It is clear that a regulation and certification is necessary for the hospitals and clinics in India. India hospitals and clinics just do not have any rules and regulations to be complied with. Thousands of hospitals and other clinical establishments operating in the country largely remains outside any regulatory supervision of the government for over several decades. Most of them have been following no good medical practices on their own and have been indulging in fraud and undesirable activities. One of the main groups of offenders in this segment is thousands of pathology laboratories and diagnostic centres spread across the country. Many a time incorrect assessment of the medical condition by these labs has been responsible for wrong prescription of medicines to the patients. Currently, health departments of most of the state governments do not have a system to check or monitor the activities of path labs and diagnostic centres.
As public health is largely a state subject, the Central health ministry has been rather passive in a framing a law to regulate these clinics, hospitals and laboratories. It is in the background of this environment, the Central government decided to bring a Clinical Establishment Act in 2010. The Act aims to bring in uniformity in the healthcare delivery in the country and prescribes penalty for the defaulting establishments. The legislation is now applicable to clinical establishments under all recognized systems of medicines or treatment under Allopathy and Ayush. It will apply to all hospitals and clinics including single doctor establishments, with or without beds. The Act includes any laboratory which offers pathological, bacteriological, genetic, radiological, chemical, biological and other diagnostic or investigative services.
As a part of setting some basic quality norms for health services in the country, the Quality Council of India is working on 42 new standards to be adhered to by hospitals and clinics in the country which will also form part of the Clinical Establishment Act. This is certainly a laudable initiative by the QCI as currently there is no uniformity in standards in health services in the country. Now, even after the adoption of the Act by state governments, enforcement of its key provisions can only determine the success of this grand initiative of the Centre.