A news report in a Mumbai daily last week highlighted the deplorable state of affairs of the 15000 pathology laboratories operating in Maharashtra including the 1600 in Mumbai. These diagnostic labs are being run by unqualified persons with no pathologists present to verify and authenticate the reports. Thousands of these labs and other clinical establishments operating not only in Maharashtra but throughout 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. An unprofessional analysis of the medical condition of a patient can result in false conclusion and wrong prescription medicines to patients by the medical practitioners. MBBS doctors need to have a postgraduation in pathology to become a pathologist as per the norms laid down by the Medical Council of India. Yet, path labs remains one big neglected area in terms of laying down quality standards by health care policy makers of the country. 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 framing law to regulate these clinics, hospitals and laboratories. Probably that is the main reason for mushrooming of path labs in every street corners of the country. What is needed to start a path lab is a simple registration from any state government under the Shops & Establishment  Act.

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 applicable to clinical establishments of 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. The registration of clinical establishments under the Act can certainly help the Centre to build a database of hospitals, their facilities and treatment procedures which in turn would assist in formulating the national policies on health. That can help the government to categorise hospitals and clinics according to the facilities available with them. But, the Act remains largely unimplemented in most parts of the country as the state governments are of the view that it will lead to escalation of cost of treatment which can ultimately affect the small  hospitals and diagnostic centres. The Indian Medical Association also thinks  that it will be impossible for small and medium size hospitals to meet the requirements in the Act and implementation of the same will force many of them to close. At the same time, Associations of the qualified pathologists and microbiologists in many states had filed PILs in various high courts in the past seeking direction to the state governments to allow specialized pathologists only to run pathology labs and certify the reports. And the courts had pronounced judgements in favour of these associations. What is to be taken note is that the state governments cannot ignore the existence of a Central Act intended for the safety of the patient community just for the commercial interests of some private clinical establishments in the states.