Friday, August 11, 2017

who should sign diagnostic laboratory reports?

Why is signing a test report such a big deal? People should be asking different kinds of questions. Are these diagnostic laboratories standard? Do they perform rigorous quality checks? Do they have SOPs? Are their instruments calibrated? Are their technicians trained?  Are these laboratories accredited? Are their reports reliable? These questions are more meaningful. Somehow, in the war of misplaced prejudices and priorities, the right questions have been ignored.

Which are the types of Laboratories?
Laboratory tests provide useful parameters that aid clinicians diagnose and treat their patients appropriately. As tests provide measurable evidence, they are the part of evidence based medicine, unlike where a clinician makes the diagnosis based on hunch or personal experience. There are a variety of tests, some basic and some advanced. Some are used to assess health and some to diagnose diseases. Some tests need simple tools whereas few others are complicated and expensive. Some tests can be carried out by laboratory technicians but few require specially trained technologists. Some establishments are mere laboratories while some are diagnostic centers, which encompass wide-ranging tests. These laboratories could either be attached to the hospitals or function standalone as private (community) establishments. Health ministry has classified laboratories as small, medium and advanced depending on the complexity of the services provided by them. These clinical laboratories are also termed as pathological labs.

What is the current market like?
As per some estimates, diagnostics in India is $5-billion industry that is growing at an annual rate of 15-16%. There are no official figures on the exact numbers of diagnostic laboratories or diagnostic centers but estimates suggest that there are over one lakh diagnostic laboratories. Of these, 70% are pathology laboratories and the rest offer radiological services. Despite the presence of dominant corporate players, the diagnostic industry is still fragmented by unorganized players to the extent of 90%.

Laws on regulation of diagnostic laboratories
The union health ministry introduced the Clinical Establishments (Registration and Regulation) Act, 2010 to register and regulate of all clinical establishments in the country. Health is a state subject and therefore is not binding on all the states. Currently, this act is applicable at ten states (Assam, Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Rajasthan, Himachal Pradesh, Mizoram, Arunachal Pradesh & Sikkim) and union territories.  West Bengal, Maharashtra, Andhra Pradesh (erstwhile), Odisha, Delhi, Manipur, Nagaland, Madhya Pradesh and Punjab, Chattisgarh, Haryana, Jammu and Kashmir, Meghalaya, Tamil Nadu and Tripura have their own acts. States of Gujarat, Kerala and Goa have neither adopted the central Act nor have their own Act. Despite being adopted or passed, the Acts are not operational in all the states. 

Role of independent accreditation
In the absence of legal framework, many laboratories have voluntarily sought accreditations from the organizations like the National Accreditation Board for Testing and Calibration Laboratories (NABL) and the College of American Pathologists (CAP). Estimates suggest that about only 1% of laboratories are currently accredited. Accreditation ensures that proper quality and standard in terms of equipment and manpower are maintained. These agencies have their own regulatory board and guidelines, which inspect laboratories and award certification when these are met.

Manpower in the laboratories
In the diagnostic laboratories, the many tests are performed by semi- or fully-automated machines and are manned by qualified technicians who have diploma, graduate or postgraduate degree in Medical Laboratory Technology (MLT). Some states have their own para-medical council, which regulate these courses and register technicians. The central government too is mulling introduction of Allied and Healthcare Professional's Central Council Bill and is in consultation with the states.

The big question now being raised is: who should certify these tests? 
Most of the tests in Biochemistry are automated; the roles of technicians is restricted to collection of specimen from the patient, loading the instruments and printing reports. These instruments are periodically calibrated and subjected to rigorous quality controls by the Quality Control managers. Often, these reports contain normal (expected) range of values and are ready to be sent to the consulting physician for interpretation. The role of the biochemist is restricted to ensure the validity of the procedure and accuracy of the test results. Final interpretation always rests with the doctors, who will utilize the knowledge in the values provided by the test to make appropriate diagnosis and for further patient management. The Microbiology division includes serology/immunology and microbial cultures. The former investigations are usually simple whereas the latter needs some interpretation by the Microbiologist before being sent to the physician. Similarly, a qualified Pathologist interprets tests related to hematology, cytopathology etc and dispatches the result to the surgeon or physician.

It is therefore clear that Biochemists, Microbiologists and Pathologists are consultants in the diagnostic laboratories who can certify the test results. This brings us the next question: What are their qualifications and who prescribes them?

Qualifications as per NABL
In its guidelines (document 112), the NABL had recognized a variety of academic qualifications comprising of MBBS, DCP (Diploma in Clinical Pathology), MD/DNB, M.Sc, and Ph.D for signatory roles in diagnostic laboratories. NABL has claimed that it certifies signatory roles based on its assessment of person's competency and doesn't rely on the qualification alone. NABL had been under pressure to exclude non-doctors with M.Sc and Ph.D qualifications from all roles. Even the union health ministry questioned NABL's guidelines and reminded it to stick with CEA guidelines. Under duress, NABL sought MCI's opinion.

What is the role of MCI?
Medical Council of India has been set up to establish uniform standards of medical education, recognition of medical qualifications and registration of doctors. It has no jurisdiction over private hospitals, nursing home or diagnostic laboratories. Yet, it took upon itself the authority to prescribe qualification for signing laboratory reports. After a delay of three years, MCI replied back to NABL stating that only persons (doctors) registered with MCI or state medical councils must sign/countersign laboratory tests. In the Executive Committee Meeting of the MCI held on January 31, 2005, the members of the Adhoc Committee appointed by the Supreme Court and members of the Executive Committee of the MCI had approved the decision of the Ethics Committee that M.Sc. (Medical Biochemistry) with or without Ph.D is entitled to independently or solely sign a Medical Biochemistry report in a clinical laboratory. In a bizarre U-turn, the Executive Committee of the MCI has claimed on April 2017, that it did not approve the recommendations of the Ethics Committee. Following massive protests, NABL decided to overlook the MCI's recommendation and reverted to its original guidelines adding that local rules/acts will supersede its guidelines, wherever applicable. Therefore, it is clear that the ultimate authority to decide who should sign laboratory test reports lies in the guidelines of the state or centrally enacted Clinical Establishments Act. In the meeting of the National Council for Clinical Establishments held on 31 October 2012, it was decided that even medical colleges would come under its ambit. When the guidelines of CEA become operational, they would be applicable only in the states where the central act would be applicable.

Let us now examine each of the degrees that can enable to render professional services in the diagnostic laboratories. 

MBBS is a graduate degree, where a medical student learns about Biochemistry in the first year (phase 1) and Microbiology and Pathology in the second year (phase 2). The understanding of the utilities of diagnostic tests are basic in this course, therefore a doctor with MBBS is suitable only for basic tests. The fact that there are postgraduate courses in Biochemistry, Microbiology and Pathology itself indicates that these are specialist courses, which require understanding at a higher level.

DCP is a two-year diploma course for doctors whose curriculum includes mostly pathology and little of Biochemistry and Microbiology. If this diploma is deemed suitable for all pathological tests, there would not have been any necessity for PG courses in Microbiology and Biochemistry. Therefore, a DCP holder is not a master of Biochemistry, Microbiology or even Pathology. 

Doctors who undertake PG courses leading to MD/DNB in Biochemistry, Microbiology or Pathology are the true specialists who have the complete understanding of the subjects at a higher level. It must be emphasized here that a doctor with MD in Pathology should not be construed as a master of all pathological tests. Even though the syllabus of MD pathology includes Biochemistry and Microbiology, it is no match for the knowledge acquired by those pursuing MD in Biochemistry or Microbiology.

This brings us the final qualification- M.Sc/Ph.D, which are often taken up by non-doctors (biomedical scientists). M.Sc in Biochemistry and Microbiology are postgraduate courses similar to that of MD courses. In medical colleges, these three-year courses are termed "medical M.Sc" and are offered under the faculty of medicine to science graduates. Long ago, medical M.Sc courses were included in the first schedule of the Indian Medical Council Act 1956, which were discreetly disowned by the MCI. In medical colleges, the medical M.Sc and MD courses are conducted parallelly by the same department using the same teachers and resources (hospital and laboratory). Like their counterparts, medical M.Sc students are imparted training in the principles and practice of diagnostic laboratory. These students also study about the disease process, specimen collection, standardization of test, quality control, and interpretation of tests at the same level as MD students do. Although their graduate degrees are different, their postgraduate degree are qualitatively similar. The proficiency to render services comes from the knowledge and skills attained in the postgraduate course, not graduate course.

Ph.D is the outcome of research performed on a small area of interest. As not all Ph.D are undertaken in the field of diagnostic medicine, it doesn't confer additional knowledge or skill involved in routine laboratory investigations. Ph.D may be helpful if the research involves usage of a particular diagnostic test as a tool in the study. 

CEA guidelines
This brings us back to the guidelines of the Clinical Establishments Act. In 2012, the National Council for Clinical Establishments brought out its guidelines. In 2014, it sought feedback on the guidelines for diagnostic laboratories, which equated medical M.Sc degree holders with laboratory technicians suitable for performing tests and operating equipment. Following the widespread protest, instead of accommodating medical M.Sc qualification, it was altogether removed from roles. Following persistent protests, the ministry came forth with a new draft guidelines for diagnostic laboratories, which too denied all roles for the medical M.Sc degree holders. These guidelines are now being reviewed by the health ministry.

Role of Biomedical Scientists
The obvious question being asked is why biomedical scientists are being denied roles in diagnostic laboratories. This is based on two assumptions; one that all matters related to healthcare are the sole domain of doctors and the second that Indian Medical Council Act prohibits non-doctors from practicing medicine. Both of these are assumptions because, healthcare doesn't belong to any one group of professionals; it is complemented and participated by both medical and para-medical specialties. Lack of clinical exposure among the medical M.Sc persons is not a tenable argument as they don’t seek to examine patients or practice medicine. The other misconception being the consideration of laboratory service as a practice of medicine. The health ministry is deliberately misconstruing the clauses in the sub-section 2 of the Section 15 of the Indian Medical Council Act, which states that only registered doctors should sign or authenticate a medical or fitness certificate or any other certificate required by any law. This is being unscrupulously extended to laboratory reports. The process of examining the patient, using the information contained in the laboratory report and treating the patient is the practice of medicine; signing the laboratory test report is not.

Why are the policymakers wrong?
The policy makers must evaluate the possible outcomes of their prejudiced and biased policies. One can't take away years of experience and proficiency in the subject by a stroke of rule. There are thousands of biomedical scientists rendering their valuable services in laboratories since decades, how can they be disqualified overnight despite the possession of apt academic qualifications? Thousands could be rendered jobless due to a partisan guideline. It makes no sense to skill individuals and then deny them to practice those skills. Given that the doctor to patient ratio in India is measly 1:1674, how can the policy makers expect more doctors to be available just to sign laboratory reports? Each year, the number of doctors specializing in Biochemistry and Microbiology is declining sharply; how can the government expect more specialists in diagnostic laboratories? If these partisan guidelines are imposed, most private laboratories will hire doctors, who would serve merely as rubber stamps, contributing nothing more than their signatures. Since there is acute shortage of specialists, one individual may deal with several laboratories thereby severely compromising the quality. These policies will pave way for increased costs to the patients and higher incidences of malpractices.

What should the policymakers do?
In many Western countries, including the US and Europe, biomedical scientists are valuable resources in diagnostic laboratories. With requisite training and experience, one could even become a laboratory director. In those countries, importance is given to training, competency assessment and certification. In India, only the degrees are given importance. Mere possession or absence of a certain degree is taken for granted as an indicator of quality in India. It is time for the policy makers to understand the role of various academic qualifications and workforce available in India and to utilize them in the needs of India's healthcare system. Biomedical scientists with medical M.Sc degree are qualified enough to compensate the lack of specialist doctors in laboratories. The policy makers must give them their due and utilize their services in India's healthcare needs.

It is not practical to assign single qualification for all the laboratory tests. Mere division of the laboratories into small, medium and advanced as in the CEA guidelines and then specify qualifications for each of them is also inappropriate. Instead, a list of tests must be specified against each degree as per their training and education. The doctors are compulsorily registered in state medical councils but the biomedical scientists engaged in professional service in laboratories have no council. Registration in a council will not only give them legitimacy but also accountability. Finally, mere possession of a degree must not be taken as an indicator of competency; training and certification must be supreme. 

Ultimately, whoever possesses the requisite training, irrespective of the degree’s nomenclature, must be eligible to sign laboratory test report.

Wednesday, July 26, 2017

decimation of biomedical scientists in India

An open letter to the office bearers of the Medical Council of India.

Open because MCI does not respond to direct letters written to it. Open also for the world to know what is going on with the India's biomedical scientists.

Why doesn't MCI respond to us?

When individuals write to the MCI, their letters are discussed in the Executive Committee meeting. None of the letters or memoranda from the National MSc Medical Teachers' Association (NMMTA), the association of members representing the teachers working in medical colleges across 26 states and are ever taken up. NMMTA office bearers even had met both the President and the Secretary at MCI office. We constitute around 13% of the teaching faculties in the medical colleges. Inexplicably, all our letters and memoranda have been consistently ignored as if we don't exist. It pains to see that our concerns are continuously ignored and trivialized.

The President had assured to look into our grievances and place our memorandum in the committee, which probably never happened. Our repeated pleas to take it up too failed to produce any results. When this was asked via the RTI act, the reply from MCI callously was "Efforts are being made to locate the relevant files relating to your representation". We were also assured by both the President and the Secretary that the decision to promote medical M.Sc degree teachers to the post of Assistant Professor without the requirement of a Ph.D would appear in the Gazette. That promise too was not kept.  It bothers us to see such discrimination at MCI. Why are our issues being trivialized and ignored? 

The rise and the fall of medical M.Sc degree in MCI

There was a time when medical M.Sc courses were offered to doctors and therefore was included in the first schedule of the IMC Act 1956. Perhaps on the recommendation of the Mudaliyar Committee, the courses were thrown open to the non-doctors to fulfill the shortage in pre- and para-clinical subjects. These non-medical teachers went on to become professors and heads of the departments. They set syllabus, taught, trained and guided both MBBS and MD students in their subjects during the course of their employment.

Until the late 1980s MCI used to recognize medical M.Sc courses and gave permission to medical colleges to conduct these courses. Since then, MCI has washed its hands off these courses. Even when asked via the RTI act, MCI has not furnished any documentary evidence of its withdrawal from the first schedule of IMC Act 1956. Has this degree lost value and importance just because it is no longer taken up by doctors? Is the value of a degree based on who pursues it? Why should the education be degraded just because "lesser children" pursue it?

Prior to 1998, non-medical teachers could head the department even without Ph.D. Subsequently, Ph.D was made mandatory for the post of Assistant Professor and above, Ph.D was made mandatory for examinership, later HOD posts too were denied and now MCI is discouraging medical colleges from hiring non-medical persons. Lately, perhaps non-medical teachers are being denied to guide MD students for their dissertation. What have we done to deserve such a downfall? Has medical M.Sc degree fallen out of favor just because MD degree in the same subjects is available in plenty?

Truth about medical M.Sc courses

Ever since MCI disowned these courses, it has suffered variations in the curriculum and syllabus across the universities. The duration of these courses in the subjects of Anatomy, Physiology, Biochemistry, Pharmacology, and Microbiology have varied from 2-3½ years although UGC maintains it to be a 2-year course. In contrast to the general M.Sc courses, the medical M.Sc courses in the medical colleges are run for 3 years. The first year is dedicated to Anatomy, Physiology, Biochemistry, just like the first year MBBS syllabus. It is this aspect that makes the M.Sc degree "medical" as one gets to know about the human body. In the remaining two years, the students focus on their specialty. These courses are run in the same department, by the same teachers using the same resources as for MD courses. The students go through laboratory practicals, dissertation, seminars and journal presentation just as their peers undertaking MD courses do. Depending on the institution, medical M.Sc students also get posted to the central laboratories and even do night shifts. Our graduate degrees are different but the postgraduate degrees are qualitatively similar. Why are we constantly at the receiving end? We agree that we haven't had the kind of 'clinical exposure' that doctors have, but we are not here to see patients. We don't pretend to be doctors or treat patients, why call us quacks? Our repeated pleas with both the Ministry of Health & Family Welfare and Human Resource Development to get the medical M.Sc courses transferred back to the MCI for regulation and recognition have fallen on deaf ears. Once back in the MCI, these medical courses could be regulated.

How did we get in here?

Most of us are from humble backgrounds, who could not get past the reservation system or pay enormously to study medicine. We were also taken for a ride with the lures of jobs in medical colleges, research institutions, and laboratories by the medical colleges that conduct these medical M.Sc courses. It is only after the completion of the degree that people came to realize the harsh realities that they have neither the dignity nor the opportunity in the healthcare setup. After spending precious time of the youth and lakhs of their parents' hard-earned money, they are bluntly told that they are not eligible to practice what they learned. What can be more painful than that?

Why did the MCI paint medical M.Sc courses poorly?

Time and again, MCI has claimed that it has nothing to do with the conduct of medical M.Sc courses, yet it takes the liberty to opine on it. In one case filed in the Jaipur bench of Rajasthan High Court, the counsel appearing on the behalf of MCI presented three table of differences between B.Sc and MBBS, MD and M.Sc, and super-speciality and Ph.D. Obviously, this table was prepared from the feedback from MCI. It is very unfortunate that this table was created with the sole intention of showing M.Sc courses in poor light and projecting medical courses as superior. In doing so, several incorrect information was projected as facts, which neither the opposing counsel nor the judge failed to notice, clarify or question. This irresponsible representation has caused immense damage to us, as they continue to be circulated.

First of all, comparing MBBS with B.Sc is inappropriate as the two courses are totally different and are not comparable in any way. It is like comparing tomatoes with rabbits. These two graduate degrees are totally different and have nothing in common. Similarly, comparing super-speciality and Ph.D is also inappropriate as the two are entirely different. Super-speciality courses are true courses with defined curriculum and syllabus whereas Ph.D is a research undertaken on a small area of interest, whose outcome is to prove or disprove a hypothesis. Once again, these two not comparable in any respect.

The only comparable courses are MD and medical M.Sc. These two are identical in course and curriculum except that the medical M.Sc course also includes one year of Anatomy, Physiology, and Biochemistry. The MCI's counsel provided incorrect information that in medical M.Sc courses, the students are not trained in clinical and diagnostic methodologies and that techniques or in the interpretation of clinical diagnostic techniques practically in relation to patients are not conducted. These are plain lies. Clinical laboratory diagnosis is an integral part of the medical M.Sc curriculum in Microbiology and Biochemistry, which lays emphasis on the interpretation of the test result with respect to patient's condition. The ultimate responsibility of interpreting a test lies with the physician dealing with the patient, not with the biochemist or microbiologist sitting in the laboratory. A thesis is not mandatory in the medical M.Sc course of some universities, but not in most universities, as claimed by the MCI's counsel. Barring few exceptions, most colleges conduct medical M.Sc as a three-year course, unlike what MCI's counsel has claimed. These inaccurate and inappropriate tables of differences are being widely circulated to further denigrate and belittle medical M.Sc degree. MCI is primarily guilty of this misinformation. The process of showing someone down to project oneself high is in a poor taste.

Unabated public shaming of non-medical persons

We and our degree are routinely shamed and belittled in private and public fora. Why are we being constantly ridiculed and denigrated like this? Why take us into the system and then thoroughly show us down at every stage and opportunity? Like every human, we too deserve the dignity of labor. Nowhere in the world has a postgraduate degree been decimated and humiliated like this.

Not just the medical M.Sc degree but also Ph.D is ridiculed by our medical colleagues. They conveniently forget that both medical and non-medical degrees are the product of the same institution. Both the medical M.Sc and Ph.D are conducted by the same department and teachers who also conduct MD courses. In most cases, the Ph.D guides in the medical colleges are MD holders, who have never undertaken Ph.D themselves. If the quality of the degree is supposedly bad, then it also reflects on the medical colleges, the department, and the medical teachers, not entirely on the degree holders. It is rather paradoxical that while the doctors are the one who set the syllabus, conduct the course, train the students, guide the dissertation, evaluate the students and award the degrees, they also engage in belittling it. We are at loss to understand how the Ph.D, which is the outcome of research on a small area of interest, empowers non-medical teachers with additional skills to conduct routine UG academic works such as setting question papers or valuating papers. But, PhD is still insisted. Obviously, this is done with the sole intention to keep us out or make it more difficult for us to participate in the prestigious, premium and lucrative exercise of conducting UG examinations. It is often argued that evaluation of medical students are "clinically oriented", therefore non-medical teachers must not be allowed to participate in it. The worth of a medical student can not be decided solely by the examinations in the pre-and para-clinical subjects. Such trivial excuses are made with an ulterior motive to deny our participation.

Our medical colleagues routinely engage in influencing college administrations, universities, MCI and health ministry seeking to deny us jobs in medical or dental colleges, routine academic roles in the examination process or guiding PG students. Why are we being disallowed to undertake the roles we are trained in? Why don't we get the value that our education offers? Why don't we get to perform the roles according to our designations? Why such disdain and prejudice towards us?

While the MD holders are entitled to enjoy every fruit that is there to offer in the system, non-medical teachers have a huge list of ineligibilities thrust upon them. Every other postgraduate degree has a value attached to it, but not ours. We are deemed to be unfit for almost every role in the healthcare; be it teaching or diagnostics. We can't set question papers, we can't evaluate answer scripts, we can't conduct viva-voce, we can't guide MD students and now we can't sign laboratory test reports. Is our postgraduate education so worthless that we are totally incapable of doing anything?

The malpractices and corruption involved in the conduct of both the UG and PG levels of medical education are no secrets. We don't intend to criticize them because we consider ourselves to be a part of the same medical education system and don't want to discredit it. Why isn't the same courtesy extended to us?

Are non-medical teachers a total misfit?

We are not doctors and don't carry that pretention either. We don't seek to examine patients or treat them. We have only three roles, which our education has empowered and skilled us: to teach, conduct research and work in the diagnostic laboratory. Yet, attempts are regularly made to deny us all of these. Why are our rights being snatched away from us?

Often we are accused by our medical colleagues that since we don't have "clinical exposure" and "bedside experience". Another argument floated is that the education is "more clinical these days" and that the knowledge of non-medicos is "bookish", we can't offer a better education to the medical students. There is no denying that as non-doctors, we lack these exposures but to allege that we can't offer good education is outlandish. Non-medical teachers teach in pre-and para-clinical subjects, which are the basic medical sciences and non-clinical subjects. These students will get to learn all the clinical aspects of the diseases and disorders once again in detail when they study clinical subjects. Integrated teaching with other departments ensures that they get wholesome knowledge. Besides, all the clinical information is available in the textbooks and the teacher too can learn from them. Learning is a never ending process and the teacher learns too. In a medical college, a non-medical teacher is also continuously exposed to other academic activities such as PG seminars, journal clubs, CMEs, workshops etc.

Non-medical teachers can be appointed only to the extent of 30%, the remaining 70% are doctors. Why should the blame of "poor education" of medical students land upon 30% non-medical teachers while 70% medical teachers absolve themselves of all responsibilities? Why can't they compensate for what a non-medical teacher lacks? Why can't they provide the "clinical knowledge" to the students, which a non-medical teacher couldn't? Making non-medical teachers the scapegoats to hide their own inefficiency is a poor strategy.

None of the Indian medical colleges feature in world's top ten medical institutions. In almost all of the top ten global institutions, non-medical teachers in the pre- and para-clinical subjects constitutes 50-60% of the teaching faculty. Isn't it wonderful that despite having such a large number of teachers without "clinical knowledge" and "bedside exposure", their institution ranks top? Why is it so convenient to always blame the non-medical teachers for the poor quality of education that our medical colleges provide?

Are non-medical teachers unproductive?

In a medical college, MD/MS degree is considered supreme. Mere possession of this degree is deemed perfect to be a teacher and all the academic responsibilities that come along with it. Since there is no insistence on quality in teaching and no evaluation of teachers' performance, the medical teachers have taken their place for granted. All their shortcomings are ignored. Since non-medical teachers with medical M.Sc degree are perceived as "outsiders" and are alleged to have gained "lateral entry", they are thoroughly scrutinized at every level. While the medical doctors get away with any or all insufficiencies, non-medicals have to prove themselves on a regular basis. In order to survive this bias, non-medical teachers always strive to give their best. In fact, some of the finest and dedicated teachers are non-doctors, a fact that the MCI President admitted during our interaction. Degrees don't make a person smart or stupid, it is one's dedication and effort that defines a person. There are useful and useless people with either degree, we have to identify people by their virtues, not by the names of the degrees. Mere possession of a celebrated degree doesn't make one great. If we are to develop our medical education like in the west, we will have to quit this academic apartheid and involve the best of minds from as many streams.

How are non-medical teachers coping with the medical system?

The experience of non-medical persons in medical college is varied; this depends on the attitude of the management, medical colleagues as well as own conduct and worth. The working conditions of many non-medical persons in medical colleges are pathetic and inhuman. The types of discrimination and humiliations that they have to bear at the hands of the medical peers on a regular basis is appalling. Some of them been harassed and humiliated constantly to such an extent that they have lost all self-esteem and live in self-pity. They have been kept suppressed so much that they fear even standing up against their mistreatment.  What did they do to deserve such a mistreatment? Why inflict so much psychological trauma? 

Many of them are appointed to the non-teaching posts of tutors or demonstrators with paltry salary. Despite putting in years of service, neither they get salary hikes nor promotions. Many of them are used only as a cheap labour and not included in the teachers' declaration forms submitted to the MCI. Government medical colleges have in-service schemes enabling employees to undertake higher education but these are nonexistent in private colleges. With research being a sham in most private colleges and funding unavailable, many non-medical persons are unable to undertake Ph.D. Due to abysmally low salaries, they can't afford to fund their own research. Neither the college nor the MCI or government has any scheme to enable these persons to undertake Ph.D. They are destined to stagnation and suffering.

Despite being denied of several academic roles and subjected to a variety of humiliations on a routine basis, non-medical teachers have always felt proud of being a part of the medical education system and have rendered duties with utmost sincerity and dedication.

Why the assault on our role in diagnostic laboratories?

By definition, the process of examining the patient and offering suitable treatment is the practice of medicine. Performing a test on a sample obtained from the patient and interpreting the result is not the practice of medicine. The sub-section 2 of the Section 15 of the Indian Medical Council Act, 1956 states, "....shall be entitled to sign or authenticate a medical or fitness certificate or any other certificate required by any law to be signed or authenticated by a duly qualified medical practitioner". There is no mention of diagnostic laboratories in this act and this should not be misconstrued as such. Issuing a laboratory test report should not be deemed as the practice of medicine. By MCI's own admission, persons with medical M.Sc were initially being registered in the MCI/state medical councils, which was mysteriously stopped. By deliberately keeping us out of the council, we are being denied the right to practice in the diagnostic laboratories. Our repeated pleas with the Health Ministry to get us registered in the MCI/Sate medical councils have not been fruitful. Unless the medical M.Sc degree holders are registered in a council, it would be difficult to serve with accountability in the healthcare sector.

From the documents available in MCI's website, it is clear that the role of MCI is medical education, registration of doctors and ensuring proper standards in the practice of medicine.  It would be wholly unreasonable to believe that laboratory practice is also the practice of medicine. MCI has claimed that it does not have jurisdiction over hospitals, nursing homes, and the diagnostic laboratories. Why has the MCI transgressed into deciding who should sign laboratory reports?

MCI's recent response to the long-pending NABL's letter was totally uncalled for. In 2005, the executive committee along with the members of the Adhoc committee appointed by the Supreme Court approved the decision of the ethics committee that M.Sc holders, with or without Ph.D could independently sign diagnostic laboratory test report. Why was this reversed in 2017? Why the U-turn now? Is it ethical on the part of MCI to overrule the ethics committee? This decision projects natural bias in the MCI. It is fortunate that NABL did not pay heed to MCI's biased opinion and sensibly reverted back to its previous guidelines of giving signatory authority based on their ability and training rather than the mere possession of a requisite degree.

Although this was a reply given to the NABL, it is causing far-reaching consequences that MCI might not have foreseen. While the MCI's reply was supposed to be in the context of NABL accredited laboratories, it is being misconstrued as a "rule" or an "order" from MCI and is being extended to all diagnostic laboratories, including those attached to teaching hospitals. It is not known if this was intentional or not. As a fallout of this letter and its misuse, many persons with medical M.Sc degree are being humiliatingly asked to keep away from diagnostic laboratories and many are facing imminent job loss. Not only the humiliation, psychological trauma but also livelihood is at stake. Many of us have trained and taught principles and practice of laboratory diagnosis to MD students; it is illogical that while our students are eligible, we as teachers are not. MCI is guilty of inflicting this damage upon us.

Some of us have initiated the laboratories, set SOPs, got the system in place and kept them functioning because no one else was available. Once a MD candidate is available, they have been asked to step outside citing eligibility. Why this misuse and abuse? Life is getting tougher each day for non-medical persons in the healthcare sector. Even those who were happily contributing to medical education and the healthcare needs of the society are now apprehensive of their future. Everybody wonders why after such long useful periods of service, are we being disowned and degraded? Why are attempts being made to establish a monopoly in the healthcare system by excluding biomedical scientists? In several accredited diagnostic laboratories in Europe and the US, one does not have to be a doctor to sign a diagnostic test report. These countries don't consider laboratory services as the practice of medicine.

In many European countries and the US, non-doctor biomedical scientists are held in high esteem, who sign and interpret test reports and also go on to become laboratory directors and policymakers in the healthcare setup. Here in India, the biomedical scientists are equated with laboratory technicians. While the developed western countries give credence to training and skills, we the perpetually developing country, give importance to the nomenclature of degrees. This is where we fail. The pride and prejudice have a blinding effect on our policy makers here.

MCI is responsible for this mess.

Rules are continuously being modified to enable us to be used as 'disposable' or 'expendable' commodities. Things were rosy when the medical education system wanted us; now that the replacement is available, all sorts of deficiencies are being discovered in us. Slowly, we are being deemed unqualified although not much has changed in the system of medical education in these decades.

Due to the reduction of the faculty strength and an increase of the PG seats in pre- and para-clinical subjects by the MCI, there has been an increase in the competition for teaching jobs in the medical colleges. With fewer jobs in the medical colleges, the competition for jobs in diagnostic laboratories too have surged. Thus, a need was been felt to eliminate the non-medical biomedical scientists in the guise of quality, eligibility, and reliability. In the guise of "paradigm shift" in the "regulation of health care", even the qualified biomedical scientists are being excluded.

What options do people with medical M.Sc degree have?

Without anyone to regulate this course and a policy-paralysis in the government, too many medical colleges started medical M.Sc courses in the five aforementioned subjects. Any medical college with existing MD course could start medical M.Sc course without MCI's approval. Since non-medical persons could be hired for low salaries and denied promotions for years together, they have been hired by many medical colleges. But, the increased competition for jobs has changed the scenario. Even MCI has asked medical colleges to hire doctors with MD as the first preference. Even for teaching jobs, a freshly passed MD candidate is preferred over a non-medical teacher with Ph.D, relevant publications and a decade of teaching experience. Such is the disadvantageous position of non-medical teachers.

With a postgraduate degree exclusively in the medical subjects, these degree holders don't have anywhere else to go. They find themselves total misfits and ineligible for jobs in non-medical establishments. With constant efforts to push medical M.Scs out of medical education and healthcare system, where are these persons to go? Out of frustration, the majority of persons with these degrees have moved away to professions that have nothing to do with their education. Barely 13% of teaching faculties in the medical colleges are non-medical.

There is no record of the number of persons with medical M.Sc degree in India, but many of them are working abroad as these countries know the value of scientists in basic medical sciences. In developed countries, the non-medical scientists have risen to occupy the highest chairs in the healthcare setup, something which is unthinkable in our prejudiced setup. It is unfortunate that our country has failed to recognize, uphold and promote biomedical scientists. Pride and prejudice have got the better of people.

People often carelessly suggest that persons with medical M.Sc degrees should take part in research. Are there sufficient avenues for research in India's healthcare? Even for healthcare research, doctors are preferred. From the information obtained through the RTI Act, it was found that only ten people with medical M.Sc degree are working as scientists in all of the central government's medical research establishments. How many medical colleges in India engage in genuine research? What has MCI done to promote research in medical colleges? In most medical colleges, the term research is restricted only to its name. Research in basic medical sciences is a sham in our country. In many western countries, research in basic sciences is compulsory along with teaching. Unfortunately, the quality of research is even more neglected than medical education in our country. Under such appalling conditions, how can we even think of research as an alternate profession?

We need recognition, not sympathy

Is a competition for jobs and promotions the sole motive for the denigration of biomedical scientists? In the developed countries doctors and non-doctors don't engage in an unhealthy competition, instead, they are complementary and supportive of each other. Why can't India do the same? Both the medical and non-medical degrees can jointly contribute to the society. We don't seek equality; we simply seek our rightful place so we can work with dignity. We seek to be considered as a natural part of the medical education and healthcare. We should be seen as assets but we are being treated as liabilities. The policy makers must not confuse between the eligibility (which is mere possession of a prescribed academic degree) and the qualification (which a person acquires through education and traninig). Mere possession of eligibility doesn't mean one is also qualified for the job.

MCI has presided over a variety of discriminations thrust upon us; this could happen because there is none to represent us or safeguard our interests at MCI. Neither the MCI nor the Ministry of Health can prevent our routine abuse for what we are, but this can be contained to some extent by upholding medical M.Sc degree and recognizing it as in important participant in India's healthcare system and medical education. Unless the MCI and the government uphold medical M.Sc degree, denigration and humiliation of the degree holders will continue unabated.

Despite being a Kunti-putra, Karna never got the recognition of being a Pandava, will we ever? MCI is about to be replaced by the National Medical Commission. We only hope that MCI goes out with a benevolent and a just act that is expected of it. We can only hope that with this awareness, justice will be done to biomedical scientists with medical M.Sc degree in both medical education and diagnostic laboratories.

If it is felt that medical M.Sc degree holders have no avenues for biomedical research, are unwanted in the medical colleges and are denied to work in laboratories, why is the government permitting medical M.Sc courses to be run? Why is the future of youngsters being destroyed? It is the ripe time for the decision making bodies in the government to take up the issues and resolve them amicably. The Prime Minister must ask the NITI aayog to take it up with both the ministry of health and the human resource development ministry to take it forward. The neglect of India's biomedical scientists is a sign of poor policy making. This policy paralysis needs urgent attention.

Friday, June 30, 2017

open letter to NABL

The guidelines on the signatory role in diagnostic laboratories have been a contentious issue since 2014. There were no government guidelines on this aspect of diagnostic laboratories. Private as well as government laboratories have appointed persons with M.Sc degree as consultants (Biochemists or Microbiologists) since a very long time. National Accreditation Board for Testing & Calibration Laboratories (NABL), an independent body had framed its own guidelines, which gave signatory rights to persons with M.Sc degrees.

With the formulation of guidelines under the Clinical Establishment Act (CEA) in 2014, a controversy has erupted. Under this guideline, all roles for M.Sc persons in diagnostic laboratories were ignored, giving signatory rights only to doctors registered with medical councils. 

Subsequently, NABL was pressurized to alter its guidelines in tune with CEA's guidelines. For some strange reasons, NABL chose to seek the opinion of Medical Council of India (MCI) on this aspect through several letters since August 2014. When people aggrieved by CEA's discriminating and unjust guidelines pointed at the eligibility provisioned in NABL document 112, the Ministry of Health & Family Welfare (MoHFW) questioned NABL's position and almost asked it to fall in line with CEA's guidelines. Yet, NABL persisted with seeking MCI's response. MCI finally responded in June 2017, which was, unfortunately, in sync with CEA's guidelines. With this reply, the NABL is technically free to modify its guidelines.

The two bodies: MoHFW and MCI appear to have colluded to form an axis of evil with the sole motive to keep non-doctors out of diagnostic laboratories. In the light of recent developments, here is an open letter to the Director of NABL, so that NABL stays away from this axis:

"As clarified in NABL's letter to the MoHFW, NABL has framed its guidelines on signatory by the persons possessing the necessary technical competence/expertise and knowledge on accreditation requirements. 

NABL had sought clarifications from MCI through its letter dated 12-08-2014 whether non-medical persons possessed eligibility to sign laboratory reports. MCI, on its part, after a long delay, superseding view of its own the ethics committee had unethically opined that only those registered with MCI/state medical councils should sign the reports. At the same time, it has skipped answering the three direct questions posed by NABL. 

There are a few issues, NABL must consider before applying changes to the NABL document 112.

1. MCI is a body established by the government for establishing and maintaining high standards of medical education and recognition of medical qualifications in India. It registers doctors to practice in India, in order to protect and promote the health and safety of the public by ensuring proper standards in the practice of medicine. The Indian Medical Council Act 1956 or subsequent amendments do not mention anything about the laboratory practice. Attempts are being made to misrepresent section 15 of IMC Act for this purpose.  Besides, service in the laboratory is not the practice of medicine. MCI, therefore, has no jurisdiction in giving its opinion on diagnostic laboratories as it is outside the domain of its operation. Since MCI has washed its hands off medical M.Sc courses since the 1980s, it has no locus standi on giving its view on the eligibility of medical M.Sc candidates in diagnostic laboratories. In 2005, the MCI under the supervision of the Adhoc committee appointed by the Supreme Court had approved in clear terms that M.Sc, with or without Ph.D are eligible to sign laboratory reports. This was already brought to your notice in previous communications. Therefore, the further insistence of seeking MCI's opinion was totally unnecessary. By issuing a contradictory opinion in 2017, the MCI clearly shows malafide intention.

2. The only government agency that has legal status to formulate guidelines on diagnostic laboratories is the National Council for Clinical Establishments, which was established under the Clinical Establishment Act (CEA). In the month of October 2014, this council framed guidelines for diagnostic laboratories and sought public feedback. It has re-published the draft guidelines in the Gazette recently and again sought public feedback. Even if the CEA's draft guidelines are adopted without modification, its jurisdiction is restricted only to the states that have adopted the central act. Therefore, NABL (a stateless entity) does not come under the jurisdiction of Clinical Establishment Act and is not bound to follow its guidelines or restrict it to only those states where CEA is active.

3. NMMTA has filed a writ petition in the Karnataka High Court against the discriminatory guidelines of the CEA and NABL is one of the respondents in this case. Since the case is ongoing, it would be prudent not to disturb the existing guidelines as mentioned in document 112.

Keeping in mind that accreditation is a voluntary process and that NABL is free to set its own guidelines and the facts that neither MCI nor CEA has jurisdiction to impose its guidelines on NABL, NMMTA implores that the document 112 remains unchanged until the case is disposed off by the court. Taking into account the public benefit and current national requirements, NABL may choose to ignore both the MoHFW and MCI and remain standing tall as a beacon of an impartial accrediting agency."

It must be highlighted here for the readers that MCI's reply to NABL is a communication between two bodies. MCI does not have the mandate to frame guidelines on the diagnostic laboratories in the government or private domain (including teaching hospitals).  Therefore, it must not be applied outside the context. A query has been filed with the MCI under the RTI act to provide documentary evidence supporting its jurisdiction (if any) on diagnostic laboratories. It would be rather unfortunate if people with vested interests start applying this as a diktat from MCI on institutions or bodies other than NABL-accredited ones. Until things become clear, people are requested not to create and spread rumors or start "applying the MCI rules" in laboratories associated with teaching hospitals. 



Friday, June 16, 2017

medical M.Sc postgraduates aren't taking doctors jobs

No, medical M.Sc postgraduates aren't taking doctor's jobs!

In a shocking article published by the Times of India on June 16th, Jaipur edition, the blame for PG seats remaining vacant in the pre- and para-clinical subjects are squarely laid on the medical M.Sc postgraduates. The article is available here: http://timesofindia.indiatimes.com/city/jaipur/few-takers-for-pg-in-non-clinical-branches-at-med-colleges/articleshow/59184208.cms

Here is an open letter to the editor of Times of India on this matter.

It is unfortunate that this article is not well-researched and is biased against M.Sc degree holders. Medical M.Sc degree was made acceptable at a time when there were few doctors with MD degree in the pre- and para-clinical subjects. It is true that now there are plenty of MD degree holders in these subjects. The reason they are not fetching jobs are many; here are some points that will help in getting a clear picture.

1. MCI has reduced the teacher-student ratio, thereby decreasing the number of teachers required in medical colleges. This has led to decrease in the job-opportunities.

2. The retirement age of teachers in medical colleges has been raised to 70 years, which too contributes to the lack of vacancies.

3. Medical M.Sc persons can be appointed only to the extent of 30% in a department, the rest 70% are MD degree holders. It is incorrect to state that "..but medical colleges are applying the rule as compulsory". In most medical colleges, non-medical faculties are much lesser than 30%. Throughout India, the percentage of non-medical teachers in these subjects is only around 13%. In fact, MCI has asked medical colleges to give MD holders the first preference for academic jobs.

4. The reason why most doctors opt for MD in pathology is not that MSc in the subject is not available, but the fact it is in high demand in diagnostic laboratory sector.

5. The statement "lateral entry in medical colleges for jobs" is inaccurate because appointments are made as per MCI guidelines only. As qualified PG degree holders, even medical M.Sc persons are entitled to a job they deserve as per their education in medical colleges and MCI's teachers' eligibility guidelines.

6. The situation is similar with medical M.Sc postgraduates. Since they have obtained PG degree in the faculty of medicine, they are not equipped to work outside the healthcare system. Since MD holders are also doctors, they can always practice because of their professional degrees but medical M.Sc postgraduates have nowhere else to go. In many of the job advertisements posted recently, medical colleges have unfairly preferred only MBBS/MD holders for academic jobs. 

7. In many western countries, pre- and para-clinical subjects are mostly taught by non-medical persons. In most of the top 10 medical colleges in the world, 50-60% of the faculties in these subjects are non-doctors. In their countries, doctors are expected to assist in healthcare rather than teaching. The primary role of doctors is to treat patients, the presence of non-doctors in the medical education is good for the society as it spares doctors required for healthcare given that patient to doctor ratio in our country is dismal.

As a responsible media, TOI is expected to make a thorough research and get a clear picture before publishing. It would be prudent that TOI makes a well-researched and a balanced article on the same.

Saturday, May 13, 2017

letter to health ministry over CEA guidelines on diagnostic laboratories

The following is the letter in response to the gazette notification of the Ministry of Health and Family Welfare on draft rules regarding diagnostic laboratory under the Clinical Establishment Act, 2010.
The draft can be downloaded here: http://www.egazette.nic.in/WriteReadData/2017/175803.pdf


Under Secretary (Medical Services),
Ministry of Health and Family Welfare,
Room No. 508, D Wing,
Nirman Bhavan,
New Delhi – 110011

Dear Sir,

Subject: Objections to the Clinical Establishments (Central Government) Amendment Rules, 2017 published in the Gazette notification dated 5th May, 2017

It gives us great pain to write to the health ministry yet again. In 2014, the National Council for Clinical Establishments sought suggestions & objections from the stakeholders on the guidelines for the diagnostic laboratory. Since then we have been protesting against the unjust exclusion of medical M.Sc degree holders under the human resource guidelines. All our protests and pleas have been completely ignored.

Umpteen number of representations have been made so far. Letters have been written to the Union health minister, Ministers of state & Secretary of MoHFW, as well as to the Chairman and members of the National Council for Clinical Establishments on this issue. Signature campaign protest was made, grievances were filed with online portal and protest event with procession and dharna was held in Delhi. Despite all these efforts, it is extremely distressing to observe total neglect of medical M.Sc degree by the concerned. It is really a sad state of affairs. Such a neglect of a qualified medical M.Sc degree is unprecedented.

It appears that the ministry of health is determined to denigrate this degree and unjustly deny the degree-holders of any role in the diagnostic laboratory. It is now clear to us that this exclusion is planned and deliberate. It is not that the health ministry is unaware of the nature of medical M.Sc courses or the roles these degree holders have been playing for several decades. We are convinced that this is a systematic attack on the medical M.Sc degree. Therefore, no amount of further objections would serve any real purpose.

However, for the sake of record, NMMTA officially objects to the exclusion of medical M.Sc degree (with or without Ph.D.) under the section IV (Human Resource).  Like MD course in Microbiology or Biochemistry, medical M.Sc courses are held in medical colleges using the same syllabus & curriculum. We are pretty sure that policy makers in the council are well aware of this fact, but want to turn a blind eye towards it. Therefore, we formally request the council to make amends in the guidelines to accommodate medical M.Sc degree (without insisting for Ph.D.) for all the three categories of the laboratories. 

We reiterate that service in the diagnostic laboratory is NOT the practice of medicine; it has already been proven in two courts of USA. Therefore, one does not need to be a doctor to certify diagnostic reports. The job of a Microbiologist or a Biochemist in the laboratory is to ensure correctness of the test report, ensure quality control and offer only a minimal interpretation. The ultimate responsibility of interpretations lies with the doctor who ordered the test on the patient. 

Before you discount medical M.Sc degree, we wish to bring to your notice yet again of the decision taken by the members of the Adhoc Committee appointed by the Hon’ble Supreme Court and of the Executive Committee of the Medical Council of India, the following decision of the Ethics Committee on January 2005: “M.Sc. (Medical Biochemistry) with or without Ph.D is entitled to independently or solely sign a medical Biochemistry report in a clinical laboratory”. Is the ministry questioning the wisdom or authority of the Supreme Court's Adhoc Committee on this matter? It must also be brought to your notice that NABL, the body that sets standards and accredits laboratories has recognized medical M.Sc as authorized signatories in its document 112. The qualifications are framed by technical experts from all the disciplines possessing the necessary technical competence/expertise and knowledge on accreditation requirements. Does the ministry intend to question the competence of the experts in determining the eligibility?

Doctors with Diploma in Clinical Pathology, who are posted for a small duration in Biochemistry or Microbiology departments hardly attend or learn anything serious at the PG level. Trusting them to deal with the interpretation of bacterial cultures would be a grave mistake. Also, persons with MBBS and Ph.D. are queerly deemed eligible to interpret certain tests that require understanding at a postgraduate level. It would be foolhardy to assume that the knowledge to interpret diagnostic tests would be acquired by undertaking a research-based Ph.D. This is especially true with bacterial cultures, which requires a PG-level understanding of the pathogenesis, which an MBBS+Ph.D is completely unaware of. This clearly shows a dritharashtra-like blind bias towards the medical degree and a contempt towards non-MBBS degrees.

It is disgusting to note the inclusion of Ph.D among the qualifications acceptable for laboratory technicians. Ph.D is one of the highest degrees in India and does the ministry seriously expect such degree holders to work in the laboratory as technicians? Is this an intentional mischief or an act of ignorance? The section 15 of IMC Act, 1956 does not mention anything about diagnostic laboratories. The ministry must not deliberately misinterpret the clause to extend it to diagnostic services.

Have the policy makers given any thought to what will become of those qualified medical M.Sc persons who are already in diagnostic laboratories for years and decades? This policy change will not only lead to career disruption of medical M.Sc degree holders working in diagnostic laboratories but also severely affect them socially, financially and psychologically. How can the government nullify with a stroke of the rule, what these people have learned in the medical college and experience gained over the years? Did these people spend three-years in medical college, lakhs of rupees on education, got trained and skilled like their MD counterparts only to be disqualified later? The government permits these courses to be run and then prevents the degree holders from practicing the skills they acquired. Is this how governments work? Every act of madness has a method, and the method adopted here seems to destroy the legacy and utility of medical M.Sc courses. This systematic destruction of medical M.Sc must stop.

The policy-makers must familiarize themselves with the relevant degrees being conducted in India and set policies in accordance with the available skilled workforce. Prejudiced, biased and myopic policies do more harm in the long-term. Although the Clinical Establishment Act or its guidelines is currently not applicable to all the states or teaching institutions, it is currently being misused and abused to prevent teaching faculties with medical M.Sc degree from working in laboratories attached to the teaching hospitals. 

Currently, there are thousands of diagnostic laboratories of all sizes across India. Are there enough doctors to cater to all these diagnostic laboratories? Implementation of these guidelines will only force the laboratories to hire part-time consultants who would offer their services to several laboratories at a time. They will end up only signing the reports but doing little else.  Who would benefit from such faulty rules? The government must factor in another fallout of this rule. Doctors naturally demand more remuneration than what the laboratory owners currently offer to non-doctors for the same work. This will add on the expenses of the laboratory, which will be conveniently passed on to the patients, thereby increasing the cost of healthcare. Is this a justifiable government policy?

Honorable Rajya Sabhha MP Shri CP Narayan raised this issue (UNSTARRED QUESTION NO 1771) on August 2016 with the MoHFW, but the ministry did not give a convincing reply. The ministry has consistently ignored multiple memoranda, grievances, letters, references and evidences from accreditation boards, as well as international standards. The partisan attitude of the ministry has been glaringly exposed. It must be borne in mind that any discipline of science can progress only when there is participation from people from diverse backgrounds; monopoly only leads to stagnation, fall in standards and rise in malpractices.

Instead of protecting the interests of biomedical scientists, this government is harming it. This government is treading on the misconception that degree alone confers competence. Mere possession or absence of a specific degree alone doesn’t guarantee quality or competence. In the developed countries more importance is given to training and certification, but we are still stuck with degrees. The government is behaving in a partisan way by promoting one degree at the cost of another. Govt must create a healthy atmosphere where all qualified degree holders complement each other instead of competing and serve the healthcare needs of the nation.

Ministry of health and family welfare is at a threshold of making a fine policy on CEA; to set it right or to make a mess is left to the policy makers. We can only hope that wisdom and benevolence prevails.

Warm regards,

National M.Sc Medical Teachers' Association (NMMTA)
www.medicalmsc.org
www.nmmta.org

Tuesday, October 4, 2016

NMMTA: the National M.Sc Medical Teachers' Association

"Birds of the same feather flock together", it is only natural and appropriate for people having things in common to come together. People from the same academic background too come together and form associations of persons. There are several associations representing diverse academic fields.

In India, Medical M.Sc courses are generally conducted by medical institutions. This 2-3 year postgraduate course is conducted in the subjects of Anatomy, Biochemistry, Physiology, Microbiology, and Pharmacology and awarded under the faculty of medicine by the universities. Several medical colleges or institutions recognized by the MCI offer medical M.Sc courses. This course, which was initially included in the first schedule of Indian Medical Council Act 1956, was regulated by the MCI until the late 1980s. MCI used to give permission for medical colleges to run these courses. Mysteriously, this process was discontinued. There are no councils in India which regulate medical M.Sc courses or register persons with these degrees.

Until now there has been no national-level association of persons representing medical M.Sc degree holders graduating from medical colleges. There is no documentation or database of numbers of persons with the medical M.Sc degree in India. Therefore, a need for national-level association was felt.

NMMTA, the National M.Sc Medical Teachers' Association, is a national organization of persons with the medical M.Sc postgraduate degree in India. It was established in 2013 as an association of persons registered under the Societies Registration Act, 1860. It came into being on 14th August 2013 following registration by the Registrar of Societies, District East, Government of NCT of Delhi. Its headquarters is based in Delhi. 

The association was created with the intention of bringing together all persons with medical M.Sc degree in the subjects of Anatomy, Physiology, Biochemistry, Pharmacology, and Microbiology that are conducted in medical institutions and awarded under the faculty of medicine. 

There are currently 740 members from 26 states and Union Territories across India, including student and honorary members. The number of persons enrolling into NMMTA is on the rise. The administration of the association is handled by the executive committee, which comprises of President, Vice-President, Secretary, Treasurer,  zonal Joint-secretaries and other members. The association conducts its executive committee and General Body meetings periodically and submits the activity to The Registrar of Societies, Delhi along with the audited financial report. 

Aims of this association include:

to bring medical scientists from different departments under one body
to promote medical science by interdisciplinary exchanges
to explore research and job possibilities for members
to coordinate recent developments in medical science with scientific exchanges from universities, colleges and healthcare industries
to represent the academic and employment-related issues of members
to bring out scientific publications

Public activity:

On 20th March, 2017, NMMTA held a protest event at Jantar Mantar, Delhi against the unjust exclusion of medical M.Sc biomedical scientists in the human resource guidelines for diagnostic laboratories under the Clinical Establishment Act. The event consisted of dharna, procession, submission of memorandum to the health minister and culminated with a press conference. This event has been covered by over 50 online news portals and several newspapers.

Reference: Membership process
Frequently asked questions: FAQ

Saturday, July 9, 2016

Are medical M.Sc's no longer wanted in India's clinical laboratory services?


08th July, 2016

Guidelines on minimum Human Resource requirement in the Standards for Medical (Clinical) Laboratory 026 of the Clinical Establishment Act

1. Clinical Establishment Act (CEA)
The Clinical Establishment Act (2010) guidelines have been specified on the minimum standards of facilities and services for regulation of all clinical establishments in the country. The Act has taken effect in the four states namely, Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all Union Territories except the NCT of Delhi since 2012. The Act has been formulated following series of meetings by the sub-committee for the development of Standard Template for the development of Minimum Standards under National Council for Clinical Establishments. 

2. Discriminatory guidelines of CEA
However, many feel that those formulating the guidelines on the prescription for human resource in medical laboratories have erred in the draft -Standard for Medical (Clinical) Laboratory, Standard No. CEA/Laboratory- 026. This error is causing serious resentment among those who are already in employment and fear job loss when the Act would be implemented in their states. While formulating the guidelines the committee had sought public opinion in March 2014. Despite several vehement oppositions to the existing norms, the policy makers went ahead with their discriminatory approach.

3. Interpretations of laboratory results
A clinical diagnostic laboratory has several divisions or specialties such as pathology, microbiology, biochemistry, genetics, molecular biology etc. These allied or para-clinical subjects are meant to assist physicians in diagnosis through laboratory tests. This requires a thorough understanding of the disease process, sample collection, and testing procedure. It does not require patient interaction as samples are often collected in hospitals and sent to laboratories. The samples are processed and tested by the laboratory technicians. Based on the knowledge, the signatory (such as microbiologist/biochemist/pathologist), validates the results, assesses the importance of results and signs it, sometimes with a comment. Many of the tests under Biochemistry are performed by semi- or fully-automated sophisticated instruments with in-built quality controls. In such cases, the role of biochemists is only to validate the results obtained. The interpretation, if any, issued by the laboratory is only preliminary and it is ultimately for the physician to interpret the laboratory result depending on the patient’s condition. In case of doubt, the clinician has the right to take a second opinion or repeat the test with a different laboratory or testing methodology. No competent clinician would ever blindly trust a laboratory report without applying mind. To squarely blame the laboratory report indicates own shortcomings.

4. Qualifications for signatories in laboratories
There is no denial of the fact that in the field of clinical diagnostic laboratory services, doctors with suitable postgraduate degree in the subjects of Biochemistry and Microbiology are suitable to sign laboratory reports. However, there is another competent degree that many are completely unaware of- the lesser-known postgraduate degree called medical M.Sc degree. This is a 2-31/2 year postgraduate degree, which is awarded under the faculty of medicine by the health universities across India. It is conducted by the same medical colleges that also conduct MD degrees using the same hospital, laboratory and teaching faculties. Like their peers studying MD degree, these students are also taught about the causative agents (etiology), disease process (pathogenesis), specimen collection, performance of relevant diagnostic tests, quality assurance and interpretation of laboratory tests.  The course involves exposure to clinical specimens, its processing in the laboratory and elaborate discussions on its interpretation. The course and curriculum of both these degrees are mostly similar. Upon passing, persons with medical M.Sc degree can competently undertake the professional role in diagnostic laboratories and they have been doing it competently since the inception of this course. Similar courses are conducted in UK too, where clinical diagnostics is a career prospect.

5. Accreditation of laboratories for good quality
All over the world, accreditation bodies such as International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation (APLAC) or Clinical Laboratory Improvement Amendments (CLIA) follow the guidelines specified in ISO 15189 with regards to medical testing laboratories. India’s own accreditation body, the National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, too follows ISO guidelines. The ISO document does not specify qualifications. Technical requirements 5.1.2 of the ISO document states the following:

The qualifications shall reflect the appropriate education, training, experience and demonstrated skills needed, and to be appropriate to the tasks performed. The personnel making judgments with reference to examinations shall have the applicable theoretical and practical background and experience.” This means that each country shall specify its own guidelines for framing qualifications as long as they receive appropriate education, training, experience and skill. This is where both NABL and CEA have erred.

Further, the clause 5.1.6 of ISO 15189 states that all laboratory personnel including signatories must undergo periodic competency assessment. Both NABL-112 and CEA-026 conveniently ignore this guideline. Perhaps the professionals recommended by these two bodies are assumed to be competent for life, who need no assessment.

6. Existing education system in India and qualified workforce
The policy makers in India must identify the prevalent education system in India that provides the requisite knowledge and skill. There are only two courses that enable persons to function as signatories in the department of Biochemistry and Microbiology- the MD degree (doctors) and medical M.Sc degree (non-doctors). DNB after MBBS too are qualified but their numbers in India are scarce. Diploma in Clinical Pathology (DCP) is basically a diploma in pathology with superficial exposure to Biochemistry or Microbiology. Therefore, only MD and medical M.Sc are the two major postgraudate courses in India that provide the education to understand the disease process and to employ suitable diagnostic tests. While the former is a celebrated course, the latter is largely an obscured and an unknown entity. Not only medical M.Sc courses in India are misunderstood but are also viciously maligned thereby discrediting all the doctors who teach, medical colleges that conduct these courses and the universities that award these degrees. Those who feel threatened that their jobs in laboratories are being taken away by the 'less-qualified' persons, level a variety of allegations including 'lack of clinical experience' to justify their tirade

7. Guidelines of NABL for medical laboratories
In order to accreditate clinical diagnostic laboratories, NABL has specified its own guidelines keeping in mind the local education system and the available workforce. Rightfully, persons with medical M.Sc (as well as non-medical M.Sc) were prescribed as an acceptable qualification for the role of signatories in clinical diagnostic laboratories as early as 2007. Incidentally, Dr. A.S Kanagasabapathy, the chairman of the first technical committee which formulated the guidelines for medical laboratories was not a medical doctor. Another premier government body, the Indian Council of Medical Research (ICMR) had approved the NABL guidelines for qualifications in its 2008 document on ‘Good Clinical Laboratory Practice (GCLP)’. Even in its most recent document, No. 112, the NABL (2016) has considered medical M.Sc (with or without Ph.D) as qualified signatories. Despite the existing norms, the policy makers of the Clinical Establishment Act decided not to consider medical M.Sc qualified to be signatories. The CEA document 026 states, “The person signing and interpreting the report shall be registered with Medical Council of India / State Medical Council”, thereby closing the doors on qualified medical M.Sc persons for this role. This stubborn decision appears to stem from personal bias and prejudice. No guideline should ever be based on presumptions or misconceptions.

8. Controversy with NABL guidelines
Although NABL has specified M.Sc as a signatory in its recent document No. 112, its intentions are not honest. It too plans for complete denial of any role to medical M.Sc persons unless they possess Ph.D and five year post-Ph.D experience.  Several representations of protests were made against the proposal. A group of 16 private diagnostic laboratories and hospitals met on 5th January 2014 at Hyderabad to discuss the proposed changes in NABL-112 guidelines. This group recommended continuation of M.Sc persons as signatories. NABL, ignored these suggestions and proposed qualifications bereft of M.Sc degree.

NABL has sought consent on its new proposal from Medical Council of India (MCI), which is a statutory body for establishing uniform and high standards of medical education in India. It also grants recognition of medical qualifications, gives accreditation to medical institutions, grants registration to medical practitioners, and monitors medical practice in India. It does not have any mandate to prescribe qualifications for persons working in clinical diagnostic laboratories. MCI has admitted that Medical M.Sc course is beyond its purview, atlhough medical M.Sc course is still included in the First Schedule of the Indian Medical Council Act, 1956. By quietly "discontinuing" the practice of recognition and registration of medical M.Sc degrees, MCI has ensured that the holders of this degree are not registered in MCI or state medical councils. By making it compulsory that only those registered with the medical councils can be signatories of laboratory reports, the CEA guidelines has tactfully ensured that all non-doctors are kept out of the system. If this is not degree-based-discrimination, what else is it?

The Executive committee of the MCI had sought clarification from its own Ethics Committee if persons with medical M.Sc could sign biochemistry reports. In reply, the following has been stated in the minutes of the meeting of the Ethics Committee of MCI held on 3rd& 4th January, 2005:
M.Sc. (Medical Biochemistry) with or without Ph.D is entitled to independently or solely sign a medical Biochemistry report in a clinical laboratory.”
In the subsequent meeting of the Executive Committee Meeting of the MCI held on 31st January 2005, the recommendation of the Ethics Committee was approved. Paradoxically, when some individuals questioned the MCI via the RTI Act, MCI replied otherwise thus contradicting its own approval. This demonstrates MCI’s prejudiced attitude towards M.Sc degree.

The standing committee of the parliament on health and family welfare’s report (No. 92) presented on 8th March 2016 in both the houses of parliament has stated that MCI has failed to address the needs of the health system in the country.  Often, it has been felt that MCI, which is entirely composed of doctors, has always been hostile in its outlook to medical M.Sc persons. The government has decided to scrap MCI and replace it with the Medical Education Commission. If MCI provides assent to the NABL’s proposal, which denies roles for medical M.Sc persons, it must be nullified. It is natural to suspect if both NABL and MCI are colluding to stonewall opportunities to medical M.Sc persons in order to protect the employment interests of own profession. Collusion among health service providers in India is an open-secret. 

9. Role of Ph.D qualification in routine tests
In its proposal to MCI [Annexure II (b) page 103], NABL seeks Ph.D and five year post-Ph.D experience to be authorized signatory. One must appreciate the ground reality in this aspect. In several western countries Ph.D programs are routine among all institutions, as they receive generous grants for research. In India, research is only a namesake and undertaking Ph.D is a herculean task. There are few health universities, which offer Ph.D programmes and there are even fewer qualified guides. The number of Ph.D seats is totally disproportionate to the number of medical M.Sc postgraduates. 

Most of the Ph.D courses are now being offered by private deemed-to-be universities, who don’t provide any financial assistance or scholarship to Ph.D scholars. Therefore, numbers of Ph.D holders are very less. Further, many medical M.Sc persons who are working in private medical colleges don’t get deputed for Ph.D with leave and salary by the employer. Hence, the only option available is to undertake Ph.D in apart-time mode. Ultimately, Ph.D is awarded by the University only after being satisfied with the quality of the research done and the ability of the scholar to defend the thesis in a public defense. Those undertaking Ph.D on a part-time mode spend two additional years on research. The research is supervised by the guide and the co-guide and the candidate has to submit progress report every 6 months to the university. Part-time Ph.D should not be confused with ‘distance’ or ‘correspondence’ education. It really doesn’t matter if the Ph.D is done full-time or part-time; part-time only means that the Ph.D scholar is externally registered. It is only the narrow-minded policy makers who come out with frivolous criteria with the sole intention of making it harder for medical M.Sc persons to work in diagnostic laboratories. Further insistence of five-year post-Ph.D experience is another ploy to prevent non-doctors from getting into the system.

The purpose of Ph.D is to advance knowledge, not merely apply existing knowledge. One must also appreciate the fact that Ph.D is an extensive research conducted on a narrow area of science. It neither confers knowledge nor skill in interpreting routine diagnostic tests. Therefore, the insistence of Ph.D is another ploy to keep medical M.Sc persons out of diagnostics. The policy makers who frame rules are either oblivious to the existing education scenario in India or deliberately being partisan to promote own professional ilk. Mere copying guidelines of the developed western countries for our country is inappropriate. What is suitable for the West may not be applicable to our country.

10. Medical M.Sc persons are not laboratory technicians
Several institutes conduct para-medical courses in Medical Laboratory Technology (MLT). These courses are offered as diploma, bachelor or master’s degree. These courses enable persons to ‘process clinical specimens’ and to ‘operate equipment’. These support staff are considered as laboratory technicians in the laboratories. In the Clinical Establishment Act, the policy makers have erroneously placed medical M.Sc persons as technicians in Annexure 4, column II. Since plenty of efforts were made in 2014 to inform the policy makers about the existence and relevance of medical M.Sc courses, it is improbable to dismiss it as an act of oversight. In the 6th meeting of the National Council for Clinical Establishments, the following was stated:

It was informed that as recommended by National Council during earlier meetings, the attempts by allied health professionals like medical technologists, MSc in medical microbiology, MSc. in medical biochemistry etc. to work as independent practitioners were not agreed to”.  

Thorough searches of first to fifth minutes of the meeting documents fails to reveal any such information. Thus, one may suspect that denying the rights to medical M.Sc persons as signatories was purely intentional. 

11. Are medical M.Sc persons really inefficient as alleged?
Medical M.Sc course is open to those who have Bachelor's degree (B.Sc) in life sciences. In most universities, the admission to these courses follows a competitive entrance examination. Therefore, the candidates must have a good academic record in both B.Sc and competitive examination. Medical M.Sc courses in the subjects Anatomy, Physiology, Biochemistry, Pharmacology and Microbiology are more popular. Generally, M.Sc courses are of two-years; the listless UGC too mentions medical M.Sc as a two-year course. However, barring few exceptions, most universities offer medical M.Sc as a three-year course. This is because, irrespective of the chosen discipline, all medical M.Sc students undergo compulsory one year of education in human Anatomy, Physiology and Biochemistry just as the MBBS students in the first year do. This is to make the students learn the structure and function of the human body; it is this year that makes medical M.Sc course truly 'medical'. After the students successfully pass the first year, they pursue their respective disciplines such as Biochemistry or Microbiology. In these two years, they undergo training just as their peer undergo MD degree. In the same department, medical M.Sc and MD courses are conducted parallelly along similar syllabus and curriculum by the same teaching faculty using the same laboratory and hospital facilities. Like MD students, these students also participate in journal and seminar presentations and write dissertations. The examination is conducted just as it is conducted for MD students. Although the underlying graduate degrees in either case are different, the postgraduate degrees are similar in many ways. Doctors with MD degrees have the rights to hold high esteem of their degrees but have no right to belittle and malign medical M.Sc degrees. There are capable and incapable people with either degree and mere possession of a degree doesn't ensure competency. What really matters is the dedication and hard work of the individual to excel in the field of study.

12. Qualifications in other countries
Even other countries such as Nepal (Nepal Health Professional Council Act), Sri Lanka (Sri Lanka AccreditationBoard for Conformity Assessment) or USA (College of American Pathologists) include persons with M.Sc degree as signatories or consultants in clinical diagnostic laboratories. As per the Guideline of Professional Classification and Registration for Health Practitioners of Saudi Arabia, persons with M.Sc degree can be appointed as specialists and senior specialists. Therefore, the same can be considered here as well. Some countries insist on additional Ph.D qualifications for non-doctors, but their system of education and research is qualitatively different from ours, hence not applicable to India and must not be enforced here.

13. Is medical M.Sc now an unwanted degree?
There are hundreds of trained and qualified persons with medical M.Sc in India, who are already working in clinical diagnostic laboratories; some of them for several years. India must utilize such large pool of human resource. Why else is government permitting medical M.Sc courses if they are deemed unemployable? This issue appeared in the daily The Hindu on 4th July. Those following this news inside and outside the country will perceive India's medical academia as an intolerant society that wishes to establish a monopoly by booting out non-doctors in the guise of guidelines. Does India want to send this message? Why did the policy makers overlook the existing NABL guidelines or the international systems? Was demoting persons with medical M.Sc based on rational findings or was it to promote one particular profession? When the policy making is left to one profession, there is always a risk of promoting and safeguarding own profession. Government policies must be bipartisan and inclusive, but it is not so in this case. 

When the products of own education system are considered unwanted and discriminated, it only adds to the existing curse of brain drain. Why should youngsters spend 2-31/2 years and lakhs of rupees only to be told later that they are unworthy of practising what they learnt in their own course? In medical colleges, the medical M.Sc course fee may be as high as two-to-three lakh rupees. Should they be investing so much of their parent’s money and own efforts only to be told later that they are only worthy of being laboratory technicians? No other degree has been maligned and demeaned as much as medical M.Sc in both medical education and clinical diagnostics and the government has done nothing to uphold its value. When MDs in these departments were in short supply, medical M.Sc's were used for teaching in medical colleges and signing reports in medical laboratories. Now that MDs are in good supply, rules are being altered to portray M.Sc’s as ineligible and fit to be excluded from the system. This is not just injustice, it is exploitation. India appears to be a difficult place for scientists as the policies, guidelines and working culture are big impediments.

14. Response of Anil Kumar, Additional Deputy Director-General, DGHS
In the news item that appeared in the daily The Hindu on 4th July, Anil Kumar representing the Directorate General of Health Services opined, "...they are not exposed to patients. They have only theoretical knowledge and no practical experience in clinical practise". It is rather appalling that policy makers seated at Delhi are totally disconnected and unaware of the the curriculum and syllabus of medical M.Sc course. Clinical investigation is the core component of this degree and a crucial part of the university practical examination. Either there is a genuine lack of awareness among policy makers or deliberate attempts are being made to project it falsely. In the news report, he further adds, "...they have been doing it illegally, as there were no regulations in the past". This statement is baseless for two reasons. Firstly, the Clinical Establishment Act is not mandatory for all states to follow. As on 21st March 2016, it is applicable only in ten states and 6 union territories (except Delhi). Therefore, the guidelines of this act are legal in only those states and union territories. The news report states that among these states and UTs, they are being implemented only in Rajasthan and Jharkhand. Secondly, to say that there were no regulations in the past is also false as 13 states have their own acts.

15. Council for registration of degrees
All doctors are registered with the state unit of Indian Medical Council. Medical M.Sc persons, who work as teachers in medical colleges and also offer professional services in clinical diagnostic laboratories are not registered by any council or professional body. In the absence of any registration, there is absolutely no data on the number of medical M.Sc persons in India. Since private deemed-universities do not come under the ambit of RTI Act, they don’t divulge data on medical M.Sc courses. This anomaly too must be corrected. Medical M.Sc course is unique that it does not fit either with para-medical council or allied health professional council. Hence, a separate council may be made for registration of medical M.Sc persons or authorize some national association of M.Sc degree holders to register them. 

16. Importance should be on competence, not degree
In majority of countries, the stress is always on training and competence. Unfortunately, in India the degree is above competence. Once a specified professional degree is acquired by the candidate, competence is automatically assumed and taken for granted. This explains why no periodic competency assessment of signatories is specified in NABL or CEA guidelines. This fallacy must be corrected. Like other countries, India too must rely on our existing education system and workforce and give more importance to training than the nomenclature of the degree. Irrespective of their degrees, all persons, whether MD or medical M.Sc must undergo prescribed training programme before becoming authorized signatories. All signatories must undergo periodic competency assessments.

17. Actions required
The government must address this issue without ignoring the genuine concerns of the aggrieved. After all, laws are believed to bring in equality and justice. It is, therefore, imperative that the guideline needs to be corrected and the mistake must be amended. The attitudes of 'holier than thou' and 'my degree is superior to yours' has no place in modern India. Monopoly and academic-inbreeding promote mediocrity and stagnation. Like any branch of science, medical science too should be open to contributions from diverse backgrounds. If needed, a commission may be formed to examine the utility and importance of medical M.Sc in medical education, healthcare and research. Persons with medical M.Sc degree are already discriminated in a variety of ways in medical colleges and if this anomaly is not corrected the discrimination will only worsen. If an aberration can be recognized and solved by the government, the aggrieved will not have to take the painful process of seeking legal remedy. The roles of medical scientists with medical M.Sc degree must be recognized, appreciated and upheld by the government giving the dignity it rightfully deserves. The lawmakers must strive to eliminate the degree-based discrimination (academic apartheid), end monopoly of one profession and ensure the dignity of labour and equal working opportunities.

Update (13-08-2017, 08-03-2017):

1. Honorable MP (Rajya Sabha) Shri. C.P Naryanan had raised a few questions "UNSTARRED QUESTION NO 1771" on the issue of denial of recognition to medical M.Sc degree. The ministry in its reply to the questions raised by the honorable member on 2nd August, 2016 stated the following, “NCEA/Laboratory 026 Standard has not been approved by the National Council for Clinical Establishments and it was used as an input for finalizing standards of laboratories by the National council.” In the unnamed document on diagnostic laboratory available at CEA website, there is no mention of medical M.Sc degree in any role under the section IV Human resource.

2. Several individuals had filed the grievance with Centralized Public Grievance Redress and Monitoring System that since M.Sc and Ph.D qualification holders are designated as authorized signatories for clinical lab reports by NABL, CEA guidelines should do the same. Instead of taking up the issue sympathetically and on merit, the MoHFW (vide a letter from Mr. Amit Biswas, Under-Secretary, MoHFW, dated 26/12/2016) has 'almost questioned' NABL on doing so and sought its reply. In that letter MoHFW stated, "Attention is invited to clause (b) of sub-section (2) of section 15 of IMC Act, 1956 which interalia provides no person other than a doctor having qualification recognized by Medical Council of India and registered with Medical Council of India/State Medical Council(s) is allowed to practice modern system of medicine or surgery or sign a clinical laboratory report." However, the said clause & sub-section of the said section 15 of IMC Act mentions the following, "shall be entitled to sign or authenticate a medical or fitness certificate or any other certificate required by any law t be signed or authenticated by a duly qualified medical practitioner". There is no mention of diagnostic report in the clause; is the ministry deliberately misinterpreting and misguiding the clause to extend the interpretation to diagnostic laboratory report? In the same letter, the Mr. Amit Biswas mentioned  'practice of medicine' citing the aforementioned rule. One can only wonder how the officer took the liberty of interpreting 'laboratory practice' as a 'practice of medicine'.

Further, attention is drawn to the following sentences in this legal document: "Laboratory testing has never been, and is not now, the practice of medicine. Clinical laboratories provide relevant information as a tool for the physician to use, but laboratory tests themselves are not the practice of medicine. It is the act of the physician in diagnosing and treating the patient by using all available information and tools at his disposal that is the practice of medicine."

In its reply to MoHFW, NABL has clarified that the eligibility guidelines for laboratory signatory is pending approval by MCI and that its guidelines would be suitably modified as per MCI's reply. The executive committee of MCI, in a meeting held on 31-01-2005 and attended by the members of the Adhoc Committee appointed by the Hon'ble Supreme Court approved the following, "M.Sc. (Medical Biochemistry) with or without Ph.D is entitled to independently or solely sign a medical Biochemistry report in a clinical laboratory". Since MCI has already approved this in 2005, will it backtrack on it now? Will that not be a contempt of the SC appointed Adhoc committee's approval?

3. National Medical M.Sc Teachers' Association (NMMTA) has filed a writ petition in the honourable Karnataka High Court on 26/07/2016 against the guidelines of the CEA.

Update 20-03-2017
The National M.Sc Medical Teachers' Association (NMMTA) held a protest event at Jantar Mantar, Delhi on 20th March, 2017 against the discriminatory attitude and policies of the MoHFW. The dharna and procession were followed up with the submission of a memorandum to the health minister and a press conference. The details of the event and media coverage is available here: https://medicalmsc.org/activities/delhichalo/

Update: 12-05-2017
On 5th May, 2017 the Ministry of Health and Family Welfare published a draft of rules with respect to diagnostic laboratories under the Clinical Establishment Act and sought public suggestions or objections within 45 days. The draft is available here: http://www.egazette.nic.in/WriteReadData/2017/175803.pdf

Despite all the opposition since it first asked for a similar feedback in 2014, medical M.Sc degree has still been left out for the roles of Technical Head of Laboratory or  Specialist or Signatories for all the three categories of laboratories. This clearly indicates that the government has NO intention of doing justice to biomedical scientists and that the notice is just a mandatory procedure.

By publishing in the gazette, the government wants to legitimize the discriminatory rules, all this when the case against it on this issue is ongoing in the court.