Companies

Drug regulator pulls up Bione for selling unlicensed home testing kits

Maitri Porecha New Delhi | Updated on April 06, 2020 Published on April 06, 2020

The Drug Controller General of India (DCGI) has pulled up Bengaluru-based Bione Ventures for selling Covid-19 home-based testing kits to customers online, when the company had not received licence for import, manufacture or marketing of these kits.

A notice issued by the DCGI said, “It has come to our notice that Bione Ventures is offering for sale rapid single use finger-prick tests for coronavirus which will give result in 5-10 minutes. The Central Drugs Standard Control Organisation has not licensed the aforesaid diagnostic kit.”

DCGI reiterated, “All are advised to follow the guidance issued by the Indian Council of Medical Research dated April 4 regarding use of Rapid Antibody based blood tests for coronavirus.”

ICMR has stated that such tests can only be carried out in health facilities and need to be reported. The government is concerned that persons who carry out home-based tests may not receive accurate results or may not report their results. In the UK, for instance, home-based tests are illegal as also they cannot be sold in pharmacies for over-the-counter use.

False negatives

“Rapid antibody tests can require several days of incubation of the virus or discernible symptoms of infection before detectable levels of antibodies develop in the body for testing. This could mean false negatives which could give a false sense of comfort to individuals when used without clinical judgement,” said Chinu Srinivasan, founder of Low Cost Standard Therapeutics, and an expert on pharma policy. Bione’s founder investor had earlier said that the home-based kits were seeing a good pre-order demand on their website and that they had the capacity to deliver up to 25,000 kits in one week.

‘Sales on hold’

After the DCGI notice, the company has turned around and has stated, “We have put everything on hold till we get more clarity.”

The company was selling rapid antibody kits for ₹2,499 and advising people to buy two kits to re-test within a few days in case the test turns out to be negative. It is also propagating preventive testing through faeces for ₹14,999 and genetic susceptibility test for ₹7,999.

Health advocacy group All India Drug Action Network (AIDAN) had written to DCGI on April 4 stating that no details were available on the company website regarding foreign manufacturers from where kits were sourced or their approvals in India. “The company’s strategy is clearly to exploit public anxiety,” said Malini Aisola, co-convenor of AIDAN.

Published on April 06, 2020

A letter from the Editor


Dear Readers,

The coronavirus crisis has changed the world completely in the last few months. All of us have been locked into our homes, economic activity has come to a near standstill. Everyone has been impacted.

Including your favourite business and financial newspaper. Our printing and distribution chains have been severely disrupted across the country, leaving readers without access to newspapers. Newspaper delivery agents have also been unable to service their customers because of multiple restrictions.

In these difficult times, we, at BusinessLine have been working continuously every day so that you are informed about all the developments – whether on the pandemic, on policy responses, or the impact on the world of business and finance. Our team has been working round the clock to keep track of developments so that you – the reader – gets accurate information and actionable insights so that you can protect your jobs, businesses, finances and investments.

We are trying our best to ensure the newspaper reaches your hands every day. We have also ensured that even if your paper is not delivered, you can access BusinessLine in the e-paper format – just as it appears in print. Our website and apps too, are updated every minute, so that you can access the information you want anywhere, anytime.

But all this comes at a heavy cost. As you are aware, the lockdowns have wiped out almost all our entire revenue stream. Sustaining our quality journalism has become extremely challenging. That we have managed so far is thanks to your support. I thank all our subscribers – print and digital – for your support.

I appeal to all or readers to help us navigate these challenging times and help sustain one of the truly independent and credible voices in the world of Indian journalism. Doing so is easy. You can help us enormously simply by subscribing to our digital or e-paper editions. We offer several affordable subscription plans for our website, which includes Portfolio, our investment advisory section that offers rich investment advice from our highly qualified, in-house Research Bureau, the only such team in the Indian newspaper industry.

A little help from you can make a huge difference to the cause of quality journalism!

Support Quality Journalism
This article is closed for comments.
Please Email the Editor
You have read 1 out of 3 free articles for this week. For full access, please subscribe and get unlimited access to all sections.