The Clinical Establishments (Registration and Regulation) Bill, 2007

Highlights of the Bill

• The Clinical Establishments (Registration and Regulation) Bill, 2007 seeks to register and regulate, and set standards for clinical establishments. It shall be applicable to all union territories and four states. Other states may adopt the Bill.

• A clinical establishment is defined as a hospital, maternity home, nursing home and any similar facility with beds. The definition also includes a laboratory that carries out pathological, bacteriological and other diagnostic services.

• The central government shall establish a National Council. Its main functions include prescribing standards for clinical establishments and maintaining a register of clinical establishments.

• Every clinical establishment will need to register. The Bill provides for both provisional registration and permanent registration upon satisfaction of prescribed conditions.

• The district registering authority is responsible for registering clinical establishments, inspecting such establishments and cancelling registrations in case of non-compliance with prescribed standards.

Key Issues and Analysis

• The definition of “clinical establishment” refers to dispensaries and clinics; however it also states that the facilities should have beds. This would arguably exclude clinics which only provide out-patient services.

• In case of change of ownership or management, the clinical establishment will need a new registration. This requirement differs from other sectors in which the registering authority is informed and the transfer is recorded in the register.

• The regulator for all clinical establishments (including government establishments) at the district level is also the administrator for government health services. This could lead to conflict of interest.

• The Bill stipulates that a register has to be maintained in digital format. This could prevent the use of new technologies which might not be digital in nature.

• The Bill is not applicable in areas where eight state Acts have jurisdiction. These Acts do not cover all the different types of clinical establishments listed in the Bill.