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2010 July - Note 7

Clinical Establishments (Registration and Regulation) Bill, 2010

The Clinical Establishments (Registration and Regulation) Bill, 2010, is in the process of becoming a law. The Lok Sabha has passed it and very shortly the Rajya Sabha may also pass the Bill.

This Bill is the outcome of the report of the Working Group on Clinical Establishments, Professional Services Regulation, and the Accreditation of Health Care Infrastructure, which was constituted by the Planning Commission, for the Eleventh Five-Year Plan. In its report, the Working Group has pointed out the ‘inadequate and inappropriate treatments, excessive use of higher technologies, wasting of scarce resources, …. serious problems of medical malpractice and negligence’

The important features of the Bill are:

  1. All clinical establishments belonging to any recognized system of medicine, as well as single doctor establishments, with or without beds, including pathology laboratories, will come under its purview and require compulsory registration. Different standards will be prescribed for different categories of clinical establishments.
  2. A National Council will classify, determine, and develop standards for clinical establishments. Each state will set up a multi-member State Council of clinical establishments, while the registering authority of clinical establishments will be a multi-member body at the district level.
  3. Provisions are made for two types of registration — provisional and permanent. Permanent registration will be provided after the standards for registration have been notified in the rules.
  4. Doctors, hospitals, and other clinical establishments will have to provide treatment and stabilize anyone who comes in with an ‘emergency medical condition’.

Although such a regulatory statutory instrument was indeed needed in India, there are a few aspects that require further consideration:

  1. The cost of healthcare will increase. Smaller players like family physicians or doctors practicing in rural areas will find over-regulation a disincentive to start their own practice.
  2. The tendency to imitate western standards, if repeated in this case, will end in disaster. We are still a developing country and our basic infrastructure in the health care sector, especially in the rural and semi-urban areas is pathetic. However, we will have to wait till the rules in this regard are publicized / made.
  3. The compulsion to treat emergency patients was always there since 1986, thanks to the judgment pronounced by the Supreme Court in the Parmanand Katara case. This law has merely given it statutory recognition. It lays down that clinical establishments will provide ‘such medical examination and treatment as may be required to stabilize the emergency medical condition’. However, one important aspect has not been addressed — who will foot the bill? Healthcare nowadays is an expensive affair. A mechanism ought to be in place to meet the actual expenditure made by the clinical establishment in such emergencies. Otherwise, the disincentive to treat emergency patients will always remain. It will also make this particular provision amenable to challenge before the constitutional courts.

Even though there are a few areas of concern, this law is a laudatory effort of the government and should help in curbing the ills that have plagued the healthcare sector in India.


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