the union, state, panchayat (rural local bodies), and municipalities through a list of subjects which are enumerated in its schedules VII, XI, and XII.

The Seventh Schedule of the Constitution lists the distribution of the subjects between the union and the states, while the eleventh and twelfth schedules deal with the distribution of responsibilities at the local level, i.e., panchayats and municipalities. Every policy thinker in India needs to fully understand these three schedules. Table 1 summarises the distribution of subjects in the domain of public health.

Table 1: Distribution of 'health' related subjects in the Indian Constitution

Government	Subject	Reference
Union	Port Quarantine	Schedule VII, List I, Item 28
Union	Union agencies and institutions for professional, vocational or technical training, etc.	Schedule VII, List I, Item 65
Union	Co-ordination and determination of standards in institutions for higher education or research and scientific and technical institutions	Schedule VII, List I, Item 66
Union	Inter-state migration and inter-state quarantine	Schedule VII, List I, Item 81
State	Public health and sanitation; hospitals and dispensaries	Schedule VII, List II, Item 6
Concurrent (both union and state subjects)	Lunacy and mental deficiency, including places for reception or treatment of lunatics and mental deficients	Schedule VII, List III, Item 16
Concurrent	Medical education and profession	Schedule VII, List III, Items 25 and 26
Concurrent	Prevention of the extension from one State to another of infectious or contagious diseases	Schedule VII, List III, Item 29
Panchayat	Health and sanitation, including hospitals, primary health centres and dispensaries	Schedule XI, Item 23
Panchayat	Family welfare, women and child development	Schedule XI, Items 24 and 25
Panchayat	Social welfare, including welfare of the handicapped and mentally retarded	Schedule XI, Item 26
Municipality	Public health, sanitation conservancy and solid waste management	Schedule XII, Item 6
Municipality	Safeguarding the interests of weaker sections of society, including the handicapped and mentally retarded	Schedule XII, Item 9

There is a significant role of union government in subjects relating to contagious diseases and pandemics. It is also responsible for setting standards of medical education and profession along with the state government. On the other hand, state and local bodies are responsible for most public health functions such as sanitisation and family welfare.

A simple reading of the distribution of functions induces many questions. For instance, vaccination is a public health function which is a part of state list under the Constitution. This is logical, given that immunisation programs require a large front-line workforce that interacts with the population. However, the design of the standard package of vaccinations for all kids, and envisioning ambitious projects like the eradication of smallpox or polio, require thinking and coordinating by the union government.

Similarly, in a public health crisis such as COVID-19 all levels of government are required to perform their specific functions that are elements of the overall public health response. These elements include tasks such as planning, funding, managing and on-ground implementation. These elements are not described in detail in the Constitution but are an important part of the legal and policy mechanisms adopted by the government.

There is at present relatively little in place, in India, by way of Parliamentary law which shapes and circumscribes the work of public health. The British-era Epidemic Diseases Act, 1897, has many problems. The legal framework under which India is responding to the COVID-19 crisis is the Disaster Management Act, 2005 which sets up a National Authority whose role is briefly discussed below.

The role of the National Authority

The Disaster Management Act, 2005 is the union law that was used by the union government in its Covid-19 response. In this Act, a disaster is defined to be:

a catastrophe, mishap, calamity or grave occurrence in any area, arising from natural or man-made causes, or by accident or negligence which results in substantial loss of life or human suffering or damage to, and destruction of, property, or damage to, or degradation of, environment, and is of such a nature or magnitude as to be beyond the coping capacity of the community of the affected area;

Under this law, the National Authority is responsible for drawing a national plan for disaster mitigation, prevention, and preparedness. This plan is to be reviewed and updated periodically. The law also recognises the role of multi-level governments as it sets up the national, state and district level authorities which are responsible to follow the guidelines of the National Authority.

The National Disaster Management Plan in India was last updated in November 2019, its only revision after the first plan was released in 2016. While the plan deals with Biological and Public Health Emergencies (BPHE), it does not provide detailed guidelines on the structural frameworks required for dealing with a global pandemic at the scale of COVID-19. In this sense, India does not have a national plan to deal with the COVID-19 crisis as of now. It would be useful to design a national plan which guides the government in undertaking a well-coordinated action to deal with the crisis. The national plan should be mindful of the spatial element of the public health interventions in COVID-19 such as:

1. Inter-state migrations, operations of flights require intervention by the union government.
2. Hospital preparedness, such as the presence of an adequate number of hospital beds, medical equipment such as ventilators and oxygen etc. require intervention at the state level.
3. Contact tracing and quarantine enforcement require intervention at the municipal or local level.

A guidance document by the National Authority with conceptual clarity about the elements of public health will be useful to minimise policy failures in COVID-19 management. At present, some clear policy failures in COVID-19 management are being observed. These failures are at all levels of the government, the union, state, and local levels. Some of them are described below as illustrations:

Union-state coordination

Actions taken by the government during a pandemic have political repercussions and therefore, a tension between the state and union government priorities can exist. For instance, in Delhi, the elected government and the Lieutenant governor had disagreed on the conditions being imposed on businesses during the lockdown period leading to uncertainty for the public.

Varying state priorities

Border state conflicts relating to inter-state travel of persons became common in the early period of the COVID-19 pandemic. In the first week of April, Karnataka state sought intervention of the Supreme Court to resolve a dispute regarding border movement with the neighbouring state of Kerala during lockdown imposed due to COVID-19. This was after the Kerala High Court passed a verdict asking Karnataka to allow movement of persons between the states. Eventually, the union government was involved in reaching an amicable settlement between the states regarding conditions of movement of persons during the lockdown.

Varying priorities of local bodies

The local bodies are empowered to take action in public interest under the Disaster Management Act. During the COVID-19 crisis, it was observed that local bodies failed to take into consideration the impact of their decision on neighbouring districts. For instance, the Noida district administration barred entry of persons from the Delhi border without a pass issued by them. This caused trouble to essential workers such as doctors and nurses who worked across the district border who would be left stuck at the border without knowledge of requirements for such a pass.

Heterogeneity within the vast country

There is great heterogeneity within the 3.3 million square kilometres of India, in the state of the epidemic, in trade-offs between mobility and disease control, and in state capacity. There is great value in having democratic legitimacy in each city or each district in choosing the optimal path.

While working through the Disaster Management Act was expedient when faced with the pandemic, as the dust settles, there is a need for health policy thinkers to envision a public health system for India. It is important to, lay this on sound legal foundations, whereby the Disaster Management Act is ultimately focused on natural disasters like earthquakes, and public health has its own legal and institutional architecture that is fit for this purpose.

Conclusion

There is a need to bring greater coherence to all the elements of state power that are in play in the response to Covid-19. This has led to twin challenges of a) micromanagement by the union bodies, and b) excessive delegation of powers to the state and local governments without adequate checks and balances. For instance, approval for Covid-19 testing labs throughout the country is done by a single body, the ICMR, an approach that has difficulties. Similarly, certain orders by district and state authorities have also been criticised during the course of the pandemic for being arbitrary.

We should utilise our fresh understanding of the present problems, to build a body of knowledge on (a) What are the tasks of public health in India (b) What is the role of the union / state / local government in each of these and (c) How to achieve state capacity on each of these components?

K. P. Krishnan is Professor at National Council of Applied Economic Research (NCAER).

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 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 SARS-CoV-2 pandemic has led to poor outcomes with respect to 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 in as much 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

Health care 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 which 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 for establishing 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 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 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.

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.