On April 7, Alt News debunked the claims of the company that the product was FDA-approved and tested by AIIMS

Sanfe Period Pain Relief Roll On, an Ayurveda product to help women with menstrual pain, was launched by an IIT Delhi start-up Redroomtechnology Private Limited on March 8 claiming to be FDA-approved. The press release sent out by IIT Delhi and a tweet from its official handle on March 8 claimed that the product was FDA-approved. The Sanfe website went one step further to claim that the product was also tested by AIIMS. The news was carried by many mainstream newspapers; The Hindu did not carry the news.

On April 7, Alt News debunked the claims made by Archit Agarwal and Harry Sehrawat who are B. Tech students at IIT Delhi and Directors of the company that the product was FDA-approved and tested by AIIMS.

Speaking to The Hindu, Mr. Agarwal admitted that the product was approved by Directorate of Ayush, Haryana, and not by FDA as originally claimed. He also admitted that the product was not tested by AIIMS.

Launch of Sanfe Period Pain Relief Roll On | Photo Credit: Special Arrangement

Speaking to The Hindu about the “trial” Bhupender Nagpal, owner of the Haryana-based Space Organics that is manufacturing the product, said: “We gave the product to 79 women working in our factory and to other women we know for testing.” Apparently, no systematic trial was carried out.

“It was a mistake, a slip. I had a chance to look at it [press release] but did not know about it. We carried a corrigendum in The Hindu on March 28 once we realised our mistake,” Dr. Srinivasan Venkataraman from the Department of Design, who is part of the start-up told The Hindu.

The corrigendum says: “…Wherever it has been mentioned that Sanfe Period Pain Relief Roll On is a FDA-approved product, it should be considered as Ministry of AYUSH, Haryana-approved product”.

On April 8, Mr. Agarwal and Mr. Sehrawat issued a press statement stating: “It is a factual and an unintentional mistake” to have stated that the product is FDA-approved. It adds: “The factual and the unintentional mistake was the consequence of our misunderstanding that FDA is the equivalent of Directorate of Ayush for this product. We deeply apologise for the mistake.”

However, IIT Delhi has taken serious note of deliberate attempt to misrepresent facts. In a press statement released on April 8 it stated: “The press release issued on March 8 claimed that the product was FDA-approved. It has come to our notice that the claim was false. An internal inquiry is being initiated against the Sanfe (Redroomtechnology Private Limited) founders and a show cause notice has also been issued to them. Based on this inquiry report action would be taken. Prima facie it appears that a certificate issued by Directorate of Ayush Haryana, Sector-3, Panchkula, has been misrepresented as that issued by FDA. IIT Delhi has zero tolerance policy for false representation of information and takes strict action in such cases.”