Health Ministry amends Clinical Establishment Act, decriminalises minor procedural non-compliances, allows appeals

New Delhi: Bringing relief to hospitals, 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, decriminalising minor procedural non-compliances.

The notification, issued on June 22, 2026, brings changes to five provisions of the Clinical Establishments Act, 2010, under the Jan Vishwas reforms to reduce the compliance burden on hospitals and other clinical establishments.

According to a statement issued by the government, "The reforms are aimed at promoting trust-based governance, reducing compliance burden, improving ease of doing business, and ensuring proportionate regulatory enforcement, while continuing to safeguard patient safety and the quality of healthcare services across the country."

The Jan Vishwas (Amendment of Provisions) Act, 2026, has made changes to 79 Central Acts managed by 23 Ministries and Departments. In the health sector, it amends 35 provisions across five Acts under the Ministry of Health and Family Welfare, replacing criminal action for minor procedural lapses with a more citizen-friendly regulatory approach.

"Under the amended framework, the term “fine” has been replaced with “penalty” in Sections 40, 43 and 46 of the Act, thereby shifting the enforcement framework from criminal prosecution to administrative adjudication. Section 44 has been amended to introduce graded and proportionate penalties for contraventions committed by companies, ensuring that enforcement action is commensurate with the nature and severity of the violation. Further, the adjudicating authority mechanism under Section 41 has been strengthened and its scope expanded to cover proceedings under Sections 40, 43 and 44, thereby facilitating transparent, efficient and accountable enforcement," the statement read.

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The amendments also provide for a structured adjudication process, including an opportunity for a hearing before the imposition of penalties, mechanisms for recovery of penalties, and an appeal framework for aggrieved parties.

These measures are expected to encourage voluntary compliance, reduce unnecessary litigation, and ensure proportionate action in cases of minor procedural non-compliance, while maintaining regulatory oversight over clinical establishments.

The notification implements the recommendations of the High-Level Committee on Regulatory Reforms and underscores the Government’s commitment to fostering a transparent, efficient and citizen-centric regulatory framework.

By replacing criminal penalties for procedural lapses with a fair and balanced administrative mechanism, the reforms seek to improve the ease of doing business in the healthcare sector while preserving the highest standards of patient care, safety and accountability.

The amendments notified under the Clinical Establishments Act, 2010, form part of this broader reform initiative aimed at creating a more responsive and facilitative regulatory ecosystem.

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