Private sector is the predominant provider of health care in India but is poorly regulated6,7 . As different states expand access to health care to achieve Universal health coverage, the role of private sector as complementary to public health needs to be recognized. They have a critical role in filling gaps in health care especially in the secondary and tertiary care level. Their partnership in implementation of key public health initiatives is also important, hence a balance has to be maintained and both over and under-regulation should be avoided. The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities and services. This has not been adopted by all states. Some states have their own medical establishment act, which is applicable in some instances only for private (Karnataka) or both public and Private facilities (Kerala).

Even before the Clinical Establishment Act 20108 was approved nationally, Karnataka a southern state in India, had a legal mechanism for private medical establishments (PMEs). It had enacted the Nursing Homes act in 1976 but had not implemented it. Following the recommendations of the taskforce (2001)9 on the health sector and the Chikungunya/Dengue outbreak in 2006 when the Government realized the need for mobilising private sector for health, the Karnataka state government repealed the old Nursing Homes Act and enacted the Karnataka Private Medical establishment act (KPME) in 200710 . The act mandates registration prescribes minimum standards and imposes certain obligations on all types of private health care facilities. The act underwent minor changes in terms of the composition of the KPMEA district registration authority in 2010 and 2012 (Fig 1). Significant revisions were made in KPMEA in 2017 after tough negotiations with private hospitals and medical professional associations. This case study gives an overview of the amendment process of the KPMEA 2017 and stakeholder analysis and participation in the policy reform process which brings out important learnings for future reforms in health sector.