statuary regulations in healthcare

8/3/2019 Statuary Regulations in Healthcare

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Dr. Vikrant Mittal


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A/C: Air Conditioning AERB: Atomic Energy Registration Board AIDS: Acquired Immuno-Deficiency Syndrome ANC: Ante Natal Care ANM: Auxiliary Nurse and Midwifery CHC: Community Health Centre CMLT: Certificate in Medical Laboratory andTechnology CPCB: Central Pollution Control Board DCI: Dental Council of India DGHS: Director General of Health Services DMLT: Diploma in Medical Laboratory and Technology EPF: Employee Provident Fund FDA: Food and Drug Authority GOI: Government of India HIV: Human Immunodeficiency Virus ICU: Intensive Care Unit IEC: Information Education Communication IHR: International Health Regulations INR: Indian National Rupee IPD: In Patient Department IT: Information Technology IV: Intra Venous LSA: Local Supervisory Authority MBBS: Bachelor of Medicine and Bachelor of Surgery MCI: Medical Council of India

MoHFW: Ministry of Health and Family Welfare MTP: Medical Termination of Pregnancy INC: Indian Nursing Council NGO: Non Governmental Organization NS: Normal Saline OPD: Out Patient Department OT: Operation Theatre PAN: Permanent Account Number PBA: Payment of Bonus Act PCPNDT: Pre Conception Pre Natal Diagnostic Test PER: Protein Energy Ratio PG: Post Graduate PGA: Payment of Gratuity Act PHC: Primary Health Centre PLWHIV: People Living with HIV PNC: Post Natal Care PPP: Public Private Partnership ROC: Registrar of Companies RTO: Road Transport Officer SC: Sub Centre US: United States


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Till mid-eighties, though laws existed,medical and health care professionals, paidlittle attention to them.

Application of Consumer Protection Act,

1984, to the doctors and health careinstitutions suddenly changed theperspective.

Practically, every stake holder realized the

importance of laws. The next two decadessaw umpteen number of cases filed againsthealth care providers and institutions.


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Healthcare organizations can be incorporated aseither for profit organization, under the CompaniesAct, 1956 or as charitable organization under ahost of other Acts like Charitable and Religious

Trust Act, 1920, Society Registration Act, 1860 orIndian Trusts Act, 1888.

It is mandatory for all organizations to register thenature of business, working hours for employees,

composition of the employees, etc under otherActs like Shop and Establishment Act(s), NursingHome Registration Act(s) or Clinical EstablishmentAct(s).

The Establishment of Medical Colleges Regulation,1999, The Nursing Council Act, 1947, The DentistAct, 1948, etc governs medical and paramedicaleducation and the mandatory requirements forestablishment of educational institutions.


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The Consumer Protection Act, 1984, protect the consumersfrom losses/ damages due to negligence by the concernedprofessional/ institution, has also been specified herewith.

Further the latest Information Technology Act, 2000 has its

implications on the healthcare industry, in terms of therelevance of the information under the Indian Evidence Act,1872.

Common Human Resources Acts have also been specified inthis document, in reference to the healthcare segment.

Similarly, in recent past, outsourcing has gained substantialrecognition and the various regulations governingoutsourcing include the Indian Partnership Act, 1932 andThe Contract Act, 1872.

It is equally essential for the Principal Employer to be awareof other applicable Acts like the Minimum Wages Act, 1948and Workmen Compensation Act, 1923. A Contractdocument is a legal document and needs to be drafted withmaximum clarity and should avoid any form of ambiguities.


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1. THE COMPANIES ACT, 1956 2. INDIAN TRUST ACT, 1882 3.CHARITABLE AND RELIGIOUS TRUST ACT, 1920 4. SOCIETY REGISTRATION ACT, 1860 5. REGISTRATION OF HEALTHCARE INSTITUTION 6. SHOPS AND ESTABLISHMENT ACTS

7. NURSING HOME REGISTRATION ACTS 8. CLINICAL ESTABLISHMENT ACTS 9. THE CLINICAL ESTABLISHMENT (REGISTRATIONS &

REGULATIONS) ACT, 2007 10. THE MENTAL HEALTH ACT, 1987 11. SETTING UP EDUCATIONAL INSTITUTIONS (MEDICAL AND

PARAMEDICAL) 12. ESTABLISHMENT OF MEDICAL COLLEGE REGULATIONS,

1999 13. INDIAN NURSING COUNCIL ACT, 1947 14. THE DENTIST ACT, 1948


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1. INDIAN PARTNERSHIP ACT, 1932 2. INDIAN CONTRACT ACT, 1872 3. CONSUMER PROTECTION ACT, 1986.... 4. INFORMATION TECHNOLOGY ACT, 2000 5. MINIMUM WAGES ACT, 1948 (MWA) 6. WORKMEN COMPENSATION ACT, 1923 AND RULES,

1924(WCA) 7. MATERNITY BENEFIT ACT, 1961 8. EMPLOYEE PROVIDENT FUND AND MISCELLANEOUS

PROVISIONS ACT, 1952

9. PAYMENT OF BONUS ACT, 1965 (PBA) 10. PAYMENT OF GRATUITY ACT, 1972 (PGA) 11. EQUAL RENUMERATION ACT, 1976


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1.RADIATION SURVEILLANCE PROCEDURES FOR MEDICAL APPLICATIONOF RADIATION, 1989 2.STATUTORY REQUIREMENTS FOR SAFE OPERATION OF MEDICAL X-RAY

MACHINES BY HOSPITALS, CLINICS AND OTHER MEDICAL INSTITUTIONSIN INDIA

3. THE PRE-NATAL DIAGNOSTIC TECHNIQUES (REGULATION ANDPREVENTION OF MISUSE) AMENDMENT RULES, 2003

4. MEDICAL TERMINATION OF PREGNANCY ACT, 1971 AND(AMENDMENT) ACT, 2002

5. DRUGS AND COSMETIC ACT, 1945 6. THE DRUGS (PRICE CONTROL) ORDER, 1987 7. BIOMEDICAL WASTE MANAGEMENT AND HANDLING RULES, 1998,

AMENDED IN 2000 8. THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994 (RULES

AMENDMENT 2008) 9. FOOD SAFETY AND STANDARDS ACT, 2006 10. MOTOR VEHICLE ACT, 1988 11. NORMS FOR MEDICAL TOURISM 12. INDIAN MEDICAL COUNCIL (PROFESSIONAL CONDUCT, ETIQUETTE

AND ETHICS) REGULATIONS, 2002


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1. INCOME TAX ACT, 1961

2. TAX LAWS FOR PRIVATE HEALTHCAREINSTITUTIONS

3. FINANCE ACT, 2008

4. SERVICE TAX OF INDIA, 1994


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1. THE EPIDEMIC ACT 1879 2. HIV / AIDS BILL

3. LEPERS ACT, 1898

4. BIRTHS, DEATHS AND MARRIAGES REGISTRATION ACT,I886

5.REGISTRATION OF BIRTHS AND DEATHS ACT, 1969

6. NOTIFIABLE DISEASES

7. INTERNATIONAL HEALTH REGULATIONS, 2005

8. INTERNATIONAL VACCINATION REGULATIONS

9. INDIAN PORT HEALTH RULES, 1955 10. ENVIRONMENT (PROTECTION) ACT, 1987

11. THE INFANT MILK SUBSTITUTES, FEEDING BOTTLES ANDINFANT FOODS (REGULATION OF PRODUCTION, SUPPLY ANDDISTRIBUTION) RULES, 1993

statuary regulations in healthcare

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