In a bid to augment testing facilities for COVID-19, the board of governors of the Medical Council of India (MCI) has made it mandatory for medical colleges with annual admissions of 50 to 250 MBBS students to set up Bio-Safety (BS) level 2 laboratory which is the minimum requirement to conduct tests of infectious diseases such as COVID-19.
For this, the board of governors in supersession of MCI has recently amended the Minimum Standard Requirements for 50/100/150/200/250 MBBS Admissions Annually Regulations, 1999.
With this amendment, all government and private medical institutes in the country will require to set up BSL-2 level laboratory testing facility for infectious pathogens in the department of microbiology in view of COVID-19 pandemic. The Union ministry of health and family welfare on June 2, 2020 accorded approval to the said amendment.
The new regulations called “Minimum Standard Requirements for 50 Admissions Annually (Amendment) Regulations, 2020 has included requirement of setting up of BSL-2 level testing facility in the department of microbiology in all medical colleges to facilitate testing of contagious diseases similar to COVID-19.
The laboratory shall include sample receiving area, hand washing and PPE donning zone, designated area for biosafety cabinet and sample handling, designated pre-PCR (RNAS extraction and template addition), PCR (for running the assay) and post PCR (for result interpretation and analysis) rooms, space for handling biomedical waste.
The human resource required for the laboratory includes one faculty/medical microbiologist trained in virology, two technicians with relevant work experience in molecular virology, one multitasking staff.
Earlier MCI had directed all the government and private medical colleges and deemed universities to set up labs to investigate COVID-19 cases as per Indian Council of Medical Research (ICMR) guidelines.
The ICMR designated 14 medical institutions to be the mentor institutions for facilitating the establishment of COVID-19 testing facilities in the respective states.