The Union Ministry of Health and Family Welfare has notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, under the Jan Vishwas (Amendment of Provisions) Act, 2026, with an aim to reduce the compliance burden, promote trust-based governance and improve the ease of doing business in the healthcare sector.
The amendments, notified on June 22, form part of the broader Jan Vishwas reforms, which rationalise provisions across 79 Central Acts administered by 23 Ministries and Departments. In the health sector, 35 provisions across five Acts have been amended to decriminalise minor procedural non-compliances while strengthening citizen-centric regulatory practices.
According to the Ministry, five provisions under the Clinical Establishments Act, 2010 have been rationalised as part of the reform process.
Under the amended framework, the term “fine” has been replaced with “penalty” in Sections 40, 43 and 46 of the Act, shifting the enforcement mechanism from criminal prosecution to administrative adjudication. Section 44 has also been amended to introduce graded and proportionate penalties for violations committed by companies, ensuring that enforcement action is aligned with the nature and severity of the contravention.
The Ministry said the adjudicating authority mechanism under Section 41 has been strengthened and expanded to cover proceedings under Sections 40, 43 and 44, enabling more transparent, efficient and accountable enforcement.
The amended provisions also introduce a structured adjudication process, including an opportunity for hearing before penalties are imposed, provisions for recovery of penalties and an appeal mechanism for aggrieved parties.
According to the Ministry, the reforms are expected to encourage voluntary compliance, reduce unnecessary litigation and ensure proportionate action in cases involving minor procedural lapses, while maintaining regulatory oversight over clinical establishments and safeguarding patient safety.
The Ministry said the amendments implement the recommendations of the High-Level Committee on Regulatory Reforms and reaffirm the government’s commitment to creating a transparent, efficient and citizen-centric regulatory framework. It added that replacing criminal penalties for procedural lapses with an administrative mechanism is expected to improve the ease of doing business in the healthcare sector while maintaining high standards of patient care, safety and accountability.
