Background: . Implementation of healthcare regulatory policies, especially in low- and middle-income countries where the private health sector is predominant, is challenging. Karnataka, a southern state in India, enacted the Karnataka Private Medical Establishments Act (KPMEA) with an aim to ensure quality of care in the private healthcare establishments. After more than a decade the implementation of KPMEA is suboptimal.
Methods: . We used a case study design. The case was 'implementation of KPMEA'. The case study site was Bengaluru Urban district in Karnataka. Data from key informant interviews, focus group discussions held at the state, district and subdistrict levels and key policy documents, minutes of the meetings, data from the State Department of Health and Family Welfare, district level KPMEA data and litigations at the High Court of Karnataka were analysed using a framework.
Results: . The policy (KPMEA) content is inadequate and requires clarity in certain provisions of the Act. There was a lack of coordination between the implementing agencies. Workforce shortages were evident. Factors that impede the enforcement of the Act include poor knowledge and lack of competency of the officials on the content and the implementation mechanics of the policy, insufficient policy oversight from the state on the districts, corruption, political interference and lack of support from the local public, especially during raids on illegal establishments.
Conclusions: . A regulatory policy such as KPMEA needs a clear, comprehensive content and directions for operationalization. However, improving the content of the policy is not easy as some aspects of the policy remain contentious with the private healthcare providers/ establishments. Addressing health governance issues at all levels is key to effective enforcement.