NABL certification must for private lab enrollment for Covid testing: ICMR

The ICMR has informed the Delhi High Court that NABL certification is must for enrollment of private labs for COVID-19 testing and NABL certifies the readiness of labs to undertake molecular testing of SARS-Cov-2 before the research body allows them for testing.

Regarding the online health service aggregators, the Indian Council of Medical Research (ICMR) said monitoring of their activities does not come under its purview.

The ICMR made the submission in an affidavit filed in response to a plea seeking contempt action against the authorities for not adhering to the Delhi High Court's earlier direction to take action against online health service aggregators which are operating illegally and collecting samples for COVID-19 tests.

The petition is scheduled to come up for hearing on Tuesday before Justice Najmi Waziri.

The ICMR has said in its affidavit that as on August 16, 2021, it has approved 134 (35 government and 99 private) labs in Delhi for RT-PCR, TrueNat, CBNAAT and other M-NAT testing platforms and the information is also available on its website.

It said the ICMR has laid down SOPs and standard guidance for setting up COVID-19 testing labs and 14 mentor institutes have been set up in India to guide the labs on implementing these SOPs and set up a testing lab.

For Delhi, the mentor institute is AIIMS, Delhi. National Accreditation Board for Testing and Calibration Laboratories (NABL) certification is must for enrollment of private labs for testing. NABL certifies the readiness of labs to undertake molecular testing of SARS-Cov-2 before ICMR onboards them for testing. Through these parameters, it is ensured that labs meet the statutory standards for COVID-19 testing, the affidavit, filed by Dr R Lakshminarayanan, Deputy Director General (Admin), Indian Council of Medical Research (ICMR), said.

The contempt plea by Dr Rohit Jain has urged the high court to allow the contempt plea and restrain the illegal online health service aggregators, which are not authorised to collect diagnostic samples for COVID-19 tests, from further committing contempt of order passed by the court last year.

The Supreme Court had on April 8, 2020 directed that COVID-19 tests must be carried out in NABL-accredited labs or any agencies approved by the WHO or ICMR.

A division bench of the high court, on August 6, 2020 had directed the AAP government to take action in accordance with law against online health service aggregators, who are operating illegally without any registration, after hearing all the stakeholders.

Advocate Shashank Deo Sudhi, representing petitioner Dr Rohit Jain, had said the brisk business of the online aggregators collecting and testing coronavirus samples was on the rise across the country.

The petitioner is time and again trying to bring to the notice of the court that the illegal online health service aggregators are neither authorised to collect samples nor test for COVID-19 or routine testing by ICMR and are not accredited by NABL being marketplace e-commerce entities, the plea said.

It claimed that this rampant illegal sample collection by online health service aggregators is leading to false negative COVID-19 results thereby letting loose the coronavirus positive patients in the society and hence unfortunately allowing them to transmit or spread the virus.

It said there is an urgent need to restrain the online health aggregators from collecting the diagnostic samples illegally to save the innocent people in the interest of the public at large and action may be initiated against them as directed by the court on August 6 last year.

The petition has sought initiation of contempt proceedings against the top government officials and others for alleged non-compliance of the high court's order asking to take action and regulate online pathological labs.

The petitioner has sought contempt action against Delhi Chief Secretary, Secretary, Ministry of Health and Family Welfare, Directors General of Health Service and ICMR for allegedly not complying with the high court's last year order.

Sudhi has submitted that the online aggregators like 'healthian' and '1 mg' are illegally operating in Delhi.

He has claimed that these online aggregators are playing with the lives of the common people and must be banned.

The plea has said that several illegal online aggregators are advertising freely by offering attractive packages for body check-ups including the test for COVID-19 through SMSs or various online modes and added that the petitioner has received advertisements of online aggregators through e-mail for getting tested.

The high court's August 6, 2020 direction had come while disposing of a PIL seeking a ban on allegedly illegal online health service aggregators from collecting diagnostic samples for testing of COVID-19 infection.