Centre Plans to Amend Clinical Establishments Rules on Diagnostic Labs

Close on the heels of Rajasthan High Court’s direction on May 30, 2018, the central government is planning to modify Clinical Establishments (Central Government) Amendment Rules, 2018 setting minimum standards for diagnostic labs.

The amendment will be based on a high power committee report. The committee was set up by the Centre on August 14, 2018 in compliance with the High Court order. The panel comprising principal scientific advisor to government of India as chairman, secretary (health), secretary (health research) and secretary (biotechnology) as members was asked to recommend suitable changes to the Amended Rules.

On May 30, the High Court had issued interim order directing the central government to furnish reason why minimum qualification has not been prescribed for basic laboratories in the notification of the Amended Rules issued by it on May 18.

As per the Rules, pathology laboratories have been classified into three categories basic composite (small), medium and advanced labs.

In respect of basic composite laboratories, the central government has in part (iii) of the aforesaid schedule under the caption “Human Resource” has prescribed the desirable minimum qualification of technical head of laboratory or specialist or authorised signatories as the Bachelor of Medicine and Bachelor of Surgery (MBBS) from a recognised university/institution.

The notification does not prescribe the minimum qualification, stated the High Court.

The high power committee has submitted its suggestions to the Centre which include certain cosmetic changes in the notification G.S.R. 468(E) dated May 18, 2018 regarding minimum standards of diagnostic laboratories.

As per the panel’s suggestion, medical tests should be undertaken on advice of a doctor. Interpretation of lab results or opinion there on when required, registered MBBS medical practitioner is essential. The authorized signatory will be liable for authenticity of the laboratory test report only, it recommended.

The panel has not suggested any changes to authorized signatory mentioned in the May 18 notification which empowers non pathologists to certify medical test reports in basic composite labs.

The revised draft notification on the basis of such suggestion is under publication in gazette for inviting comments from public within a period of thirty days after which the notification will be finalised.

RD Rastogi, additional solicitor general appearing for the Centre on November 14, 2018 submitted that at least eight weeks’ time be granted so as to place before the court the amendments introduced to the aforesaid Rules.

Dr Rohit Jain, secretary, Practicing Pathologists Society termed the high power committee’s recommendation which will precede changes in May 18 notification just an eyewash. The committee did not take into account Supreme Court and various High Courts’ orders recommending that laboratory report cannot be issued without the signature or counter signature of the practicising pathologist recognised by the Medical Council of India, he opined.