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AMRI disaster: An expose of regulations

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Kumkum Sen
Last Updated : Jan 21 2013 | 1:22 AM IST

The regulator is the state-appointed protector of the interest of those receiving the establishment’s care.

For my year end column, it was a conscious decision to write on the first medical establishment disaster in country, having missed writing on the Supreme Court’s ruling in the Uphaar case. The parallel cannot be overlooked, though Hotels and hospitals are establishments which involve short term accommodation, in providing and catering to certain specific requirements of the resident customer. In case of hotels, selection involves criterion based on the customers’ requirements, comfort, cost, location, special facilities. Hospitals are usually a Hobson’s choice, depending on clinical specialisation, otherwise the doctor’s or insurer’s preference. The tragedy has, as in the case of Uphaar, put the regulator’s role under the scanner. Undoubtedly India has some global quality institutions, and can project itself as a healing hub with highly skilled doctors. Even then, the question which was raised in the context of Uphaar and in any tragedy of this magnitude, why could this not have been averted by the Management or the Regulator? How effectively is the health care sector in the country regulated? What are the regulatory frameworks? How are safety requirements addressed, apart from those involving medical services and care? Who are accountable, in cases such as the AMRI Hospital disaster? Is there any designated person, a counterpart of a factory occupier under the Factories’ Act, within the establishment who faces the music if the establishment is not equipped with proper fire fighting systems? Why were combustibles stored and permitted to remain in the basement in contravention of all laws?

To get a proper perspective, it’s important to understand how India’s healthcare system works and the legal and regulatory framework has evolved. Hospital health care services are provided by both public and private health sectors. Health being a State subject, the primary responsibility is that of the State Governments, which provide health services under the ESI Schemes and other State operated institutions. The private sector has developed in an ad-hoc manner since the size and facilities are not based on any classification.

Maharashtra was the first State to introduce a State Law in 1949. The next in line was West Bengal in 1957, possibly as the visionary first Chief Minister was a reputed doctor. This was replaced in 2010 by the West Bengal Clinical Establishments Registration & Regulation Act (‘Act’). The Act applies to all clinical establishments in West Bengal which include clinical laboratories, nursing homes, physiotherapy establishments, regardless of size, including single Doctor Establishments, but does not cover Government operated establishments.

Chapter III of the Act provides for registration and licensing and it is nobody’s case that AMRI Hospital was not duly registered. Media Reports suggest that the licence was suspended due to certain non compliances, which triggered the disaster. The responsibilities for the regulatory functions vest in a senior Health Services Officer designated as the Registering Authority (‘Authority’). In order to determine whether registration should be permitted, the Authority has to be satisfied on various issues to ensure inter alia, that the location, construction and accommodation fulfil the minimum standards necessary for a clinical establishment, as proposed in the Licence’s application, and such findings duly recorded in writing. The Authority also has the power to cancel registration and/or the licence, if the conditions of are in breach, or on account of dissatisfaction with the person(s) entrusted with the management of the Clinical Establishment. Such contraventions, specifically includes quality issues pertaining to construction, accommodation or equipment. The Authority has the power to issue directions for removal / rectification of deficiencies, in an ‘Improvement Notice under the Act.

In the present case an Improvement Notice was apparently issued to AMRI sometime in September, 2011 requiring removal of the highly combustible material being stored in the Annexe basement, but there was no follow up by the Licensing Authority to ensure that remedial steps were taken by the establishment. Possibly the occurrence of a fire in October led to the licence being suspended, but the Authority did not exercise its powers to direct suspension of fresh admissions to the establishment or temporary closure till remedial steps were taken. After the event, the Government in a knee jerk reaction arrested the board members. Were the issues escalated to the Board by the Administrator, arrested subsequently? There is no clarity on this.

On liabilities and accountability, the Act provides that in case of companies every person who at the relevant time is responsible for the conduct of its business would under section 31 of the Act, be held liable, however sub-section (2) clarifies that if such contravention is established to be with the consent or connivance of or attributable to any negligence on part of any Director or other officers, such persons will be deemed to be guilty – the mens rea concept. Section 33 provides that other than the monetary compensation in cases of grievous injury or death arising from any contravention or negligence, the name and place of residence of the person(s) held guilty and the offence and penalty imposed will be notified by way of a public notice, and compensation recovered if required, by forfeiture of the establishment and even personal property.

The matter will not be adjudicated by a Civil Court but by the Statutory Tribunal constituted under the Act, which also provides from the regulatory regime and the appeal from any order will lie directly to the High Court. It is unlikely that the Tribunal in a case of this nature would hold its statutory arm to be negligent. Even the Supreme Court, while agreeing with the Delhi High Court in the Uphaar case held that the performance of the Licensing Authority and the MCD was “mechanical, casual and lackadaisical”. Unfortunately, the Supreme Court also held that this would not translate in the monetary liability. The regulator is the state-appointed protector of the interest of those receiving the establishment’s care. If there is dereliction of duty by the Regulator then if not parting with money, some heads need to roll.

Kumkum Sen is a partner at Bharucha & Partners Delhi Office and can be reached at kumkum.sen@bharucha.in  

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First Published: Dec 19 2011 | 12:06 AM IST

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