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Thursday, November 30, 2023

Two Made-in-India COVID-19 test kits get ICMR approval

ICMR has approved two ‘Made in India’ RT-PCR (Reverse transcription polymerase chain reaction) test kits for use in approved government and private laboratories. These test kits have been found to have 100% concordance among true positive and true negative samples.

ICMR NIV Pune evaluated 9 locally made and non-US FDA EUA/CE IVD  kits, out of which only test kits with 100% concordance among true positive and true negative samples have been recommended for commercial use in Bharat. In addition to the above, US FDA EUA/CE IVD approved kits can be used directly after due approval from DCGI (Drugs Controller General of India) and intimation to ICMR.

US Food and Drug Administration (FDA) is the American federal agency which regulates their healthcare products, while Emergency Use Authorization (EUA) authority allows FDA to facilitate public health during emergencies. CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe.

The two ‘Made in India’ kits which have been approved are MyLab’s “Patho Detect COVID-19 Qualitative PCR kit” and Altona Diagnostics’ “RealStar SARS-CoV-2 RT-PCR kit 1.0”

Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, which specialises in molecular diagnostic kits, developed its test kit for COVID-19 in just six weeks –

“With emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kit has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time,” Hasmukh Rawal, Managing Director, Mylab Discovery Solutions said. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.

“We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on the sensitive PCR technology, even early-stage infection can be detected, with highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too,” said Shailendra Kawade, Executive Director at Mylab.

So far the Indian government has been sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients. However, the dependency on foreign kits has been troublesome and supply is getting blocked due to grounded airlines. This can change with the approval for made in India kits.

Mylab promised that it can manufacture up to 1 lakh tests in a week that can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit. An average lab with automated PCR can test more than 1000 patients a day.

With local sourcing of test kits, it will be a breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost. Moreover, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to seven-plus hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions at the same time on one machine.

Altona Diagnostics is a German company with an Indian subsidiary. While it had launched the Covid19 testing kit in Germany on 20 Feb itself, what has just been approved by ICMR is a made-in-India version of the German kit.

A week back, ICMR had said that 121 government and 60 private labs would be equipped with Covid19 testing capability by the month end. As of 23 March, 92 government labs and 16 private labs were operational for Covid 19 testing.

As per the latest testing strategy published on 20 March, testing is being carried out for

  • Symptomatic individuals who have undertaken international travel in the last 14 days
  • All symptomatic contacts of laboratory confirmed cases
  • All symptomatic health care workers.
  • All hospitalized patients with Severe Acute Respiratory Illness (fever AND cough and/or shortness of breath).
  • Asymptomatic direct and high-risk contacts of a confirmed case should be tested once between day 5 and day 14 of coming in his/her contact.

Asymptomatic individuals with international travel history in last 14 days, all family members living with a confirmed case, and other high risk contacts of confirmed cases are being home quarantined.

The entry of cheaper Made-in-India testing kits should help expand the testing net, which will help to aggressively isolate infected cases. Government should move ahead on war footing to launch a publicity blitz to educate people on basics of home quarantine, procedure to be followed in case someone experiences symptoms (ideally, home collection of samples should be provided) and other precautionary measures. Home quarantine should be aggressively enforced, and anyone found breaking it should be immediately moved to a govt. quarantine facility. Also, separate hospitals, sections in existing hospitals need to be scaled up for testing Covid19 suspects and to keep them isolated during recovery.

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