Shield for noble Hands...

Rules and Regulations

  • Regulations Related to Treatment of Patients:
    • Valid consent for examination/investigation/treatment/research procedure (or informed refusal of consent), as applicable
    • Confidentiality of privileged communication, as far as permitted under the law;
    • Life Saving treatment of emergency cases
    • PNDT Act 1994
    • Do Not Resuscitate (DNR) order & issue in India
    • Rules for issue of prescriptions
    • Maintenance of Medical Records of the patients treated for a period of Three/ Five,/Ten / Thirty years and as per the format
    • Reporting of Medico-Legal cases / Rape cases / Child sexual abuse (POCSO Act) to the police
    • Reporting of occurrence of occupational diseases
    • Responsibility for ensuring safety of patients
    • Rights of patients
    • Privacy of patients during consultation, examination and treatment
    • Professional indemnity insurance cover of an appropriate amount
    • Laws applicable to medical negligence - Vicarious Liability, Respondent Superior
  • Submission of Reports/Returns to Health Authorities:
    • Cases of notifiable diseases as applicable in the city/state
    • Report of cases of food poisoning, if required by Municipal Health Authorities (FSSAI)
    • Incidence of needle stick injuries
    • Annual report under BM Waste Management Rules, 1998 (if applicable)
    • Reports on the MTPs carried out
    • All reports related to Mother & child care.(As per format)
  • 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 organizations 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.
  • Registration/Requirement of Licenses
    • Registration certificate of the clinic with the Municipal Authorities
    • Recognition for usage of narcotic drugs
    • Authorization for generation of Bio-Medical Waste, if treating 1,000 or more patients per month
    • Permit for Procurement/Usage of spirit
    • Registration under the Medical Termination of Pregnancy (MTP) Act 1971, the Pre-Natal Diagnostic Techniques (PNDT) Act, 1994 & any other Act of Govt. as applicable.
  • Regulations Related to Employment of Staff
    • Employment of staff (Doctors, Nurses, Pharmacists) only after proper credentialing;
    • Prevention of sexual harassment of women at work place
    • Responsibility of employer for safety of employees
    • Immunization / other measures for protection of staff from Occupational Health hazards.
  • Sign Boards
    • Rules for the size, contents and correct place for sign boards
    • Information to be displayed at the Clinic
    • Certificate of registration of clinic with the Municipal Authorities
    • Respective Council Registration Certificate
    • Clinic Timings, Closed Days
  • Display of fee structure - A physician should announce his fees before rendering service and not after the operation or treatment is under way.[Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002].
  • Documents to be maintained by the Clinic
    • Registration certificate of the clinic with the Municipal Authorities
    • Record of employment of adults, letters of employment issued and hours of work
    • Maintenance of record of patients treated and a register of medico-legal cases (MLCs)
    • Maintenance of a register of medical certificates issued
    • Professional qualifications (degrees/diplomas) of the staff
    • Record of consumption of Morphine (if applicable)
    • 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 (Section 197 of Indian Penal Code)
  • 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: All of these regulations may not be applicable to every clinic.