To provider registration and regulation for all clinical establishments within the country with a motive to prescribing the minimum standards of facilities and services provided by them to citizens of the country the govt. of India (central govt.) enacted the Clinical Establishments (Registration and Regulation) Act, 2010 (“Act”) as per commission namely “Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure” for the 11th Five-Year Plan, Health regulation in India highlighted number of factors and issues.
These include proclamation of legislation for health facilities & services, , human power ( i.e. Education, Licensing & Professional Responsibility), disease control & medical aid, Pharmaceuticals & Medical Devices, Ethics and Patients Rights, Radiation Protection, Poisons & Hazardous Substances, Occupational Health and Accident Prevention, Elderly, Disabled & Rehabilitation Family, Women and child Health, Mental Health, Smoking/Tobacco Control, Social Security & Health Insurance, Environmental Protection, Nutrition. Hence, the report focused for the requirement for a central legislation for registration of clinical establishments within the country and uniform standards have to be developed for the entire country.
Objective of the Act
- The Clinical Establishments (Registration and Regulation) Act, 2010 made Compulsory for registration of all clinical establishments, likewise as diagnostic center’s and single-doctor chambers across all recognized systems of medicine both within in the public and private sector (except those operated by the defense forces).
- The main work of the registering authority to facilitate policy formulation, resource allocation and regulates standards of treatment. The Act entrust Standard Treatment Guidelines for common disease conditions, that a core committee of experts has been formed.
- Further, the Act makes all clinical establishments to provide medical care and treatment necessary to stabilize any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly like pregnant labour women and accident cases of any type.
The act come into force in Four states of India namely Arunachala Pradesh, Himachal Pradesh, Mizoram, Sikkim and all union territories vid notification dated 28th January, 2010. Later, in light of to article 252 (1) of the Indian constitution Uttar Pradesh, Rajasthan and Jharkhand adopted this Act.
Clinical Establishments (Registration and Regulation) Act,2013 :Overview
It is the duty of state to bring improvement in public health and consider this responsibility as primary duties as mentioned in Article 47 of Indian Constitution. In Essence, it is the duty of state to prohibit consumption of intoxicating drinks (except medicinal purpose) and drugs which are injurious to public health.
Therefore, to accomplish above-mentioned responsibility, The legislature of India enacted the Clinical Establishments (Registration and Regulation) Act, 2010 with objective to provide for the registration and regulation of clinical establishment in India and also matters related to it.
According to this Act “Clinical establishment” includes all clinical establishment of hospitals, nursing home, maternity homes, clinics and dispensaries or any institute may have been called by any name which provides services and facilities related to diagnosis, treatment or care for illness, injury etc. or any place established in connection to mentioned clinical establishments like diagnosis or treatment of certain diseases. It also includes any clinical establishment controlled, managed or owned by government or government departments.
Procedure for registration of clinical establishment
Section 11 of the acts convey that no person shall run a clinical Establishment unless has been duly registered in accordance with the provision of the Act.
The prescribed application format for the permanent registration of the clinical Establishment is issued by the Ministry of Health and Family Welfare according to there notification the applicant has to provide information Such as, among others, establishment details, types of service, system of medicine, etc.
Minimum Standards to be followed by Clinical Establishments
Further, section 12 of the act lays down some conditions for the registration and continuation of clinical establishment. Those conditions are:
- Min. standards of facilities and services
- Min. requirement of officials
- Provision to maintenance of records and reports
- Any such other condition may be prescribed
These minimum standards for hospitals are implemented on the ground of level of care provided by the hospital.
To conclude with, it is the necessity of an hour to use a common standard legal compliance in hospital industry to bring a universal guidelines regarding medical law in India with the motive of this Government of India enacted the clinical establishment Act,2010. This Act brought an excellent ease in registration of any new clinical Establishments also help in bringing transparency in medical service. After this Act it can be presumed that every clinical establishment in India will be systematized and strictly compelled equipped with all the fundamental minimum standard of treatment and medical care and hence, whole scenario of healthcare section in India is anticipated to grow through a huge appreciable revolution after this Act.
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