The much-delayed ‘Clinical Establishments (Registration and Regulation) Bill' will be introduced in the budget session of Parliament as the Centre has approved the proposal of the Union Health Ministry in this regard. The Bill, which has been pending for several years, aims to bring in uniformity in the healthcare delivery sector by making the registration of all clinical establishments mandatory and prescribing enhanced penalty for the defaulters. The next session of Parliament is expected to commence in the last week of February.

The Union cabinet in its meeting recently has approved the proposal of the health ministry for the introduction of the Bill in order to achieve the mandate of Article 47 of the Constitution for improvement in public health. Once the Bill gets the approval of Parliament, initially the law will come into effect in the states of Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all union territories. It is expected that other states would also adopt this legislation later.

The Bill was to be introduced in the last session of Parliament and in fact it was also included in the legislative business prepared for the last session, but the health ministry could not complete the procedures for the introduction of the Bill.

The main purpose of the law is to provide a legislative framework for the registration and regulation of clinical establishments in the country and also seeks to improve the quality of health services through the National Council for Standards by prescribing minimum standards of facilities and services which may be provided by them. This would permit categorization and classification of different clinical establishments depending on their geographical location as well as services offered. It will also initiate the process for the creation of a national registry of clinical establishments existing in the country.

Even though several states have already enacted laws for regulating health care providers, the general perception is that current regulatory process for healthcare providers in India is inadequate or not responsive to ensure health care services of acceptable quality and prevent negligence.

Presenlty, the supervision and regulation of the quality of services provided by the health care delivery system to the people by both public and private sectors has largely remained a contentious matter and therefore, unresolved issue. The current structure of the healthcare delivery system does not provide enough incentives for improvement in efficiency. The private sector health care delivery system in India has remained largely unregulated and uncontrolled. Problems range from inadequate and inappropriate treatment, excessive use of higher technologies, wastage of scarce resources and problems of medical malpractice and negligence.

Once the law comes into effect, all the clinical establishments in the country have to follow the mandatory registration. As per the Bill, clinical establishment would include hospitals, maternity home, nursing home, dispensary, clinics and similar facilities with beds that offer diagnosis, treatment or care for illness or injury or pregnancy in any recognised system of medicine (Allopathy, Yoga, Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani). It also includes any laboratory (either established as independent entity or part of an establishment) which offers pathological, bacteriological, genetic, radiological, chemical, biological and other diagnostic or investigative services. Furthermore, the establishment can be owned by the government or department of the government, a Trust (public or private), a corporation (including a cooperative society), a local authority and a single doctor establishment.