Private healthcare providers in India are above the law, leaving patients without protection

Irrational and unethical practices

Poor regulation results in fluctuating standards and irrational and unethical practices, such as unnecessary surgeries and diagnostic tests, commission for referrals, overcharging, and non-transparency in fees, which are widely reported in the media.2 3 4

Concerns raised by the judiciary, the National Human Rights Commission of India, and consumer organisations led parliament to enact the Clinical Establishments (Registration and Regulation) Act 2010 (CEA), which aims to regulate clinical establishments and prescribe minimum standards for personnel, infrastructure, records, and reporting information.5 The act covers public and private clinical establishments in recognised systems of medicine (allopathy, ayurveda, homeopathy, naturopathy, siddha, unani, and yoga), including single doctor clinics, laboratories, diagnostic centres, and all types of hospital.

The CEA currently applies in Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all union territories. Bihar, Jharkhand, Rajasthan, Uttar Pradesh, and Uttarakhand have adopted the act by passing a resolution in their state assemblies under article 252 of the constitution. Other states may choose to adopt the CEA or to introduce their own legislation.

Implementation has been slow and limited. Many states where the CEA applies have not framed the rules or notified the state councils and district registration authorities required under the act because of unresponsive bureaucracy and insufficient human resources, finances, and technical capacity. Only the states of Himachal Pradesh, Jharkhand, Sikkim, and a few union territories have implemented the act.

Opposition from the Indian Medical Association has deterred Rajasthan, Uttar Pradesh, and Bihar from implementing the act.6 Public interest litigation in Bihar led the judiciary to direct the state government to enact and implement the rules.7

Nevertheless the CEA has generated awareness and put pressure on states to enact legislation. Delhi, Goa, Haryana, Kerala, Maharashtra, Odisha, Punjab, and Tamil Nadu, are moving to enact modified versions of the CEA. However, private providers and medical associations have opposed such implementation.8 Their concerns include that the CEA will lead to “license and inspector raj”—that is, onerous state bureaucracy—and that the medical profession is already governed by several acts with harsh penalties for transgressions.9

Registration under the CEA requires application to the district registration authority, either by post, online, or in person. There is no inspection; after registration is applied for a decision has to be made within 45 days, and there are provisions for appeal if registration is denied. The act has no provision for imprisonment, only monetary penalties, because the intention is to seek compliance rather than to take punitive action. The CEA was enacted by the central government because many states did not have appropriate legislation for regulation and some states requested it.

Medical emergencies

Another reservation expressed is that the act makes it obligatory for clinical establishments to treat and stabilise patients who are in an “emergency medical condition.”10 Many private hospitals do not admit such patients because of fears of legal action or that the patient is uninsured or is unable to pay. The Supreme Court of India in 1989 passed a ruling making it obligatory for practitioners and establishments to provide emergency medical care, but few private hospitals comply (Parmanand Katara v Union of India and others).11 The CEA emphasises the judgment that clinical establishments should provide medical examination and treatment within the “staff and facilities available” such as may be required to stabilise any patient who presents in an emergency medical condition. A dentist or a laboratory will not be held accountable for not treating a patient with a cardiac emergency.

The CEA’s fixing of rates and charges is also opposed.12 Hospitals and practitioners exercise coercive financial practices, including disproportionate and excessive billing, demanding money before the operation; non-transparency in and non-disclosure of anticipated costs; and forcing patients to purchase devices, consumables, and drugs only from specific vendors.13 Healthcare costs are the single leading cause of impoverishment in India, and it is imperative that rates and charges are set and displayed.

Current regulatory and accountability mechanisms are not sufficient to ensure quality and prevent negligence. Patients’ interests are not adequately protected. India’s plans for universal healthcare coverage through the private health sector, the National Health Assurance Mission, will be stymied without appropriate regulation. Politicians at the highest levels must ensure private healthcare delivery is properly regulated to stop people being subjected to irrational and unethical practices.