Interview: ‘We need a medical regulator that is more like a tribunal and not the consumer court’

Two recent events have put the private health sector in India under intense scrutiny in recent weeks. One is the death of seven-year-old Adya Singh at Fortis Memorial Research Institute in Gurugram. The child had been admitted in the hospital with dengue and died there after 15 days. Her family said that they had been billed Rs 15 lakh, an amount that most believed was grossly inflated. A government investigation into the case found irregularities, unethical practices and violation of the protocol for diagnosis and medical duties. A doctor at the hospital has been charged with culpable homicide and local authorities are considering action against the hospital management.

The second case is that of Max Super Speciality Hospital, where a premature infant, declared dead and handed over to the parents, was later found to be alive. Although the child was taken back to hospital for treatment, he did not survive.

These two cases are only the latest in a long list of reported malpractices, negligence, and ethical violations at private hospitals across India. The main reason that these violations are all too common is the lack of strict and uniform regulation of healthcare in the country.

In a conversation with Scroll.in, Shailaja Chandra, former secretary in the health ministry, highlights how the private medical healthcare system of India is set up in such a way that there is little accountability, how there are numerous gaps between old laws that are irrelevant to new healthcare systems and new laws that are robust but not being implemented, and why there should be a body to oversee healthcare just like there are for telecom and aviation.

Excerpts from the conversation:

In any country or system of healthcare you will have cases of medical negligence because no system is perfect. And human error is possible because so many people – doctors, nurses and different levels of staff are involved in patient care. But medical negligence seems to be happening with alarming regularity in India...

The private health sector is the outcome of a policy climate that encouraged the establishment of specialty hospitals. During the 1980s up to the time of liberalisation, there was nothing like a private healthcare sector other than small nursing homes, which took care of maternity cases and so on. For complicated cases patients were taken to public sector hospitals like Safdarjung or Lok Nayak Jayaprakash Narayan or Ram Manohar Lohia or the All India Institute of Medical Sciences. There was nothing like corporate hospitals. Then, between 1992 to about 1998, a slew of concessions were given and Foreign Direct Investment was permitted for the health sector. With that, foreign money and Indian money could come into the health sector, treating is as an industry. Land was given at concessional rates to hospitals as well as income tax exemptions and huge customs duty exemptions. This ensured that it was worthwhile and profitable for investors to invest in the health sector.

Between 1991 and 2000 when I was in the health ministry, I do not remember any parliamentary briefing or any meeting with the secretary or my colleagues when this subject of regulation of private health sector was even mentioned. We were all wrapped up in projects on malaria, leprosy, TB, blindness, food adulteration and all those things. Not once did the subject of regulating the private health sector came up.

Regulation was only confined to asking hospitals to earmark and admit patients from the weaker sections as per the undertaking given while availing of the concessions, generally providing 10% of in-patient department and 25% outpatient department care free of cost. Even this was completely unsuccessful. The health ministry had no power or political will to enforce it.

This lack of regulation has continued over the years even as more private health establishments have been set up, which is particularly troubling in a country where there is low penetration of medical insurance and more than 60% of healthcare expenditure comes out of the patients’ pockets.
Super-speciality corporate hospitals hire highly qualified people, have state of the art equipment and are highly organised. So a man who has money but no insurance, has at least this outlet where he might be paying four times what he should but he gets the service.

Meanwhile, the health sector in small towns offering medical or surgical services is dominated by single practitioners only. Of the 10.4 lakh healthcare enterprises, which include hospitals, nursing homes, diagnostic centres and laboratories about 8% are hospitals, while 50% are single practitioners. Of the 50%, unqualified practitioners account for more than the qualified doctors. This creates a bottleneck where only people with resources can go to specialty private hospitals while the rest have to go to small nursing homes or depend on overcrowded government hospitals.

Once admitted into a high-end private hospital, patient has no estimate of what the ultimate bill might be as the hospital charges whatever it wishes to. Private hospitals are in it for profits and do not operate based on charitable or altruistic motivation. Therefore, these horror stories of people being overbilled are often correct. If you look at private hospitals, there will be anything from a 100 to 500 cases against each in consumer courts, most often about billing.

In many private hospitals, the doctors or management do sit down with patients or their families and have a kind of counselling telling them what their bills are running into, so that there is no shock at the end. But not everyone does it. The worst-case scenario is of reports of a patient being forced to be on ventilator when it was unnecessary after a couple of days or when the patient was already brain dead. But they would have billed him for 10 days when he would have needed to be in the ICU for only two days. But this is the version of patients.We need an unbiased body which can look at the facts and decide and in the absence of that it is a family’s word against a hospital.

Where have the various existing medical regulations failed?
Every state has a Nursing Homes Act, drawn up around the 1950s, which not at all attuned to the kind of healthcare institutions in the country now. The Acts require all establishments to be registered and their licences can be cancelled, but there are no provisions on malpractice or overbilling and so on.

The Medical Council of India is supposed to set standards but it only registers doctors on the medical register of India. State medical councils enrol doctors on state medical registers. Now, medical councils are elected bodies and members have to fight elections. Their purpose is to look after the interests of doctors and not to annoy them with enquiries and punishments – very rarely does the council resort to suspending a licence of a doctor, leave alone cancelling it. There is virtually no oversight of doctors or deficient or unethical treatment by the national or state medical councils.

The Clinical Establishments Act 2010 covers every kind of medical establishment, whether it is a laboratory, a single practitioner or corporate multispeciality hospital, public sector or private sector. It was passed by parliament in 2012 but has not been implemented properly by any of the states. That requires rules and staff to undertake the functions and act if the information given while registering an establishment is disregarded or circumvented.

What has been the biggest hurdle to implementing any kind of regulation?
There is huge resistance by doctors mostly at the state level, especially by the Indian Medical Associations who have stone-walled any efforts to regulate. Being so it is a controversial subject that the political executive at the state level would rather not confront. Only Karnataka and West Bengal have tried to bell the cat, by passing state-level laws, where they have faced a lot of resistance.

Other state governments see it as more of a political thing because they have now realised that for the first time in India there is a public uprising about issues connected with the quality and pricing of healthcare. People may not be articulating it as such but they are mad about inflated bills, wrong diagnosis, over treatment, under treatment and all other kinds of things, including how a patient is not consulted or counselled about anything in a hospital.

How do we now start making health establishments accountable?
Apart from implementing the Clinical Establishments Act which is a must, we need a regulator that is more like a tribunal and not the consumer court. The consumer court only looks at faulty service and award of compensation and has no medical advice available to it while deciding case of medical negligence or malpractice. A particular administrative member may or may not have a health background. Even among lawyers, there are only those who add on to their areas expertise and do a little of medical negligence and malpractice cases but there are no specialists in these areas. Medical negligence and malpractice cases need lawyers that can interpret medical findings and are conversant with best practices and treatment regimen. So, you can’t sue a doctor for anything and you are only stuck with the consumer court. The consumer court has a long pendency and might be looking at a case of the operation of a toaster or lift and case of a hospital on the same day. That is not the ideal forum.

We need medical tribunals starting with an ombudsman at the sub-district level, a district forum, a state forum and a national forum. Each of these should have a judge, a doctor and a medical administrator who knows about hospital administration. We need such medical tribunals that can look into these specific cases of malpractice, negligence, apathy and overbilling.

For that, we need standards. If you look at any district in India, there will be a qualified doctor but he needs help with his practice. So, he picks a guy literally off the road and teaches him how to put intravenous fluids and such medical procedures. These assistants watch how doctors prescribe antibiotics and steroids and learn the repertoire of about 20 medications and how to give them for day-to-day problems. These unqualified then assistants start treating patients on their own and refer the cases that they cannot handle to the very doctors who trained them for a commission of around 30%. This is very common and the Indian Medical Association does not deny this.

So, you have a situation where at the lowest level there are no qualifications prescribed and all your technical people, even non-doctors, could have learnt skills anywhere. Now, there is nothing wrong at one level just as you trust an electrician who has no qualifications but can set right almost anything in your house. He doesn’t know the physics of it but he knows the mechanics of it. In a poor country there will be this informal kind of business. But, should health be treated as such?

This is not just a question of regulating the lowest level but there are no standards anywhere all the way up to corporate hospitals. It is all left to market forces.

The Clinical Establishments Act has drawn up standards that hospitals must meet and needs healthcare providers to declare the services provided. If there are transgressions of these standards, the authorities can cancel registration. This should be implemented without further delay across the country. If the states do not listen the subject of medical standards and quality of care should be brought on the concurrent list of the Constitution.

The Delhi state government has cancelled Max Super Speciality Hospital’s licence on grounds that it has not offered free treatment for the poor as per the agreement with the state government based on which it got land at concessional rates. The hospital was also supposed to reserve beds meant for fever patients but has used it to treat other cases. And then there has been this this case of alleged negligence. But doctors have made a point that forcing the hospital to close will leave patients in the lurch. How do you think this should have been handled?

When I first heard about what had happened at the hospital, I felt that it was high time someone took action against the hospital and said so in a television interview when they asked me. But I would have to go back on that because it cannot be a situation where you close the whole hospital. The first priority should be giving patient care, not disciplining the doctor or hospital. However, I would say that if they have not been providing the free treatment that they are supposed to, then they should have been given a month’s notice saying that the hospital will be closed down and informing patients through public notice that the hospital will be closed and that they have to make other arrangements.

You cannot shut a hospital overnight, because there are a lot of critical and serious cases for which treatment cannot just be stopped. These are not just consultations but operations, dialysis, haemophilia cases where treatment is going on all the time and over a period of time. You cannot leave those patients in the lurch. Patients have to find another doctor, get an appointment and in doing this can lose precious time and may lose a life.

Before the Karnataka Private Medical Establishments Act was passed last month, one of the contentions of doctors who were protesting the Act was that public hospitals were being left out of this set of rules. Should there be separate regulations for public and private hospitals?
No, and the Clinical Establishments Act covers public and private establishments. All state regulations should cover public and private medical establishments. Public hospitals have enormous problems. For instance, government doctors siphon off patients telling them to come to their private practices where they charge them five times the cost. They also need to be put under check. There are many ways whereby the medical sector can be regulated and, indeed, that is a crying need today.