Indian pharmaceutical industry is well developed and is somewhat adequately regulated under specific Central acts and rules and enforced by the state governments. But, the other part of the healthcare sector namely 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 group 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 a 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.

After the notification of the Act in 2010 the Centre has asked all the state governments to pass resolutions in their respective Assemblies to adopt the Act and to make it applicable in their regions. But only four states namely Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and Union territories have adopted the Act so far. Objections raised by some of the organizations representing the medical fraternity to the adoption of the Act seems to be the reason why remaining states are not cooperating with the Centre. This is something totally unacceptable in a federal set up. The state governments should ignore such unreasonable opposition by the doctors’ bodies and support the Centre in implementing the Act countrywide for the overall public good. One of the fundamental objectives of the Act is to make registration of all clinical establishments mandatory so as to build a national database for these establishments. A reliable database can only help the Centre and state governments to classify hospitals and clinics according to the facilities available with them and  formulate national policies on health. Now 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.