The Union Ministry of Health and Family Welfare has notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, effective from June 22, 2026, following changes introduced under the Jan Vishwas (Amendment of Provisions) Act, 2026.
The Clinical Establishments Act, 2010 governs the registration and regulation of clinical establishments across India. The Jan Vishwas Act, 2026, which was published in the Official Gazette on April 8, 2026, amends certain enactments to decriminalise and rationalise offences to strengthen trust-based governance and improve ease of living and doing business.
As part of the Jan Vishwas reforms, five provisions of the Clinical Establishments Act, 2010 were rationalised.
In a statement released on Thursday, the ministry said 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 Act has introduced reforms across 79 Central Acts managed by 23 ministries and departments. Within the health sector, 35 provisions across five Acts under the Ministry of Health and Family Welfare have been amended to decriminalize minor procedural non-compliances and strengthen citizen-centric regulatory practices.
“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,” 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 also been amended to introduce graded and proportionate penalties for contraventions committed by companies, ensuring that enforcement action is aligned with the nature and severity of the violation.
In addition, the adjudicating authority mechanism under Section 41 has been strengthened and its scope expanded to cover proceedings under Sections 40, 43 and 44, enabling more transparent, efficient and accountable enforcement.
The amendments also establish a structured adjudication process, including:
• An opportunity for establishments to be heard before penalties are imposed
• Mechanisms for recovery of penalties
• 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 notification implements recommendations of the High-Level Committee on Regulatory Reforms and reflects the government’s commitment to creating 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 added.
Sections 40, 43 and 46 of the Clinical Establishments Act
40. Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere, be punishable for the first offence with fine which may extend to ten thousand rupees, for any second offence with fine which may extend to fifty thousand rupees and for any subsequent offence with fine which may extend to five lakh rupees.
43. Whoever contravenes any provision of this Act or any rule made thereunder resulting in deficiencies that do not pose any imminent danger to the health and safety of any patient and can be rectified within a reasonable time, shall be punishable with fine which may extend to ten thousand rupees.
46. Whoever fails to pay the fine, the State Council of clinical establishment may prepare a certificate signed by an officer authorised by it specifying the fine due from such person and send it to the Collector of the District in which such person owns any property or resides or carries on his business and the said Collector, on receipt of such certificate, shall proceed to recover from such person the amount specified thereunder, as if it were an arrear of land revenue.
