LAWS RELATED TO HEALTHCARE

ESTABLISHMENT

DR PAVANKUMAR PATIL
PUBLIC RELATION OFFICER IMA KSB
VICE PRESIDENT PHANA
JT SEC IMA CGP
KMC MEMEBR
 CATAGORISATION OF LAWS

• Laws governing the commissioning of hospital

• Laws governing to the qualification/practice and conduct of professionals
• Laws governing to sale, storage of drugs and safe medication
• Laws governing management of patients
• Laws governing environment safety
• Laws governing to employment and management of manpower
• Laws governing to medicolegal aspects
• Laws governing the safety of patients, public and staff within the hospital premises
• Laws governing professional training and research
• Laws governing professional training and research
• Licences/certifications required for hospitals
• Periodic reports and return as legal commitment for hospitals
• List of courses which claim to be imparting alternative medicine knowledge but at not recognized by any statutory
medical council
 LAWS GOVERNING THE COMMISSIONING OF
HOSPITAL
1. Clinical establishment act or Nursing Home Registration Act—required for even day care
centres admitting patients
2. The Clinical Establishment (Registration and Regulation) act, 2010 is central act and each state
has to make its own similar act since health is on concurrent list in constitution of India
3. Lease/Builder/developer’s agreement for premises/ space/tenement/flat/house
4. Stamp duty payment act on agreements
5. Regional town planning act restricting commercial activities of land in residential zone
requiring change of use from local authority- for premises/space/ tenement/ flat/house
6. National Building Act 2005 for premises/space/ tenement/flat/house
7. Urban Land ceiling Act 1976 if land use is restricted as per ULCRA
8. Companies Act 1956 if operating as limited liability company, private or public limited company and not as
proprietor
9. Indian trusts act 1882 if operating as trust, foundation, charitable institute
10. Society Registration Act 1860 if operating as society
11. Indian Boilers Act 1923 for use of autoclaves
12. Radiation Protection Certificate from BARC under Atomic Energy (Radiation Protection) Rules, 2004
under Atomic Energy Act 1962for x-ray and CAT scan machines
13. Lift Act and Rules 1939 or similar act in your city for lifts, escalator, elevators
14. Indian Electricity Act and Rules 1956 and Electricity Regulatory Commission (Grant of consent for captive
power plants) Regulations for use of electricity
15. Fire Prevention and Fire Safety Act 1986, and Fire Safety Rules 16. Indian Telegraph Act 1885 for use of
phones, fax, internet, mobile phones
16. cable television networks (regulation) act, 1995 if using TV network
17. Gas Cylinder Rules 2004 for using cooking gas
18. Insecticide Act 1968 if using pesticides
19. Art and surrogacy act
 LAWS GOVERNING TO THE QUALIFICATION/PRACTICE
AND CONDUCT OF PROFESSIONALS

1. The Indian Medical Council Act 1956 apart from MBBS, Titles of seven courses of past are listed in schedule 3,
part 1 of the Indian Medical Council (IMC) Act, 1956, are listed below:
i. DMMS—Diploma in Modern Medicine and Surgery (Orissa)
ii. DMS—Diploma in Medicine and Surgery (Madras, Indore)
iii. LCPS—Licentiate of College of Physicians and Surgeons (Bombay)
iv. LMF—Licentiate of Medical Faculty
v. LMP—Licentiate Medical Practitioner
vi. LMS—Licentiate of Medicine and Surgery
vii. LSMF—Licentiate of State Medical Faculty
2. Central Council of Indian Medicine (CCIM) for ayurvedic, siddha and Tibb doctors
3. State notification allowing for ayurvedic, siddha and Tibb doctors to prescribe allopathic medicines
4. Central Council of Homoeopathy
5. State Medical Practitioners Act, or similar act applicable in city
6. State Medical council Act, 1965 , or similar act applicable in city
7. Indian Medical Council (Professional Conduct, Etiquette, and Ethics Regulations
2002)
8. Indian Medical degree Act 1916
9. Indian Nursing Council Act 1947
10. Delhi Nursing Council Act 1997, Maharashtra Nurses Act,1966 or similar acts in
cities
11. The Dentist’s Act 1948
12. The Pharmacy Act 1948
 L AW S G O V E R N I N G TO SA L E , S TO R A G E O F D R U G S A N D S A F E M E D I C AT I O N

1. Central Excise Act 1944—to store the spirit,

2. Blood Bank Regulation Under Drugs and Cosmetics (2nd Amendment) Rules 1999 for blood bank,
blood storage facilities For manufacture, storage, sales and distribution, dispensing of drugs—
Drugs and Cosmetics Act and rules + Pharmacy Act + Sales of Good Act 1930+ VAT Act/ Central
Sales Tax Act 1956 + Drugs and Magic Remedies (Objectionable) Advertisement Act,1954+IPC
Section 274 (Adulteration of drugs), Sec 275 (Sale of Adulterated drug), Sec 276 (Sale of drug as
different drug or preparation), Sec 284 (negligent conduct with regard to poisonous substances)

3. Narcotics and Psychotropic Substances Act, 1985 for morphine, ketamine, pentazocine, Propafol,
Fentalamine storage
 LAWS GOVERNING MANAGEMENT OF PATIENTS

1. Birth and Deaths and Marriage Registration Act 1886

2. Law of Contract,1872- Section 13 (for consent) + Guardians and Wards Act 1890
3. The Medical Termination of Pregnancy Act and rules
4. Preconception and Prenatal Diagnostic Technology (prohibition of sex selection) act and PNDT
Rules
5. Supreme court and other court judgments regarding treating emergency patient, not insisting for
deposit of money before admission, transfer of patient to other hospitals, eye camps, sterilization
operation camps
6. Transplantation of Human Organ Act and Rules
7. The Epidemic Disease Act 1897
8. The Mental Health Act 1987 + Indian Lunacy Act 1912
9. Indian lepers act 1898
 LAWS GOVERNING ENVIRONMENT SAFETY

1. Biomedical Waste Management Handling Rules 1998 for bio-waste

disposal
2. Environment Protection Act and Ru1e + Noise Pollution Control
Rule + Air (prevention and control of pollution) Act for use of
generator
3. Prohibition of Smoking in Public Places Rules 2008
4. IPC Section 278 (making atmosphere noxious to health), Sec 269
(negligent act likely to spread infection or disease dangerous to life,
unlawfully or negligently)
 LAWS GOVERNING TO EMPLOYMENT AND
MANAGEMENT OF MANPOWER

1. Shops and Establishment Act or similar 10. SC and ST ACT 1989

law in your city 11. ESIC Act and rules
2. Maternity Benefits Act and rules 12. Employee Provident Fund Act 1952
3. Equal Remuneration Act 1976 13. Payment of Gratuity Act 1972
4. Minimum Wages Act 1948 14. Indian Trades Union Act
5. Profession tax 15. Industrial Dispute Act 1947
6. Payment of Wedges Act 1936 16. Negotiable Instrument Act 1881

7. TDS under income tax act 1961 17. Persons with Disabilities Act 1995

8. Workmen’s Compensation Act 1923

9. Payment of Bonus Act 1956
 LAWS GOVERNING TO MEDICOLEGAL ASPECTS

1. Indian penal code(IPC)1860 read with supreme court Jacob Mathew versus State of Punjab and Martin F. D’Souza
Versus Respondent Mohd. Ishfaq regarding arrest of doctors
2. Criminal procedure code 1973, read with Supreme Court Jacob Mathew versus State of Punjab and Martin F.
D’Souza Versus Respondent: Mohd. Ishfaq regarding arrest of doctors 3
3. Consumer Protection Act 1986 read with supreme court judgement in Laxman Balkrishna Joshi versus Trimbak
Bapu Godbole,1968, IMA versus VP shantha read with Kusum Sharma versus Batra Hospital & Medical Research,
Dr. Balram Prasad Versus Dr. Kunal Saha regarding negligence related to doctors and compensations awarded
4. Indian Evidence Act-1872 read with supreme court Dr JJ Merchant versus Shrinath Chaturvedi and Kishan Rao
versus Nikhil Super Speciality Hospital
5. Law of privileged communication- Sections 126 to 129 of the Indian Evidence Act, 1872 deal with privileged that
is attached to professional communication and confidentiality read with supreme court MR X Versus Hospital Z of
1998
6. Law of torts
7. IPC Section 52 (good faith), Sec 80 (accident in doing lawful act), Sec 89 (for insane & children), Sec 90 (consent
under fear), Sec 92 (good faith/consent), Sec 93 (communication in good faith
8. Law of consent in contract act, IPC and supreme court judgment of samira Kohli versus Dr Prabha Manchanda
 LAWS GOVERNING THE SAFETY OF PATIENTS, PUBLIC
AND STAFF WITHIN THE HOSPITAL PREMISES

1. IPC Section 336 (act endangering life or personal safety of others), Sec 337
(causing hurt by act endangering life or personal safety of others), Sec 338
(causing grievous hurt by act endangering the life and personal safety of others).

2. The Medicare Service Persons and Medicare Service Institutions (prevention of

violence and damage or loss to property) Act or similar law in your city
 LAWS GOVERNING PROFESSIONAL TRAINING
AND RESEARCH

1. NMC act 2019 and rules and regulations for MBBS with internship training, MD, MS,
Mch, DM, fellowship or any other MCI recognized PG fellowship and diploma
2. National board of examination rules for DNB, FNB training
3. Ethical Guidelines for Biomedical Research on Human Subjects, 2000
LAWS GOVERNING PROFESSIONAL TRAINING AND RESEARCH
LICENCES/CERTIFICATIONS REQUIRED FOR HOSPITALS

1. Income Tax Act 1961

2. Goods and service tax, profession tax etc.
3. Insurance Act 1938
4. The Insurance Regulatory and Development Authority of India Act, 1999
5. FEMA 1999 (FOREIGN EXCHANGE MANAGEMENT ACT)
6. Gift Tax Act 1958
7. Wealth Tax Act 1958
8. Sales of Good Act 1930
9. Indian Copyright Act 1957
 PERIODIC REPORTS AND RETURN AS LEGAL COMMITMENT FOR
HOSPITALS
Sr. no Lic14ences/certifications Frequency
1 Registration under societies act if needed Initially and renewal yrly
2 Inspection for electrical installation Initially
3 NOC municipal office Annually/3 years in some cities
4 Licence for storage of petrol/diesel 2 yearly
5 NOC from Delhi fire services Before implementation
6 Registration for operation of X-ray Every 2 years
7 Drug Licence for medical store Every 5 years Licence to operate
blood bank Every 5 years
8 Registration under PCPNDT Act 1994 Every 5 years
9 PAN no. under IT act Once only
10 Registration for GST Once only
11 Registration for EPF Once only
12 Registration for ESI Once only
13 Registration MTP Act Once time
Sr. Lic14ences/certifications Frequency
no
13 Indemnity insurance policy Yearly
14 Hospital Error and omission policy Yearly
15 fire and special perils policy Yearly
16 Authorization for BMW yearly/ 3 years
 P E R I OD I C R E P O RT S A N D R E T U R N A S L E GA L C OM M I T M E N T
F O R H O S P I TA L S

Sr. no Lic1914ences/certifications Frequency

1 Biomedical waste generation Annual
2 Income Tax Annual
3 Units processed in blood bank Monthly
4 MTP reports Monthly
5 PNDT report Monthly
6 Employees provident fund Monthly/annual
7 ESI act Monthly/annual
8 GST Monthly/quarterly online
9 TDS Quarterly
10 Registration of births and deaths On every occurrence
11 Post polio paralysis case On every occurrence
12 12. Communicable disease report On every occurrence
13 Radiologist registration PNDT On induction of a new
14 USG machine registration For each new machine
15 Needle stick injuries On occurrence
16 Thermoluminescent dosimeters Badges Quarterly (TLD)
17 Nursing home registration act Annual
18 The clinical establishment act Annual depends on state
19 State medical council 5yearly
 LIST OF COURSES WHICH CLAIM TO BE IMPARTING ALTERNATIVE
MEDICINE KNOWLEDGE BUT AT NOT RECOGNIZED BY ANY STATUTORY
MEDICAL COUNCIL

1. The Indian medical board (alternative system is issuing rmp(am)) certificate for practicing in alternative
therapies
2. Dr. B.C. Roy Memorial Complementary Medicines Research Centre (BMCRC) are registered under act
xxvi of 1961 by the govt. Of west bengal and under scientific institution act 1854. Our registration no. Is
s/76111
3. National board of alternative medicines
4. Sarswatichandra medical science and academy
5. Institute of alternative medicines and research
6. Alternative medical council Calcutta
7. Indian council of Medicotechnicals and healthcare
8. Indian board of alternative medicines
9. The open international university for alternative medicines (oiuam)
10. Central institute of medical science and technology
 CONCLUSION

• Knowing laws, rules, regulations, bye laws and implementing them is need of
hour.
• Even though various laws given below regulate medical practice in India they
are only indicative but not exhaustive hence one has to keep an eye on
changing laws.
• Try and be part of making these laws, active involvement of we doctors with
policy makers
• Figure out loop holes in each law from both side administrative and we as
practioners.
 Thank u
If u come across any new Law feel free to buzz me on

Dr Pavankumar Patil
drpavanpatil@gmail.com
6364149150