At a time when there is regulatory confusion and well-founded concern over the cost and quality of health care, the Clinical Establishments (Registration and Regulation) Bill, 2010 passed by both houses of Parliament is an important step forward. Provided its objective is pursued sincerely, the legislation can go a long way in empowering patients who are now forced to deal with a medical establishment that is opaque, unaccountable, and often unethical in its working. Among other things, the Bill provides for compulsory registration of all clinical establishments in recognised systems of medicine (allopathy, yoga, naturopathy, ayurveda, homoeopathy, siddha, and unani); the publication, within two years of its commencement, of a national register of establishments; and the laying down of minimum standards, also within a period of two years. By prescribing penalties for violations by private as well as public institutions, it promises to raise standards of accountability. It can also eliminate quackery. The Bill protects the regulatory role of the State administration, as the district registering authority will have the district collector and the district health officer as members. Moreover, there will be a State Council involving senior officials and medical authorities.
A lot of work waits to be done to standardise protocols, define malpractice, and codify patient rights. The annual health expenditure in India is estimated by the Insurance Regulatory and Development Authority to be in the region of Rs.300,000 crore. Nearly a third of this goes towards hospital-related procedures and treatment, and the rest for outpatient and domiciliary treatment, medicines, investigations, and so on. Much of this is spent out-of-pocket. Given the impoverishing nature of costs and the poorly evolved state of health insurance, there is an urgent need for comprehensive regulation. It is notable that the new measure has come about as a result of resolutions passed by the legislatures of Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, where it will automatically go into force along with the Union Territories. It is open for other States, including those that have similar laws, to adopt it. The IRDA, meanwhile, is expected to come out with draft norms for health insurance, including standard definitions of illnesses. Much time has been lost: a Bill with the same objectives introduced in Parliament three years ago lapsed. Regulation of quality and cost is doubly necessary considering that the State governments are now sending poor patients to for-profit private hospitals under subsidised health insurance schemes.