An Indian company continues to sell products deemed “fraudulent” by the US Food & Drug Administration (FDA) for false claims of COVID-19 cures.
The FDA issued a warning letter to BGP LLC of Santa Monica CA in May of 2021, accusing the company of fraud related to the marketing of its “Biocence” products. The FDA letter accuses BGP of illegally marking its Biocence line as “unapproved and misbranded products related to coronavirus disease.”
BCP made multiple false claims about its Biocence products, including that one product “causes a 99.97% reduction of the COVID-19 Virus” and “nurses and doctors [are] now using Biocence to stay protected at Covid-19 prescreenings!”
FDA warns the public that the claims are false, and that Biocence does not have any properties which could cure or prevent COVID. The primary ingredient listed for the “antiviral” product is eucalyptus.
Despite the fact that this public warning was published eight months ago, one company in India continues to sell the fraudulent products, potentially putting its customers’ lives at risk. GNH India claims to be an official distributor of Biocence, and sells the exact products mentioned in the FDA warning letter.
At the same time, GNH India claims to hold ISO 9001 certification issued by the certification body URS. A press release by one executive claims it first received the certification in 2016.
The URS website claims its ISO 9001 certification “increases your customers‘ trust in you as a safe supplier of products and services.”
GNH India also claims to hold “WHO GSDP requirements for International wholesale and Clinical trial supplies” issued by another certification body, SGS.
Oxebridge could not verify the ISO 9001 certificate via either the IAF CertSearch database or the IQNet database; this is likely due to URS not participating in either verification program. An attempt to verify the certificate on the URS website resulted in a website error. Oxebridge has written to URS and will update this article with any confirmation received.
UPDATE 22 January 2022: GNH India is threatening legal action against Oxebridge for its reporting. See here. They have still not produced an actual ISO 9001 certificate, but instead a continuation letter.
UPDATE 28 January 2022: GNH India continues to refuse to take action, instead insisting the products are lawful. It now also claims not to be an authorized distributor of Biocence, despite the GNH website clearly stating otherwise.
The full text of GNH India’s response is below.
Mr. Christopher,
We are not an Authorised distributor of Biocence. We are licensed distributors for Medicinal products by Indian FDA
US FDA has Warned Biocence for making OFF LABEL claims.
Surprised to see that native English speaker as your self does not understand the meaning of Warning letter.
Where as if you spend 2 minutes on our webpage – we have displayed the product As it is from https://dailymed.nlm.nih.gov/dailymed/ portal which is maintained by NIH (U.S National Library of Medicines)
Once NIH takes the product off their Library, we too will follow.
In the mean time, we will be happy have video call with you to explain the difference between Warning letter and withdrawal letter.
By posting such base less articles, you are damaging your organisations reputation.
We will wait for 15 days from today, in case the article is not deleted from all webpages / posts / sites in electronic form and written, we will be forced to take legal action.
CC: Ms. Shweta, please monitor for further legal action.
Regards,
Mr. Ravi Kumar (B.Com)
Admin ExecutiveGNH India Pharmaceuticals Limited
Gala # 11, 1st Floor, Kamat Industrial Estate, Opp. Siddhi Vinayak Temple, Prabhadevi.Tel: +91 22 6270 6999 | Fax: + 91 22 6270 6909
contact@gnhindia.com
cc: shwetadkhanna@gmail.com
In contradiction to Mr. Kumar’s email, below is a screenshot of the GNH website declaring GNH a distributor of Biocence:
URS has an auditor in the region with the same name as the GNH executive Ravi Kumar; it is investigating whether this is the same person, and thus whether GNH certified itself using the URS logo. The name “Ravi Kumar” is common, however, and this may be a coincidence.
Oxebridge has reported GNH India to both the US FDA and Indian FDA in Maharashtra.
UPDATE 29 January 2022: In a new email, Mr. Kumar continues to make an argument that GNH merely sells the product “as is” and does “not make any claims on product performance on our site.”
However, the GNH site reproduces the labels of the Biocence product which claims it “Safely Eradicates 99.9% of Multi-Resistant Organism (MDRO’s) that cause majority of HAI’s and CAI’s in 30 seconds or less,” and “BIOCENCE WS Multi-use Selective Antibacterial / Antiviral Human OTC Drug,” among other performance claims. Those exact claims from the label were quoted verbatim in the FDA Warning Letter, and FDA cited specific regulations that those claims violated. The GNH site then links to the Biocence site which makes the additional fraudulent claims about COVID treatment.
The GHN website’s legal policy page then reinforces that GNH stands behind the claims made by the manufacturers’ claims:
The FDA Warning Letter demands that the products be removed from sale, but GNH continues to refuse to do so.
Oxebridge has now reported GNH to the US Federal Trade Commission (FTC) as urged by the FDA Warning Letter.
