Clinical Establishments Act: Centre replaces criminal penalties with administrative adjudication

The Union Health Ministry has notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, replacing criminal penalties for certain procedural violations with an administrative adjudication mechanism as part of the Jan Vishwas reforms.

The amendments, notified on June 22, operationalise provisions of the Jan Vishwas (Amendment of Provisions) Act, 2026, which seeks to decriminalise minor procedural non-compliances across multiple central laws and promote trust-based governance.

The Jan Vishwas law, published in April this year, and aimed at reducing compliance burden and improving ease of doing business, amends provisions across 79 Central Acts administered by 23 ministries and departments. In the health sector, 35 provisions spread across five laws under the Ministry of Health and Family Welfare have been modified, a statement by the ministry said.

Under the amended framework, the term “fine” has been replaced with “penalty” in Sections 40, 43 and 46 of the Act, 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, the statement said.

Further, the adjudicating authority mechanism under Section 41 has been strengthened and its scope expanded to cover proceedings under sections 40, 43 and 44, facilitating transparent, efficient and accountable enforcement, it stated.

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-compliances, while maintaining regulatory oversight over clinical establishments,” the statement said.

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 ministry said.