Drug regulator pulls up Bione for selling unlicensed home testing kits

Maitri Porecha New Delhi | Updated 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

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