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HIGH COURT OF JUDICATURE FOR RAJASTHAN - JAIPUR BEN
SUO – Appellant
Versus
THE STATE OF RAJASTHAN THROUGH PRINCIPAL SECRETARY – Respondent
CW 4061/2015
['AJEET BHANDARI', '', 'SANDEEP PATHAK', 'SHYAM ARYA AAG', '', 'SHYAM ARYA', 'ASHISH KUMAR', 'R D RASTOGI ADDL S G', 'AJAY KUMAR BAJPAI', 'VIBHUTI BHUSHAN SHARMA', 'RAUNAK DIXIT']
Only qualified MBBS practitioners should be permitted to sign pathology reports.
Headnote:
MEDICAL ESTABLISHMENTS - CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 - PATHOLOGY LABORATORIES - QUALIFICATIONS - SUMMARY
Fact of the Case:
A PIL was filed in 2015 raising concerns about the operation of pathological labs in Rajasthan, specifically the issue of unqualified persons running such labs. The petitioner sought directions to close down labs run by unqualified persons, ensure that labs are run by qualified pathologists, and enforce the provisions of the Clinical Establishments (Registration and Regulation) Act, 2010.
Finding of the Court:
The court noted that rules under the Clinical Establishments (Registration and Regulation) Act, 2010 had been framed by the Central Government and the State Government, and that the State had also constituted a State Council for clinical establishments. The court further noted that the Central Government had amended the rules in 2020 to prescribe minimum qualifications for authorized persons who can sign pathological reports.
Issues: 1. Whether unqualified persons should be allowed to operate pathology laboratories. 2. Whether the Clinical Establishments (Registration and Regulation) Act, 2010 and the rules framed thereunder are being properly enforced.
Ratio Decidendi: The court held that the Clinical Establishments (Registration and Regulation) Act, 2010 and the rules framed thereunder provide a framework for the regulation of clinical establishments, including pathology laboratories. The court further held that only qualified MBBS practitioners should be permitted to sign pathology reports, as per the order of the Hon'ble Supreme Court dated 12.12.2017.
Final Decision: The court directed the State to undertake an exercise to review the present situation in the State and find out whether any clinical establishments are being run contrary to the provisions of the Act of 2010 and the rules framed by the Central Government and the State Government from time to time. The court also left open the issue of qualifications to be examined when occasion arises in case any petition is filed challenging the rules framed by the Central Government or State Government.
HIGH COURT OF JUDICATURE FOR RAJASTHAN
BENCH AT JAIPUR
D. B. Civil Writ Petition (PIL) No. 4061/2015
Suo Motu
----Petitioner
Versus
1.
The State of Rajasthan through Principal Secretary,
Medical and Health Department, Government of
Rajasthan, Secretariat, Jaipur.
2.
The Principal Secretary, Medical and health Department,
Government of Rajasthan, Secretariat, Jaipur.
3.
The Director, Medical and Health Service, Opposite Udyog
Bhawan, Jaipuur.
4.
5.
Union of India through, Secretary, Ministry of Health and
Family Welfare Department, Government of India, New
Delhi.
Indian Association of Medical Microbiologists (IAMM),
Department of Microbiology, Lady Harding Medical
College, through its Secretary, New Delhi-110001.
----Respondents
For Petitioner
:
Mr. Abhay Bhandari Senior Advocate
assisted by Mr. Vaibhav Bhargava
Advocate through Video
Conferencing.
Mr. Sandeep Pathak Advocate through
Video Conferencing.
For Respondents
For Applicant
:
:
Mr. R.D. Rastogi Additional Solicitor
General assisted by Mr. Devesh Yadav
Advocate through Video
Conferencing.
Dr. Vibhuti Bhushan Sharma
Additional Advocate General through
Video Conferencing.
Ms. Mrinmoi Chatterjee Advocate
through Video Conferencing.
HON'BLE MR. JUSTICE MANINDRA MOHAN SHRIVASTAVA
HON'BLE MR. JUSTICE BIRENDRA KUMAR
Order
11/01/2022
(2 of 6)
[CW-4061/2015]
This PIL petition was initially filed by one Dr. Surendra
Kumar Upadhyay in the year 2015 raising an issue of public
importance relating to operation of pathological labs in the State
of Rajasthan. The petitioner sought to invoke jurisdiction of this
Court seeking issuance of various directions as below:
“It is, therefore, most respectfully prayed that this
Hon’ble Court may very graciously be pleased to
accept and allow this P.I.L. (Writ Petition) and by
an appropriate writ order or direction:
(i) The Respondents be directed to close down
various Pathological Laboratories being run by
unqualified persons including Lab Technicians in
the State of Rajasthan.
(ii) The Respondents be directed to ensure that no
Pathology Laboratory is run by any unqualified
person or Institute having no recognized
Pathologist registered with the Medical Council.
(iii) The Respondents be directed to enforce the
provisions of The Clinical Establishment
(Registration and Regulation) Act 2010 with the
qualification that Pathological Laboratories should
be run, maintained and established by a person
who is qualified in M.D. in Pathology or Diploma
holder in Clinical Pathology.
(iv) Respondents be directed to ensure that
franchise centre in the State of Rajasthan of any
laboratory or hospital situated outside Rajasthan
should also be manned by qualified Pathologists.
(v) The Respondents may be directed that it shall
ensure by appropriate law or regulations that all
those hospitals, Nursing Homes, clinics who are
having facility of in house pathological laboratories
must be manned by a qualified pathologist who
should give the final report.
(vi) The respondents be directed to appoint a post
of qualified pathologist in all Government
Hospitals, Satellite and District Level Hospitals,
Community Health Center and Primary Health
Center where pathological test are conducted.”
(3 of 6)
[CW-4061/2015]
During pendency of the petition, the original writ
petitioner died. This Court, taking note of the importance of the
issue raised in this petition, directed the petition to continue as
suo motu writ petition.
On 25.04.2016, an order was passed by this Court
raising concern that the rules under The Clinical Establishments
(Registration and Regulation) Act, 2010 (hereinafter referred to as
‘the Act of 2010’) have not been framed. Thereafter, another
detailed order was passed on 04.08.2016, raising concern that
there is mushroom growth in establishment of pathology centres
without any registration as required und
