Clinical Establishments (Registration and Regulation) Bill 2010

Applicability

• Applies to all Union Territories and four states: Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim.
• Other states may adopt it by passing a resolution in their State Legislature.
• Does not apply to clinical establishments managed by the Armed Forces.

Definition of Clinical Establishment

• Includes hospitals, clinics, maternity homes, dispensaries, and similar facilities.
• Covers all recognised systems of medicine: Allopathy, Ayurveda, Yoga, Naturopathy, Siddha, Unani, and Homoeopathy.
• Includes standalone laboratories offering pathological, chemical, and diagnostic services.
• May be owned by government, private entities, trusts, or even a single doctor.

National Council for Clinical Establishments

• Established by the Central Government.
• Chaired by the Director General of Health Services (DGHS).
• Includes 22 members representing medical associations, consumer groups, and systems of Indian medicine.
• Key functions include:
  • Determining minimum standards of health care.
  • Classifying clinical establishments into categories.
  • Maintaining the National Register of Clinical Establishments.

Registration Requirements

• Mandatory registration for all clinical establishments to operate.
• Conditions for registration include:
  • Minimum standards of physical infrastructure and facilities.
  • Minimum qualifications for personnel.
  • Compliance with notified standards for each category of establishment.

Types and Validity of Registration

• Provisional Registration:
  
  • Granted initially for one year.
  • For establishments where standards are already notified, provisional registration will be time-bound.
• Permanent Registration:
  
  • Valid for five years.
  • Renewal application required six months before expiry.
  • Applicant must provide evidence of compliance with minimum standards.

State and District-Level Authorities

State/UT Council

• Includes Secretary (Health), Director of Health Services, representatives from State Medical, Pharmacy and Nursing Councils, and consumer/NGO representatives.
• Responsible for maintaining State Registers and overseeing implementation.

District Registering Authority

• Consists of District Collector, District Health Officer, and three experts nominated as per central rules.
• District Health Officer / Chief Medical Officer handles provisional registration.

Inspections and Enforcement

• Registering authority may order an inspection through a multi-member team.
• Authority may issue show-cause notices for non-compliance.
• Power to cancel registration for violations.
• Can enter and inspect an establishment suspected of operating without registration, after prior notice.

National and State Registers

• A National Register to be compiled within two years of commencement.
• First set of standards to be finalised within two years of formation of the National Council.