Dedicated units to fast-track approval of new testing kits for Covid-19

Since February, ICMR’s apex virology laboratory, the National Institute of Virology (NIV) in Pune, has approved four of 15 new test kits that don’t have European Union or US Food and Drug Administration approval

Approvals for diagnostic devices for coronavirus disease (Covid-19) can be granted within seven to 10 days if necessary conditions are met, the country’s apex drugs and diagnostics regulator Central Drugs Standard Control Organisation (CDSCO) has said at a time when India is trying to fast-track the process in the wake of rising cases in the country.

Currently, a part of the Covid-19 test kits are procured from the US and Germany by ICMR-NIV and distributed to the testing laboratories across the country (Pratham Gokhale/HT File Photo)

CDSCO has created a coronavirus unit that will examine applications quickly and recommend them for approval.

“Since the cases are rising nationally and globally, there is an urgent need to scale up not just testing but also development of therapeutics and vaccine. Expert teams have been holding consultations and decided there was a need to expedite the process of approvals,” said a senior official of the Union ministry of health.

“Fast-tracking approvals doesn’t mean compromising on quality. The product will have to meet certain standards; only those that pass the scrutiny of our expert team will be considered for approval,” the official added.

As per the current protocol, the country’s apex biomedical research organisation, the Indian Council of Medical Research (ICMR), validates testing kits that do not have international approval (US FDA or European CE), and recommend them to CDSCO for final approvals for manufacture, sale and distribution in India.

Manufacturers of kits already in use in Western countries can approach CDSCO directly with relevant documents to seek approval for their commercial testing kits. The kits are largely for nasal and throat swab tests.

Since it was approached by commercial testing kit manufacturers in the start of February, ICMR’s apex virology laboratory, the National Institute of Virology (NIV) in Pune, has approved four of 15 new test kits that don’t have European Union or US Food and Drug Administration approval.

ICMR has also recommended 11 antibody based (blood) rapid test kits with CE-mark, and one out of eight blood test kits without any international approval has been validated.

Currently, a part of the Covid-19 test kits are procured from the US and Germany by ICMR-NIV and distributed to the testing laboratories across the country.

“Test kits with 100% concordance (match) among true positive and true negative samples are being approved for commercial use in India. There is absolutely no compromise on the quality of product since sensitivity and specificity is of utmost importance when approving a test kit,” said a senior official in ICMR.