New Delhi: Reducing compliance burden, the Union Ministry of Health and Family Welfare notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, replacing criminal penalties for procedural lapses with a fair administrative mechanism, an official said on Thursday.
The reforms are aimed at promoting trust-based governance, 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 official said in a statement.
The Union Ministry notified the amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, on June 22 in pursuance of the Jan Vishwas (Amendment of Provisions) Act, 2026, which was published in the Official Gazette on April 8, 2026.
The Clinical Establishments (Registration and Regulation) Act governs the registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities.
The notification implements the recommendations of the high-level committee on regulatory reforms and underscores the Union government’s commitment to fostering a transparent, efficient and citizen-centric regulatory framework, the statement said.
“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,” it added.
The Jan Vishwas (Amendment of Provisions) Act, 2026, rationalises provisions across 79 Central Acts administered by 23 Ministries and Departments.
In the health sector, 35 provisions across five Acts under the Ministry of Health and Family Welfare have been amended to decriminalise minor procedural non-compliances and strengthen citizen-centric regulatory practices, the statement said.
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.
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, the system said.
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, it added.
The adjudicating authority mechanism under Section 41 has also been strengthened and its scope expanded to cover proceedings under Sections 40, 43 and 44, thereby facilitating transparent, efficient and accountable enforcement.
“The amendments also provide for a structured adjudication process, including an opportunity of hearing before the imposition of penalties, mechanisms for recovery of penalties, and an appeal framework for aggrieved parties,” the statement said.
“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,” it added.
(IANS)
