Minutes of the meeting held under the Chairmanship of DGHS on 14.01.2020 at 10.
30 AM in
Resource Centre, Room No.445-A Wing, Fourth Floor, Nirman Bhavan, New Delhi
A meeting was held under the Chairmanship of Dr. Rajiv Garg, DGHS on 14.01.2020 at 10.30 AM in
the Resource Centre, Room No.445-A Wing, Fourth Floor, Nirman Bhavan, New Delhi, to consider
amendment in the Gazette Notification of Government of India in respect of the Clinical
Establishments (Central Government) Amendment Rules, 2018, dated 21st March 2018, especially
with respect to the authorized signatory in Medical Diagnostic Laboratory Reports.
List of participants is annexed.
After welcome and introduction, Dr. Rajiv Garg, DGHS informed that today’s meeting has been
called to bring about a consensus on the Minimum Standards to be followed in provision of Medical
Diagnostic Laboratory Services within the current legal framework and various Courts Orders. He
called upon participants that they may appreciate that it is highly important to implement Standard
based laboratory care in order to provide accurate lab reports so that Clinicians can make the
correct diagnosis of the medical condition and are able to deliver the required Medical care to the
patients. The implications of wrong reports are very serious in nature.
Dr. Anil Kumar, [Link], made a Power-Point Presentation incorporating the following:-
Purpose and main provisions of the Clinical Establishments Act, 2010 (CEA), current situation of
laboratory work in Government Sector and interpretation of Gazette Notification dated 21.05.2018.
He informed that following two issues are there for consideration by this Committee:
1. Direction by the Hon’ble High Court of Jaipur, vide its Order dated 30.05.2018,
wherein it is mentioned that “why the minimum qualification were not prescribed for the
Basic Composite Laboratory in the Notification”. Further order dated 06.11.2019 has
directed this Ministry to finalize and publish the Notification (i.e., if amended) within three
months, i.e., by 06.02.2020.
2. As per the Order of Hon’ble High Court of Delhi dated 26.11.2019, Ministry shall
decide the representations of various associations in the court cases within the time allowed
by the Jaipur High Court.
He also informed the processes involved including chronological sequence of events before and after
the publication of the Gazette Notification dated 21.05.2018. The Court Orders existing at that time,
especially the Delhi High Court Order dated 15.09.2017 and Supreme Court Order dated 12.12.2017,
and opinions of various stakeholders including public comments received were considered while
finalizing the Notification. He highlighted that as per the order of Delhi High Court dated 15.09.2017,
medical report is a medical certificate, as provided under the Indian Medical Council Act, 1956.
He further informed about the provision of the Indian Medical Council Act, wherein only the medical
practitioner registered with MCI or State Medical Council is authorized to sign the medical
certificate. Under PCPNDT Act, medical geneticists having medical qualifications or PG degree in
Biological Sciences are allowed to conduct tests related to Pre-Natal Diagnostic Techniques but no
where it is mentioned that they can sign the report. Under Drugs and Cosmetics Act, drug testing is
allowed by those holding PG Degree in medicine/Pharmacy/Sciences. He interpreted that the drugs
testing may not be considered as a medical diagnostic report. He informed about the key provisions
under Delhi High Court Order dated 15.09.2017 and Hon’ble Supreme Court Order dated 12.12.2017
and subsequent stand of Board of Governors in supersession of MCI, wherein it has explained the
Supreme Court Order and endorsed and informed about the Government Gazette Notification dated
21.05.2018.
1
After presentation, DGHS invited comments from the participants, the main points of which are
summarized as under:
Dr. Ajay Soni, ACBM stated that the convention of signing the Lab Reports, which was in practice in
the Country before May, 2018, has not been followed in drafting of the Notification. There was no
regulation prior to the Gazette Notification in this regard. PCPNDT, Drug & Cosmetics Act which are
Acts of MoHFW allow equal status to the Non-Medical Post Graduates in Sciences. In many other
Countries also, the non-medical Lab Scientists are holding the posts of Lab Directors and also signing
the Reports. He stated that their association has no issue of their members being called as
Technicians as mentioned in the Judgment dated 15.09.2017 of the Hon’ble High Court of Delhi.
Dr. Neetu Khurana informed that only doctors are answerable in respect of lab reports to Consumer
Court, Medical Council and other Courts. PhDs have the capability to carry out the tests related to
their respective topics/fields only, there is no regulatory body for them and they are not answerable
in the Courts.
Dr. Subrata Sinha stated that anyone who conducts the test is also liable, as in many tests the non-
medical person is also the Professional In-charge. Why should the doctors want to be responsible for
the work done by the Scientist/Technicians.
Dr. B.C. Koner informed that the provisions of Civil and Criminal Negligence apply only to Doctors
and not to non-medical persons.
Dr. Uma Kanga said that they do not give any opinion or make any diagnosis in respect of the tests
conducted by them. They report only for the work done by them. Gazette Notification has ignored
the competency of [Link]./Ph.D. Scientists. While during the selection process, even in UPSC and
AIIMS, the members of their association have been considered equal to medical doctors.
Mr. Devesh Deval informed that we should not justify the quackery and dilute standards. It is wrong
to state that there was no regulation before the CEA, as IMC Act is an old Act and it clarifies that only
a MBBS Doctor, registered under IMC Act can sign any medical certificate. Lab report is also a
medical certificate. Specialist/Super-Specialist Doctors are there for opinions in their respective
specialities. There is shortage of medical teachers in the country and to meet the same, the
[Link]./Ph.D. is allowed only to a limited extent. We have to have the systems and standards in place
all over the country. Initially people with MSc. Biochemistry, Microbiology were accommodated as a
good will gesture in Medical Colleges in MCI – “Point was objected by the non-medical participants”.
He further stated that we should have system approach for regulation of various aspects of Labs and
ensure implementation of the same. It is true that the system for regulation of non-medical persons
in the Labs needs attention.
Dr. R. K. Vats stated that those doctors and non-medical Lab Professionals who have passion to
serve the country, should own up what they are doing. Lab reports should be written clearly and
scanned signatures should not be used on the reports. He also emphasized that each Laboratory
personnel is entitled to do his/her work and own it. Further he mentioned that it is preferable that
the reports are signed in ink/pen, so that the responsibility is identified. He said that we all are in
Medical Profession and should not go to Courts for each and everything. He further informed that
MCI has, after discussions, arrived at a consensus on this issue and it will be shared with the
[Link]/ Ministry officially.
Dr. Smita Mishra said that there is no distinction between two categories of Lab Personnel, i.e.,
medical and non-medical, in many foreign countries. Standards of training should be prescribed and
competency testing should be done. A Board should be constituted for that purpose.
2
Dr. V.K. Gupta stated that those who do [Link]/Ph.D courses from Medical Colleges, are exposed to
the patient care during their training and such non-medical personnel may be considered for
allowing them to sign the lab reports.
Dr. Rohit Jain raised the point that independent signing by the non-medical persons shall be in
violation of the Order of the Hon’ble Supreme Court of India and the Court had already dismissed a
review petition in this regard. He further stated that every report needs interpretation and there is
nothing like technical report in the medical field.
Dr. Chand Wattal stated that there is no term referred to as Technical Report in medical field, e.g.,
in tests like HIV Testing, where the report is given as either positive or negative, it has serious
implications, if wrong reporting is done. Only a Doctor is competent to give such report, as a medical
expert will issue such a report after reconfirming the test and post – test counseling. There is no
technical report involved here.
Dr. R.N. Tandon said that Non-medical persons cannot be regulated under MCI, so if they are to be
involved they should be brought under regulation by constituting a Council. There is no such report
available about deficiency of doctors in the Country on the ground. He also mentioned that the
qualified doctors are not getting jobs. Government is already allowing Non-MBBS doctors to get
involved in Medical domain in full strength, which is hampering the carrier of MBBS Doctors. MBBS
Doctor is responsible to the patient and answerable to authorities and Courts. The Government
should consider the whole scenario, considering the benefits and welfare of the patients.
Dr. Promila Gupta raised an issue of shortage of Man Power and Infrastructure to check and
countercheck each and every report for its authenticity. Dr. Rohit Jain replied that the ground of
shortage of Man Power and Infrastructure is not admissible in a Court of Law. Dr. B.C. Koner stated
that giving liberty to non medical persons to issue and sign the lab reports will lead to mushrooming
of Labs run by unregulated personnel in the Country. A regulatory body is required before permitting
non-medical persons.
Dr. Ajay Soni, said that they are ready to be regulated and they have already made a demand for
creation of a Regulatory Council for the members of their associations. Dr. N.K. Mehra and Dr. Uma
Kanga endorsed his view.
Dr. Vandana Jain stated that competency testing of laboratory personnel should be done like it is
being done under NABL Accreditation Program.
Dr. Vikas Manchanda informed that the health workers are allowed to conduct tests after receiving
intensive training, and ASHAs are conducting screening tests only. Further the health workers work
under the supervision of Primary Health Center (PHC) Medical officer who is a MBBS doctor.
Laboratory Science is an established branch of medicine and advancements in this field are
happening every day. There is no term like technical report and Lab report is only of one type, which
contains interpretation. The report, like urine culture, has to be reported in the context of patient
and antibiotic sensitivity is required to be tested as per the organisms grown on culture. Only
medical doctors possess such knowledge. Similarly, simple test like Haemoglobin has to be reported
in terms of counts of RBCs, WBCs. [Link]./[Link] are trained only in a focused area and have no
exposure to patient care. First a system of certification and regulation should be developed before
including the non-medical personnel.
Dr. Ritu Singh stated that the Lab Reports have to be in co-relation with clinical condition of
patients. MBBS should be made essential in Basic Laboratories.
3
Dr. Subrata Sinha said that by boycotting the Scientists with [Link]./[Link] Qualification, progress of
Laboratory Science will stop, as only Scientists bring about advancements in the field.
Dr. K.L. Ramesh informed that in NCDC and Vector Borne Program, non-medical laboratory scientists
are signing the lab reports. He was also earlier HOD of Biochemistry Department of Dr. RML Hospital
and in that capacity he was signing all the reports despite being from non-medical background. No
issue of wrong reporting arose at any point of time, during his tenure at Dr. RML Hospital, New
Delhi.
Principal Consultant, Dr. Promila Gupta concluded the meeting with a request to the participants to
send their additional comments, if any, by 17th January, 2020 positively.
The meeting ended with a vote of thanks to the Chair and participants.
4
Annexure
LIST OF PARTICIPANTS
[Link]. Name Designation Address E-mail
MoHFW / DGHS/ MCI
1. Dr. Rajiv Garg DGHS [Link] dghs@[Link]
2. Dr. R.K Vats SG, MCI MCI Secy-mci@[Link]
3. Dr. Promila Principal Consultant Dt. GHS [Link]@[Link]
Gupta
4. Dr. Anil DDG (P) Dte. GHS [Link]@[Link]
Manktala
5. Dr. Anil Kumar [Link] [Link] [Link]@[Link]
6. Mr. Devesh Director (ME) MoHFW [Link]@[Link]
Deval
7. Ashish V Gawai DS (FR/MS) MoHFW [Link]@[Link]
8. Dr. Smita AC (KC) NACO [Link]@[Link]
Mishra
9. Dr. Somenath Consultant SAG, TB 533-A, Nirman Karmakars@[Link]
Karmakar Division, MoHFW Bhawan
Representatives of Associations
1. Dr. R.N. Tandon Past HSG, IMA IMA House ITO IP Hsg2016-18@[Link]
Estate
2. Arjun Maitra General Secretary Lucknow secretary@[Link]
NMMTA
3. Dr. Ajay Soni President, ACBM Nagpur [Link]@[Link]
4. Dr. Harsh Biochemist ACBM Delhi Hvsingh77@[Link]
Vardhan Singh
5. Dr. Uma Kanga Asst. Prof. Dept. of umakanga@[Link]
Transplant
Immunology &
Immunogenetics
AIIIMS, New Delhi
6. Prof. N.K. ICMR National Chair AIIMS, New Delhi [Link]@[Link]
Mehra and Ex-Dean, AIIMS
7. Dr. Chand Chairman, Clinical Sir Ganga Ram chandwattal@[Link]
Wattal Microbiologists Sir Hospital
Ganga Ram Hospital
IAMM Representation
8. Dr. Rohit Jain Secretary, Practicing Jaipur, Rajasthan funkyaarjay@[Link]
Pathologists Society
9. Dr. Pradeep Suri Executive Committee, EPN, New Delhi drsuri2001@[Link]
CAPP Association of
Practicing Pathologists
10. Dr. Amit Singh SR Dept. of [Link]@[Link]
Microbiology
AIIMS, Bhopal
5
Subject Experts
1. 9 Dr. Ritu Singh Dir. Prof. & HOD LHMC drritusingh19@[Link]
. LHMC, SSKH RSCH
2. Dr. Nita Dir. Prof. & HOD Dept. of nitakhurana@[Link]
Khurana Pathology MAMC,
New Delhi
3. Dr. V.K. Gupta Dir. Professor, GIPMER Vkg7479@[Link]
Biochemistry, GIPMER New-Delhi
110002
4. Dr. Bidhan Director Prof. & HOD Dept of bckoner@[Link]
Chandra Koner Biochemistry
MAMC, New
Delhi
5. Dr. Anita Dir. Prof. Path Dept. of dranangia@[Link]
Nangia Pathology LHMC,
New Delhi
6. Dr. Subrata Prof. Head, Deptt. AIIMS, New Delhi sub_sinha@[Link]
Sinha Biochemistry, Lab
medicine AIIMS, New
Delhi
7. Dr. Vikas Associate Prof. & HOD Dept. of micromamc@[Link]
Manchanda Dept. of Microbiology Microbiology,
MAMC Maulana Azad,
Medical College,
New Delhi
110002
8. 1 Dr. L.M. Advisor, Sir Ganga New Delhi Lalitmohan67@[Link]
0 Srivastava Ram Kolmet Hospital
.
9. 1 Dr. K.L Ramesh Advisor, NCDC (On National Centre rameshlk9@[Link]
1 behalf of Director for Disease
. NCDC) Control
Accreditation Bodies
1. 1 Dr. Vandana Directors NABL QCI Plot 44 Sector 45, vandana@[Link]
. Jain Gurugram
2. 1 [Link] M. CEO, NABH, QCI ITPI Building, 4-A CEO@[Link]
. Kochhar Ring Road
National Council Secretariat Members
1. . Col (Dr. Abhai Consultant, CEA, C/o NCS, DGHS Consultant.ce17@[Link]
Garg) NCS
2. 1 Mr. Akshat Legal Assistant, NCS 560-A, 5th Floor, [Link]@[Link]
. Agarwal Nirman Bhawan
3. Ms. Anuradha Statistical Assistant, 560-A, 5th Floor, [Link]@[Link]
NCS Nirman Bhawan
