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The Power Players of Indian Healthcare: Who Regulates, Accredits and Funds Hospitals

By Updated 9 min read

Quick answer

Who regulates healthcare in India?

Health is a state subject under the Constitution, so state governments license and inspect hospitals, while central bodies regulate specific areas:

  • State health departments: hospital registration and licensing
  • National Medical Commission: medical education and doctors’ professional conduct
  • CDSCO: drugs, medical devices and clinical trials
  • National Health Authority: the Ayushman Bharat PM-JAY insurance scheme and digital health mission
  • NABH, under the Quality Council of India: voluntary hospital accreditation
Illustration of a doctor surrounded by hospital, medical record and equipment icons
In this article (9 sections)
  1. How healthcare regulation is split in India
  2. Government ministries and regulators
  3. Accreditation and quality bodies
  4. Licences and laws every hospital deals with
  5. Government health schemes hospitals take part in
  6. Industry and professional associations
  7. How hospitals show they are improving
  8. Keeping up with changes
  9. Frequently Asked Questions

Running a hospital in India means answering to a long list of authorities: the state health department for the licence, the pollution control board for biomedical waste, the fire service, the radiation regulator and, if you choose them, accreditation bodies and government insurance schemes. This guide maps who does what, so administrators, quality managers and anyone setting up a hospital know which body handles which part of the job. Each section links to the official site and to our detailed guides.

How healthcare regulation is split in India

Under the Constitution, “public health and sanitation; hospitals and dispensaries” is a state subject. That is why hospital registration, inspections and most operating licences come from state or district authorities, and why the rules differ from state to state.

Parliament still legislates on subjects such as drugs and the medical profession, which are on the Concurrent List, and the central government runs national schemes and programmes. Accreditation sits outside both: it is voluntary, run by independent boards and assessed against published standards.

In practice, a hospital deals with three kinds of body:

  • State and district authorities for registration and operating licences.
  • Central regulators and agencies for drugs, devices, medical education, radiation safety and national schemes.
  • Accreditation and quality bodies for voluntary standards such as NABH.

Government ministries and regulators

  • Ministry of Health and Family Welfare (MoHFW): sets national health policy and runs central health schemes and programmes. Its technical wing, the Directorate General of Health Services (DGHS), advises on medical and public health matters.
  • National Medical Commission (NMC): regulates medical education and the professional conduct of doctors. It replaced the Medical Council of India in September 2020. Doctors you employ need a valid registration with a state medical council or the NMC.
  • Indian Nursing Council (INC): the statutory body for nursing education standards, under the Indian Nursing Council Act, 1947. Nurses register with their state nursing council.
  • Central Drugs Standard Control Organisation (CDSCO): the national regulator for drugs, medical devices and clinical trials, headed by the Drugs Controller General of India. State drug controllers license pharmacies, and blood centres need approval from both.
  • National Health Authority (NHA): runs Ayushman Bharat PM-JAY, the government health insurance scheme, and the Ayushman Bharat Digital Mission (ABDM). Hospitals join PM-JAY through their State Health Agency; see our guide to PM-JAY empanelment.
  • Atomic Energy Regulatory Board (AERB): licenses X-ray, CT, cath lab, nuclear medicine and radiotherapy equipment and sets radiation safety rules. See our AERB guidelines for hospitals.
  • State pollution control boards: grant the authorisation hospitals need under the Bio-Medical Waste Management Rules, 2016. See our biomedical waste management guide.
  • Ministry of Ayush: oversees Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy. It matters if you offer Ayush services, and NABH has separate standards for Ayush hospitals.
  • Indian Council of Medical Research (ICMR): the apex body for biomedical research, which publishes the national ethical guidelines for research involving people. It matters if your hospital runs clinical research or an ethics committee.

Accreditation and quality bodies

Accreditation is voluntary, but it is the clearest way for a hospital to show that it meets a recognised standard.

  • Quality Council of India (QCI): the national quality body set up by the Government of India with industry. Its constituent boards include NABH, NABL and NABCB.
  • NABH (National Accreditation Board for Hospitals & Healthcare Providers): accredits hospitals, small healthcare organisations, blood banks, and eye care, dental, medical imaging and Ayush providers, among others. It also certifies entry-level hospitals, nursing excellence, emergency departments, stroke centres and medical laboratories, and runs empanelment for CGHS and ECHS. The current hospital standards are the 6th edition, effective 1 January 2025, with 639 objective elements. Start with our guides to the NABH accreditation process, the 6th edition standards and entry-level certification.
  • NABL (National Accreditation Board for Testing and Calibration Laboratories): accredits laboratories, including medical laboratories against ISO 15189. See our NABL audit checklist.
  • NABCB (National Accreditation Board for Certification Bodies): accredits the certification bodies that issue ISO 9001 and similar management system certificates.
  • Joint Commission International (JCI): an international accreditation that some Indian hospitals hold alongside or instead of NABH. See our guide to JCI standards.
  • NQAS, Kayakalp and LaQshya: the government’s quality programmes for public health facilities, run with the National Health Systems Resource Centre (NHSRC). NQAS certifies facilities against national quality standards, Kayakalp rewards cleanliness, hygiene and infection control, and LaQshya covers labour rooms and maternity operation theatres. See our guides to the NQAS checklist and Kayakalp guidelines.
  • CAHO (Consortium of Accredited Healthcare Organizations): a common platform for NABH- and NABL-accredited organisations that runs training workshops and conferences.

Licences and laws every hospital deals with

Most of these are granted by state or district authorities, so check your state’s current rules and forms. Our list of hospital licences required in India covers the documents and steps.

RequirementWho grants or enforces it
Hospital registrationState or district health authorities, under the Clinical Establishments Act, 2010 (adopted by 19 states and union territories, according to the Ministry’s portal) or the state’s own law
Biomedical waste authorisationState pollution control board, under the Bio-Medical Waste Management Rules, 2016
Fire safety certificate (NOC)State fire service, under the state’s fire safety rules, which usually refer to the National Building Code (BIS replaced NBC 2016 with the National Building Construction Standards 2026 in April 2026); see our NBC standards guide
X-ray, CT and other radiation equipmentAERB licence, under the Atomic Energy (Radiation Protection) Rules, 2004
Ultrasound and prenatal diagnosticsRegistration with the district appropriate authority, under the PC&PNDT Act, 1994
In-house pharmacyDrug licence from the state drugs control department, under the Drugs and Cosmetics Act, 1940
Blood centreLicence from the state licensing authority, approved by CDSCO
Organ transplantsRegistration with the appropriate authority, under the Transplantation of Human Organs and Tissues Act, 1994
Medical termination of pregnancyApproval of the facility by the district-level committee, under the MTP Act, 1971
Mental health servicesRegistration with the State Mental Health Authority, under the Mental Healthcare Act, 2017
Patient dataData Protection Board of India, under the Digital Personal Data Protection Act, 2023 (rules notified in November 2025; most obligations apply from May 2027)

India has no health-specific privacy law like the US HIPAA, so the data protection law applies to patient records as it does to other personal data. For how long to keep records, see our guide to health data retention policies in India.

Government health schemes hospitals take part in

  • Ayushman Bharat PM-JAY: eligible families get health cover of up to ₹5 lakh a year for secondary and tertiary hospital care. Since 29 October 2024 it also covers all citizens aged 70 and above, whatever their income, through the Ayushman Vay Vandana card. PM-JAY took over the older Rashtriya Swasthya Bima Yojana (RSBY) when it launched in 2018.
  • Ayushman Arogya Mandirs: primary care centres, known as Health and Wellness Centres until 2023, that form the other pillar of Ayushman Bharat.
  • Ayushman Bharat Digital Mission (ABDM): launched in September 2021 to connect health records. Patients get an ABHA health account, and hospitals and professionals can register on the Health Facility Registry and the Healthcare Professionals Registry.
  • CGHS and ECHS: health schemes for central government employees and pensioners (CGHS) and for ex-servicemen (ECHS). Private hospitals join through empanelment, which NABH administers; see our guide to the NABH portal for CGHS and ECHS.
  • National Health Mission (NHM): funds public health facilities and programmes through its rural and urban sub-missions.
  • Pradhan Mantri Swasthya Suraksha Yojana (PMSSY): sets up new AIIMS-type institutions and upgrades government medical colleges.
  • Universal Immunization Programme (UIP): provides free vaccines for children and pregnant women.

Industry and professional associations

How hospitals show they are improving

Quality standards ask hospitals to measure results as well as write policies. NABH’s 6th edition, for example, added annexures on patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs), medication errors, risk management and clinical audit. The measures most hospitals track fall into three groups:

  • Patient experience: satisfaction survey scores, Net Promoter Score, complaints and how quickly they are resolved, and OPD waiting times.
  • Clinical quality and safety: healthcare-associated infection rates, medication errors, patient falls, readmissions and mortality.
  • Efficiency: bed occupancy, average length of stay and discharge turnaround time.

Our guide to quality indicators for NABH covers the indicators in detail. For the patient experience measures, LazyMonkey’s patient feedback system for hospitals collects feedback through QR codes and discharge surveys and sends real-time alerts on critical responses.

Keeping up with changes

These rules change often. Recent changes include the NMC replacing the Medical Council of India (2020), PM-JAY extending cover to everyone aged 70 and above (2024), NABH’s 6th edition hospital standards (2025) and the Digital Personal Data Protection Act (2023, with rules notified in 2025). Before acting on any requirement, check the regulator’s official site or your state’s latest notification.

Frequently Asked Questions

Who are the major power players in Indian healthcare?

On the regulatory side, the Ministry of Health and Family Welfare, state health departments, the National Medical Commission, CDSCO and the National Health Authority. On quality, the Quality Council of India’s NABH and NABL. Among providers, government institutions such as the AIIMS and large private hospital groups such as Apollo Hospitals, Fortis Healthcare, Max Healthcare and Narayana Health.

Does the Medical Council of India still exist?

No. The National Medical Commission replaced it on 25 September 2020, under the National Medical Commission Act, 2019.

Who gives a hospital its licence in India?

The state government. Depending on the state, registration is under the Clinical Establishments Act, 2010 or the state’s own law, and separate approvals are needed for fire safety, biomedical waste, radiation equipment and the pharmacy.

Is NABH accreditation mandatory?

No, it is voluntary. NABH also runs the empanelment process for CGHS and ECHS, and offers entry-level certification for hospitals that are not yet ready for full accreditation.

Does India have a health data privacy law like HIPAA?

Not a health-specific one. Patient data held digitally is covered by the Digital Personal Data Protection Act, 2023. Its rules were notified in November 2025, and most obligations apply from May 2027.

What replaced the Rashtriya Swasthya Bima Yojana?

Ayushman Bharat PM-JAY, launched in 2018, took over RSBY. It provides cover of up to ₹5 lakh per family per year for hospital care.

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Filed under Hospital Quality & Compliance · First published

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