STUDIES and media reports have brought out the failure of the government in carrying out its stewardship role. The regulatory framework has not been responsive in ensuring that health services are of acceptable quality, with controlled costs and regulations to facilitate transparency and accountability to prevent negligence. Regulations have assumed importance in the context of the recently launched National Health Protection Scheme also known as Ayushman Bharat. For Ayushman Bharat to succeed, it is necessary that healthcare delivery is regulated, and providers are made accountable to ensure that patients receive quality services. This would ensure that fraud and other abuses are minimized and the patient’s rights safeguarded. This article will focus on the role of government in the regulation of clinical establishments, human resources, pharmaceuticals and medical devices, thereby protecting patient and consumer rights.

In India one needs a license to run restaurants, taxis, liquor shops and for all kinds of economic activity. However, such requirements are not necessary to run clinical establishments in many states of the country.¹ Till a decade ago Maharashtra, Delhi and West Bengal had inherited legislations (a British legacy), to register private nursing homes and hospitals. In Maharashtra, the Bombay Nursing Home Registration Act, 1949 and in Delhi the Delhi Nursing Home Registration Act 1953 are still in force. They have not been updated despite the changing profile of healthcare delivery and public health needs that may have lost their relevance over time.

In 2017, West Bengal enacted the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017. Till a few decades ago Assam, Arunachal Pradesh, Bihar, Chhattisgarh, Goa, Haryana, Himachal Pradesh, Jharkhand, Kerala, Karnataka, Mizoram, Meghalaya, Nagaland, Rajasthan, Tripura, Uttarakhand, Tamil Nadu and Uttar Pradesh did not have legislations that governed the operating of private clinical establishments.

It is clear that the government failed to discharge its regulatory obligation. In some states such as Maharashtra, Delhi, Odisha, West Bengal, Madhya Pradesh, Andhra Pradesh, Jammu and Kashmir, legislations existed only on paper, and their implementation and enforcement was questionable. Further, they were restricted to only allopathy establishments. Laboratories and diagnostic centres were not covered, and minimum standards related to infrastructure, human resources, patient safety and basic minimum quality were not covered. There was no provision to display information of the services and charges.² It is a matter of grave concern that a dominant section of healthcare which concerns life, functions without any accountability,

In this scenario, the Indian Parliament, on 3 May 2010, passed the Clinical Establishments (Registration and Regulation) Act, 2010 (CEA 2010). Its purpose was to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services provided by them. The act covers all clinical establishments – public and private – run by all recognized systems of medicine. The CEA 2010 was applicable to Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and all Union Territories. Uttar Pradesh, Rajasthan, Bihar, Jharkhand, Uttarakhand, Assam and Haryana have adopted the act. However, the implementation has been woeful and not as per expectation.

 

The central act has, however, brought into focus the functioning of private clinical establishments, nudging states to enact appropriate legislation or make changes in their existing legislation. Even today Gujarat, Punjab and Goa do not have any legislation to regulate private hospitals and laboratories.

Presently the government does not have adequate information regarding the number of private clinical establishments, their manner of functioning, their financing, the human resources employed, the standards of care being followed, or their outcomes, in the states across the country. Media reports and various studies claim that the quality of care provided is often questionable, with evidence of irrational and inappropriate treatment, tendency to conduct unnecessary surgeries, illegal clinical drug trials, an excessive use of medicines and technologies, overcharging, including the widespread practice of ‘cuts’ and ‘commissions’ for referrals, all of which is unethical and inflates costs.

A widely shared grievance is that there is a total lack of transparency on charges for treatment and the appropriateness of interventions and treatment provided. Clinical establishments lie under a thick fog and the public knows little except by way of first hand experiences.

In the CEA 2010, and many states that have introduced legislation, there is an absence of regulation around fees and charges by private clinical establishments. Issues related to differential rates, overcharging and excessive billing, commissions for referrals, demanding money before operation procedures and forcing patients to purchase from specific vendors are not touched upon. There are no mechanisms for clinical and social audits to monitor inappropriate treatment, unnecessary surgeries, mandatory investigations and over-prescriptions. Healthcare is an highly specialized field, that inherently leads to a deep asymmetry of information between the consumer and provider, with the former having to rely on the advice of the latter which leaves the consumer at the mercy of the provider for all treatment and the ensuing costs.

 

Legislations exist to license medical professionals through statutory councils. These councils are mandated to monitor standards of education, oversee qualifications, registration, and professional conduct of doctors, dentists, nurses, pharmacists and practitioners of ayurveda, yoga, unnani, siddha and homeopathy. The key legislations are the Indian Medical Council Act 1956, Dentist Act 1948, Indian Nursing Council Act 1947; Indian Medicine Central Council Act 1970; Homeopathy Central Council Act 1973; and Pharmacy Act 1948 and their subsequent amendments from time to time.

The non-performance of the Medical Council of India (MCI) was clearly brought out in the 92nd Report of the Parliamentary Standing Committee of 2016, which observed that the MCI as the regulator has repeatedly failed in all its mandates, over decades. It observed that the MCI failed to create a curriculum enabling doctors to acquire appropriate skills; ensure merit in admissions, particularly private medical institutions that tended to admit students based on the ability to pay capitation fees; failed to raise the abysmally low doctor population ratio; failed to instil respect for a professional code of ethics and take disciplinary action against doctors violating the code of ethics; and more.

 

The report noted that between 1963-2009, the Ethics Committee of the MCI blacklisted just 109 doctors. In contrast, in 2016-17 alone, the Medical Board of California (MBC), USA, revoked 143 licenses and issued 86 public reprimands. Similarly, the General Medical Council (GMC) of Britain issued 11 warnings, suspended 93 licenses, and permanently debarred 70 doctors in 2016. It called for radical reforms in the regulatory framework and suggested the formation of a National Medical Commission (NMC) through a new act.

The National Medical Commission Bill, 2017, has been referred to a Parliamentary standing committee.³ The NMC Bill is the latest attempt at reforming the MCI and the 13th legislative attempt (bills and amendments) and various interventions by the judiciary are well recorded due to the history of the failures of MCI in carrying out its mandatory functions.

Further, a similar situation exists with the nursing and dental councils. In 2017 the Supreme Court ruled that the Indian Nursing Council (INC) does not hold the power to grant recognition to nursing colleges. The order also restrained the council from publishing information on its website – indicating that institutions imparting nursing education have to obtain recognition from the council. This was in response to a petition by a member of the Karnataka Nursing Council, who claimed that the INC was a hotbed of corruption and that its agents illegally charge Rs 5 to 35 lakh for recognition.

 

In February 2017⁴ the Central Bureau of Investigation (CBI), booked the president of the Dental Council of India (DCI), along with the chairman of a dental college, and a former vice chancellor among others, for alleged irregularities, including receiving pecuniary benefits from private colleges in return for the increase in number of BDS/MDS seats.⁵

Another major issue regarding human resources for health is the absence of legislation for the paramedical and allied health professionals such as physiotherapists, optometry, occupational therapists, radiotherapy, laboratory technicians, and imaging technicians, among others. They function without any regulation related to their standards of education, the recognition of their qualifications and their registration and professional conduct. This is a matter of concern.

Another anomaly is that yoga and naturopathy are recognized by the Ministry of AYUSH under the MOHFW, however, they are not recognized by legislation as in the case of ayurveda, homeopathy, unnani and siddha. The Central Council for Research in Yoga and Naturopathy was established as a registered society in 1978, which registers practitioners. It is necessary to regulate these professions through appropriate legislation.

 

The Drugs and Cosmetics Act, 1940 (D&C Act 1940), Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, as amended from time to time, are the principal legislations that govern pharmaceuticals and medical devices. The D&C Act 1940, provides for provisions of safety, effectiveness, quality, import, manufacture, distribution and sale of drugs and cosmetics. In addition to the rules, the schedules regulate life period of drugs, vaccines, prescription drugs, standards of condoms and cosmetics, GMP for ayurvedic drugs and requirement and guidelines on clinical trials to enumerate a few.

The major issues of concern related to pharmaceuticals are the proliferation of spurious and substandard drugs, continuation of irrational fixed dose combinations, questionable regulations of clinical trials, the safety of patients, dual licensing mechanism, inadequate regulatory expertise, malpractice in drug dispensing, and importantly, the coordination and functioning between different ministries.

While most functions that pertain to drug regulation come under the central government, governed by the Central Drug Standards Control Organization (CDSCO), others such as licensing and monitoring of manufacturing units and distribution channels, quality control etc. are monitored by state drugs authorities under the administrative control of the state governments. This leads to anomalies: if a state drug controller refuses a license, the manufacturer can go to another state and reapply to get the license. Another example to highlight this dichotomy is the licensing of blood banks under the dual authority of the state and central governments: the State Drug Controller issues the license, and CDSCO, the central license approving authority, where there is minimal supervision or quality control for the supply of blood and blood products from the blood banks to hospitals and nursing homes, monitors the process.

 

The Parliamentary Standing Committee, in its 59th Report of 2012 on the functioning of the CDSCO, noted that most of the ills that beset the system of drugs regulation were mainly due to the skewed priorities of CDSCO, which tended to accord a higher priority to the concerns of the drugs industry rather than the consumers.

The committee indicated its serious concern of understaffing CDSCO, which did not correspond with the volume and nature of work. It also observed a host of issues involving capacity building of CDSCO like the upgradation of its existing offices, setting up of new offices, creation of new central drug testing laboratories and equipping them with state of the art technology. This was to enable them to carry out sophisticated analysis of drugs, upgradation of existing drugs testing laboratories, skill development of the regulatory officials, implementation of an effective result oriented pharmacovigilance programme, increased transparency in decision making etc. to realize the desired objectives.⁶

Currently critical and high-end implantable medical devices and equipment, defibrillators, dialysis, pacemakers, PET, CT scans and MRI equipment is not regulated under any legislation. These issues assume importance since eighty per cent are imported and the government regulates the manufacture, sale and their import.

 

Patients can seek remedial measures against medical negligence through various laws like the Indian Penal Code 1860 which prescribes penalties for causing death by negligence, the Indian Contract Act of 1872, Civil Law of Torts, the Consumer Protection Act of 1986, and the various Medical Council Acts where members of the profession are mandated to abstain from committing acts of medical negligence. The medical councils are very reluctant to provide redressal to the consumer who seeks justice in cases of medical negligence. The MCI’s functioning is questionable in investigating and taking action against doctors accused of malpractice or negligence.

A public interest litigation in 2000 revealed that there was no system for maintaining an updated database of complaints against doctors. Some complaints were pending for more than 42 years and only a few doctor’s licenses have been permanently cancelled. In the past 23 years, the Maharashtra Medical Council solved only 47 per cent of the 1,245 medical negligence cases.⁷

The Consumer Protection Act 1986 provides remedies for medical negligence through the establishment of consumer courts that have judicial powers comparable to civil courts as it was intended to provide for speedy disposal of consumer disputes. However, there are more than 500 consumer courts, a majority of them inadequately staffed and lacking the necessary infrastructure. The number of cases filed with the consumer courts is growing, thereby creating a backlog. More than 200,000 cases are pending with these courts making them somewhat ineffective.

 

There has been considerable resistance to the introduction of legislation from the medical profession, especially private providers. States keen to adopt the central act or enact suitable legislation or modify existing ones, find their efforts thwarted. The medical associations among others oppose new legislation and approach the courts for stay orders, which hinders the enactment and implementation of the acts and rules. Their concerns with the central act are that it leads to ‘license and inspector raj’, curtails the freedom of medical practice, and that the penalties are harsh, even though the CEA 2010 provides for provisional registration through an online system of self-declaration, with no inspection by the authorities and time bound grant of registration. There are only monetary penalties with no provision for imprisonment, as the intention is compliance rather than punitive action.

The act mandates that clinical establishments should provide basic emergency care, is opposed by private hospitals and the Indian Medical Association (IMA). It is well known that private hospitals do not admit accident victims since it can lead to medico-legal complications or because of the patients’ inability to pay. As this malaise is widely prevalent, the Supreme Court in 1989 passed a ruling (Parmanand Katara v. Union of India, AIR 1989 SC 2039) making it obligatory for practitioners and establishments to provide medical care for those requiring emergency care. The failure of the government to enforce this order, enact appropriate legislation and implement existing ones, endorses multiple market imperfections to proliferate.⁸

 

Besides the imperative need to legislate, there is also a need to bring in a paradigm shift in its enforcement. This could be through the use of web based technology which would help reduce transactions, impose hefty penalties which could act as deterrents, and penalize those who violate the law. It could also exhibit periodic information from providers. Information and data needs to be put out in the public domain, which would facilitate transparency in their functioning and billing practices. Implementation of existing legislations is paramount and it is necessary that governments provide sufficient resources to give it a high priority. Public awareness about rights and duties and their involvement, is imperative for better adherence to regulations.

One of the critical inputs is to strengthen capacity through the provision of sufficient resources and developing capacities to enact, monitor and enforce the legislations. Further, there is a need to have a convergence of regulatory bodies at various levels and build strategic links and partnerships with local bodies and stakeholders.

Regulation is limited in what it can accomplish. There are no automatic formulae to ensure successful implementation. While there is a tendency to view regulation as the solution to the various problems, the limitation of legislations to address these problems must be recognized. Some problems may require much broader-scale changes such as overall organization or administrative processes being overhauled.

 

Footnotes:

1. The clinical establishments include hospitals, maternity homes, nursing homes, dispensaries, clinics (including single doctor and dental clinics), laboratories, diagnostic, therapy centres, by all recognized systems of medicine in public and private facilities.

2. S. Nandraj, Regulating Healthcare Establishments: The Case of the Clinical Establishment Act, 2010, in Samiran Nundy, Keshav Desiraju and Sanjay Nagral (eds.), Healers or Predators? Healthcare Corruption in India. Oxford University Press, Delhi, 2018.

3. Department-Related Parliamentary Standing Committee on Health and Family Welfare, 92nd Report on the Functioning of the Medical Council of India (MCI). Presented to the Rajya Sabha on 8 March 2016.

4. Hemali Chhapia, Times of India, 15 September 2017, https://timesofindia.indiatimes. com/city/mumbai/sc-strips-indian-nursing-council-of-power-to-grant-colleges-recognition/articleshow/60521801.cms

5. Rahul Tripathi, The Indian Express, 22 February 2017, https://indianexpress.com/article/india/cbi-files-fir-against-dental-council-chief-4537229/

6. Department-Related Parliamentary Standing Committee on Health and Family Welfare, 59th Report on the Functioning of the Central Drugs Standard Control Organization (CDSCO). Presented to the Rajya Sabha on 8 May 2012.

7. Aayushi Pratap, Hindustan Times, 12 November 2018, https://www.hindustantimes. com/mumbai-news/23-years-on-maharashtra-medical-council-solves-only-47-of-1-245cases/story-tvCpgMYqxcv8NKYDN5lEaP.html

8. S. Nandraj, ‘Unregulated and Unaccountable: Private Health Providers’, Economic and Political Weekly, 28 January 2012.