Holding Healthcare Providers Accountable: Regulation of Healthcare Facilities
Healthcare facilities in India are regulated, among other approaches, through minimum standards legislation enacted by various states between the 1940s and the 2000s. These are laws that require facilities to be licensed, and which make licensing conditional on compliance with certain minimum standards. These laws traditionally focus on regulating the burgeoning private healthcare industry and often exclude government run facilities from their scope.
Dissatisfaction with these laws and their poor enforcement led to calls for a better legal regime. Consequently, Parliament enacted the Clinical Establishments (Registration and Regulation) Act, 2010 (CEA 2010), which provided a common regulatory structure and applied to government and private facilities. However, since facilities regulation is constitutionally within the exclusive competence of the states, the CEA 2010 applies directly only to Union Territories (with the exception of Delhi, which has its own legislative assembly) and to twelve states which have consented to its application. The remaining states have either continued with their pre-existing legislative frameworks, updated their legislation in line with the CEA 2010, or diverged from the CEA 2010 in significant ways.
There has emerged in recent years a sense that the CEA 2010 did not solve the issues with minimum standards legislation, with a 2021 NITI Aayog Report observing that it still remains to be seen whether the CEA 2010 will be more effective than the statutes that preceded it. Enforcement has continued to be unsatisfactory in various states that have adopted it. The Act also has various gaps, like the absence of grievance redressal systems, that prevent it from being an effective and patient-centric healthcare regulation.
Using a combination of desk research, legislative analysis, and data collection from authorities, this report examines minimum standards regulation for healthcare facilities in India. We provide a comparative legislative analysis of regulatory structure, the registration process, inspections, enforcement actions, appeals, and grievance redressal. This analysis is supplemented with some limited data obtained from the relevant statutory authorities in every state.
In territories where the CEA 2010 applies, we found several issues with implementation and enforcement; for instance: (a) the registration of clinical establishments is sporadic and uneven; (b) only one district authority stated that an application for permanent registration had been disallowed – raising the question of how stringently applications are being reviewed and compliance is being monitored; (c) based on data received from regulators, inspection and inquiries by authorities appear to be infrequent, with rare exceptions; and (d) the minimum standards for being granted permanent registration are yet to be notified. An analysis of the Act alongside the data on implementation, reveals an appellate mechanism (against decisions of regulators) that is underdeveloped and underutilised. Additionally, grievance redressal systems for patients are makeshift at best and non-existent at worst.
The central government has made efforts to persuade all states to adopt the CEA 2010 or enact similar laws. However, seventeen territories have not adopted the CEA 2010, and instead have their own laws in place. We do note, however, that several state laws enacted after the CEA 2010 include both private and public institutions within their scope, marking a departure from the pre-CEA 2010 laws that generally excluded government establishments from their application. In most states, registration of healthcare establishments takes place at the district level. Most of these laws prescribe clear minimum standards. Most of the laws permit inspection without notice and do not require regular inspections. Only two states mandate the publication of inspection records. More than half of the laws provide for some form of grievance redressal or complaints mechanism for patients. Fewer than half of the laws envision a structured suspension or shut-down protocol by providing for what happens to inpatients when a facility’s registration is cancelled. Ten states provide for imprisonment as a penalty, whereas seven do not. Every law permits facilities to appeal a denial of registration, but our data suggests that this mechanism is used very rarely.
Our data collection exercise suggests that either the maintenance of records or the actual implementation of facilities regulation statutes throughout the country is haphazard. In many cases, we found that states did not have or could not provide basic data regarding the enforcement of facilities regulation. Our legislative analysis suggests that the CEA 2010 has various lacunae which prevent it from being a patient-centric facilities regulation statute. As it stands, some states might benefit more from amending their existing laws and applying them to government facilities than from adopting the CEA 2010. There is a consensus that facilities regulation in India has not been particularly effective. However, further research is necessary to evaluate the relativeeffectiveness of different facilities regulation regimes. We hope this report is a helpful starting point, as well as a useful resource for policymakers, activists, academics, and others engaged in trying to understand and improve healthcare facilities regulation in India.