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 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.
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.
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.
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,
