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Laxmi Yadav, Mumbai January 30 , 2019
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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