Petition Closed

Withdraw CEA Rules-2017 & Establish Statutory Regulatory Agency for Med.Lab Professionals

This petition had 2,399 supporters

The serious objections to the 'draft Schedule' related to the qualifications and the signing authority inserted after Rule 9 of Clinical Establishments (Central Government ) Rules, 2012. [Refer Notification No. G.S.R (General Statutory Rules). 441 (E) issued in 'the Gazette of India Extraordinary' dated 5th May 2017]

Sh.J.P.Nadda Ji, 

Union Minister for Health and Family Welfare, 

Ministry of Health and Family Welfare,

Nirman Bhawan, New Delhi.-110011

Subject:, - Objections and suggestions regarding Clinical Establishments (Central Government) Amendment Rules, 2017 Reference: Notification No. G.S.R. 441 (E) issued in 'the Gazette of India: Extraordinary' dated 5th M 2017.


The petition is concerning the notification mentioned above published in 'the Gazette of India: Extraordinary' dated 5th May 2017. The Indian Confederation of Medical Laboratory Science (ICMLS) is an umbrella organisation of 25 associations representing more than 50 thousand medical lab professionals working under various Central, State, Autonomous and private health care establishments. We on behalf of ICMLS, wish to submit the petition containing our objections and suggestions for the kind consideration of Ministry of Health and Family Welfare, Govt. of India.
We have no objection on the Govt. of India's prescribed minimum standards for the Clinical Establishments offering services and facilities such as diagnosis, treatment etc and with regard to infrastructure, maximum fee and charges, etc. under Rule 8A in CEA Amended Rules, 2017; (from now on 'Amended Rules‘) by virtue of powers conferred by section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (from now on 'Act‘). 

We also believe that there should be an accountable, responsible and a foolproof system of health Governance to stop the malpractices in the healthcare sector. The move, therefore, to frame MINIMUM STANDARDS under Clinical Establishments (Registration & Regulation) ACT-2010 is a welcome development. But we have serious objection to draft Schedule relating to the qualification and the signing authority inserted after Rule 9 to CEA Rules, 2012 [refer Notification No. G.S.R. 441 (E) issued in the Gazette of India: Extraordinary dated 5th May 2017] (from now on 'Rules‘), which is illegal, unconstitutional, arbitrary and beyond jurisdiction and in violation of provisions of the Act including Section 52 on the legal, functional and administrative ground:-

1) BECAUSE the Ministry of Health and Family Welfare (from now on 'Ministry‘) is in active connivance with the vested interest, inside and outside the Ministry by making self-styled interpretation of various provisions of Act including section 52. On the pretext of this Act, the Ministry wishes to control each aspect of health care regulation including Medical laboratory professionals' qualifications and scope of practice beyond its jurisdiction. The Council want to control everything inside, and outside of the 'Clinical Establishment‘ that never admits the patients, never involved in diagnosis or treatment or care of illness.

2) BECAUSE The Clinical Laboratory is a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information/data for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure or otherwise describe the presence or absence of various substances or organisms in the body. Reference: CLIA.

3) BECAUSE as per statement of objectives, the sole purpose of CEA-2010 is to register and regulate all clinical establishments and other matter connected in addition to that defined under section 2 of the Act and have granted no power to frame rules for registration and regulation of medical lab professionals and other allied health professionals.

4) BECAUSE specific statutory Regulatory Agency must be created for the registration and the regulation of medical lab professionals and other AHPs. This statutory, regulatory agency can then, regulate professional practices and prescribe minimum essential professional qualification and also decide the scope of practice as per length of study and curriculum, etc. in line with other health regulators like MCI for Doctors, INC for Nurses, PCI for Pharmacists, DCI for Dentists, etc. 

In the present case, instead of expediting the process for the establishment of a similar statutory, regulatory agency for medical lab professionals, which has been lying pending over the past several decades, the Central Government has arbitrarily notified Rules under CEA-2010 beyond its jurisdiction.

5) BECAUSE  Section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010) never confers the power either to the Central Government or the National Council for Clinical Establishments to decide matters concerning the essential professional qualifications and the signing authority of medical lab professionals. 

The National Council for Clinical Establishments (from now on 'Council') is misinterpreting the section 52 which just empower the central government to frame rules concerning the qualification and the terms and condition governing the appointment of the members of the National Council under clause c of subsection (1) of section 10.

6 (a) BECAUSE Medical Laboratory Technologists / Medical Laboratory Scientists are trained only in the management, scientific and analytical practice, they never involved in clinical practice. They neither admit patients, make the diagnosis nor provide treatment or care for illness; therefore, no patient is admitted by them or under their control for medical treatment. Rather, they only provide information/data analysis for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise, describe the presence or absence of various substances or organisms in the body.

6 (b) BECAUSE of the BMLS (Bachelor of Medical Laboratory Science) Technocrats only perform a full range of clinical laboratory tests and should be able to extrapolate data acquired while MBBS (Bachelor of Medicine and Bachelor of Surgery) medico diagnose and manage common health problems and practice evidence-based medicine. BMLS curriculum is absolutely laboratory oriented intensive workout (includes Lab Management, Lab Quality, and Scientific analysis) whereas MBBS curriculum is more of medicine based patient preparation with the minimal orientation towards laboratory investigation and analysis. Therefore, it is wrong and incorrect on the part of 'Council‘ to authorize an MBBS Physician to validate and sign the work of clinical laboratory independently done by Allied Health Professionals. It is an indirect attempt to capture the business of highly trained and qualified professionals without any logic and justifications.

6 (c) BECAUSE in all Semesters of curriculum BMLS, MLT/MLS are given intensive orienting workout in different subjects i.e., Bacteriology, Haematology, Biochemistry and Histopathology and are applied aspects, whereas, in MBBS, it is carry over brief practical in one subject only i.e., Microbiology, Pathology, etc. The semester wise comparative chart of BMLS and MBBS showing duration of Courses, ethics of courses, eligibility for admission to courses and practical based Semester wise course contents, which had the due approval of ‗Ministry‘ is being attached for your kind perusal and due consideration. It is clearly evident from the comparative chart that the Medical Laboratory Technologists or Laboratory Scientists are well trained and highly qualified professionals in their field and are competent to perform pre-analytical, analytical, and post-analytical processes to generate a test report based on laboratory Standard Operating Procedures (SOP) and statistical calculations, thus are legally authorized for the laboratory work done by them. Copy of semester wise comparative chart is being attached as Annex-III and Syllabus of MBBS AIIMS New Delhi is as Annex-IV

7) BECAUSE the rules-2017 notified by the central government under Clinical Establishment Act, 2010 has been stretched beyond limits to regulate and control the Medical Lab Profession by medical fraternity with mala fide and bad intentions and with extraneous reasons and consideration to capture business.

8 BECAUSE the futile and overreaching attempt to control and regulate Medical Laboratory workforce and its practices by Council under the Act is a part of bigger conspiracy in continuity of attempts being made by medicos to capture the business and profession of Medical Laboratory Technologists/Medical Laboratory Scientists under the garb of CEA-2010, Indian Medical Council Act, 1956 and State Medical Council Act(s). The Hon‘ble Supreme Court is already seized of the matter in Special Leave Petition (Civil) No. 28529 of 2010 titled Association of Self Employed Owners (Para Medical) of Private Pathology Laboratories of Gujarat vs. North Gujarat Pathologist Assn. & Ors. The Honourable Supreme Court has been pleased to implead Ministry of Health and Family Welfare, New Delhi and Medical Council of India as necessary parties Suo moto vide Orders dated 9.8.2016. A copy of Interim Orders dated 9.8.2016 is attached as Annex A-1.

9) BECAUSE the Medical Laboratory Technologists / Medical Laboratory Scientist are not para-medicals. The work of para-medicals is entirely different. The para-medicals perform pre-hospital emergency services to safely lift or carry immobile patients from homes or accident site to hospitals/clinics. The word „para-medical‟ has been defined as under; Dictionary Definition-paramedical adj: of or denoting a person who supplements physicians and nurses in their activities; "ambulance drivers are paramedical personnel" n: a person trained to assist medical professionals and to give emergency medical treatment. Extensive Definition-A paramedic is a medical professional, usually a member of the emergency medical service, who primarily provides pre-hospital advanced medical and trauma care. A paramedic is charged with providing emergent on-scene treatment, crisis intervention, life-saving stabilisation and, when appropriate, transport of ill or injured patients to definitive emergency medical and surgical treatment facilities, such as hospitals and trauma centers.

The use of the specific term paramedic varies by jurisdiction, and in some places is used to refer to any member of an ambulance crew. In countries such as the United States and the United Kingdom, the use of the word paramedic is restricted by law, and the person claiming the title must have passed a specific set of examinations and clinical placements, and hold a valid registration, certification, or license with a governing body. Even in countries where the law restricts the title, popular media has created a culture whereby lay persons may incorrectly refer to all emergency medical personnel as 'paramedics', even if they officially hold a different qualification, such as emergency medical technician-basic.
Places of work Paramedics are employed by a variety of different organisations. A paramedic can be employed by government agencies as part of a public hospital system, as a separate municipal EMS service, or sometimes, especially in the United States, as part of a fire department.
Paramedics are also employed by private sector organizations (private hospitals, private ambulance companies, corporations, mines, air ambulances, racetracks, etc.)., Paramedics may also work on a volunteer basis, receiving no monetary compensation for their services (i.e. Volunteer Rescue Squad / Volunteer Fire Department and community response units).

10) BECAUSE the Medical Laboratory Technologists / Medical Laboratory Scientist belongs to a category of Allied Health Profession. The word ‗Allied Health Professional has already been comprehensively defined in the report of Ministry ―Paramedics to Allied Health Professionals: landscaping the journey and way forward. 

11) BECAUSE it is relevant to look at the Statement of Objects and Reasons as placed before Rajya Sabha on 3rd February 2017 with Bill No. LVIII of 2016. STATEMENT OF OBJECTS AND REASONS- The Clinical Establishments (Registration and Regulation) Act, 2010 was enacted to provide the registration and regulation of the clinical establishments with a view to the minimum standards of facilities and services which may be provided by them so that the mandate of Article 47 of Constitution of India for improvement in public health may be achieved.
This act was enacted in the year 2010. Certain Rules to operationalise the Act were also issued. However, there is widespread commotion and unrest among the public that certain clinical establishments are (i) subjecting the patients to unnecessary and unwanted diagnostic tests and threatening the patients of dire medical consequences if they do not undergo the tests prescribed to them, (ii) charging the patients with exorbitant fees for the diagnostic and treatment services (iii) prescribing expensive branded medicines ignoring availability of generic medicines, (iv) totally keeping the
bystanders, relatives in the dark about the condition of the patient being treated and the treatment extended in the intensive care units and emergency wards and (v) not complying with the conditions imposed by governments after getting concessions and relaxations from the Government. In this context, there is a definite need for evolving a proper procedure/ mechanism to streamline these clinical establishments and forcing them to adopt a uniform system of charging for diagnostic tests, doctor fees, costs for medical facilities offered by them. There shall be proper the check on these clinical establishments and bills charged by them so that they cannot exploit the common people approaching them for the treatment of various diseases apart from compelling them to use expensive branded medicines. There are instances wherein these clinical establishments are charging the CGHS/Health Card/ Insurance Patients to the extent of their maximum eligibility by compelling them to undergo various tests, treatments, which may not be necessary for their recovery. The proposed Bill addresses the above concerns to a certain extent. Therefore, the concerns shown and expressed in Statement of Objects and Reasons with Bill have no nexus with Medical Laboratory Technologists / Medical Laboratory Scientist or Medical Laboratories. Therefore, the Act does not cover the establishment of Medical Laboratory.

12) BECAUSE it is now very important at this stage to refer to various sections and provisions of Act which have been interpreted by the Council in a self-style manner. However, we are not against the prime objective of the Act but wish to submit how the word “Medicine” is used arbitrarily everywhere just to control every segment of health care with pure mala fides and under the influence of medicos to capture business and independent profession of Medical Laboratory Technologists / Medical Laboratory Scientist The Definitions have been given in Section 2 of Act; Section 2 (c) ―(c) “clinical establishment” means— (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or (ii) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not,‖ The word ‗medicine‘ means the science and practice of the diagnosis, treatment, and prevention of disease.

The Medical Laboratory Technology / Medical Laboratory Science is not a system of medicine. They do not diagnose and prescribe drugs and medicines for the treatment of patients. The ‗Council‘ has been stretching the word ‗clinical establishment‘ beyond limits to bring the independent establishment of medical laboratory and Medical Laboratory Technologists / Medical Laboratory Scientist under its ambit and scope in an illegal and arbitrary manner. Section 2 (d) ―(d) ―emergency medical condition‖ means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) of such a nature that the absence of immediate medical attention could reasonably be expected to result in— (i) placing the health of the individual or, with respect to a pregnant women, the health of the woman or her unborn child, in serious jeopardy; or (ii) serious impairment to bodily functions; or (iii) serious dysfunction of any organ or part of a body; No such activity is carried out in a Medical Laboratory by Medical Laboratory Technologists / Medical Laboratory Scientist; therefore, the „Council‟ has no power and authority to prescribe minimum standards and educational qualifications and signing powers for the work carried out in Medical Laboratory by highly qualified and trained Medical Laboratory Technologists / Medical Laboratory Scientist. Section 2 (h) (h) ―recognised system of medicine‖ means Allopathy, Yoga, Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani System of medicines or any other system of medicine as may be recognised by the Central Government;‖ The section 2 (c ) (i) talks of “clinical establishment” means— (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or .. Firstly, the Medical Laboratory Science is not a system of medicine as defined under section 2 (h), and secondly, it falls under the category of Allied Health Sciences.

13) BECAUSE the Council while making categorization of 'Clinical Establishment‘ of different systems under section 13 (1) of Act has included Diagnostic Centres and Allied Health Professionals at Sr. No. 5 & 6, which is illegal, unconstitutional and arbitrary. The Medical Laboratory Science is not a system of medicine. Therefore, it has not been included or mentioned in section 3 (2) (c), (d) & (k) of Act. The Council has been acting according to its whims and fancies by widening and expanding the extent and scope of word 'clinical' and 'different systems of medicine‘ in the Act with pure

The Council has been acting according to its whims and fancies by widening and expanding the extent and scope of word 'clinical' and 'different systems of medicine‘ in the Act with pure mala Fide and under the influence of medicos to capture business and independent profession of Medical Laboratory Technologists / Medical Laboratory Scientist. 

14) BECAUSE the  'Council‘ has constituted various Sub-Committees under Section 3 (1) of Act. Since the Act did not mean to control and regulate the Medical Laboratory Technologist / Medical Laboratory Scientist or their educational qualifications, jobs, duties and responsibilities, therefore, no Government or private or professional bodies representative of Medical Laboratory Science has been included in these Sub-Committees. Whereas, one representative from DCI, MCI, INC and PCI have been included. The representatives of other system of medicines have also been included under section 3 (c) & (d). The representative of Indian Medical Association, a professional body, has been included under section 3 (e). The representative of the paramedical system has also been added under section 3 (i). Though the Joint Forum of Medical Technologists of India (JFMT), which is a national registered body of AHPs, exists and is the voice of thousands of AHPs including medical lab technologists no representation has been given to this professional body. No representative of the Indian Confederation of Medical Laboratory Science (ICMLS) has been included as well which is a representative voice of more than 50 thousands of Medical Laboratory Technologists/ Scientists.

15) BECAUSE the Medical Laboratory Technologists / Medical Laboratory Scientist are educated and trained to analyse human fluid samples using techniques available to the clinical laboratory, such as manual white blood cell differentials, analysis by a microscope and advanced analytical equipment. They perform a full range of laboratory tests – from simple blood and urine tests to more complex tests and report laboratory findings to pathologists and other physicians.

16) BECAUSE under the prevailing law anyone can own a laboratory and there is nothing which restricts setting up of a medical laboratory by a medical practitioner only whose name has been entered in the register maintained under the Indian Medical Council Act or State Council. A laboratory can be set up even by a Company or be run by qualified professionals.

17) BECAUSE there is no law in the States nor there is any Central legislation which insists on additional qualification in lab services as a pre-condition for owning or running a private laboratory or independently working in a Government Medical Laboratory. A laboratory, under the existing laws, can be set up by any person.

18) BECAUSE the Medical Laboratory Technologists / Medical Laboratory Scientist do not fall within the purview of the Indian Medical Council Act, 1956 and, therefore, the provisions of the said IMC Act, 1956 are not applicable to them. The IMC Act, 1956 prohibits a person other than a medical practitioner enrolled in the register maintained under the IMC Act, 1956 from practising medicine. It does not prohibit running a medical laboratory by a highly trained and qualified Medical Laboratory Technologist.

19) BECAUSE the work of Medical Laboratory Technologists / Medical Laboratory Scientist cannot be termed as practising modern medicine.
Their work is restricted to examine the specimen samples and reporting the data observed on analysing the said sample. The said report is then carried to a person who would read the report, interpret the analytical values in the context of other visible symptoms of the patient, his history and then prescribe medicine or advise therapy/treatment. Thus, the work being done by Medical Laboratory Technologists / Medical Laboratory Scientist is essentially a pre-diagnosis work, and the report prepared by them works an aid in diagnosis and treatment of the patient. Therefore, it cannot be said that the Laboratory Technologists / Medical Laboratory Scientist are practising modern medicine, and therefore the Act or Rules are not be attracted to the work being done by the Medical Laboratory Technologists / Medical Laboratory Scientist.

20) BECAUSE it is an irony that the establishment of Medical Laboratory run by trained and qualified medical technologists is ‗not any recognised system of medicine‘ and cannot be registered with ‗Council‘ yet the ‗Council‘ wish to control and regulate the establishment of Medical Laboratory and its human resource.

21) BECAUSE the ‗Ministry‘ has proposed and placed a number of Bills for constituting Central Regulatory Authority with different nomenclatures for Medical Laboratory Technologists / Medical Laboratory Sciences before the August Parliament since the year 2004, like ―Paramedical and Physiotherapy Central Council Bill-2007‖, ―National Commission for Human Resources in Health (NCHRH) Bill -2011‖, Most recently, the ‗Ministry‘ has placed the Bill with following Statement of Objects and Reason titled as ‗Allied Health Professionals Council Bill, 2017. It is evident that the ―Ministry‘ has separate proposal to control and regulate ‗Allied Health Professions‘ by an independent Act even after the CEA came into existence in the year 2010.

22) BECAUSE the ‗Ministry‘ has recently issued Model Curriculum for Medical Laboratory Sciences, the cadre hierarchy, jobs, duties and responsibilities of
Medical Laboratory Technologists in 2017. It will be observed that the ―Council‖ has been acting contrary to the document released by Ministry of H&FW. The copy of Chapter 5: Job description for all levels (page 162-189) can be seen in ―Govt. of India Model Curriculum Handbook of Medical Laboratory Science‖, which is relevant, is being attached as Annex- A-II

23) BECAUSE though, the object and purpose to control and regulate the establishment of Medical Laboratory under the Act is mala fide and mischievous yet it is well known that the present strength of MBBS and Pathologists in the country will not be able to handle the huge task and work spread over across the country as proposed under the ‗Schedule‘. The MCI has been facing severe shortage even to manage qualified Physicians / Surgeons / Pathologists, etc. to run MBBS and MD courses in Government and private medical colleges / universities and these Colleges / Universities indulge in unfair practices by showing fake recruitment to fulfil the minimum standards fixed for by the MCI. The illegal and arbitrary proposals of „Council‟ will not only cause the delay in diagnosis and treatment by withholding results and reports of the medical laboratory but it will further create the shortage. Besides, the proposed ‗Schedule‘ to control and regulate the establishment of Medical Laboratory under the Act is illegal, unconstitutional, arbitrary and there is total non-application of mind. It may create kiosk and sheer mess, and will breed corruption, having no nexus with object and reasons given by legislature.

24) BECAUSE the Hon‘ble Supreme Court in Special Leave Petition (Civil) No. 28529 of 2010 titled Association of Self Employed Owners (Para Medical) of Private Pathology Laboratories of Gujarat vs. North Gujarat Pathologist Assn. & Ors is already seized of the identical issue and has been pleased to implead Ministry of Health and Family Welfare, New Delhi and Medical Council of India as necessary parties suo moto vide Orders dated 9.8.2016.

25) BECAUSE: Bachelor and Master degree in MLS are similar recognised degree programme run in hundred of Indian universities like many other professionals Degrees and Diploma in health care like MBBS, BAMS, BHMS, BUMS, BSc Nursing, BDS, Diploma and Degree in Pharmacy for which professional are authorises for their respective practice but it highly unfortunate that even after acquiring master and doctorate from same universities, Medical Lab professionals are deprived of their right of work in the profession. This is here pertinent to mention that if the government failed to establish any regulatory body that does not mean that professional MLS degree awarded by universities are fake. This is just a mockery of a well-established system; while Master degree holder in the same field can be a scientists/Researcher in ICMLR, CSIR, etc. and can also be appointed a faculty in various prestigious universities and institutions but cannot be authorized for the work about he/she has learned and earned his/her degree.

26) BECAUSE the Rural health statistics of 2015, published in officials Report of Ministry of Health and Family Welfare, Govt. of India is showing that already there is an acute shortfall of medical doctors in PHCs and CHCs are 3002 and 17525 respectively.

27) BECAUSE The India‘s creaking health infrastructure is facing one of its most dire challenges yet: a severe shortage of doctors and medical practitioners, which results in deficient care for hundreds of millions of people across the country. According to the Organization for Economic Cooperation and Development, India has 0.7 doctors per 1,000 people – lower than Pakistan‘s 0.8, China‘s 1.5, and the UAE‘s 2.5. The public health system, especially medical facilities in rural areas, bears the brunt of this deficit. As of March 2015, 8 percent of India‘s 25,300 primary care centres had no doctor. More than 80 percent of community clinics, where specialists practise, had no surgeons; 76 percent had no obstetricians and gynaecologists, and 82 percent had no paediatricians, according to a study by the Lancet – a UK medical journal.

Further, The FT‘s Amy Kazmin argues that Indian doctors are scapegoats for the country‘s failing health care system. Public expectations about treatment simply cannot be met without more public spending. Symptoms of the problem are occurring with a growing number of assaults on doctors by patients. India is suffering from an acute doctors shortage, with just one physician for every 1,800 people. Government spending is just 1.4% of GDP, compared with China which spends 3.1%. As a result, the healthcare system has neither the manpower nor the equipment to provide a reasonable standard of care for patients ( 08/05/17)

28) BECAUSE alone in one state Maharashtra there are Huge vacancies for specialist doctors which have forced the government to come up with an innovative solution — to start primary health centres (PHCs) where doctors will be available through telemedicine. In tribal regions facing the dearth of both public and private doctors, officials said, nurses and para-medical staff would be trained to treat patients, while doctors would be consulted through video-conferencing. In these PHCs, a kiosk will have a telemedicine consultation facility on one side and a laboratory on the other for diagnostic tests. Doctors attached with rural hospitals, and medical colleges will provide consultation through video conferencing. Nurses will be trained to conduct physical examinations and narrate symptoms to a specialist via the video call. The concept has already been rolled out in a few PHCs in Melghat. It will be scaled up to include other tribal regions (Gadchiroli, Nandurbar, Chandrapur and Konkan belt) in dire need of specialists. ―These are areas where doctors are not willing to get posted,‖ said Dr Satish Pawar, director of Directorate of Health Services (DHS). Nearly 40 per cent of posts for specialists such as paediatricians, gynaecologists, nutritionists, obstetricians and ophthalmologists are vacant in the state, according to official figures. In Palghar for instance, paediatricians, gynaecologists, nutritionists, etc. visit from five private hospitals in Mumbai for monthly camps. The new district has high vacancies in medical posts and alarming malnutrition rates. Hospitals have adopted blocks in the district to conduct screening and treat children. According to Vijay Satbir Singh, Additional Chief Secretary, Public Health, efforts are under way to recruit over 1,332 doctors and para-medical staff in Maharashtra. Of these, 545 are for super-specialty medical posts.―We plan to rope in BAMS (Bachelor of Ayurveda, Medicine and Surgery) doctors for tribal postings where MBBS graduates are not willing to go. We have noticed that BAMS doctors are ready to practise in tribal areas,‖ he said. In certain regions of Nandurbar, the government has also appointed ‗flying doctors‘, who visit villages on motorbikes to treat patients. These are BAMS doctors who stock regular medicines for fever, cough and cold with them. ―It is expected that with technological advancements, specialists from far away can be roped in on a regular basis. This will also address maternity and infant growth,‖ Singh added.

29) BECAUSE Most pathology laboratories in Maharashtra do not have a doctor to look at reports. With more than 10,000 diagnostic laboratories and just over 2,200 certified pathologists, most pathological laboratories in Maharashtra are run without a doctor, according to data from the Directorate of Medical Research and Education (DMER)

30) BECAUSE to cope up the manpower crises the Central Government is planning to start nurse practitioner course and also planning to train pharmacy professionals to prescribe medicine for supporting basic health care services.

31) BECAUSE Union Cabinet has already approved BSc Community Health course to fill up the GAP in the rural health system. The main objective of the course is to create mid-level health professionals with necessary public health and ambulatory care competencies to serve the rural population.However, medico‘s organisation like IMA is opposing this move of the government. And at the same time, most of their members prefer to go abroad rather than serving in our country rural health settings. This is nothing but showing a medico-centric approach towards health sector.

32) BECAUSE the health regulators are intended to ensure that the public is protected from unscrupulous, incompetent and unethical practices in the health sector and to assure the general public that services rendered by an individual or by establishments are qualitative and safe and duly regulated. To understand this health issue in a comprehensive manner, all basic elements of health regulation i.e. history, the purpose of health regulation, professional competencies, training as well as educational and professional qualifications of a professional. The right and scope of practices, existing health regulators and its regulatory approaches should be discussed simultaneously to arrive at a final fruitful decision. The public protection should be of the utmost importance while defining the scope and right of practices of a particular profession, and we shall leave out all other aspects as being secondary to the basic issue of public protection.

33) BECAUSE Health care is now a team works yet presently more than 30 health care categories are unregulated and out of the purview of any central council. In this context, it would be far better if the government would speed up the process for enacting an Allied Health Professional Bill which has been lying pending for the last many decades. It is high time to think out of the box. Such a move will help government for regulating health care in a comprehensive manner and to fill up the gap in manpower shortage and availability in rural health care rather to work for a medico-centric system.

34) BECAUSE medical lab handles highly sophisticated machines, diagnostic tools, techniques and procedures that a sound professional education, training, skill, and expertise in the related field. It is very amazing to see that even after acquiring professional masters and doctorate in relevant area, Lab professionals are not supposed to do their professional work independently. As per proposed draft, they will do everything in Lab but not authorised to sign the report which they generate after detailed analysis and scientific procedures. What does it mean? A MBSS doctor who is trained in medicine only and not for Lab Medicine, posted for few days or month in a Lab orientation during his professional training as a part of the MBBS programme is authorised to sign the report. While a Biomedical lab professional/Scientist who holds a dedicated professional education and training in the relevant field is not authorized to do anything legally. Such a professional is more competent than an MBBS doctor to certify his conclusions.

35) BECAUSE Strangely, he/she can be a Scientist/Researcher in ICMR or may be a teacher of Medical Sciences in Indian universities in the same stream. So, they can teach the subject but not practice in their field for which they are qualified and trained – is it not very surprising? However, there is no uniformity yet. The following is the list of major qualifications that exist for Medical Lab Professionals - For what purpose they are authorised if they can not authenticate what they perform
Common Qualification in Lab Medicine:- DMLT, BMLS, BScMLT/BMLT/MScMLT PhD in Lab Medicine. Specialised Courses-  Microbiology- BSc (Microbiology), MSc ((Microbiology), PhD Microbiology  Virology- MSc, PhD  Biochemistry- BSc, MSc, PhD  Pathology & Transfusion Medicine- MSc, PhD  Molecular Biology- MSc, PhD  Genetics-MSc, PhD  Experimental Medicine-MSc PhD
 Immunology-PhD  Cytology-PhD  Parasitology- PhD  Cytogenetic-PhD  Total Quality Management/Quality Assurance in Lab Sciences- MSc, PhD  Clinical Research- MSc-Other related subjects

36) BECAUSE of All above mentioned, Health Professionals are extensively utilised as the resource person for teaching, training, research and practice in their related area but are not authorised to sign a report. May we ask what the use of such academic degree is? What will be the purpose of this workforce if they are not authorised to do anything legally? In this context, we would like to clarify, however, that it is now a fact that more than 70% clinical decisions are based on Lab reports/data/provisional diagnosis which we made. Nevertheless, any Lab whether it is diagnostic/clinical lab or imaging centre, never claim to make a final diagnosis. It is the treating Physician who is supposed to make a final of based on the Lab reports and clinical history and presentations. So, why is such a big turf war for the authoritative position? The basic job of an MBBS is to practice in Allopathic system of Medicine and not in Lab Practices which is an independent multispecialty filed.

37) BECAUSE As far as MD Pathologists are concerned, yes, they are specialised for various pathological aspects like Histopathology/Histo-cytology etc. They should only be authorised for the said purpose. The statement that a Pathologist can sign any report in pathology is wrong. Simultaneously, there should be an equal and defined scope for a like Microbiologists, Biochemists and Biomedical Technologists/ Scientists of related subjects as per their qualification and experience.

38) BECAUSE Registration in MCI as an MBBS Physicians does not empower them to rule the entire medical profession. As already submitted, no single health stream can claim as a supervisor of the whole health system in modern medicine. Otherwise, there are many other medical practitioners also, registered and licensed with their respective councils like BHMS, BUMS, BAMS, BDS etc., who too will sooner, rather than later, will demand their scope of practice in Lab practices on the same pattern as being sought to establish in the case of MBBS Physicians.

39) BECAUSE One single activity does not make a profession. There are groups of identical function which make a profession. Therefore, overlapping of practices up to an extent with defined scope should be acceptable in present health system.

40) BECAUSE The Medical Laboratory Profession is an independent and well-established system in health care which is utmost important for the proper diagnosis and treatment. As far as size of medical laboratory workforce is concerned, it is one of the biggest segment of the modern health care delivery system after nurses. This segment of health care is largely managed by the medical lab technology professionals‘ i. E Medical Lab Technologists and Lab Scientists presently who are mostly professional graduate and post-graduate even doctorate in lab sciences. Recently MOHFW has designed a national curriculum for BMLS and master degree-MMLS degree courses. These courses are designed to create a pool of professionally qualified medical lab professionals who will specifically be taught about multidisciplinary lab sciences and will be trained about technological competencies for performing laboratory analysis through various scientific tools and techniques. While MBBS doctors are primarily taught and trained for clinical competence just for diagnosis and treatment of the diseases and not about technical competence which is very necessary to perform scientific laboratory analysis. Curricula of both courses are annexed herewith for reference.

Given the above scientific parameters and discussions, proposed Rules are irrational, biased and unconstitutional which are needs to be reviewed as per their professional qualifications with a holistic viewpoint towards medical laboratory profession. There should be a rationalise discussion of the expert from related professions if Ministry of health & FW is intended to provide a justified scope of practice as per above-mentioned parameters. Further, up to an extent an overlapping scope of practice is in reality in a rapidly changing health care environment the criteria related to who is qualified to perform functions safely without risk of harm to the public are the only justifiable conditions for defining scope of practices as per suggested parameters- The basic elements for deciding the right and scope of practices are as under -  Historical basis and evolution as a Profession  Level of Professional education and training  Evidence-based assessment of role, skill and capabilities of professionals  Practicality in implementation  Study Curricula of professional course  Regulatory Mechanism It is, therefore, respectfully submitted that the move of ‗Council‘ to expand and widen the scope to bring Medical Laboratory Technologists and Scientists under the ambit of Act is illegal, unconstitutional and arbitrary and in violation of Statement of Objects and Reasons of basic Clinical Establishment (Registration and Regulation) Bill, 2010.
It is hoped that the proposal and move by ‗Council‘ to add draft Schedule related to qualification and signing authority of medical laboratory professional inserted after Rule 9 to CEA Rules, 2012 vide Notification No. G.S.R. 441 (E) issued in the Gazette of India: Extraordinary on dated 5th May 2017 will be dropped and withdrawn more so when the Ministry is already considering bringing of a specific Central Regulatory Bill for regulation of Allied Health Profession and Professionals. Further, we on behalf of ICMLS are ready to discuss all issues in detail, if required
By the Council at any stage. We extend our full support and cooperation for the betterment and augmentation of clinical lab services. Thanking you in anticipation, Yours Sincerely,

Yours Sincerely,
K.S. Sehrawat, President, ICMLS

Dr. Pankaj Kaul, General Secretary, ICMLS


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