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Thursday, January 27, 2022

Three laws, multiple prescriptions

What are the norms private medical practitioners follow in West Bengal, in Karnataka and in multiples states and Union Territories that have adopted the Clinical Establishments (Registration and Regulation) Act, 2010 passed by Parliament?

Written by Abantika Ghosh |
Updated: November 30, 2017 4:36:42 am
Regulation of private healthcare sector Both West Bengal and Karnataka’s Acts prescribe different regulatory structures from that envisaged in the Clinical Establishments (Registration and Regulation) Act 2010 (CEA), passed by Parliament for regulation of the private healthcare sector.

The prolonged agitation by doctors in Karnataka earlier this month, protesting against amendments to the Karnataka Private Medical Establishments Act, 2007 regulating private hospitals is in sharp contrast to the response in West Bengal to Chief Minister Mamata Banerjee’s Town Hall-style meeting in February, wherein she announced that the state government would bring legislation to rein in private hospitals.

Hospitals in West Bengal hardly got time, however, to join forces and protest before the law, termed the West Bengal Clinical Establishment (Registration, Regulation and Transparency) Bill, 2017, was passed by the state Assembly on March 3. The contrast is significant because Karnataka is said to have been “inspired” by the Bengal Act into changing its existing Medical Establishments Act of 2007.

Significantly though, the Karnataka Act includes much more severe penal provisions, including imprisonment in case of lapses. Its model of a District or Metropolitan Grievance Redressal Committee as an inspection authority is also among its more contentious provisions.

Both West Bengal and Karnataka’s Acts prescribe different regulatory structures from that envisaged in the Clinical Establishments (Registration and Regulation) Act 2010 (CEA), passed by Parliament for regulation of the private healthcare sector. This has been adopted by 16 states and Union Territories, which include Bihar, Jharkhand, Uttarakhand, Himachal Pradesh, Arunachal Pradesh, Sikkim, Rajasthan, Mizoram, Uttar Pradesh, Puducherry, Dadra and Nagar Haveli, Daman and Diu, Andaman and Nicobar, Chandigarh, Lakshadweep and Assam.

All three Acts require a mandatory registration of medical establishments, albeit with different authorities— but that is where the similarities end.

The Acts differ significantly in three main areas. The first deals with the regulatory authority supervising medical establishments. Under the West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017, the West Bengal Clinical Establishment Regulatory Commission constituted by the state government is tasked with the “regulation and supervision of the functioning and activities of the clinical establishments”. The chairperson is a former High Court judge, a former chief secretary or additional chief secretary in the state government or a similarly ranked person in the government of India. The vice-chair is a “person of eminence” and members are selected from diverse fields, including medicine, law, public health, academics, social services and consumer interests. All members are appointed by the government.

Also read | Why are doctors in Karnataka up in arms against the state government?

In the Karnataka Private Medical Establishments Amendment Bill, 2017, tabled in the state Assembly recently, the District Metropolitan Grievance Redressal Committee has been given the authority to inspect a private medical establishment to check if provisions of the Act are being followed.

This body is led by the chief executive authority of the zilla panchayat — the fact that a political person heads the committee is a major grouse among doctors. The authority consists of the district superintendent of police, the district surgeon, one representative of private medical establishments in that district, the public prosecutor and one nominated woman representative.

The National Council of Clinical Establishments, as laid down in the CEA 2010, on the other hand, is chaired by the Director General of Health Services, with one member each elected by the Dental Council of India, the Medical Council of India, the Pharmacy Council of India and the Nursing Council of India, three by the Central Council of Indian Medicine, one by the Central Council of Homoeopathy and one by the Indian Medical Association. In addition, there are members from the Bureau of Indian Standards, national-level consumer groups, the North Eastern Council, etc.

The council is tasked with the registration of all medical establishments after ensuring that minimum standards are adhered to. Each state has to have a state council with a similar mandate.

Each Act also has different approaches to penal provisions overseeing the private practice of medicine. Of the three acts, only the Karnataka version has provisions prescribing jail terms for contraventions of the Act. A person convicted of running a medical establishment without registration can face a prison term of upto three years and a fine of upto Rs 5 lakh. A violation of registration conditions can be met with provisions for a prison term of three years or a fine of upto Rs 1 lakh. Failure to inform the public about the charges for various services would attract a prison term of six months to three years and a fine of upto Rs 5 lakh.

The West Bengal Act provides for a fine of upto Rs 1 lakh for non-registration of clinical establishments and a penalty of Rs 1,000 per day after that upto a maximum of Rs 10 lakh. Disobedience can invite a penalty of upto Rs 5 lakh, as can willful destruction or falsification of medical records. The penalty for medical negligence as specified in the Act can range from Rs 3 lakh for a simple injury to Rs 10 lakh for death.

In the CEA 2010, the penalty for contravention ranges from Rs 10,000 for the first offence, which goes up for every subsequent offence, to a maximum of Rs 5 lakh. Willful disobedience or withholding of information can attract a fine of a maximum of Rs 5 lakh. Significantly, the provisions apply to government departments too.

There are also marked differences in how the three Acts treat the general obligations of medical establishments. Under the Karnataka Act, medical establishments have to conform to standards laid down in this Act or the rules made therein, and also make available, for the information of patients and the general public, the schedule of charges payable for different medical treatments and other services, using brochures, booklets and notice boards.

Every establishment has to maintain clinical records and mandatorily treat victims of road traffic accidents or criminal assaults whenever they come to a hospital. According to the patients’ charter, every patient has the right to complete information on the disease, treatment and medical procedure and a right to give informed consent on his or her own course of treatment.

The West Bengal Act says that every establishment will have to follow fixed rates, including package rates for medical investigation, bed charges, operation theatre procedures, implants, ICU charges, etc., and also provide proper estimates for treatments not covered in packages. The Act says, “…every clinical establishment shall strictly discourage repetitive laboratory tests…”. Establishments are also required to mandatorily obtain consent for the continuation of ventilator support after a patient is declared brain-dead.

The CEA 2010 envisages registration as the cornerstone of regulation, with registration conditions placed in the domain of the state government. As part of the enforcement plan of the Act, standard treatment guidelines have so far been prepared for 21 specialty areas, including endocrinology, oncology, neurology, orthopaedics and cardiovascular diseases. Guidelines have also been prepared for treating common problems like snake bites, dry eye disease, epilepsy, diabetic foot and osteoarthiritis of the knee.

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