COVID-19 testing kits made in India
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COVID-19 testing kits made in India approved by NIV Pune

The government has initiated a fast-track system to improve the domestic production of testing kits for COVID-19, permitting validation by the National Institute of Virology, Pune, also as it aims to pre-empt a surge of COVID-19 cases in the nation.

ICMR – Indian Council of Medical Research stated Indian producers can produce testing kits COVID-19 even if they do not have approval from the USFDA and European CE and supply it to private as well as government labs with NIV validation.

Balram Bhargava, Director General, ICMR said, “We have fast-tracked the approval system,” and “Currently COVID-19 testing kits made in India require validation from NIV and then can apply for manufacturing license to the Drug Controller General of India (DCGI).”

Altona Diagnostics and MY LAB are the two manufacturers who already got approvals for their kits.
The fast-tracking of approval and validation is a result of the increase in the number of COVID-19 cases. 

Only 50 government laboratories conducted COVID-19 confirmatory tests until recently. ICMR has permitted some private labs to start testing for the pandemic, and since then the number of laboratories conducting the test has increased to 111


“Commercial kits for real-time PCR based diagnosis of COVID-19 must be USFDA approved or European CE certified or both for in-vitro diagnosis of COVID-19 emergency usage”, as per the previous guideline by the council, but it has currently made clear that NIV-validated kits would certainly be allowed for testing.

Additionally, the government shrugged off the suggestions that there is a lack of personal protective equipment.

Until March 19, India was exporting PPEs, even though guidelines released by the World Health Organisation on February 27 had stated that global accumulation of PPEs was meager. It also said, “Surging international demand is not only due to the number of COVID-19 cases but by misinformation, panic purchasing and stockpiling as well and this will certainly lead to more shortages of PPE internationally.

Lav Agarwal, joint health secretary responded to the question about this, “What guidelines? Show us the guidelines you are talking about. We have taken ample measures every now and then to ensure the availability of PPEs”.


Author: Sruthi S