India’s MyLab receives drug regulator CDSCO validation for first “made in India” COVID-19 testing kits

In what is certain to provide massive boost to India’s already unprecedented coronavirus containment measures, Pune based molecular diagnostic company MyLab has received validation for its COVID-19 testing kits, making it the first such company in India. On top of that, the company’s kit reduce testing time from the usual 4 hours to 2.5 hours.

The company has received commercial approval from the Central Drugs Standard Control Organisation. The increased testing kits will cause an increase in the Indian testing rate which currently stands at 15 per million. The kits received validation from National Institute of Virology. Named MyLab PathoDetect COVID-19 Qualitative PCR Kits, the testing aid is reportedly priced at about INR 1200 (~$18).

The kit, known as Reverse transcription polymerase chain reaction is a laboratory technique which combines reverse transcription of RNA into DNA and amplifies specific DNA targets using polymerase chain reaction. It is primarily used to measure the amount of a specific Ribonucleic acid (RNA). The other company that has received approval to create them is Germany’s Altona Diagnostics. The other companies which were shortlisted for validation on Monday include BGI, Krishgen Bio System, HIMEDIA, Huwel, IIT Delhi and Kilpest.

According to Dr.Gautum Wankhede, Medical Director at Mylab, the testing kits present results in about 2.5 hours which is an improvement from the current lab based testing which takes four hours. The kits can study 1000 samples from big labs and 200 from smaller ones at once.

As private entities also begin to attain the licence to test for the pathogen, the number of tests will record a significant increase in the country. A licence to get a test validated is different from a license to manufacture one. A company first has to show that their test worked after which they receive approval of those tests followed by a license for sale.

Mylab has committed to the production of 100,000 tests per week which may be increased if required. This is set to add significantly to India’s existing capacity, which stands at 12,000 tests per day as of now. India has also increased its testing capacity with addition of private labs, expanding collections centre numbers to 15,000 across the country.