CLINICAL ESTABLISHMENTS ACT (CEA)

An Ayurvedic Pharmacy, Rishikesh.

An Ayurvedic Pharmacy, Rishikesh. (Photo credit: Wikipedia)

The Centre’s ambitious plan to have an umbrella regulatory body for medical and paramedical
education hit a roadblock as the Parliamentary Standing Committee on Health rejected the
National Commission for Human Resources for Health (NCHRH) Bill, 2011. As retribution to it the
center wanted to implement the CLINICAL ESTABLISHMENTS ACT (CEA) which was introduced as
a Bill in 2010 in the parliament, as early as possible and was pressurizing the state governments
to accept it.
IMA had launched a protest campaign and AMC supported it wholeheartedly and also
participated as an active partner when IMA has called for a bandh on 25th June 2012.
Later, when Hon Health Minister was keen on tabling this ACT in the State, AMC had coordinated
with IMA and contacted our local MLAs. The idea was to reject the CEA in the present Avatar and
put it to discussion with involvement of all medical associations and make it doctor/ patient
friendly and then accept it. That time, we were successful in persuading the Hon. Minister Mr
Suresh Shetty to postpone the tabling of CEA 2010 in the Maharashtra Vidhansabha session.
In December 2013, multiple stake holders of healthcare in Mumbai collaborated on a single
platform chaired by the “Observer Research Foundation” and submitted a joint statement to the
Health Minister, Shri Suresh Shettyji expressing their apprehensions of the Central CEA and urging
him to create a Maharashtra specific draft of CEA. The State Govt. accordingly created an Expert
Committee to draft the Maharashtra specific CEA.
The Expert Committee of Maharashtra Clinical Establishment Act had five meetings so far since
5
th of January 2014. The committee comprises of around 19 members of which AMC is one of
them. There is a fair mix of individual consultants, Association of different systems of medicine,
NGOs, MMC council members and the Ministry of health. The AMC CEA committee comprising of
Dr. Lalit Kapoor, Dr. Ketan Parikh, Dr. Bipin Pandit, AMC NoAH office Bearers and the President &
Secretary are seized of this matter and are giving their active suggestions on behalf of AMC.
Nursing Homes all over Maharashtra are providing 70 % of total healthcare services. The matter
of concern in the expert committee of the Government is that there are a number of irrational
demands being made by the consumers without knowing the ground realities of medical
establishment. We have to use our wits and forceful arguments to put forth a doctor’s view point
and get them enlisted in the ACT.
The immediate cause of concern following the completion of draft of MCEA is the
draft minimum standards under Clinical Establishment Act, put by
the Ministry of Health and Family welfare on its website Not only are some of these
outright hilarious, they are mostly out of sync with reality.
These standards have been prepared without adequate and appropriate consultation with
stake holders. We at AMC, fear that this particular standards created at central level may be
adopted into the Maharashtra CEA after it is enacted and sub committees are made to draft the
rules.
To give you a brief review of the proposed standards;
Of utmost concern is Annexure 6 list of legal requirements for minimum standards being
prescribed for hospitals. AERB licences, Completion certificates, NOC from fire department, Diesel
storage license, DG set approval for commissioning, Retail and bulk drug licence, Narcotic drug
license, medical gases / explosive act license, boiler licences, Spirit license, NOC under Pollution
control act, sales tax registration. It is also not clear what is being asked for under electricity
rules. These licenses and registrations are being imposed to perpetuate and re-establish
inspector Raj and all small and medium scale healthcare facilities will close down.
3) It is surprising how the minimum standards for hospitals under ayurveda stream do not require
such stringent legal clearances. The list of statuary compliances seem to be only things like
vehicle registration certificate of ambulance, Right to Information Act , Consumer Protection Act,
Medical Negligence. What is expected of these hospitals under the RTI Act or CPA is unclear. It is
also surprising that hospitals under ayurveda which are having surgical facility like operation
theater , labour room do not seem to require basic lifesaving equipments like defibrillator, pulse
oxymeter etc. whereas smaller allopathic establishments are being burdened with unnecessary
requirements. A hospital whether allopathic or ayurvedic has to have similar legal, building,
labour, electricity, pollution, drug licensing. The requirement for Ayurvedic Hospitals even 100
bedded seem to be more in line of a general advisory rather than the minimum standards as
prescribed for small allopathic hospitals 1/ 10th the size.
4) Annexure 5 Staff requirement for level 1 hospitals is making it mandatory for pharmacist to be
employed. It is not clarified whether emergency drugs stocked for only inpatient use is classified
as pharmacy requiring services of pharmacist.
5) Annexure 3 Endoscopic cleaning machines are still not routinely used in even premier
institutes and manual cleaning is the norm. Minimum standards should prescribe minimum
standards and not what is latest technologically available. CO2 monitor and many other similar
equipment are mentioned which may not be needed in places not running ICU.
6) What is the need for a 4 wheel drive vehicle in a Level 2 hospital? All hospitals are not located
in remote areas and in a city a 4 wheel drive is unnecessary.
7) There is no discrimination regarding size of hospital as has been done for ayurvedic hospitals.
Small superspeciality hospitals have now sprung up in cities which provide limited GI endoscopy?
GI Surgery, Obs and Gyn, Laproscopic surgery, even cardiology set ups. A superspeciality hospital
may be less than 10 bed or more than 500 bed and there is no difference in requirement of
minimum standards under the present list.
Minimum standards should mean minimum standards necessary to provide adequately
satisfactory healthcare to its consumers. CO2 monitors and Endoscopy washers are not minimum
standards. Further, minimum standards have to be uniform across Government, Private,
allopathic, Ayurvedic, homeopathic, naturopathy, siddha, Sowa rigpa, Unani, Yoga or
physiotherapy.
AMC has incorporated its recommendations in the Maharashtra Clinical Establishment Act with
the intentions of having a clarity of purpose and in order to make the regulatory structure
envisaged in the proposed legislation to be participatory, accountable and transparent.
Accordingly the said draft has been finalized as attached here.
We further believe that the Act needs to be less bureaucratic and avoid harassment of the
healthcare providers. It should be aligned within existing structures and systems. Our next focus
is that the various sections and clauses in the Act and Rules are practical, enforceable and
implementable.
In the interests of public provision of care and public health, the clinical establishment whether
public or private need to be given sufficient time to come up to the required minimum standards
prescribed. There cannot be two sets of application of the provisions of the legislation for public
and private clinical establishments.
We suggest that the Rules are drafted taking into consideration the relevant and pressing
problems of the clinical establishments and implore to the Health Ministry to develop minimum
standards with considerations of the same.
Almost all of the pre-requisites require a great amount of inclusive discussion with the
stakeholders. Otherwise the CEA would become another of the many Indian legislations which
appear rosy on paper but has no use in bringing about the necessary changes.

Dr Sangeeta Pikale Dr Vipin Checker Dr Sujata Rao

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