Important Legislations Regarding Healthcare Business By Admin - December 17, 2020 Last Updated at: Dec 17, 2020 0 376 PART – II Important legislations relating to healthcare business in India laws governing commencement of health care units Legislation Effect of the legislation (Crux of the Act) The Companies Act, 2013 Registration of the healthcare units as a Company- either public limited or private limited. This Act shall also provide guidelines relating to the management of affairs of the healthcare units. The Partnership Act, Registration of the healthcare units as a partnership firm which will govern the acts and deeds of the partners of the healthcare business. Society Registration Act –1960 Registration of the healthcare units as a cooperative society. Clinic Establishment Act, 2010 Clinical Establishments Act aims to register and regulate clinical establishments based on minimum standards in to improve the quality of public health care in the country and ensuring compliance of other conditions of registration like compliance to standard treatment guidelines, stabilization of an emergency medical condition, display of the range of rates to be charged, maintenance of records, etc. Bombay Nursing Home Act An Act to provide for the registration and inspection of nursing homes in the Province of Bombay and certain purpose Connected therewith Government Buildings Act,1899 An Act to provide for the exemption from the operation of municipal building laws of certain buildings and lands which are the property, or in the occupation, of the Government and situate within the limits of a municipality. The Electricity Act, 2003 An Act to consolidate the laws relating to the generation, transmission, distribution, trading and use of electricity and generally for taking measures conducive to the development of electricity industry, promoting competition therein, protecting the interest of consumers and supply of electricity to all areas, rationalisation of electricity tariff, ensuring transparent policies regarding subsidies, promotion of efficient and environmentally benign policies, the constitution of the Central Electricity Authority, Regulatory Commissions and establishment of Appellate Tribunal and for matters connected therewith or incidental thereto. Indian Telegraph Act This Act intended to give the Central Government power to establish telegraph lines on private as well as public property. Atomic Energy Regulatory Body Approval for Radiology / Nuclear Medicine Services under the Atomic Energy Act – 1962 The Atomic Energy (Radiation Protection) Rules, 2004 [AE(RP)R-2004], promulgated under the Atomic Energy Act, 1962, provides the legal framework for the safe handling of radiation generating equipment (in this context – X-ray equipment). The Shop and Establishment Act, 1953 To regulate the conditions of work and employment in shops, commercial establishments, residential hotels, restaurants, eating houses, theatres, and other places of public entertainment. The Factories Act, 1956 The Act aims to regulate the working conditions in factories, to regulate health, safety welfare, and annual leave, and enact a special provision in respect of young persons, women, and children who work in the factories. Law governing the conduct of professionals – Doctors/Nurses/lab technicians The Indian Medical Council Act, 1956 Reconstitution of MCI & maintenance of medical register and for matters connected therewith. Indian medical council (professional conduct, etiquette, and ethics) regulations, 2002 Regulations of professional conduct, etiquette, and ethics for registered medical practitioners. The Indian Medical Degree Act, 1916 Regulate the grant of titles implying qualification in western medical Science The Indian Medicine Central Council Act,1970 Regulate Indian System of Medicine viz Ayurved, Siddha, Unani Tibb; maintain the central register and ethics. The Dentist Act,1948 Regulate the standard of dental education, profession, and ethics. Indian Nursing Council Act,1947 Regulate uniform standard of training for nurses, midwives, and health visitors The All India Council for Technical Education Act,1987 Establishment of an All India Council for Technical Education, planning, coordination, and maintenance of norms and standards The Apprenticeship Act, 1961 Regulation and control of training of apprentices. The Rehabilitation Council of India Act, 1992 Regulate the training of rehabilitation professionals and the maintenance of a Central Rehabilitation Register. The Homeopathy Central Council Act,1973 Constitution of a Central Council of Homeopathy and maintenance of a Central Register of Homeopathy Allied and Healthcare Professional’s Central Council Act, 2015. Regulation and maintenance of the standards of education and practice of Allied and Healthcare Professionals. get legal advise Law governing drug substances and medicines Drug and Cosmetics Act,1940 The Drugs and Cosmetics Act, 1940 is an Act India that regulates the import, manufacture, and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective, and conform to state quality standards. Sales of Good Act – 1930 Contracts or agreements related to the sale of goods are governed under this Act. Any distribution, sale, retail, wholesale of medicines, drugs, instruments shall be covered under this Act. Pharmacy Act – 1948 This Act prescribes the minimum standards of education and approves courses of study and examinations for Pharmacists, and Provincial Pharmacy Councils, which will be responsible for the maintenance of provincial registers of qualified pharmacists. Narcotics and Psychotropic Substances Act -1985 An Act to provide for detention in certain cases to prevent illicit traffic in narcotic drugs and psychotropic substances and for matters connected therewith. Blood Bank Regulations under Drugs and Cosmetic ( 2nd amendment ) rules – 1999 Guidelines relating to the setting up of blood banks and regulatory aspects of blood are governed under this Act. Adulteration of Drugs (IPC Sec 274) This section lays down that Who ever adulterates any drug or medical preparation which will lessen the efficacy or change the operation of such drug or medical preparation, or make it noxious shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both. Sales of Adulterated Drugs ( IPC Sec 275 ) This section states that whoever sells the adulterated drugs-knowingly or unknowingly, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both. Sales of Drug as Different Drug or Preparation ( IPC Sec 276 ) According to section 276 of the Indian penal code, Whoever knowingly sells or offers or exposes for sale, or issues from a dispensary for medicinal purposes, any drug or medical preparation, as a different drug or medical preparation, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both. Law governing the management of patients Birth, Death and Marriage Registration Act – 1886 An Act to provide for the voluntary registration of certain Births, and Deaths, for the establishment of General Registry Offices for keeping Registers of certain Births, Deaths, and Marriages, and for certain other purposes. The Epidemic Disease Act – 1897 This Act intends to provide for the better prevention of the spread of Dangerous Epidemic Diseases. Drugs and Magic Remedies (objectionable) Advertisements Act 1954 – 1954 An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities, and to provide for matters connected therewith. Lepers Act – 1975 An Act to provide for the segregation and medical treatment of pauper lepers and the control of lepers following certain callings. Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act – 1982 An Act to provide for the use of ears of deceased persons for therapeutic purposes and matters connected therewith. The Mental Health Act – 1987 An Act to consolidate and amend the law relating to the treatment and care of mentally ill persons, to make better provision for their properly and affairs and for matters connected therewith or incidental thereto. Transplantation of Human Organ Act – 1994 An Act to provide for the regulation of removal, storage, and transplantation of human organs for therapeutic purposes and the prevention of commercial dealings in human organs and matters connected therewith or incidental thereto PNDT Act – 1994 The main purpose of enacting the act is to ban the use of sex selection techniques before or after conception and prevent the misuse of prenatal diagnostic techniques for sex-selective abortion. MTP Act – 1971 An Act to provide for the termination of certain pregnancies by registered Medical Practitioners and matters connected therewith or incidental thereto Rules for Insurance Cover for the Sterilization Cases under The Affordable Care Act (ACA) The Affordable Care Act (ACA) includes a requirement that new private health insurance plans cover at least one form of all 18 FDA-approved contraceptive methods for women as prescribed without cost-sharing. This means that female sterilization procedures must be fully covered by private health insurance plans. Indian Contract Act, 1872- Section 13 (Consent) -na- Laws relating to environmental protection State Municipality Sanitation and Public Health Bye-Laws Every state lays down its own rules and regulations governing environmental practices to be followed while using any premises for healthcare purposes. Environment Protection Act – 1996 This Act states rules to protect and improve the quality of the environment and preventing and abating environmental pollution, the standards for emission, or discharge of environmental pollutants from the industries, operations or processes shall be as specified in 2 Biomedical waste management handling rules – 1998/2000 This enactment lays down rules regarding transportation, treatment, disposal, and/or any other form of handling of bio-medical waste Rules regarding the safe discharge of effluents in the public sewers/drains These rules prescribe standards for discharge of effluents in the public sewers IPC sec 278 (making atmosphere noxious to health) Whoever voluntarily vitiates the atmosphere in any place to make it noxious to the health of persons in general dwelling or carrying on business in the neighbourhood or passing along a public way, shall be punished with fine which may extend to five hundred rupees. Labour legislations relating to health-care Payment of Wages Act – 1936 The Payment of Wages Act, 1936 (the Payment of Wages Act) is an Act to regulate the payment of wages to certain classes of employed persons. The Payment of Wages Act seeks to ensure that the employers make timely payment of wages to the employees working in the establishments and to prevent unauthorized deductions from the wages. Industrial Disputes Act – 1947 The ID Act provides for the constitution of the Works Committee, consisting of employers and workmen, to promote measures for securing and preserving amity and good relations between the employer and the workmen and, to that end, endeavours to resolve any material difference of opinion in respect of such matters. Factories Act, 1956 The Factories Act, 1948 (the Factories Act) lays down provisions for the health, safety, welfare, and service conditions of workmen working in factories. It contains provisions for working hours of adults, employment of young persons, leaves, overtime, etc. The Employee’s Compensation Act, 1923 The Employee’s Compensation Act, 1923 (the EC Act) aims to provide financial protection to workmen and their dependents in case of any accidental injury arising out of or in course of employment and causing either death or disablement of the worker using compensation. Minimum Wage Act – 1948 The Minimum Wages Act, 1948 (the Minimum Wages Act) provides for fixing of minimum rates of wages in certain employments. The minimum wages are prescribed by States through notifications in the State’s Gazette under the Minimum Wages Rules of the specific State. ESI Act – 1948 The Employees’ State Insurance Act, 1948 (the ESI Act) is social welfare legislation enacted to provide certain benefits to employees in case of sickness, maternity, and employment injury. In terms of the provisions of the ESI Act, the eligible employees will receive medical relief, cash benefits, maternity benefits, pension to dependents of deceased workers, and compensation for fatal or other injuries and diseases. Employees Provident Fund and Misc. provision Act – 1952 The Employees Provident Funds and Miscellaneous Provisions Act, 1952 (the “EPF Act”) provides for the institution of provident funds, pension funds, and deposit-linked insurance funds for employees and applies to all establishments employing 20 or more persons or class of persons. An establishment to which the EPF Act applies shall continue to be governed by this Act, notwithstanding that the number of persons employed therein at any time falls below 20. Payment of Bonus Act – 1965 The Payment of Bonus Act, 1965 (the “Bonus Act”) provides for the payment of bonus to persons employed in certain establishments in India either on the basis of profits or on the basis of production or productivity and is applicable to every establishment in which 20 or more persons are employed and to all employees drawing remuneration of less than Rs 10,000.. Payment of Gratuity Act – 1972 The Gratuity Act provides for a scheme for the payment of gratuity to employees engaged in factories, mines, oilfields, plantations, ports, railway companies, shops, or other establishments. The Gratuity Act enforces the payment of “gratuity”, a reward for long service, as a statutory retiral benefit. Equal Remuneration Act -1976 The Equal Remuneration Act, 1976 provides for the payment of equal remuneration to men and women workers for the same work and prevents discrimination, on the ground of sex, against women in the matter of employment, recruitment, and for matters connected therewith or incidental thereto. This Act applies to virtually every kind of establishment. The Shop and Establishment Act, 1953 To regulate the conditions of work and employment in shops, commercial establishments, residential hotels, restaurants, eating houses, theatres, and other places of public entertainment. Maternity Benefit (Amendment) Act – 2008 Maternity Benefit Act, 1961 (Maternity Benefit Act) regulates the employment of women in certain establishments for a certain period before and after childbirth and provides for maternity benefits and certain other benefits including maternity leave, wages, bonus, nursing breaks, etc, to women employees. Sexual Harassment at the Workplace (Prohibition, Prevention and Redressal) Act, 2013 The Sexual Harassment at Workplace (Prohibition, Prevention and Redressal) Act, 2013 (SHW Act) was enacted by the Parliament to provide protection against the sexual harassment of women at the workplace and prevention and redressal of complaints of sexual harassment and for matters connected therewith. Other important legislation Vaccination Act – 1880 Explosive Act 1884 (for diesel storage) – 1884 Indian Boilers Act – 1923 Arms Act – 1950 Prevention of Food Adulteration Act -1954 The Indian Fatal Accidents Act – 1955 The Radiation Surveillance Procedures for the Medical Application of Radiation – 1989 Protection of Human Rights Act – 1993 Petroleum Act + Storage Rules – 2002 Disaster Management Act – 2005 Consumer Protection Act – 1986 Law relating to intellectual property rights Trademark Act, 1999 This Act provides for registration and better protection of trademarks for goods and services and the prevention of the use of fraudulent marks. Copyright Act,1956 This Act provides for registration and protection of copyrightable work- websites in particular and the prevention of the use of fraudulent materials.