Indian kit gets nod for commercial use

NEWDELHI: A coronavirus disease (Covid-19) testing kit developed by the Pune-based molecular diagnostic company MyLab Discovery Solutions became the first Indian kit to be approved for commercial use by the Indian Council of Medical Research (ICMR) on Monday. Another kit developed by the German Altona Diagnostics was also approved, India’s apex medical research body said.

These are the only two of the nine kits that gave 100% accurate positive and negative results as per tests conducted by National Institute of Virology (NIV).

“ICMR has recommended that kits that have 100% concordance to true positive and negative be used. Only two of nine kits validated by NIV fit the criteria. There are other tests that have been approved by global agencies,” said a senior ICMR official who asked not to be named.

ICMR has allowed some private labs to start testing for Covid-19. However, it allowed the centres to use only the kits approved by agencies such as the US Food and Drug Administration or with the “CE” marking of the European Union.

“Two of the test kits developed by Indian companies are with

NIV right now for validation, to check whether they are at par with the existing kits or even better. Eight others in various stages of development and are being supported,” said Dr Renu Swarup, secretary, department of biotechnology, Science ministry.

Meanwhile, several Indian companies and research organisations are working on developing cheaper indigenous test kits.

The test kit developed by it costs one-fourth of the currently available kits and reduces testing time by 65%, according MyLab Discovery Solutions . “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,” said Hasmukh Rawal, the firm’s MD.

ICMR has fast-tracked its mechanism for validation of newer test kits. Companies can also apply for an approval for newer test kits to the Drug Controller General of India with an intimation to ICMR.

“Apart from US FDA approved testing kits, others that are validated by the ICMR-NIV, Pune. Two of the eight kits have been validated against the existing tests and they can be manufactured for Indian labs,” said Dr Balram Bhargava, director general, ICMR, told HT.