Minimum Standards -- Clinical Establishments -- Suggestions

29 April 2014

Before the Chairman,
National Council for Clinical Establishments,
Government of India, New Delhi

Comments, suggestions, objections, including deletions/additions to the draft minimum standards for various categories of Clinical Establishments submitted by QPMPA

Through Dr. Anil Kumar, CMO (AK), Room No. 506 ‘D’ Wing, 5th Floor, Nirman Bhawan, New Delhi 110018

Ref:  Notice published at --http://www.clinicalestablishments.nic.in/WriteReadData/414.pdf

Sub: Minimum Standards proposed under Clinical Establishments Act, 2010 & Rules, 2012 - regarding

Respected Chairman,

Your team has done a wonderful job in drafting the minimum standards for Clinical establishments and the Treatment guidelines. Congratulations.

QPMPA is the first organisation in India to have demanded a Clinical Establishments Regulation Act in 1980s. We are proud of our founder president Dr. T. M. Paul, who proposed this, for his farsightedness. That has become a reality now in India within forty years and we are happy.

However, our suggestions were not to plunder and bleed the private sector healthcare institutions white, but to bring in some kind of standardisation all over India and stop the prevalent quackery.

We know fully well that the present exercise to ‘improve the minimum standards proposed with feedback from stakeholders’ is a futile one as things are finalised and fixed by the concerned parties well in advance – the usual practice in democratic India. The last Para of the notice cited proves that. Through an Email we requested for an extension of the last date but that was ignored. Our suggestions are based on practical knowledge of more than forty years of rendering quality health care at affordable cost to people of Kerala. And if accepted, it will be well and good for the country.

We have gone through the draft of minimum standards of Clinical Establishments published on MOHFW website. We have strong reservations and objections to those. We are an organisation of private sector hospital/clinic owners, hence we are more interested in their issues and our comments are confined to small hospitals/clinics.

Clinical Establishments Act & Rules reminds us of Muhammad Bin Tughluq, an Indian Sultan of yesteryears. The content is great, totally unrealistic and not suitable for our country now or later. It has to be redrafted on the basis of ‘levels of care’ rather bed strength. Minimum standards must be uniform minimum. Watertight demarcation of different levels is not possible because Indian health care scenario is totally different.

Clinical Establishments Act appears to be a regulatory model with patient safety as the central theme. Are we forced to think that the people are not safe now and this piece of legislation will bring in dramatic changes? The economic and cultural background of India is given the least consideration in formulation of the Act/Rules/Standards. Easy access to health care is going to be denied to the poor and vulnerable people if this law is implemented. Even today there is no dearth of laws to hamper smooth functioning of existing institutions. If this law is implemented no doctor will dare to start a new clinic and most of the existing clinics will close. The beneficiaries will be the powerful quacks spread all over India and the corporate hospitals. This in turn will increase cost of clinical care and will hurt the poor.

The extent of new corruption that can creep into the already corrupt system is unimaginable. The ‘licence raj’ will be so huge that it will collapse by itself. Even small hospitals are to procure and keep costly and unaffordable gadgets that may not be used at all in a life time.

80% of the population has more faith in private sector health care as statistics show. To keep minimum standards hospitals will have to tax poor patients mercilessly. It is beyond doubt that the law makers did not consider the basic requirements of hospitals in Indian context before slapping minimum standards on them. The lack of knowledge about ground realities is evident in all the drafts.

We feel that there are ulterior motives behind all these bluffing exercises. Indian patients will be forced to approach the Insurance companies. In turn Insurance companies are going dictate terms and conditions with doctors and hospitals on how to treat patients. The noblest profession in the world will be regulated and manipulated for commercial gains. However, the oldest profession (brothels), we hope, will be spared from modernisation and so will survive and nobility disappear!

Kindly consider the following and do the needful:-

1. Unrealistic minimum standards proposed for Indian hospitals is the greatest drawback of Clinical Establishments Act, 2010 & Rules 2012. India lives in villages. In cities also there are slums. How can these peoples afford the hospitals once CEA is in place? It will be ideal to exempt small scale hospitals / clinics from the purview of CE Act and that will help the poor get cheap healthcare.

2. Categorisation of hospitals based on bed strength instead of levels of care is a serious lapse since number of beds has nothing much to do with patient care. Realities in health care of rural India are not considered and reflected in the prescribed standards which can be met only by affluent countries.

3. Issues relating to existing hospitals, their resources and future are not given due consideration.

4. Different levels of care have to be defined based on social requirements and availability of resources such as location, space, manpower, etc.

5. The levels of care can be 4 to 5. You now have seven levels – 4 types of Polyclinics and 3 types of Hospitals. We hardly need 5 as below: 

5.a. Doctor having a consulting room and an assistant: - The doctor must decide what all he needs for his practice. Delhi is not the place to decide how he does his job.

5.b. Small hospital in village having primary care facilities: - Bed strength has no relevance as admissions are only for acute situations. Facilities for observation are all that are required. A hall with screens, good ventilation, lighting, toilet facilities and other medical infrastructure.

5.c. Hospital with 10-15 beds having general medicine, surgery, paediatrics and gynaecology manned by experienced doctors who can perform small surgeries, fracture reduction, provide antenatal care, attending to uncomplicated deliveries, immunisation, etc.:- They must have Lab, X-ray, ECG and portable Ultrasound machine. Here again bed strength is not a criteria as cost can be contained by judicious admission procedures.

5.d. Referral hospital with facilities like Operation theatre, medical and surgical ICUs, etc.

5.e. Teaching hospitals.

6. The story told by Dr. P. Kamalasanan & Dr. Geetha: - In rural Kerala, most of the hospitals have one or two specialities, like ours. We have General Medicine and Gynaecology because I am a physician and my wife is a gynaecologist. We have a bed strength of 20. We are practising there for the last 40 years. We have organised various amenities based on our clinical requirements; nothing more or nothing less. When we went through the proposed Act we found it unrealistic. And naturally we wondered where these champions of affordable health care to poor Indians were hiding all this time. We cannot offer ‘cost effective treatment’ to the poor people of our village if we comply with these champions of poor. How can we plan and reshape our hospital as they prescribe? They have to give exceptions, exemptions and extensions for existing institutions or else we have to close our hospital.

7. The standards / minimum requirements are to be decided based on efficiency and economic viability.

8. The Treatment Guidelines cannot be made mandatory. These guidelines are meant to aid clinicians nationally and are nowhere must they be binding. The individual doctor’s discrete and ethical decision must be final.

9. At the heart of ‘clinical negligence’ lies the question of whether or not the practice of a doctor has fallen below the required standards of care. Under common law, the minimum acceptable standard of care is measured against responsible medical practice, and not against guidelines. In law, therefore, it is expert medical evidence that primarily assists the court in determining what the standard of care should be, and clinical guidelines should have only a subsidiary role. The Act does not protect doctors following Treatment Guidelines.

10. Mixopathy – AYUSH + Allopathy – should not be encouraged under one roof.

11. Annexures – That said in the “Table of Contents” pages of the Standards do not tally with that in the text. One is Annexure 6 -- it is there in the text but not mentioned in the Contents pages of Hospitals 1, 2 & 3. Kindly note that your team has not perfected the copy-paste technique. We are now sure that some pages will be replaced.

12. Annexure 4 deals with drugs. In Polyclinics the list shown has 14 drugs and in Hospitals 34 to 35. This annexure could have been avoided by saying that the institution will store all required drugs. That depends on the doctors working there.

13. Annexure 6 – List of Legal requirements: It is there in the Level 1, 2 & 3 Hospitals. There are 26 to 28 legal requirements. Polyclinics are spared and thank you for that.

14. One requirement of CE Act is to achieve all India uniformity for Clinical Establishments and prevention of duplication. Items in Annexure 6 will prove that claim wrong. A Clinical establishment must be registered at three levels, viz., under Nursing Home Act/Medical Establishment Act/Clinical Establishment Act. It appears that the drafters are ignorant of the Nagarapalika/Panchayathi Raj Acts and the registration of Clinical Establishments under that. The purpose is to please four set of Officials periodically.

15. Health is a State subject and State Acts & Rules are more important. License is a form of regulation all over the world. Unfortunately, in India it is a means to harass the licensee. License fee is nominal everywhere; but in India, it has been transformed as a source for income generation for government. Pollution Control Board is one example. For the PCB, the license fee is proportional to the income of the institution!

16. Is drug not an integral part? To run a hospital the proposed Standards demand “retail and bulk” Drug License, Narcotic Drug License, Medical Gases Licenses, Spirit License and Sales Tax registration.

16.a. Retail & Bulk Drug Licenses – Drug License is a must for Drug Stores where there is sale. In a hospital, drugs are not sold, but only dispensed. For it a license is not required as per Drugs & Cosmetics Act, 1940 & Rules, 1945. Collecting the cost of drugs after issuing bill is not ‘sale’ and Drugs Act has not restricted that. Please remove the Drug License part so that at least the harassing drug officials can be kept away to ensure the smooth running of hospital.

16.a.(i). A Drug License is required for Govt. Hospitals. Unfortunately, many Govt Hospitals are working without a Pharmacist and Drug License. A Drug License is issued in the name of a Pharmacist, and he decides everything in the Pharmacy by colluding with the Drug Inspector who is his real boss.

16.a.(ii). A clinical establishment cannot function smoothly with a Drug License issued for the Pharmacist. Also it cannot function with the Drug Inspector dictating terms and conditions in the hospital. The Drugs Act is meant to ensure that doctors and public are getting standard drugs. The Act is not to regulate the practise of doctors in hospitals. A mechanism must be developed to supply Narcotics & Surgical Spirit for all hospitals taking registration under CE Act. Recently there was an Apex Court Ruling that a license is not required for Narcotics. Four Licenses – ‘Drug’, ‘Narcotics’, ‘Medical Gases’ & ‘Spirit’ – must be done away with.

16.a.(iii). Drugs Control Departments all over India are forcing Private Clinical Establishments to take Drug License to dispense drugs from hospitals/clinics/etc., violating the provisions of the Drugs Act and Rules. Rule 123 and Item 5 in Schedule K exempts “a registered medical practitioner” from the provisions of Chapter IV of the Drugs & Cosmetics Act, 1940 and Rules, 1945. Chapter IV covers Sections 16 to 33A. If the Drug License part is not removed from Annexure 6, the Drugs Department will gain an upper hand to enforce it.

16.a.(iv). The Kerala High Court declared that the phrase “a registered medical practitioner” used in Item 5 of Schedule K means “a single registered medical practitioner” and the exemption under Schedule K is applicable only for “a single registered medical practitioner”. It additionally declared that the exemption will vanish if two or more doctors (RMPs) sit together and work under one roof. More than 10 judges are involved in this legal battle in Kerala High Court/Apex Court between QPMPA vs. Drugs Control Department of Kerala from 1991 (OP No. 2170/1991).  Finally, in Review Petition (RP) No. 794/2010 the QPMPA was forced to inform the Court that the phrase “a registered medical practitioner” means all the registered doctors and that the “a” used in the phrase is “an indefinite article” of English grammar and means all registered doctors and not one doctor.

16.a.(v). From the Review Petition cited, the Court found out their folly but ego did not permit them to accept the truth. To juggle the world they imposed a penalty of Rs. 10,000 saying -- what QPMPA submitted was not a “Review Petition” but an “Appeal”. I, the Secretary, paid the amount as the association is bankrupt now. The great advantage for the Judiciary is that no one can easily get a copy of the petition/memorandum filed. The world sees only the judgments!

16.a.(vi). The Drugs Controllers quote Section 18 (c) of the Drugs Act and Rule 65 (5) (1) -- Conditions of License – when demanding hospitals to take license. Rule 65 being vast the Officials eager to trap RMPs into taking Drug License fail to read even Rule 65 (5) (1) fully. More on this can be read at http://www.qpmpa.org/node/62

16.a.(vii). Pharmacists: Pharmacy Act, 1948 Section 42 clearly says that an RMP can dispense medicines without a Pharmacist. The cited Section permits doctors to run hospitals without a pharmacist. The Drugs Act also permits it. Kindly remove the Drug License requirement from Annexure 6. In the ‘list of personnel’ please add that a Pharmacist may be appointed if required, depending on the number of doctors and patients. A Pharmacist is a must for Govt. Hospitals only as per the Drugs Rules 123, Item 5A, Schedule K. Kindly refer Rule 2. Definitions in Drug Rules, 1945 – Rule 2 (f) & (g).  

16.b. Sales Tax Registration – The State tax Officials are after hospitals to improve/increase their catchment area and clinical establishments are their favourite target. Kindly take steps to stop them and remove that item from Annexure 6. Declare that Clinical Establishment shall not tax patients.

17. Pollution Control: Pollution Control Board (PCB) is another department to plunder and loot citizens nationally. As per Annexure 6 two permissions are required from PCB – Biomedical Waste disposal/Air & Water Pollution. Waste water from Hospitals is under the “Red category” of the PCB in Kerala and the fees proportional to the income of the institution. Many cases are filed in Kerala High Court and the issue is a big headache for all healthcare institutions in Kerala. This must be made uniform all over India.  

18. 4-wheel drive ambulance: We appreciate the vision of our planners. Luckily they could not imagine the advantages of a helicopter. We feel that an ambulance for all clinical establishments is a good idea provided the GOI pays. On the strength of this single amendment the Health Minister’s name will be there in the history of India in golden letters. The minimum standards mention that an ambulance is not compulsory for Level 1 & 2 hospitals. However, it appears that the drafters missed an important section in the CE Act – “that there should not be any material deterioration of the patient while transferring.”

19. Electricity Rules in Annexure 6: We fail to understand what you have in mind about Electricity Rules included in the annexure. This is yet another department plundering private hospitals. The Electricity Board charges Rs. 8.50 per unit consumed by private hospitals. There are others in the same field paying Rs. 5.10 per unit. Private clinical establishments are reclassified into a separate group and charged heavily. The ill organised doctors are paying that by charging poor patients. There is no clear definition for hospitals – Industry, Commercial Establishments or Service sector. Every department try to portray hospitals/clinical establishments to suit their convenience. Through CE Act a uniform picture must evolve and energy charges must be made uniform all over India for health care Institutions. The tax on electric energy for hospitals must be abolished.

20. Shift duties/Staff strength: The strict 8 hour duties cannot be implemented. The fixing of duty timing must be left to Hospital managements and not the Labour department. Govt can check whether Labour Laws are followed. The average occupancy in most of the private hospitals is less than 50%. Fixing staff on bed strength will not be viable for private hospitals. Moreover, in Level 1 & 2 hospitals owned and managed by single/couple doctors, the patient is looked after directly by the doctor and hence there should not be a compulsory staff pattern for them.

21. Stabilisation/Transportation/Cost involved: It appears that the drafters of standards are wiser than those who coined the Act. Compelling a doctor to treat a patient and then punishing him if something goes wrong is against human rights and constitutional rights. All patients with some legal background can demand free treatment and care in the name of emergency!

22. Last but not least: The time to amend Clinical Establishments Act and Rules, to remove all the offending sections and to add new ones to ensure uniformity all over India has come. By registering under CE Act, an owner of a Clinical Establishment must get all the required licenses and permissions to run the same. If that is done the shortage of healthcare facilities in rural areas will be solved by the young ones coming out every year. Incentives like interest free loans to develop healthcare establishments for qualified hands will be appropriate.

Dear Sir,

These are few of the suggestions we present before you for consideration. We have only discussed problems of Clinics and hospitals. Kindly pardon us if we have gone out of the way.

Thanking you and with regards,

Yours sincerely,

Kishore Kumar (Secretary, QPMPA)

Encl: 3 QPMPA Journals to understand the course of Drug License case –
(1) Vol. XXIV – No. 2 -- March/September 2010,
(2) Vol. XXIV – No. 3 – October/December 2010 &
(3) Vol. XXVIII – No. 1 – November/March 2014.

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