Plea against allowing non-medical persons to certify lab reports

Pathology is the medical specialty concerned

Picture: Pixabay

Last Updated on December 20, 2020 by The Health Master

New Delhi: The Delhi High Court on Thursday issued notice to the Central government on a plea challenging the Clinical Establishments Amendment Rules, 2020, under which it has allowed unregistered and unqualified non-medical persons like MSc and Ph.D. holders to certify medical diagnostic reports.

A division bench of Chief Justice DN Patel and Justice Prateek Jalan sought the response of the Union of India through the Ministry of Health and Family Welfare, National Medical Commission and slated the matter for further hearing on January 19, 2021.

The plea, filed by Dr Rohit Jain through advocate Mrinmoi Chatterjee, said the notification is illegal, arbitrary, unconstitutional and ultra vires of the parent act itself.

Advocate K Parmeshwar, appearing for the petitioner, argued that the impugned notification has been issued without following due process of law as prescribed under the Clinical Establishments (Registration and Regulation) Act, 2010.

Also read | Plea against all Medical Devices being notified as drugs

He submitted that as per Clinical Establishments Act, 2010, it is mandated under Section 7 that any determination of minimum standards for clinical establishments has to be undertaken by the National Council for Clinical Establishments, which is a 20 member committee through a consultative process.

“However, no member of the said committee attended the meeting held on January 14, 2020, and no consultative process was followed. The said National Council has not conducted a meeting since July 13, 2018,” Parmeshwar argued.

The plea said by way of the CEA Rules, 2020, the Centre has allowed unregistered and unqualified non-medical persons like MSc and PhD holders to sign medical reports, issued by basic, medium and advanced diagnostic laboratories, which it said is contrary to legal provisions and settled law on this issue.

“Pathology is the medical specialty concerned with the study of the nature and causes of diseases and is a part of Modern Medicine. Only a pathologist can certify a medical diagnostic report after arriving at the correct prognosis based on his expertise. The role of a pathologist is crucial to early diagnosis and to prevent misdiagnosis or late diagnosis,” the plea said.

It said as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 under Clause 1.1.3 it is provided that “no person other than a doctor having qualification recognized by the Medical Council of India and registered with the Medical Council of India / State Medical Council(s) is allowed to practice Modern System of Medicine or Surgery.”

“A person obtaining a qualification in any other system of Medicine is not allowed to practice the Modern System of Medicine in any form.” Allopathy is the general form of Modern Medicine and the said regulations made it clear that a person not qualified by the MCI or SMC cannot practice modern medicine,” the plea said.

The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.