Has ICMR become a super-regulator of sorts in the medical sector?

Clearly, the ICMR as a research body is not the best equipped to handle the role of a regulator for the sector. Yet it has become the most visible face of India's fight against Covid-19

Some missteps return to haunt. In the year 2017, the Central Government had put up a draft public health bill to regulate the sector in India. There were loud protests from the states and from the interest groups ranged against it. 

The states saw it as an invasion of their territory, the interest groups felt the bill did not write in consent from patients to isolate them, restrict their movement or even test them when there was a public infection. The Public Health (Prevention, Control and Management of Epidemics, Bio-terrorism and Disasters) bill, 2017 consequently, went nowhere. 

Most importantly, it sought to develop a cadre of officials to address a public health emergency. “We were empowering the states to become regulators for just such a contingency, without having to create a new one at the Centre”, said a senior official associated with the writing of the bill. The absence of a regulator has never been felt as acutely as now. 

Following the regulatory void in the health sector, as the Covid-19 pandemic struck, it could seem that the Indian Council of Medical Research (ICMR) had been thrust into the role without much preparation. The preparations to identify a suitable agency were scuttled when the bill sank. The health ministry and the state governments were made to scramble for a response--basically which agency would lead the public health battle.  

The assumption of the quasi-regulators’ role by ICMR is also quite in keeping with India’s chequered history of setting up regulators for different sectors. There are over 50 of them, but as lead author Shubho Roy points out in this 2018 NIPFP paper, “In most cases, regulators have created a new kind of central planning, where every detail of products and processes is codified into regulations…”

Clearly the ICMR as a research body, set up in 1948, is not the best equipped to handle the role of a regulator for the sector. Yet it has become the most visible face of India’s fight against the pandemic. While there is the National Centre for Disease Control, based in New Delhi and conceived on the models of CDC in the US to address such spread of epidemics, the ICMR was the agency of choice for the health ministry from the first day. From March 21, a day before the countrywide lockdown, ICMR has issued most of the key circulars beginning with the guidelines for testing by private laboratories and regularly appearing on the daily media briefings with the health ministry. It has since issued every sort of notifications from testing strategy, identification of labs, technical documents and advisories, set up bio repositories and work with the media. 

“The wider network of laboratories with ICMR enjoying BSL4 standards (medical laboratories are graded from 1 to 4 on their level of sophistication) possibly tipped the decision in its favour,” said Oommen C Kurian, Senior Fellow & Head of Health Initiative at Delhi-based think tank, Observer Research Foundation. 

It also worked because the hierarchy of regulators is not clear for the health sector. There are several of them, such as the Central Drugs Standard Control Organisation, whose job is to approve medicines and lay down their standards as well as set rules for conduct of clinical trials. Then there is the National Medical Commission, which regulates medical education and practices and finally the National Pharmaceutical Pricing Authority of India, which sets standards for pricing of drugs. But it is difficult to know who sets the standards for public health care in India. “Most of them are busy with overlapping documentation and that reduces their bandwidth,” said one of the experts who wished to remain anonymous. 

To ensure a monolithic regulator by getting the parts in position would mean constructing an edifice like the RBI for the health sector. “There can be a composite one like a tree, with branches to serve the different needs,” said a former senior adviser to the health ministry. It would, however, need some changes in the Constitution, which is a tall order, since it is the states that will still need to deliver on public health. So they will need to come on board. A regulator is also necessary to protect the health records of millions of Indian who are now coming on board the government health schemes. In this pandemic, none of the bodies have had time to look at this aspect, yet personal data about the patients is strewn all over.  

There is a bit of a legal challenge for it to happen. Health is strewn across various parts of the Indian Constitution. Clause 6 of the State list includes public health and sanitation, but inter-state quarantine comes under the Union list. Both the states and the Centre have the right to make laws for “prevention of the extension from one state to another of infectious or contagious diseases” under the concurrent list. “There are too many moving parts in the health sector,” said Kurien. 

Former vice chairman of NIPFP, Sumit Bose notes: “While the education budget is largely delivered under a few major programmes like Sarva Shiksha Abhiyan, the health sector is fragmented with far more programmes.” A Parliament reply offers a list of 38 such programmes , many with their sub-programmes. “The Central Government supplements the efforts of the state governments in delivery of health services through various schemes of primary, secondary and tertiary care,” it explains.  

Experts agree that the delivery of public health is less a function of a regulator and more of state capacity. Yet this capacity rises when the chain of command is clear. “One doesn't need to regulate much if the hospitals are in the public domain, but in India with most of the capacity residing in the private sector it becomes important”, said Alok Kumar, Adviser (health) in Niti Aayog. There are other challenges too.

Before the British left India, they had built up a cadre of public health officials. It crumbled within the next few decades as the frequency and intensity of public health crises faded away. Only Tamil Nadu among the major states kept the idea alive. Covid-19 has shown how useful it was with the state recording a low fatality rate, as patients got medical support early in the disease. Late last year, the states and Centre took the first steps to revive this cadre as part of National Health Priorities. As Kumar puts it, “One has to decide if an epidemic breaks out, should one assume it is a once in a century event and let each state decide on their response or set up redundancies like establishing a regulatory muscle.” 

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