Jan Vishwas Bill to Transform Health Sector with Penalty Reforms

As per the provisions of the Bill, 784 provisions across 79 Central Acts administered by 23 Ministries have been amended.​

Within the health sector, the amendments span key legislations including the Drugs and Cosmetics Act, 1940; the Pharmacy Act, 1948; the Food Safety and Standards Act; the Clinical Establishments (Registration and Regulation) Act, 2010; and the National Commission for Allied and Healthcare Professions Act, 2021, said a statement.​

These reforms align with the broader objective of simplifying compliance while maintaining robust safeguards for public health, it said.​

A central feature of these reforms is the replacement of criminal penalties, particularly imprisonment for minor procedural violations, with graded monetary penalties.​

This marks a shift towards a more facilitative regulatory framework while retaining strict action for serious violations affecting public health and safety.​

Under the Drugs and Cosmetics Act, 1940, several provisions have been amended to substitute imprisonment with financial penalties and to introduce a structured adjudication mechanism, the statement said.​

Notably, an adjudication mechanism has been introduced for violations under Section 27A(ii) and Section 28A. This ensures that minor cosmetic violations (other than spurious or adulterated products) will not require court intervention and can instead be addressed through a civil penalty framework.​

Further, violations such as non-maintenance of documents or non-submission of information, which were earlier punishable through court-imposed fines or imprisonment, can now be adjudicated through this civil penalty mechanism.​

For the first time, the legislation provides for the appointment of adjudicating authorities by the Central Government and State Governments, along with a defined process that includes the issuance of show-cause notices, provision for personal hearings, and an appellate mechanism.​

This reform will significantly reduce the burden on courts, minimise layers of litigation, and enable faster resolution of minor compliance issues, said the statement.​

It will particularly benefit the cosmetics industry by enabling structured, predictable handling of minor infringements, including procedural lapses such as failure to maintain statutory records or documents, thereby freeing them from prolonged litigation.​

Similarly, amendments to the Pharmacy Act, 1948, aim to modernise penalty provisions and enhance accountability through increased financial penalties for non-compliance. The reforms also ensure alignment with updated legal frameworks, it said.​

Under the Food Safety and Standards Act, 2006, provisions have been streamlined to strengthen enforcement while ensuring that penalties are proportionate to the nature of the offence. This supports a balanced approach between regulatory oversight and ease of compliance.​

The Clinical Establishments (Registration and Regulation) Act, 2010, has been updated to emphasise monetary penalties for non-compliance, particularly in cases where deficiencies do not pose immediate risks to patient safety. This encourages corrective action without resorting to criminal proceedings, the statement said.​

Further, the National Commission for Allied and Healthcare Professions Act, 2021, has been strengthened to ensure compliance with professional standards and regulatory requirements, with penalties designed to deter violations while maintaining proportionality.​

The alignment of these reforms across multiple health-related legislations reflects a coherent policy approach aimed at harmonising regulatory frameworks, it said.​

By standardising the shift from criminal penalties to civil penalties and introducing adjudication mechanisms, the amendments ensure consistency, predictability, and proportionality in enforcement. ​

This alignment reduces regulatory fragmentation, simplifies compliance requirements, and provides clarity to stakeholders operating across different segments of the health sector.​

- IANS