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NHRC directs Union health ministry to rectify Clinical Establishment Amendment Rules, 2018 as per SC order
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Laxmi Yadav, Mumbai
January 30 , 2019
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The National Human Rights Commission (NHRC) has directed the Union
health and family welfare ministry to rectify Clinical Establishment
Amendment Rules, 2018 in view of the Supreme Court orders dated December
12, 2017 and July 10, 2018 which upheld the stand of the Medical
Council of India that medical test report can be countersigned only by a
registered medical practitioner with a postgraduate qualification in
pathology.
The NHRC had given instruction to the ministry on a
complaint filed by Dr Rohit Jain, secretary of Practicing Pathologists
Society (PPS), Rajasthan. The commission in its letter dated December 4
last year asked the ministry to take requisite action within 8 weeks and
inform the complainant of the action taken in the matter.
Dr
Jain in a letter to NHRC on July 27, 2018 had requested for
rectification in Clinical Establishment Amendment Rules, 2018 in view of
the Supreme Court orders.
He had drawn attention of the human
rights commission to the fact that the minimum qualification of
technical head of laboratory/specialist/authorized signatories of basic
composite laboratories (small labs) as designated by the ministry in the
amended rules is MBBS which is desirable. Small labs form more than 90
per cent of the diagnostic labs in India. This would promote quack
practice in diagnostic segment against the Preamble of Article 21 &
47 of the Constitution of India, stated the complainant.
This
has paved the way for anyone to sign medical test report thus
compromising diagnosis and treatment of diseases. Even the
interpretation or opinion to be recorded on a medical test report has
not been made mandatory, said Dr Jain.
This contradicts the MOHFW
letter No. V.11025/01/2016-MEP (Pt.VI) dated December 26, 2016 which
said that no person other than a doctor having qualification registered
with Medical Council of India/State Medical Council(s) is allowed to a
practice modern system of medicine or surgery or sign a clinical
laboratory report.
The amended rules are also in violation of
section 15(2)C of the Indian Medical Council Act, 1956 and the Supreme
court orders- dated December 12, 2017 in SLP No. 28259/2010 and July 10,
2018 in the review petition (civil) No. 1825/2018 in SLP No.
28259/2010. It has also violated Medical Council of India letter(s)
dated June 14, 2017 & December 14, 2017.
The secretary of
PPS, Rajasthan has appealed to the NHRC to immediately rectify this
error in the best interest of health of the citizens of India and change
the minimum qualification for basic composite labs as per the above
mentioned Supreme Court orders and does not leave majority of Indian
population to quacks.
In order to put an end to quackery,
amendment needs to be done in Clinical Establishment Amendment Rules,
2018 setting minimum standards for path labs, he said, adding that it
will save the very preamble of the Clinical Establishments Act, 2010 as
per Article 47 of the Constitution of India and curb violation of human
rights in diagnosis and treatment of patients.
Following the
direction of NHRC, the health ministry has on January 25, 2019 written
to the complainant stating that the matter is under examination in the
ministry in consultation with MCI and the concerned ministry/department.
On
May 18, 2018, the health ministry had notified Clinical Establishment
Amendment Rules outlining minimum standards for diagnostic labs with an
aim to put an end to quackery in medical diagnostics. The amended rules
have classified diagnostic labs into three categories-- basic composite
(small) labs, medium labs and advanced labs. For medium and advanced
labs, a post graduate in pathology or biochemistry or medical biology is
an essential qualification. But, there is no minimum qualification for
small labs. For them, a pathology degree in medicine or surgery from a
recognised university is desirable.
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