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Since areas like Hospital operations and functionality management are already explained in previous answers I would here explain you about the laws and legal requirements to start up a new hospital in India.Hospitals can primarily be of two types- government or private. Further, they can be general, speciality or multispeciality hospitals. Following are the rules and regulations need to comply for setting up a private hospital in Delhi:Registration/Requirement of LicensesClinical Establishments (Registration and Regulation) Bill, 2007 is passed by the parliament and implemented by the states, registration of all clinics (Private/Public) of all systems of medicine will become mandatoryRegistration with the municipal authorities (Delhi Shops and Establishments Act, 1954)Recognition for usage of narcotic drugs (Delhi Narcotic Drugs (Amendment) Rules, 2002Authorisation for generation of Bio-Medical Waste, if treating 1,000 or more patients per monthPermit for procurement/usage of spirit2. Land and ConstructionLand allotted for agriculture cannot be used. To start building the hospital wing, several permissions from local authorities need to be taken. Numerous documents need to be approved, like land deed, architect’s plan, etc.An occupation certificate is obtained after clearing all formalities.Electricity and waterAs per the requirements of the hospital, permission has to be taken from the local governing body to obtain electric meters and water supply.SewageProper disposal of waste requires a well planned sewage and drainage system, which is done after permission is required from the local board.Fire and Health LicenceA Fire licence is necessary to prove that the hospital will not cause any damage or loss of life and needs to be procured from the local municipal council.  Procuring a health licence is vital to provide health care to the patients.Biomedical wasteThis is very vital aspect and permission of Municipal Corporation is required for installing incinerators required to dispose of medical waste and body parts.By ministry of environment and forestControlled by state pollution control boardRegulations Related to Employment of StaffEmployment of staff (Doctors, Nurses, Pharmacists) only after proper credentialingPrevention of sexual harassment of women at work placeResponsibility of employer for safety of employeesRules governing the employment of staff (Delhi Shops and Establishments Act, 1954)Immunisation / other measures for protection of staff from Occupational Health hazards.Sign BoardsRules for the size, contents and correct place for sign boards (IMC Regulations 2002)Information to be displayed at the HospitalCertificate of registration of clinic with the municipal authoritiesIMC/SMC registration certificate (IMC Regulations, 2002)Charges for consultation and other procedures/services (IMC Regulations 2002)Clinic timings, closed days (Delhi Shops and Establishments Act, 1954)Documents to be maintained by the ClinicRegistration of the clinic with the municipal authorities (Delhi Shops and Establishments Act, 1954)Record of employment of adults, letters of employment issued and hours of workMaintenance of record of patients treated (IMC Regulations 2002) and a register of medico-legal cases (MLCs)Maintenance of a register of medical certificates issuedCopies of medical certificates issuedRegistration certificates of doctors/nurses/pharmacists with the State Medical Councils (SMCs)Professional qualifications (degrees/diplomas) of the staffRecord of consumption of Morphine (if applicable) (Delhi Narcotic Drugs Rules, 2002)Account of money receipts and expenses (Income Tax Act, 1961)Authorization for generation of Bio-Medical Waste and record of category wise waste generated (BMW Management Rules, 1998)Issue of any medical certificate, notification, document or report, which is untrue, misleading or improper is a misconduct and punishable offence (IMC Regulations 2002, Section 197 of Indian Penal Code)Regulations Related to Treatment of PatientsValid consent for examination/investigation/treatment/research procedure (or informed refusal of consent), as applicable (IMC Regulations, 2002)Confidentiality of privileged communication, as far as permitted under the lawLife saving treatment of emergency casesRegistration under the Medical Termination of Pregnancy (MTP) Act 1971, the Pre-Natal Diagnostic Techniques (PNDT) Act, 1994, as applicableRules for issue of prescriptions (IMC Regulations, 2002)Maintenance of Medical Records of the patients treated for a period of three years and as per the format vide Appendix 3 to the IMC Regulations, 2002Reporting of Medico-Legal cases to the policeReporting of occurrence of occupational diseasesResponsibility for ensuring safety of patientsRights of patientsPrivacy of patients during consultation, examination and treatmentProfessional indemnity insurance cover of an appropriate amount (Insurance Regulatory and Development Authority Act, 1999)Laws applicable to medical negligence - Vicarious Liability, Respondeat Superior, Indian Contract Law, Tort law, Consumer Protection Act, 1986, Indian Penal Code sections (52, 80, 88, 89, 92, 93, 274-276, 284, 304-A, 336, 337, 338 and 376-D).Drug and Cosmetics Act 1940, Drugs (Control) Act 1950, Narcotic Drugs and Psychotropic Substances Act 1985, Drugs and Magic remedies (Objectionable Advertisements) Act, 1954, Pharmacy Act, 1948.2.  Submission of Reports/Returns to Health AuthoritiesCases of notifiable diseases as applicable in the state (Section 371, Delhi Municipal Corporation Act)Report of cases of food poisoning, if required by Municipal Health Authorities (Prevention of Food Adulteration Act, 1954)Incidence of needle stick injuriesAnnual report under BM Waste Management Rules, 1998 (if applicable)Reports on the MTPs carried outReports on the USG abdomen (abdominal ultrasonography) done on the pregnant women.Safe disposal of infectious/hazardous waste generated at the clinic (BMW Management Rules, Environment Protection Act 1986, IPC Section 269, 270).Prohibition of unethical activities, such as soliciting patients directly or indirectly, by a physician, a group of physicians, or by institutions or organisations by advertising, self-promotion or self-aggrandizement use of touts for procuring patients giving/offering or receiving rebates, gifts, commissions, cutbacks or kickbacks in return for referral or procurement of patients etc (IMC Regulations, 2002).Prohibition of Smoking in Public Places Rules, 2008, Fire Safety Regulations, Financial Regulations: Income Tax Act, Value Added Tax (VAT) Act, Central Sales Tax Act, etc.State laws for prevention of vandalism/violence against medical service staff and institutions.Presently, the operation of private clinics is being governed by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 and certain other legislations as outlined below.Cases of notifiable diseases as applicable in the state (Section 371, Delhi Municipal Corporation Act)Report of cases of food poisoning, if required by Municipal Health Authorities (Prevention of Food Adulteration Act, 1954)Incidence of needle stick injuriesAnnual report under BM Waste Management Rules, 1998 (if applicable)Reports on the MTPs carried outReports on the USG abdomen (abdominal ultrasonography) done on the pregnant women.Safe disposal of infectious/hazardous waste generated at the clinic (BMW Management Rules, Environment Protection Act 1986, IPC Section 269, 270).Prohibition of unethical activities, such as soliciting patients directly or indirectly, by a physician, a group of physicians, or by institutions or organisations by advertising, self-promotion or self-aggrandizement use of touts for procuring patients giving/offering or receiving rebates, gifts, commissions, cutbacks or kickbacks in return for referral or procurement of patients etc (IMC Regulations, 2002).Prohibition of Smoking in Public Places Rules, 2008, Fire Safety Regulations, Financial Regulations: Income Tax Act, Value Added Tax (VAT) Act, Central Sales Tax Act, etc.State laws for prevention of vandalism/violence against medical service staff and institutions.Note:1. All of these regulations may not be applicable to every Hospital.2. Delhi Laws quoted above may be substituted by the relevant state laws