Pune firm gets approval for first ‘Made in India’ Covid-19 testing kit; 16 private labs approved by govt
A Pune-based company has said that it has received commercial approval from the Central Drugs Standard Control Organisation (CDSCO) for its Covid-19 test kit.
“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, MD of molecular diagnostics company Mylab Discovery Solutions, said on Monday.
The company said the kit will cost nearly one-fourth of the current procurement cost.
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The Indian Council of Medical Research (ICMR) has, meanwhile, given a green signal to 16 private laboratories across the country to conduct Covid-19 testing in India.
The apex medical research body has also issued guidelines for private laboratories by capping the test rates.
The maximum cost for testing samples is capped at Rs 4,500 (Rs 1,500 for screening test for likely cases and additional Rs 3,000 for confirmation test).
“All these laboratories have over 15,000 laboratory chains across the country. Our work is in progress to include more laboratories soon,” Dr Balram Bhargava, Director General of ICMR, said on Monday.
These include Lal Path Labs from Delhi, Unipath Specialty Laboratory from Gujarat, Strand Life Sciences and SRL Limited from Haryana, CMC and Apollo Hospitals in Tamil Nadu. While Maharashtra has five laboratories which include Thyrocare Technologies Limited, Suburban Diagnostics (India) Pvt. Ltd, Metropolis Healthcare Ltd, Sir HN Reliance Foundation Hospital and Research Centre, Molecular Medicine, Reliance Life Sciences Pvt. Ltd and SRL Limited.
“As far as testing kits manufacturers are concerned, we have fast-tracked approval for Indian Covid-19 testing kits for commercial use. About two manufacturers have already got the approval,” Dr Bhargava said.
“Only test kits with 100 per cent concordance among true positive and true negative samples have been recommended for commercial use in India. In addition, US FDA approved kits can be used directly after due approval from DGCI and intimation to ICMR,” Dr Bhargava further said.
There are 471 Covid-19 patients across India and the respiratory illness has killed nine people so far, the Centre has said.