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[Cites 14, Cited by 0]

Punjab-Haryana High Court

Anil Kumar vs State Of Haryana & Another on 17 October, 2022

       IN THE PUNJAB AND HARYANA HIGH COURT AT
                      CHANDIGARH

                                                 Date of Decision: 17.10.2022

102+217 (1)                                        CWP-13277-2017 (O&M)

ANIL KUMAR
                                                                 ... Petitioner
                                 VERSUS

STATE OF HARYANA & ANOTHER
                                                              ... Respondents

 (2)                                               CWP-13455-2017 (O&M)
REWARI LAB TECHNICIANS ASSOCIATION, REWARI
                                                                 ... Petitioner
                                 VERSUS

STATE OF HARYANA & ANOTHER
                                                              ... Respondents

 (3)                                               CWP-13609-2017 (O&M)

ANKUR & ANOTHER
                                                                ... Petitioners
                                 VERSUS

STATE OF HARYANA & ANOTHER
                                                              ... Respondents

 (4)                                               CWP-13830-2017 (O&M)

MEDICAL LABORATORY TECHNOLOGISTS WELFARE
ASSOCIATION
                                                                 ... Petitioner
                                 VERSUS

STATE OF HARYANA & ANOTHER
                                                              ... Respondents

 (5)                                               CWP-19591-2017 (O&M)

RAJESH KUMAR ETC.
                                                                ... Petitioners
                                 VERSUS

STATE OF HARYANA ETC.
                                                              ... Respondents




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(6)                                                 CWP-27505-2017 (O&M)

KANHIYA LAL AND OTHERS

                                                             ... Petitioners
                                 VERSUS

STATE OF HARYANA AND ANOTHER
                                                            ... Respondents

                                    AND

 (7)                                         CM-15425-CWP-2019 IN/AND
                                                  CWP-2751-2018 (O&M)


ASSOCIATION OF PRIVATE LABORATORY TECHNICIANS,
BHIWANI

                                                              ... Petitioner
                                 VERSUS

STATE OF HARYANA AND OTHERS
                                                            ... Respondents


CORAM: HON'BLE MR. JUSTICE VINOD S. BHARDWAJ.
                       ****

Present:   Mr. Amarjit Beniwal, Advocate for
           Mr. Jagjeet Beniwal, Advocate
           for the petitioner(s) in CWP-13277-2017 &
           CWP-27505-2017.

           Mr. Ankit Aggarwal, Advocate for
           Mr. Pankaj Bali, Advocate
           for the petitioner(s) in CWP-13830-2017.

           Mr. Akhil Bhasin, Advocate
           for the petitioner(s) in CWP-13455-2017 &
           CWP-13609-2017.

           Mr. Harsh Kinra, Advocate
           for the petitioner(s) in CWP-19591-2017.

           Mr. R.K. Malik, Sr. Advocate with
           Mr. Sandeep Dhull, Advocate
           for the petitioner(s) in CWP-2751-2018.

           Mr. Vivek Chauhan, Addl. A.G., Haryana.




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             Mr. M.S. Longia, Advocate
             for the respondents-MCI/NMC
             in all the petitions.

             Mr. Hardeep Singh, Advocate for
             Mr. Rajesh Kumar Sheoran, Advocate
             for respondent No.4- HSBTE.

             None for remaining respondents.
                                    ****

VINOD S. BHARDWAJ, J. (ORAL)

CM-15425-CWP-2019 IN CWP-2751-2018 This is an application for placing on record the affidavit of the State Government dated 06.05.2019 as Annexure P-7 to show that the Government of Haryana has adopted the Ministry of Health & Family Welfare's notification dated 18.05.2018.

For the reasons mentioned in the application, the same is allowed subject to all just exceptions.

The affidavit of the State Government dated 06.05.2019 is ordered to be taken on record as Annexure P-7. Registry is directed to tag the same at an appropriate place of the paper book and page mark the same.

MAIN CASES This order shall dispose of a batch of seven writ petitions raising identical issues of law with the consent of the parties. For the facility of reference, facts have been extracted from CWP-2751 of 2018 titled as 'The Association of Private Laboratory Technicians Vs. State of Haryana and others'.

The aforesaid writ petition has been filed for seeking quashing of the order dated 24.05.2017 (Annexure P-2) issued by respondent No.1 i.e. State of Haryana to the extent of Clause-II provided therein which reads thus:

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"ii. The qualified Laboratory Technicians and any other staff with B.Sc. M.Sc/PhD degrees etc. in Medical Lab Technology are allowed to conduct lab tests as per their qualification. They cannot issue signed laboratory report without authentication of the same by Registered Medical Practitioner."

Further, the letter dated 14.06.2017 (Annexure P-3) issued by the Medical Council of India is also under challenge to the above extent for the reasons that the same have resulted in imposition of a condition that all the lab reports are to be signed and/or countersigned by the persons registered with Medical Council of India or State Medical Council. A further declaration is also sought that the technical reports stating tests results and merely indicating the analysis of samples without recording any opinion thereon would not fall within the scope of 'Medical Laboratory Reports' under the impugned order (Annexure P-2) and the letter dated 14.06.2017 (Annexure P-3) and hence the petitioner would be entitled to issue the same.

Briefly summarized, the facts of the present case are that the petitioners are Lab Technicians Associations of Medical Laboratory Technologists who are qualified "Lab Technicians" and pray to be permitted issuance of the analysis of the samples without any opinion on the lab test results and conditions of signature by registered Medical Practitioner be dispensed with. As the names of Lab Technicians are not registered with State in Registers of the Medical Council of India and/or State Medical Council, hence, the imposition of any such condition is arbitrary and will deprive the members of the Petitioner-Associations of their right to conduct trade and profession. Reliance has also been placed on the judgment of Delhi High Court in support of their case.

4 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -5- Short reply has been filed by the Medical Council of India. The relevant extract of the same reads as under:

"4. It is submitted that the present writ petition has been filed by the Association of Private Laboratory Technicians of Bhiwani who are purportedly engaged in the activities laboratory testing The petitioner by way of the present writ, being aggrieved by the Guidelines dated 24.05.2017 issued by respondent no.1-State Govt. of Haryana whereby Laboratory Technicians cannot issue laboratory report without authentication by Registered Medical Practitioners and the letter dated 14.06.2017 issued by the answering respondent Medical Council of India, whereby in response to the various queries raised by National Accreditation Board for Testing & Calibrating Laboratories as contained in the communications dated 12.08.2014/08.10.2014. It was decided that all laboratory reports are to be signed/countersigned by persons registered with Medical Council of India/any of the State Medical Councils The petitioner seeks for quashing of the letter dated 14.06.2017 issued by the answering respondent whereby the aforesaid decision of the answering respondent has been communicated to the National Accreditation Board for Testing & Calibrating Laboratories and also the abovementioned Guidelines dated 24.05.2017 issued by respondent no. 1-State Govt. of Haryana. The petitioners further pray for a direction that the technical laboratory reports and the analysis of the samples shall not fall within the scope medical laboratory repots and that the same can be issued without being signed/counter signed by persons registered with Medical Council of India/any of the State Medical Councils.
5. It is most respectfully submitted at the very outset that the present writ petition is entirely misconceived, since the members of petitioner Association are not registered medical practitioners possessing any recognized medical qualification included in the Schedules of the IMC Act, 1956. In any event, by way of the letter

5 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -6- dated 14.06.2017 the answering respondent has responded to the queries of National Accreditation Board for Testing & Calibrating Laboratories as contained in the communications dated 12.08.2014/08.10.2014 and that the same does not provide any cause of action to the petitioners to approach this Hon'ble Court. Thus, the present writ petition is barred on account of want of cause of action and deserves to be rejected. It is prayed accordingly.

6-9 XXXX XXXX XXXX XXXX

10. In discharge of its statutory obligations towards maintenance of highest standards in medical education in the country, by virtue of provisions of Section 33 of the Act the MCI has been empowered with the prior approval of the Central Govt. to frame regulations for laying down minimum standards of infrastructure, teaching and other requirements for conduct of Medicine courses including the requirements for admission to MBBS and Postgraduate courses. It is submitted that the MCI further lays down in detail the course content, the duration, distribution of teaching and training days on various subjects and also for conduct of examination etc. 11-32. XXXX XXXX XXXX XXXX

33. It is submitted that the reasons for which registered medical practitioners possessing at least the qualification of MBBS cannot be equated with members of petitioner-Association is based on rational grounds and they are under:

MBBS B.Sc.

Structured course - 4 ½ years of Structured Course - 3 years Course - with theory papers, duration with theory papers, written and practical written and practical examinations. examinations.

1 year of Internship/practical No practical training or training - in patient care internship undergone. applicatory studies and hospital management.

6 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -7- Course curriculum, syllabus, Medical Council of India examination pattern, practical which has the statutory duty to training requirements etc. are maintain standards of medical approved by the Medical education has no say in the Council of India - expert Course Curriculum, syllabus statutory body to maintain mode of teaching etc. which standards of education. definitely has huge impact on standards of education.

Exposure to day to day No such exposure functioning of Hospitals, its Departments etc. from the very inception of their education.

Exposure to Patient Care No such exposure Trained in clinical and No such training diagnostic methodologies and techniques.

Trained in interpretation of No such training clinical diagnostic techniques practically in relation to patients.

Trained in different disciplines No such training of medicines, i.e. knowledge and exposure to different branches and subjects of medical course.

MD/MS M.Sc.

Structured course - 3 years Structured Course - 2 years duration with theory papers, duration with theory papers, written and practical written and practical examinations. examinations.

Course curriculum, syllabus, Medical Council of India examination pattern, practical which has the statutory duty to training requirements etc. are maintain standards of medical approved by the Medical education has no say in the 7 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -8- Council of India - expert Course Curriculum, syllabus statutory body to maintain mode of teaching etc. which standards of education. definitely has huge impact on standards of education.

           Exposure         to     day          to     day No such exposure
           functioning of Hospitals, its
           Departments etc.
           Exposure to Patient Care                          No such exposure
           Trained       in        clinical            and No such training
           diagnostic methodologies and
           techniques.

Trained in interpretation of No such training clinical diagnostic techniques practically in relation to patients.

Trained in different disciplines No such training of medicines, i.e. knowledge and exposure to different branches and subjects of medical course (interdisciplinary exposure) Research paper (thesis) in one No such Research paper in of the areas of the course most unisersities.

SUPER-SPECIALTY Ph.D. Structured Course of 3 years Course not structured- 2-4 duration.

years (normally) duration.

                                                             Full time research only on a
                                                             single   chosen      topic   in   a
                                                             particular discipline
           Exposure         to     day          to     day No such exposure
           functioning of Hospitals, its
           Departments etc.
           Exposure to Patient Care                          No such exposure
           Trained       in        clinical            and No such training




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           diagnostic methodologies and
           techniques.

Trained in interpretation of No such training clinical diagnostic techniques practically in relation to patients.

Specialization in a particular Theoretical Specialization in branch of Medicine/Surgery in one particular topic only. addition to the knowledge of No disciplinary knowledge of interdisciplinary research, medical profession practice of medicine/surgery and patient care.

OTHER DIFFERENCES Eligible to practice modern Not eligible for the same. medicines Eligible to give clinical findings Not eligible for the same. and certify the same Eligibility to certified diagnostic Not eligible for the same.

           and clinical reports
           Exposure and experience to Lacks               such     exposure    and
           practical     working        conditions experience
           and management of department
           of     hospitals       and      medical
           colleges.
           Mandatory                 registration No such registration required.
           required under the provisions of
           Indian Medical Council Act,
           1956
           Amenable to disciplinary action Not           covered     under      the
           by Medical Council of India provisions                   of        these

under Indian Medical Council Regulations (Professional Conduct, Etiquette and Ethics) 9 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -10- Regulations, 2002 They are accountable for their No such accountability.

conduct, etiquette and code of ethics for medical professionals 34-39. XXXX XXXX XXXX XXXX

40. It is submitted that the present writ petition has been filed by the Association of Private Laboratory Technicians of Bhiwani who are purportedly engaged in the activities laboratory testing The petitioner by way of the present writ, being aggrieved by the Guidelines dated 24 05 2017 issued by respondent no.1-State Govt. of Haryana whereby Laboratory Technicians cannot issue laboratory report without authentication by Registered Medical Practitioners and the letter dated 14.06.2017 issued by the answering respondent - Medical Council of India, whereby in response to the various queries raised by National Accreditation Board for Testing & Calibrating Laboratories as contained in the communications dated 12.08.2014/08.10.2014, it was decided that all laboratory reports are to be signed/countersigned by persons registered with Medical Council of India/any of the State Medical Councils: The petitioner seeks for quashing of the letter dated 14.06.2017 issued by the answering respondent whereby the aforesaid decision of the answering respondent has been communicated to the National Accreditation Board for Testing & Calibrating Laboratories and also the abovementioned Guidelines dated 24.05.2017 issued by respondent no 1-State Govt. of Haryana. The petitioners further pray for a direction that the technical laboratory reports and the analysis of the samples shall not fall within the scope medical laboratory repots and that the same can be issued without being signed/counter signed by persons registered with Medical Council of India/any of the State Medical Councils.

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42. It is submitted that the matter in respect of the clarifications as sought by National Accreditation Board for Testing & Calibrating Laboratories, was considered by the Ethics Committee of the answering respondent in its meeting held on 9 & 10 October, 2014, wherein the Ethics Committee referred to its earlier decision taken on 26th & 28th August, 2004 wherein it had been decided that Pathology Reports have to be signed only by medical practitioners registered with the MCI/the various State Medical Councils. The said decision of the Ethics Committee dated 26th & 28th August, 2004 had also been approved by the General Body of the MCI. Thus, it was decided by the Ethics Committee to reiterate its earlier decision that only registered medical practitioners shall be allowed to signed medical laboratory reports.

43. XXXX XXXX XXXX XXXX

44. It is submitted that the said matter was considered by the Ethics Committee of the answering respondent in its meeting held on 28.01.2015, wherein after due discussion and deliberation, a Sub-Committee was constituted comprising of the following doctors

i) Head of the Department of Laboratory Medicine, AIIMS, New Delhi.

ii) Head of the Department of Biochemistry, GB Pant Hospital, New Delhi.

iii) Head of the Department of Microbiology, PGIMER, Chandigarh.

iv) Head of the Department of Pathology. MAMC, New Delhi.

45. It is submitted that the aforesaid recommendations of the Ethics Committee of the answering respondent were placed before the Executive Committee of the answering respondent in its meeting held on 16.03.2016, wherein after due deliberation the aforesaid recommendations had been approved.

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46. It is submitted that the said matter was considered by the Ethics Committee of the answering respondent in its meeting held on 18.04.2016, wherein after due discussion and deliberation it was decided to obtain the comments of the members of the Sub- Committee as approved by the Executive Committee of the answering respondent in its meeting held on 16.03.2016 on the matter. Accordingly, the answering respondent vide letters dated 17.01.2017 had requested all the members of the Sub-Committee to furnish their comments /reports in respect of the matter.

47. It is submitted that thereafter the answering respondent had received comments in this regard from the Head of the Department of Laboratory Medicine, AIIMS, New Delhi, Head of the Department of Microbiology, PGIMER Chandigarh & Head of the Department of Biochemistry, GB Pant Hospital, New Delhi

48. It is submitted that the said matter, alongwith the comments as received from the Head of the Department of Laboratory Medicine, AIIMS, New Delhi, Head of the Department of Microbiology. PGIMER, Chandigarh & Head of the Department of Biochemistry. GB Pant Hospital, New Delhi was subsequently considered by the Ethics Committee of the answering respondent in its meeting held on 6th & 7th February, 2017 The Ethics Committee of the answering respondent had also considered the judgement dated 17.09.2010 passed by the Hon'ble High Court of Gujarat in the case of Association of Pathologist of Bhavnagar & Ors. Vs. Secy. Health Department & Ors. - SCA No. 7999/1998 & connected matters. The Ethics Committee of the answering respondent, after due discussion and deliberation, had made certain recommendations to the Executive Committee of the answering respondent in this regard.

49. It is submitted that the aforesaid recommendations of the Ethics Committee of the answering respondent were placed before the Executive Committee of the answering respondent in its meeting held on 11.04.2017, wherein after due deliberation, the Executive Committee in this regard decided not approve the 12 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -13- recommendations of the Ethics Committee dated 6th & 7th February, 2017. The Executive Committee of the answering respondent had further reiterated its earlier decision dated 15.01.2015, wherein after due deliberation it had approved the recommendations of the Ethics Committee dated 9th & 10th October, 2014 that all laboratory reports are to be signed/counter signed by persons registered with the MCI /the concerned State Medical Council.

50. It is submitted that the said matter was further considered by the Ethics Committee of the answering respondent in its meeting held on 6th & 7th June 2017, wherein after due deliberation, in view of the decision of the Executive Committee of the answering respondent dated 11.04.2017, it was decided to inform National Accreditation Board for Testing & Calibrating Laboratories of the same The decision of the answering respondent has been communicated to respondent no 3- National Accreditation Board for Testing & Calibrating Laboratories vide letter dated 14.06.2017, copy whereof is annexed herewith as ANNEXURE R-3/7.

51. It is further submitted that the answering respondent had received letter dated 10.07.2017 from the Central Govt. whereby a representation of the members of certain similarly situate Association dated 29.06.2017 had been forwarded. The answering respondent vide its letter dated 24.07.2017. Copy whereof is annexed herewith as ANNEXURE R-3/8, had informed the Central Govt. that members of the similarly situate Association, who possess the science qualifications of M.Sc., & Ph.D. cannot be authorized to sign the laboratory reports.

52. It is submitted that laboratory reports are very crucial so as to arrive at a final diagnosis of the ailment of the patient so as to begin treatment but in case if laboratory reports are issued erroneously and without any clinical co-relation/interpretation, the same can have grave/fatal consequences on the treatment of 13 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -14- the patient. If a wrong line of treatment is adopted due to misleading laboratory reports the life of the patient is at risk.

53. It is submitted that before signing/counter signing/authenticating any laboratory report, thorough clinical knowledge is imperative which can only be possessed by a person who has undergone at least the MBBS course and is a medical practitioner registered with the MCI or the concerned State Medical Councils In case, persons other than registered medical practitioners are allowed to sign/counter sign/authenticate the laboratory report, the same might not be true & authentic and will severely hamper the clinicians from making a final diagnosis of the ailments which will impact the treatment of the patient.

54. It is further submitted that the answering respondent has come across a number of cases while dealing with matters concerning allegation of medical negligence/professional misconduct against doctors, wherein the registered medical practitioner prescribed treatment on the basis of a laboratory reports issued by a person other than a registered medical practitioner and after detailed inquiry it was found that the wrong treatment of the patient was due to serious errors in the laboratory report. Thus, it is of utmost importance that laboratory reports are signed/counter signed/authenticated only by a medical practitioner registered with the MCI or the concerned State Medical Councils.

55. It is submitted that signing/counter signing/authenticating of any laboratory report is within the exclusive realm of the functioning of a medical practitioner registered with the MCI or the concerned State Medical Councils and also of a person possessing a Postgraduate medical qualification in the specialty of Pathology, who can be considered as a Pathologist The making and signing/counter signing/authenticating of any laboratory report is within the scope of practicing modem scientific medicine which can only be performed by registered medical practitioners.

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56. It is submitted that the concept of clinical co-relations being an essential part of making laboratory reports, is entirely unachievable by the members of petitioner, since they entirely lack any orientation towards clinical knowledge and skills. A registered medical practitioner is trained and competent in co- relating the laboratory reports with the clinical findings.

57. It is submitted that prior to issuing the laboratory reports, the quality control (EQAS & IQC) needs to be verified which is only within the knowledge of registered medical practitioners.

58. It is further submitted that the answering respondent is empowered to take action against registered medical practitioners in matters wherein allegations of medical negligence and professional misconduct have been made but the answering respondent cannot take any action against the members of petitioner in case they sign/counter sign/authenticate issue, erroneous misleading or wrong laboratory reports.

59. It is submitted that even members of petitioner who possess Ph.D. qualifications are incompetent to sign/counter sign/ authenticate/issue laboratory reports since Ph.D. is completed only on a particular topic and such persons do not have any holistic knowledge of the concerned subjects.

60. It is most humbly submitted that as per the provisions of IMC Act, 1956 and the Regulations framed thereunder, no other person other than a person possessing a Postgraduate medical qualification in the specialty of Pathology, can be considered as a Pathologist. It is submitted that the IMC Act 1956 and the Regulations made thereunder, provide for the Postgraduate specialty of Pathology and also provides for detailed course/curriculum."

Reference has also been made to various other judgments to support the contentions.

A separate reply has been filed on behalf of the respondents No.1 and 2. Relevant extract of the said reply reads thus:

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4. That petitioners claim themselves to be qualified lab Technicians but they are not authorized to sign the clinical lab report in View of Medical Council of India (MCI) guidelines dated 14.06.2017, which clearly provides that all lab reports to be signed/Countersigned by persons registered with MCI/State Medical Council.

It is further submitted that qualified MBBS doctor can co- relate the test reports and physical symptoms of the patient and prescribe treatment accordingly. If Lab Technician is allowed to sign the Clinical Lab report, it will result into quackery.

5. That it would be appropriate to mention here that Executive Committee of the Medical Council of India decided that All lab reports to be signed/Countersigned by persons registered with MCI/State Medical Council. The copy of MCI letter No.MC1-211(2) (Gen.)/2014-Ethics/118642 dated 14.06.2017 is annexed as Annexure R-2/1 for the kind perusal of this Hon'ble Court.

The Health Department Haryana issued the guidelines dated 24.05.2017 for running of Clinical Laboratories in Haryana which clearly provided minimum qualification required for signing of clinical lab reports is MBBS or above who are registered with Medical Council of India or State Medical Council as per Indian Medical Council Act, 1956. The Health Department Haryana guidelines dated 24.05.2017 are in consonance with Medical Council of India view point.

6. That Association of Practicing Pathologists, Haryana filed the CWP No.27666 of 2013 with the prayer for closing down all the illegal/unauthorized pathology laboratories in the State of Haryana which are being run by the Laboratory Technicians or by the other unqualified persons/institutions and all such laboratories which are not being run by a qualified medical practitioner possessing i.e. MD Pathologist and also praying for framing a proper policy/regulations for regulating the opening and/or running the pathology laboratories in the State of 16 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -17- Haryana and to constitute an appropriate authority for the regular checking and supervision of such laboratories. Health Department Haryana filed the written statement on 31.01.2014 wherein it was clearly mentioned that at present there were no such guidelines for regulation of pathological laboratories in State of Haryana.

7. That the said Civil Writ Petition No.27666 of 2013 was disposed of on 24.03.2014. The operative part of the order dated 24.03.2014 is as under:

"In view of the aforesaid stand we call upon Medical Council of India/respondent No.4 to respond to the communication dated 17.01.2014 of the State of Haryana within a maximum period of 15 days from today and supply copy of guidelines, if they so exist. Since a Committee already been constituted, has we would expect the State of Haryana to take expeditious steps to both frame the policy and thereafter take action under the policy. The Committee will take into consideration the material placed by the petitioner. We feel that the time period up to the next date is sufficient for the State of Haryana to do the needful.
Petition stands disposed of with the aforesaid directions.
List for compliance on 25.07.2014. State of Haryana will file a compliance report at least three days prior to the next date of hearing."

8. That State of Haryana filed the compliance. Report on 22.07.2014 wherein it was mentioned that State of Haryana has passed the "The Haryana Clinical Establishments (Registration & Regulation) Act, 2014". The rules under the Act are being prepared which was also include guidelines for running the pathological laboratories in the Government as well as private sector.

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9. That the Hon'ble High Court disposed of the said petition, on the basis of affidavit dated 22.07.2014 of State Government, on 25.07.2014 with the direction that the rules under Haryana Clinical Establishments (Registration and Regulation) Act, 2014 shall be published within a period of six months. Relevant portion of order dated 25.07.2014 is as under:

"As per the compliance it is stated that The Clinic Establishments report, Haryana (Registration & Regulation) Act, 2014 has been notified 28.03.2014 and that the Rules under the Act are under preparation. Mr. Gupta states that the Rules shall be published within a period of six months.
In view of the said fact, no further orders are called for in the present writ petition."
10-11. XXXX XXXX XXXX XXXX
12. That State Government after through discussion in the matter filed a Review Application NO.CW-377 of 0216 in CWP No.27666 of 2013 for modification of the order dated 24.03.2014.
13. The Review Application No.CW-377 of 2016 was dismissed by the Hon'ble Court vide order dated 07.04.2017. The relevant part of the order dated 07.04.2017 is reproduced as under:
"It is evident that no effective and concrete steps have been taken to implement the order dated 24.3.2014, the review of which is sought. The review application in the circumstances lacks bona fide. It appears that it is only when the contempt petition was filed and the respondent in the contempt petition was summoned then the review application has been filed to get time. It is even otherwise barred by substantial time.
In the circumstances, there is no merit in the review application and the same is accordingly dismissed with cost of Rs.20,000/-. Since the review application has been dismissed on merit, the question of delay in filing the 18 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -19- review application is only academic and the same is accordingly dismissed."
14-15. XXXX XXXX XXXX XXXX
16. That State Government considered the entire matter at length and decided to issue certain guidelines for regulation of pathology labs and signing of clinical pathology reports and same was issued on 24.05.2017 (Annexure P-2) which has been impugned in the present writ petition. It is further submitted that Civil Surgeon of the district was appointed as Nodal Officer to implement these guidelines. It is pertinent to mention here that these guidelines dated 24.05.2017 are in consonance with Medical Council of India view that "All lab reports to be signed/countersigned by persons registered with MCI/State Medical Council."

17. XXXX XXXX XXXX XXXX

18. That the guidelines dated 24.05.2017 were apprised to the Hon'ble High Court vide letter dated 23.08.2017 through the office of Advocate General Haryana. The Hon'ble High Court was pleased to take on record the guidelines dated 24.05.2017, issued in compliance of the Hon'ble High Court order dated 24.03.2014 passed in CWP No.27666 of 2013.

19. That the Hon'ble High Court vide order dated 18.12.2017 passed in COCP No.2016 of 2016, was pleased to pass the following directions:

"Learned counsel for respondent NO.4 submits that instructions dated 23.8.2017 have been issued empowering Civil Surgeon to take necessary action in view of the order passed by the writ court and reiterated in RA-CW-377- 2016 in CWP-27666-2013. He seeks liberty to file an affidavit regarding progress after issuance of instructions. Let affidavit of Financial Commissioner cum-Secretary, Health Department, Government of Haryana be filed well in time before the next date of hearing."
           20-22.          XXXX           XXXX          XXXX          XXXX



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23. That Health Department Haryana vide letter No. 4PM- 2017/8271 dated 23.08.2017 (in COCP No.2016 of 2016) prayed the Hon'ble Court through Advocate General Haryana to give one year time to Clinical Laboratories to comply with the guidelines dated 24.05.2017 as Clinical Laboratories may require some changes infrastructure and require engagement of doctors registered with the Medical Council for signing the Secretary to Lab reports. Government The Principal Haryana, Health Department filed the affidavit dated 09.02.2018 in COCP No.2016 of 2016 in CWP No.27666 of 2013 and aforesaid letter No.4PM-2017/8271 dated 23.08.2017 was annexed as Annexure D-1. It is further submitted that Director General Health Services, Haryana vide letter No. 4PM-2018/1012 33 dated 08.02.2018 informed all Civil Surgeons of Haryana State that cutoff date for comply with the guidelines dated 24.05.2017 has been fixed as 23.05.2018 and one year time has been given for comply with the guidelines.
24. That State Government has framed these guidelines dated 24.05.2017 after considering the matter at length and going through the Medical Council of India view point. These guidelines have been framed in compliance of Hon'ble High Court order dated 24.03.2014, 25.07.2014 passed in CWP No.27666 of 2013. These guidelines are framed to regulate the laboratories and to provide quality health services to the public at large. Therefore, these guidelines dated 24.05.2017 (Annexure P-2) are legal, just, fair and passed in accordance with views of Medical Council of India and Indian Medical Council Act, 1956."

It was thus contended that the test results were required to be countersigned by the qualified Doctors and that mere absence of giving an analysis of the test result should not be perceived as absence of a report. The test applied and the basis of report itself is required to be verified by the 20 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -21- qualified Doctors so that the lab reports can be safely relied upon by the physians.

Learned Sr. Counsel for the petitioner argues that vide aforesaid communication, the respondent-State of Haryana has held that qualified laboratory technicians and any other staff holding B.Sc., M.Sc., Ph.D. Degrees in Medical Lab Technology were allowed only to conduct lab tests but were not allowed to submit any laboratory report without authentication of the same by the Registered Medical Practitioner. He further argues that the Medical Council of India had issued the letter dated 14.06.2017 (Annexure P-3) conveying the decision of the Executive Committee to the effect that all lab reports are required to be signed and/or countersigned by persons registered with the Medical Council of India or State Medical Council. The aforesaid communication of Medical Council of India was subject to challenge in Writ Petition (Civil) 6740 of 2017 titled as 'Association of Clinical Biochemists and Microbiologists ACBM (Regd.) & Anr. Vs. Union of India & Others' before the Hon'ble High Court of Delhi. The aforesaid writ petition was disposed of vide judgment dated 15.09.2017. The relevant extract of the said judgment reads thus:

"14. The decision of the Executive Committee that all reports are to be signed/countersigned by persons registered with MCI/State Medical Council must be read which in the context of the three questions set out in the impugned communication. The said decision of the Execution answers questions nos.2 and 3 in the affirmative and there can be no dispute that MCI's decision in this regard is in conformity with the provisions of Section 15(2)(d) of the IMC Act and cannot be faulted.
15. Insofar as the first question is concerned that is, whether M.Sc/PHD candidates, who are not registered with MCI, are

21 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -22- eligible to sign medical laboratory reports the same must be answered in the negative as has been done by MCI. However, MCI decision in this regard must be read in the context. The expression "medical laboratory reports" as used in the first question cannot be misunderstood to mean test reports which merely indicate the result of tests and/or the manner in which the tests are conducted.

16. The expression "medical laboratory reports" must in the context of the impugned communication, be understood to mean reports that contain medical diagnostic results and/or an opinion with regard to the tests results. A technical report stating test results and indicating the analysis of samples. without recording any opinion thereon, would not fall within the scope of medical laboratory reports as contemplated under the impugned communication.

17. The impugned communication, thus, cannot be understood in a wider sense as urged by the petitioner and must be read in the restrictive manner as indicated above.

18. The petitioners can have no grievance if the impugned communication is read in the manner as indicated above and, therefore, no further orders are required to be passed in this petition."

He further contends that a technical report of the test analysis without an opinion thereof would not fall within the definition of "Medical laboratory report" and is not required to be signed. The petitioners and/or members of the petitioner Association thus cannot be denied their right to submit a report of the test conducted without any opinion thereupon. He further argues that the aforesaid decision of the Hon'ble Delhi High Court has become final and eventually, the Ministry of Health and Family Welfare 22 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -23- published a notification on 18.05.2018 in the Gazette of India. The relevant extract thereof reads thus:

              III     HUMAN RESOURCE

                      (a)      Minimum          "Desirable: Bachelor of XXX   XXX
                      qualification of          Medicine and Bachelor
                      Technical Head            of Surgery (MBBS) from
                      of Laboratory or          a recognized university,
                      Specialist     or         institution.
                      *Authorised               **Wherever
                      Signatories.              interpretation of lab
                                                results     or  opinion
                      *The authorised           thereon are required,
                      signatory will be         registered Bachelor of
                      liable          for       Medicine and Bachelor
                      authenticity of the       of Surgery (MBBS)
                      laboratory     test       medical practitioner is
                      report.                   essential."



The aforesaid notification had been published in exercise of the powers under Section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010.

A further reliance is placed on the affidavit of the State Government dated 06.05.2019 submitted in COCP No.2016 of 2016 in CWP-

27666 of 2013. Reliance was placed on paragraph No.3 and 4 thereof, which are reproduced hereinafter below:

"(3) The Central Govt. [(Ministry of Health and Family Welfare), Deptt. of Health and Family Welfare] framed rules under Section 52 of the Central Act and notified the same on 23rd May, 2012.
(4) That these Rules become automatically applicable to State of Haryana as well."

He thus contends that the Notification published by the Government of India specifically prescribes that wherever interpretation of a 23 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -24- result or opinion thereon is required, the same alone needs to be signed by a registered Bachelor of Medicine and Bachelor of Surgery and not otherwise.

Hence, the petition deserves to be allowed.

Learned counsel for the Respondent No.3-Medical Council of India reiterates the submissions made in the written statement and contends that the submission advanced by the learned counsel for the petitioner are based upon selective reading of the judgment of the Hon'ble Delhi High Court in the matter of Association of Clinical Biochemist's case (supra) and the same does not advance the cause of petitioners. He makes a reference to paragraphs No.9 and 10 of the aforesaid judgment to buttress his submissions.

The same are extracted as under:

"9. At this stage, it is relevant to refer to clause (c) and Section 15(2) of the IMC Act, which reads as under:
"15(2)(c) 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:
XXXX XXXX XXXX XXXX 15(3) Any person who acts in contravention of any provision of sub-section (2) shall be punished with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees, or with both;"

10. It is apparent from the above that no person other than a duly qualified medical practitioner is entitled to sign any medical report. Thus, members of petitioner association cannot sign a medical report or a medical certificate. However, the same does not preclude the members of the petitioner association to give a technical report as to the tests conducted by them. Plainly, such report can only be for consumption of medical practitioners and 24 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -25- pathologists. The said report cannot be treated as diagnosis of any medical condition. Thus, there can be no objection if the technical report submitted by the qualified technicians indicates the result of their tests or the technical analysis of the samples, as long as the members of the petitioner association refrain from expressing any medical opinion or holding out the technical result of the medical tests conducted by them as a diagnosis of any medical condition."

He further contends that even as per the aforesaid judgment, the communication sent by the Medical Council of India and the decision of the Government of Haryana cannot be construed to empower the Lab Technicians to carry out tests for the purpose other than for opinion of a Medical Practitioner.

He further contends that the controversy in question was also examined by a Division Bench of Gujarat High Court at Aurangabad in the matter of 'Association of Pathologist of Bhavnagar Vs. Secretary, Health Department' in Special Civil Application No.17485 of 2006 decided on 17.09.2010. The relevant extract of the aforesaid judgment relied upon by the learned counsel for the respondent No.3 is extracted hereinafter below:

"29. The Supreme Court in the case of Mukhtiar Chand (Dr.) vs. State of Punjab & Haryana, reported in (1998) 7 SCC 579, while examining the provisions of Section 15(2) of the Indian Medical Council Act, 1956 held that "a harmonious reading of Section 15 of the 1956 Act and Section 17 of the 1970 Act leads to the conclusion that there is no scope for a person enrolled on the State Register of Indian Medicine or the Central Register of Indian Medicine to practice modern scientific medicine in any of its branches unless that person is also enrolled on a State Medical Register within the meaning of the 1956 Act".

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30. It is true that the members of the Association of Laboratory Technicians possess different qualifications such as Bachelorette of Science or Bachelorette or Diploma in Medical Laboratory Technician (Pathology). Though the Laboratory Technicians have obtained such qualifications with subjects like Pathology, such qualification cannot be termed to be a course in medical subject as recognized by the Medical Council of India. In Group 'D' at Sr. No. 6 to Annexure-I to the Establishment of New Medical Colleges Regulations, 1993, 'Pathology' is a subject of higher course in Medical Science. It is distinct and different than the qualification of Medical Laboratory Technician. A person who passed Medical Science in Pathology cannot be equated with Laboratory Technician, who merely obtains a Diploma in Medical Laboratory Technician course, which may be of one or other faculties like Biology or Hematology or Microbiology or Chemistry and he cannot be termed to be a Pathologist.

30-31. XXXX XXXX XXXX XXXX

32. It is a different thing that a Pathologist, registered with the Medical Council of India, can take help from a Laboratory Technician, who has the knowledge to analyze human fluid samples using techniques available to the clinical laboratory, such as manual white blood cell differentials, analysis by a microscope and advanced analytical equipment. For doing so, the Laboratory Technicians may perform a full range of laboratory tests - from simple blood and urine tests to more complex tests, and report laboratory findings to pathologists and other physicians. But it cannot be said supplied to any patient for its utility, though such report may be submitted before a Pathologist, who being registered, is competent to medical practice under the Act and being satisfied, the Pathologist may sign the same for utility of the patient or to diagnose, treat, operate or prescribe medicine or any other remedy, etc. 33 We accordingly hold that the Laboratory Technicians being not Pathologists, cannot run any laboratory independently. They 26 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -27- cannot directly give any report to any patient or any other individual, or to any institution or practicing doctor, without the authentication of the same by the pathologist registered with the Medical Council. Though it is open to any person or institute to run a pathology laboratory, but no report can be issued without the signature or counter signature of the practicing pathologist recognized by the Medical Council of India. The respondents are directed to ensure that no pathology laboratory is run by any unqualified person or institute having no recognized pathologists registered with the Medical Council. However, if such pathological laboratory is run by a pathologist registered with the Medical Council, or if such pathological laboratory engages a pathologist registered with the Medical Council, the respondents may allow such laboratory to run. Individual Laboratory Technician cannot be allowed to run pathological laboratory independently without engaging a pathologist registered with the Medical Council.

The writ petition preferred by the Association of Pathologists of Bhavnagar in Special Civil Application No. 7999 of 1998, North Gujarat Pathologists Association in Special Civil Application No. 17485 of 2006 and Gujarat Association of Pathologists and Microbiologists in Special Civil Application No 8211 of 2008 are allowed. The contrary prayers made by the Association of Self Employed Owners (Para Medical) of Private Pathology Laboratories of Gujarat in Special Civil Application No. 6715 of 2008 and Anand People's Medicare Society and others in Special Civil Application No. 8193 of 2009 are rejected."

He further contends that the aforesaid judgment of the Gujarat High Court was challenged before the Hon'ble Supreme Court and that the said judgment has been upheld by the Hon'ble Supreme Court in the matter of 'North Gujarat Unit of Association(s) Vs. North Gujarat Pathologists 27 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -28- Association' in Special Leave to Appeal (Civil) 28529 of 2010 decided on 12.12.2017 by observing thus:

"We dispose of all these special leave petitions and other pending applications, if any, by taking a view that the stand of the Medical Council of India that Laboratory Report can be counter signed only by a registered medical practitioner with a post graduate qualification in pathology is correct."

The Hon'ble Supreme Court upheld and affirmed the stand of the Medical Council of India to the effect that that laboratory reports can be countersigned only by registered Medical Practitioners with a Postgraduate in Pathology and that a Lab Technician cannot run a laboratory independently and cannot give any report to any patient or an individual, without authentication by a pathologist registered with Medical Council of India and/or State Medical Council.

Learned counsel for the respondent-State of Haryana has additionally argued contended that the Government of India has notified the amendment to the Schedule, under Clinical Establishments (Central Government) Rules, 2012 vide amendment of 2020 i.e. 14.02.2020 in place of Schedule notified on 18.05.2018 qua heading of Sr. No.III and relating to entry specified therein. As per the aforesaid, the requirement prescribed for clinical establishment has been altered and the same now reads thus:

        (1)                 (2)                           (3)          (4)    (5)

        "III HUMAN RESOURCE

               a) Minimum qualification       Essential-                XXX   XXX

of Technical Head of 1. MBBS registered with Laboratory or Specialist MCI or State Medical or Council with at least one *Authorised Signatories. year training or work experience in a Medical Diagnostic Laboratory of 28 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -29-

            NOTE::                    same or higher level in a
                                      Government.
            1.     *The    authorized or Recognized medical

signatory will be liable college or hospital or for authenticity of the institution or organization. laboratory report only.

Those working in

2. Medical tests should Government sector shall be normally be undertaken exempted from the aforesaid on the advice of a training or experience registered medical or practitioner. 2. M.Sc in Pathology or Medical Microbiology or Medical Biochemistry from a recognized university or institution with at least three years training or work experience in Medical Diagnostic Laboratory or same or higher level in a Government or Recognized medical college or hospital or institution or organization shall be entitled to conduct the tests, generate and sign test reports in respect of tests of their respective specialty, without recording any opinion or interpretation of laboratory results.

All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such.

Note:

Laboratory technician with qualification as mentioned in Part III (b) of this Notification working in a Medical Diagnostic Laboratory registered under a Central or State Clinical Establishments Registration Act, as applicable, and a Health care worker in a Government National Health program trained for conducting identified specific tests, may conduct the tests and generate test result which shall be submitted to the signatory 29 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -30- authority at Sl. Nos. 1 or 2

as applicable."

It is, thus, argued by the learned counsel for the State of Haryana that in view of the above amendment, the persons who hold Post Graduation in Pathology, Medical Microbiology or Medical Biochemistry from recognized institute with at least three years of training and/or work experience are entitled only to conduct the test, generate and sign the test reports in respect of the tests of their respective specialty without recording any opinion or interpretation of laboratory results while others have to submit their test result to them. It is, thus, contended that in light of the amendment in the Rules, even for the purposes of conducting of the tests and generation and signing of the test reports, a person is required to hold the eligibility qualification as well as the experience prescribed in the Notification dated 14.02.2020. He contends that the petitioners or the member of the petitioner association are Graduates and Diploma holders and do not hold the qualification prescribed as per the Rules. He, however, contends that the State would have no objection to the persons, who fulfill the qualification and the criteria prescribed under the Rules of 2020 to conduct the tests and to generate and sign the test reports in respect of the test of their respective specialty.

While controverting the submissions advanced by the counsel for Medical Council of India, learned Senior Counsel for the petitioner contends that the judgment of the Hon'ble Supreme Court would not be applicable inasmuch as the same relates to the countersigning of a laboratory report and that as the High Court of Delhi has already held that in the event there is no opinion expressed by the technician, such a laboratory report is not required to 30 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -31- be countersigned and that the aforesaid aspect has not been taken into consideration.

I have heard the learned counsel for the respective parties and have gone through the relevant documents and judgments relied upon by them.

It is evident from above that the petitioners place reliance on the Notification dated 18.05.2018 and the judgment of Delhi High Court. It was also sought to distinguish that a "test result" should not be equated to a "test report" and Lab Technicians should be permitted to sign the same.

However, it has also remained undisputed that High Court of Gujarat has held a different view and above view prohibits the Lab Technicians from conducting tests as well. Besides, a similar controversy also came for consideration before M.P. High Court in the matter of Smt. Kamla Patel Vs. State of M.P. & others - W.A. No.1440/2006 decided on 11.04.2007 reported as AIR 2007 M.P. 192- wherein it was held as under:

1. In these batch of cases, the common question to be decided is whether Laboratory Technicians can run pathological laboratories without engaging the services of a Pathologist having MBBS degree or any higher degree.
2-8. XXXX XXXX XXXX XXXX
9. We have considered the aforesaid submissions of the learned Counsel for the parties and we find that under Article 19(1)(g) of the Constitution every citizen has the freedom to carry on any occupation, profession, trade or business. Clause (6) of Article 19 of the Constitution states that nothing in sub clause (g) of Clause (1) of Article 19 shall prevent the State from making any law imposing in the interests of the general public, reasonable restrictions on the exercise of the right conferred by sub-clause (1)(g) of Article 19 of the Constitution and in 31 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -32-

particular nothing is in sub-clause (6) of Article 19 will prevent the State from making any law relating to the professional or technical qualifications necessary for practicing any profession or carrying on any occupation, trade or business.

10-12. XXXX XXXX XXXX XXXX

13. The aforesaid analysis of the provisions of the law prescribing the profession or technical qualifications necessary for the practice of medicine and the law prescribing the qualifications for running a pathology laboratory would show that laboratory technicians registered as a paramedical practitioner under the Adhiniyam, 2000, cannot sign or authenticate any pathological test/report or certificate and he can only assist the pathologist registered in the State Medical Register as a medical practitioner in carrying out the technical tests in the pathology laboratory In other words, a laboratory technician registered as a paramedical practitioner under the Adhiniyam, 2000 can only assist the pathologist in the technical tests in a pathology laboratory in the State of Madhya Pradesh, but he cannot sign or authenticate any certificate or test report relating to pathology and such certificate or test report can only be signed and authenticated by a pathologist having the required qualification such as MBBS, MD or other degrees as mentioned in the Act, 1956, and also registered as a Medical Practitioner in the State Medical Register under the Adhiniyam, 1987.

14. The impugned order dated 13-1-2003 of the learned Single Judge in Writ Petition No. 3821/2002 and the impugned order dated 13-11-2006 of the learned Single Judge in W.P. No. 15891/2006 are accordingly modified and the Writ Appeal No. 1440/2006, Writ Appeal No. 1418/2006, Writ Petition No. 13151/2006 and Writ Petition No. 3332/2007 are allowed to the extent indicated above. The State/respondents will now act as per the law laid down in this judgment. Considering the facts and circumstances of the case, the parties shall bear their own costs."

32 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -33- The aforesaid judgment necessitates even the test report to be approved by a registered Medical Practitioner.

It thus needs to be determined as to what is "report" and whether a "test result" can be said to be a "report" or not is a question that arises for consideration.

"Report" has not been defined under the Regulations or the Medical Council of India Act. Accordingly, ordinarily understood meaning of "Report" can be looked into from other sources such as:
Sr. Name of Dictionary Meaning of "Report"

No.

1. Black's Law Dictionary A formal oral or written presentation of 10th Edition- facts or a recommendation for action. Page No.1492.

2. Chambers, 21st Century 1. A detailed statement, description or Dictionary, 2006 account, especially one made after Page No.1184. some form of investigation.

2. A detailed and usually formal account of the discussions and decisions of a committee, inquiry or other group of people.

3. To give a formal or official account or description of (findings, information, etc.), especially after an investigation.

3. Wharton's Law Lexicon. A formal oral or written presentation of 15th Edition. facts.

Page No.1488.

4. Oxford Advanced Learner's To give people information about Dictionary, 7th Edition something that you have heard, seen, Page No.1286. done, etc. Hence, an account of events or facts in itself can be viewed as a report. Expression of an opinion is thus not a pre-requisite for a "Medical Lab 33 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -34- Report" and should not be so prescribed as a sine-qua-non by judicial interpretation without taking account of its understanding in the trade. An opinion by the analyst on the result of test is a part of the "prognosis". The methodology adopted in carrying out test and the manner in which test result is derived is equally an opinion of the Lab Technician and it cannot be said that the "test results" do not require formation of any opinion by the Technician or that such test results are purely mechanical features. Invariably, the test reports are required for medical purposes only and it would not be comprehensible that any person would undergo any medical test for no medical requirement. It plays a crucial role in diagnosis of illness and treatment to be given. The entire treatment chart is founded on such test results.

The petitioners have not disputed that the regulatory Authority for Clinical Establishments is the National Council of India. The letter of 2017 used the expression "Medical Test Report" as a comprehensive term which is required to be interpreted in a manner as is understood in the trade. "Report"

as commonly understood did not prescribe "opinion" to be a pre-requisite. A statement of facts or events can also be a report. Even communication of incident can be a report. A response to a query can also be a report. Any such "qualification of a mandatory opinion on test analysis before it can be held as Report" would be a hyper-technical dissection of the expression oblivious of the understanding and intent of the regulating Authority. The clarification issued vide notification of 18.05.2018 shows that the respondent carved an exception in the schedule to allow the Lab Technicians to conduct tests restricted interpretation or opinion to the registered Medical Practitioner.

Hence, the expression substituted was not an expression used earlier. There is 34 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -35- a clear departure. The expressions have been modified further in 2020. The entitlement to conduct the test and to submit the analysis is thus conferred by the amendments and was to a part of the Statute earlier.

The High Court of Delhi has proceeded to prefer one interpretation of an expression over another without going to the object of the directions and the normal usage assigned and understood for a term in the trade. Such exercise may not be appropriate since no such distinction is suggested in the statutory framework or the intention of the Regulatory Bodies. It would not be proper for the Court to assign grammatical meanings and selection of vocabulary in substitution of the words used by the Regulatory Body and then to give an interpretation as is likely to defeat the object for which such necessity is prescribed. The mischief sought to be remedied cannot be provided an escape by adopting a hyper-technical literal interpretation ignoring the normal understanding and common usage of the expression and thus paving way for menace to continue.

I thus find myself in respectful disagreement with the judgment of the Hon'ble Delhi High Court and am inclined more towards the view taken by the High Court of Madhya Pradesh as well as High Court of Gujarat as affirmed by the Hon'ble Supreme Court of India.

The schedule has now been amended vide Notification dated 14.02.2020, which specifically contemplates that only the persons holding the essential qualification as prescribed therein shall be entitled to conduct the test report, generate and sign the test reports in respect of the tests of their respective specialty and thus puts the controversy to rest. Once the qualification and eligibility has been amended in the Schedule of 2020, which automatically are applicable to the State of Haryana and when such 35 of 36 ::: Downloaded on - 24-12-2022 15:29:25 ::: CWP-13277-2017 (O&M) with six connected petitions -36- amendment is not a subject matter of challenge in the present petition, the continuation of the present petition would be only an academic exercise. The present batch of petitions thus has no subsisting cause of action due to subsequent developments and the Notification dated 14.02.2020 issued by the Ministry of Health and Family Welfare, Government of India. The petitions thus deserve rejection also for the above reason.

A liberty is, however, is granted to the petitioners to avail remedies available to them in accordance with law against the abovesaid Notification dated 14.02.2020, if so advised.

Petitions are accordingly, disposed of.





                                                (VINOD S. BHARDWAJ)
17.10.2022                                             JUDGE
rajender

             Whether speaking/reasoned          : Yes/No
             Whether reportable                 : Yes/No




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