Health regulation reform: The Health Ministry has made two very different regulatory moves. One eases punishment for some lapses under the Clinical Establishments Act. The other tightens control over cell and gene therapies under the Drugs Rules, 1945.
Both moves can be defended. Small clinics should not be dragged through criminal courts for minor procedural breaches. Patients should not be exposed to stem cell cures, gene therapies or xenografts without serious central scrutiny.
But both reforms must pass a harder test than administrative tidiness. Do they make care safer, standards clearer, enforcement fairer and treatment less unequal? If not, Jan Vishwas will mean comfort for providers, and advanced therapy regulation will mean faster commercialisation for firms already rich enough to comply.
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Health regulation reform: Jan Vishwas health reforms and patient safety
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 Health Ministry have been amended to decriminalise minor procedural non-compliance.
For the Clinical Establishments Act, five provisions have been rationalised. Sections 40, 43 and 46 now replace “fine” with “penalty”. Section 44 introduces graded penalties for contraventions by companies. Section 41 strengthens the adjudicating authority mechanism, extends it to proceedings under Sections 40, 43 and 44, and provides for hearings, recovery of penalties and appeals.
This is a shift from criminal prosecution to administrative adjudication. For small clinics and nursing homes, that can reduce court cases and compliance anxiety. It can also allow enforcement staff to focus on violations that cause harm to patients rather than minor documentation lapses.
But decriminalisation does not automatically strengthen public health regulation. It moves power from courts to administrative authorities. That makes published procedures, reasoned orders, accessible appeals and protection against selective enforcement more important, not less.
The phrase “trust-based governance” may help smaller establishments that struggle with paperwork. It can also become a cover for weaker oversight if Health Ministry rules and state enforcement practice favour ease of doing business over patient protection. The question is not whether a sanction is criminal or civil. The question is whether the sanction changes behaviour in hospitals, clinics and diagnostic centres.
A large hospital chain may treat a civil penalty as a cost of doing business. A small provider may face ruin if enforcement is inconsistent. If the same breach draws different treatment in different states or districts, administrative penalties will not be proportionate in practice.
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Clinical Establishments Act needs inspection capacity
The government says patient safety and quality remain protected. That assurance depends on inspection systems, public reporting and enforceable standards. Without those, administrative rationalisation can soften oversight while appearing to modernise it.
The reform is therefore best read as a move from punitive legality to managerial regulation. That can work if the state uses discretion to identify repeated violations, unsafe facilities and false compliance. It will fail if discretion merely lowers the cost of non-compliance.
The Clinical Establishments Act already sits in a difficult regulatory space. India has a wide range of providers, from large corporate hospitals to small clinics and semi-formal facilities. Many patients depend on under-resourced providers because they have no practical alternative. Regulation in such a system has to protect patients without shutting down access. That requires steady inspection, clear standards and fair enforcement. It cannot be achieved by changing the word “fine” to “penalty”.
Cell and gene therapy regulation under CLAA
The Drugs Rules amendment raises a different problem. Cell or stem cell-derived products, gene therapeutic products and xenografts have now been brought under the CLAA framework. These include stem cell-based regenerative treatments, CAR-T therapies for some blood cancers, gene replacement and gene-editing products, and animal-tissue-derived products such as xenografts used in cardiology and orthopaedics.
These products are not ordinary medicines. They involve biological material, donor screening, manufacturing controls, traceability, storage conditions and long-term safety monitoring. A contaminated or poorly characterised product can cause serious harm. A therapy sold without evidence can drain household savings while offering little benefit.
Central oversight can reduce fragmentation between states and make approval standards more uniform. It can also help identify unproven stem cell and gene therapy claims that have flourished in poorly supervised markets. This is the strongest public health case for the amendment.
The weakness lies elsewhere. Licensing cannot substitute for inspection capacity, accredited laboratories, ethics review, pharmacovigilance and post-market surveillance. A central licence means little if the regulator cannot inspect manufacturing sites, verify data, monitor adverse events or act against misleading claims after approval.
Cell and gene therapy rules need GMP, GCP and GLP
India has basic regulatory structures for Good Manufacturing Practice, Good Clinical Practice and Good Laboratory Practice. The harder task is routine implementation. Cell and gene therapies require stricter manufacturing discipline than many conventional products. Facility design, aseptic processing, validated analytics, cold chains, batch release and chain-of-custody records are not optional details.
Indian GCP rests on ICMR and CDSCO guidance on ethics review, informed consent and trial oversight. Larger trial sites and contract research organisations can meet international expectations. Many investigator-led trials and public-hospital studies still struggle with monitoring, data systems and trained research staff.
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The same pattern appears in manufacturing and testing. Some public institutions and private laboratories have credible capacity. Many smaller manufacturers will find advanced therapy production standards difficult without investment in clean-room facilities, analytics, quality assurance and trained personnel. GLP systems exist, but electronic data integrity, non-clinical study quality and independent quality units remain uneven outside well-funded centres.
The amendment will expose these gaps. Advanced therapies need donor screening, traceability, adverse-event monitoring and transparent evidence standards, especially where treatment costs are high and patients have few alternatives. Rules should also deal directly with exaggerated claims by stem cell and gene therapy clinics. Promotional material can harm patients as much as defective manufacturing when it sells hope without evidence.
Public investment will decide who benefits
Advanced therapies are capital-intensive. Firms with research depth, manufacturing facilities and regulatory teams will move first. A centralised licensing framework may reduce confusion and speed commercialisation, but it will not by itself correct unequal market power or limited access.
Public hospitals and research institutions may struggle to meet the same standards as well-funded private providers. Their constraints are familiar: weaker infrastructure, slow procurement, limited regulatory staff and uneven research support. If compliance costs rise without public investment, India may get a two-tier market in which innovation is available mainly in private urban hospitals.
This risk is not theoretical. Out-of-pocket spending already shapes access to advanced cancer care and rare disease treatment. If the state only certifies products that private hospitals can deliver, it will lend public authority to therapies that most patients cannot afford.
Public-sector capacity is therefore part of regulation, not an optional welfare add-on. India needs public GMP-compliant facilities, clinical trial networks, biobanks, testing laboratories, adverse-event systems and translational research support. Procurement, reimbursement and pricing policy should also decide whether approved therapies reach beyond affluent patients.
Private participation can serve public health if the rules curb false claims, improve safety and expand access through public institutions. If the reforms mainly shorten the path to private commercialisation, the legal framework will look cleaner while the gains remain narrow.
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Dr Joe Thomas is Global Public Health Chair at Sustainable Policy Solutions Foundation, a policy think tank based in New Delhi. He is also Professor of Public Health at Institute of Health and Management, Victoria, Australia. Dr Thomas was the founding Secretary General of the Global Commission on Ageing in developing countries. He is an author of reports from seven PPD member countries documenting the ageing situation, health and well-being, and policies to enable and support environments.