Health regulation is critical to define and maintain standards, strengthen accountability, provide social and financial risk protection, assure good clinical outcomes and increase transparency in a country’s health care system. Regulation may be understood as government control over activities of individuals or organisations, and more specifically as government action to manipulate variables such as prices, quantities, distribution, and quality of products or services to achieve desired outcome. India’s diverse and mixed health care system is governed by a multitude of regulations on the one hand while on the other, certain vital areas remain unregulated. We undertook a desk review of the existing regulatory instruments in India to describe the landscape of health regulation in the country, at the Central government level, specifically related to health care delivery. Using a framework of analysis we examined the regulations for different cadres of practitioners, in-patient health facilities, outreach services, supportive services, professional actions, illnesses and diseases, and outbreaks, epidemics and pandemics. The focus was on examining the regulation of entry/licensing, quality, quantity, pricing and cost containment, patient safety, information provision and grievance redressal. In this blog we share some of our learnings from the study and highlight key concerns with regard to the regulation of health care delivery in India.
Conflict, overlap and conflation between different laws and regulatory agencies: Design level flaws and conflation between different Acts seem to be contributing to poor regulation of some aspects. For instance, the presence of multiple regulatory agencies (e.g., inspection of pharmacies by inspectors under the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948) and the need for dual licensing from both the State and Central licensing authorities (e.g., in the case of blood banks) pose a challenge for service providers and make the regulatory process cumbersome and unclear. Jurisdictional disagreement and confusion in the roles of the Central and State regulatory bodies has led to the proliferation of several medical, dental and nursing educational institutions with inadequate infrastructure and staff. For instance, in the state of Uttar Pradesh though the Indian Nursing Council withheld the recognition of government nursing schools because their teaching staff did not have the required training, the State Nursing Council continued to recognise those schools. Access of adolescent girls to legal abortion services under the Medical Termination of Pregnancy Act, 1971 has come into conflict with the Protection of Children from Sexual Offences (POCSO) Act, 2012, a legislation to protect people below 18 years of age from sexual offences. Pregnancy of an under-18 girl is treated as a sexual offence under the POCSO Act, 2012, requiring mandatory reporting to the police. Such mandatory reporting is in conflict with the provisions of confidentiality under the MTP Act, 1971 and deters doctors from providing and adolescent girls from seeking legal abortion services.
Poor implementation of laws: Healthcare providers in India are regulated by central and state statutes such as the Clinical Establishments Regulations, Drugs and Cosmetics Act, 1940, Shops and Establishments Acts, Consumer Protection Act, 2019, Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 etc. Additionally, there is voluntary and legally mandated self-regulation by peers through accreditation bodies and professional councils/commissions respectively. However, weak regulation by the statutory professional councils, inherent conflict of interest of their members and inability of the councils to fulfil their mandated responsibilities have led to poor regulation of health care providers. In the last couple of years, three new laws have replaced the earlier laws to regulate the education and practice of doctors of allopathy and Indian systems of medicine. The draft laws to replace existing legislation regulating dentists and nurses are under consideration. It remains to be seen whether the change in laws will lead to better regulation of the providers.
Another reason for weak implementation of laws is delay in the notification of rules and regulations, and lack of budget, human resources and the required infrastructure. For instance, delay in the notification of the minimum standards for distinct categories of mental health establishments and regulations with respect to the making of advance directive, for implementation of the Mental Healthcare Act, 2017. Though the HIV/AIDS (Prevention and Control) Act, 2017 grants the right to anti-retroviral therapy (ART) to the affected persons, there are only 528 ART centres nationally for 2.3 million HIV positive persons, which makes accessibility a challenge.
Outdated legislation: Until the Clinical Establishments Act, 2010 came into being, unlike most other business establishments such as shops and beauty parlors that need a license to operate, health facilities did not require registration or a license to operate in many States. States’ laws in this regard were outdated, inadequate in content and coverage, with no formulation of rules and byelaws, and no prescribed minimum standards. While some states have updated their legislation since then, some continue to have ones whose scope is limited to the hospitals and nursing homes providing allopathy care, leaving laboratories, diagnostic centres, clinics run by single doctors and dentists, clinical establishments from other recognised systems of medicine and government establishments out of their purview. In some cases, penalties for non-compliance are minimal, to the extent of being ineffective.
Some other examples where legislation has not kept pace with the changing times and needs is the regulation of sale of drugs through online pharmacies and management of epidemics and pandemics. The draft Drugs and Cosmetics (Amendment) Rules, 2018 were formulated under the Drugs and Cosmetics Act, 1940 to regulate online-pharmacies but not notified. The Epidemic Diseases Act, 1897, enacted 124 years ago and invoked during the COVID-19 pandemic is outdated and ill-equipped to respond to outbreaks and epidemics in the 21st century.
Absence of legislation: Amidst the plethora of laws, there are no legislative mechanisms in India for regulating the cost of health care services/procedures, conducting clinical and social audits, and ensuring patients’ rights. Additionally, legislation to regulate the quantity and distribution of practitioners, health facilities, laboratories, blood banks, ambulances, pharmacies, according to the population, geography and need for health care services is lacking, leading to skewed distribution of services between urban and rural areas, as well as regional disparities.
At a webinar organised to release the study report, some participants were of the opinion that voluntary self-regulation and market-led regulation are important regulatory mechanisms apart from the ones established by law. They observed that self-regulation by voluntarily seeking accreditation from bodies such as the National Accreditation Board for Hospitals & Health care Providers (NABH) as a mark of quality, and the market-led regulation that comes from competition among providers help in improving the quality of health care services. While stressing on the need to focus on ethical practice, and quality and cost of care, they cautioned against over-regulation that could harass providers, promote corruption, and consequently affect health care services adversely. The participants reflected upon the differential regulation of the public and private health care sector in India with the private sector perceived to be subjected to more stringent regulation than the public sector – an argument that the private sector often uses in its defence and to oppose regulation. This is an ongoing debate in the country. A viewpoint expressed was that while law by itself does not solve all the problems, it definitely provides the people an avenue to demand services from the government and hold it accountable to protect and promote public health.
Going forward, we feel there is need to develop a cohesive ecosystem for health regulation that has equal representation from the government, regulatory bodies, professional associations, civil society, and the private sector, particularly to set realistic expectations. It is important to gauge the capacity of regulatory bodies that are established at the district and state levels to implement health legislation and strengthen them so that they can perform their regulatory roles as envisaged. Laws that are outdated or overlap/in conflict with each other need to be reviewed and amended for appropriateness, consistency and clarity while ensuring ease of access to services. Building accountability mechanisms among regulators, providers and healthcare users, prioritising the publication of information and health data in the public domain, and facilitating strong patient/consumer institutions and redressal platforms would help in strengthening the regulation of healthcare delivery in India.
ABOUT THE AUTHORS
Pallavi is a Specialist at Health Systems Governance, Health Systems Transformation Platform, New Delhi, India. She can be reached at firstname.lastname@example.org.
Sonali is a Research Associate at Health Systems Governance, Health Systems Transformation Platform, New Delhi, India. She can be reached at email@example.com.
Sunil is an Advisor to Health Systems Governance, Health Systems Transformation Platform, New Delhi, India. He can be reached at firstname.lastname@example.org.