Delhi HC Directs Govt To Revisit CEA Rules, 2018 Barring Non Medicos To Sign Reports

Mumbai, 6 May 2019: The Delhi High Court has directed the central government to revisit Clinical Establishments (Central Government) Amendment Rules, 2018 barring medical M.Sc. degree/PhD in biochemistry, microbiology and genetics etc from certifying medical test reports in medium and advanced diagnostic laboratories within three months.

A division bench of Justice Ravindra Bhat and Justice Prateek Jalan had last month asked the government to file counter affidavit indicating the process of review of CEA Rules by May 15, 2019.

The bench issued direction while hearing petitions filed by Indian Association of Medical Microbiologists (IAMM), National M.Sc. Medical Teachers’ Association, Association of Clinical Biochemists and Microbiologists (ACBM), All India Association of PhDs, Doctors, Scientists and Consultants in Medical Science.

The petitioners challenged the constitutional validity of Clinical Establishments (Central Government) Amendment Rules, 2018 as it has no mention of non-medically qualified individuals, specifically in biochemistry, microbiology and genetics etc., as signatory authority in medium and advanced laboratories.

The petitioner stated that CEA Rules 2018 effective May 18, 2018 divided pathology laboratories into three categories namely, basic composite, medium and advanced, based on the kinds of tests which can be performed in such labs. For basic composite (small) labs, non-medically qualified individuals, specifically in biochemistry, microbiology and genetics are allowed to certify medical test reports. But a post graduate in pathology or biochemistry or medical biology is an essential qualification for medium and advanced labs.

The petitioners submitted that some of them are highly qualified individuals in the field of microbiology, biochemistry and genetics, and individuals from this category have been authorized signatories in the past. They contended that, as a result of the CEA Rules, they apprehend that they would be rendered redundant and registered laboratories would be compelled to employ less experienced personnel, besides imposing hierarchy of MBBS and other medical professionals, including those who are unable to get employment elsewhere.

It is also stated in most of the developed countries like UK and USA, pathology reports are signed and certified by such professionals without any insistence on the certification of medical professionals. It is submitted that, in these circumstances, the prevailing status quo, which had permitted the non-medically qualified individuals, specifically in biochemistry, microbiology and genetics etc., to sign as authorized signatory, should continue at least till the disposal of the present writ petition, if necessary, by extending the last date for registration of laboratories under the CEA Rules.

The counsel for the central government urged that pursuant to repeated representations, a review of the regime and the rules was directed on July 17, 2018 and that stakeholders were asked to submit comments/objections on draft of revised CEA Rules by April 15, 2019. It is also submitted that six months’ period is further required to complete the process.

The High Court asked the government to complete the process within three months, and to indicate the process of review on May 15, 2019 to facilitate the court’s decision. Pharmabiz