Indian-made Coronavirus test kits not good enough?

Health Ministry guidelines only allow for USFDA or EU-CE approved test kits and only one Ahmedabad company CoSara diagnostics has US FDA approval for manufacturing

health ministry

As per the guidelines for the testing of Covid-19 in private laboratories issued by the Union Health Ministry, matters for Indian manufacturers may get complicated given that only United State Food and Drug Administration (US-FDA) or European Conformitè Europëenne (CE) have been mandated for use.

The guidelines issued by the Ministry of Health and Family Welfare state that “commercial kits for real-time PCR based diagnosis of Covid-19 should be USFDA approved or European CE certified, or both, for in vitro diagnosis of Covid-19 under emergency use.” The guidelines exclude all the kits, like the low-cost one developed by IIT-Delhi, currently being tested at the National Institute of Virology, Pune (NIV).

With the shutdown of exports, a shortage of testing kits was inevitable but it was expected that once Indian companies got their test kids validated, they could start manufacturing and supplying the kits to private labs to amplify testing.

Whatever happened to Make in India?

Now, companies trying to get their test kits validated have questioned the government’s move asking why the Drug Controller of India (DGCI) which confirmed the government’s guidelines, even issued test licenses to Indian companies if they were only going to allow certain certifications.

A lab owner told The Times of India, “Where will labs get USFDA or CE approved kits overnight when most countries are not allowing exports? This would mean that even Chinese and South Korean kits, if imported, cannot be used.”

An owner from another company said, “Why did the DGCI issue test licenses to Indian companies so that they can get their test kits validated, if they were going to allow only USFDA-approved or CE-certified tests? It’s a totally crazy move. Why is NIV working to validate the tests if they cannot be sold in India?”

Veena Kohli from the Association of Diagnostic Manufacturers of India has expressed her displeasure over the move and said she would be writing to the Central government against these guidelines. She said, “A lot of effort and R&D had gone into developing these kits in record time and our companies must be given to prove the quality and reliability of their test kits.”

Rajiv Nath of AiMed told TOI, “It is disheartening that the health ministry endorses overseas regulatory approvals as a means of qualification while keeping out Indian manufacturers instead of respecting India’s own regulatory processes.”

TOI reported that NIV had finished validating Indian test kits and had submitted the results to the Indian Council of Medical Research (ICMR).

The ICMR has approved six private laboratories for Covid-19 testing. Four of the labs are in Maharashtra and one each is in Karnataka and Gujarat. The laboratories approved are Thyrocare, Suburban Diagnostics, Metropolis Healthcare and HN Reliance Foundation Hospital and Research Centre, Newberg Anand Reference Laboratory and Unipath Specialty Laboratory. The ICMR has mandated that the costs of tests at private laboratories must not be above Rs. 4,500, which is a whopping amount.

Speaking to The News Minute about the guidelines Dr. A Velumani, MD, CEO and Chairman of Thyrocare which is importing its testing kits from Altona, a German brand said that the inadequate supply of test kits poses a challenge for private labs. The guidelines he says “limits the number of players and creates a monopoly which increases costs”.

The curious case of CoSara 

Meanwhile, it has come to light that there is only USFDA-approved manufacturer, an Ahmedabad-based company called CoSara Diagnostics which has an association with a US firm, CoDiagnostics. However, the issuance of the guidelines and the approval to CoSara point out to a deeper conspiracy during this crisis. The prices of the 18 companies chosen to get their test kits validated were to be between Rs. 400 – 500. CoSara, which had already received approval for the manufacturing of the kits a day before the 18 firms were chosen, refused to divulge the cost of its kits, but the same is said to be between Rs. 1,000 – 1,200.



Given this scenario, will the 18 companies who are NIV validated but not USFDA or EU-CE approved be allowed to manufacture test kits? Or will CoSara diagnostics in Ahmedabad enjoy monopoly, displaying the corruption and partiality thus delaying mass testing and putting the life of the common man in further danger than it already is?


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