startups

Delhi Startup Reportedly Lies About FDA Approval, AIIMS Clinical Test

0
sanfe e1554727413327

Last month on Women’s Day i.e 8th March, researchers at Indian Institute of Technology, Delhi (IIT Delhi) including a professor in the department of design — Prof Srinivasan Venkataraman and the institute’s incubated startup Sanfe, which was co-founded by 3rd year students of IIT Delhi, had launched Sanfe Period Pain Relief Roll On device to relieve periods pain and ease out the mood swings faced by women during menstruation cycle.

sanfe founders

Sanfe Co-founders

Developed by two B. Tech 3rd year students of IIT Delhi — Mr Archit Agarwal and Mr Harry Sehrawat, along with an a Professor Dr. Srinivasan Venkataraman at IIT Delhi, Sanfe Period Pain Relief Roll On is an essential oil based natural formulation which has to be applied during periods on cramp affected areas (lower abdominal area, lower back and legs).

According to AltNews investigative report, a fact checking and fake news busting website, Sanfe has made three claims on approvals by top medical and Clinical test agencies including Food and Drug Administration (FDA) of the U.S. . The startup, in its official website which is now deleted (see archived page), the startup had claimed — 1) it received ‘FDA approval claiming no side-effects’; 2) Received an ‘AYUSH ministry certificate of safety’ and 3) The product by the startup is developed, medically tested in collaboration with AIIMS Delhi.

Advertisements


Several top media outlets such as Indian Express, NDTV, Times of India, The Economic Times, India Today, DNA India, reported as per the Official IIT Delhi website.

However, in a surprise revelation, especially from a premier institute like IIT Delhi, a cross check email to all FDA, AIIMS and Aayush Ministry, it comes out that none of the claims are true and in case of FDA approval, the startup is in fact playing cheap word-game where it comfortably says that Sanfe doesn’t have the American FDA approval, but actually acquired the approval from FDA, Haryana.

As FDA approval of treatments is public information, cross check with two online databases here, (Drugs@FDA and Orange Book), it was found that Sanfe was not approved by the FDA.

Going forward, an email from AltNews team to Division of Drug Information in the FDA’s Center for Drug Evaluation and Research (druginfo@fda.hhs.gov) also confirmed that ‘Sanfe Period Pain Relief Roll-On’ is NOT a U.S. FDA approved drug product (see screenshot of email response below).

FDA email altnews

Further when AltNews team confronted one of the co-founders, Archit Agarwal, about the reason behind the startup’s misleading claims on FDA approval, he said that the AYUSH certificate was ‘FDA like’ and hence was advertised that way.

As a matter of fact however IIT-Delhi never claimed that Sanfe was approved by AIIMS for clinical tests and its also evident on IIT-Delhi Website’s page.

Its very unfortunate that students of India’s premier institute IIT Delhi, which counts Infosys co-founder N.R. Narayana Murthy, Flipkart founders Sachin Bansal, Binny Bansal and Nikesh Arora of Softbank as some of its notable alumni, fell short of code of ethics and tried to forge on medical claims that is related to health and women — two most lowest priorities of India, nowadays.

IIT Delhi has taken serious note of deliberate attempt by student co-founders of Sanfe, who misrepresent facts.

On April 8, the founders of the startup — Mr. Agarwal and Mr. Sehrawat issued a press statement and apologized stating: “It is a factual and an unintentional mistake” to have stated that the product is FDA-approved. 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.”

In this matter, IIT Delhi has issued an official press statement as follow –

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.

Like this content? Sign up for our daily newsletter to get latest updates.

Advertisements


Vardaan
Founding editor at IndianWeb2, he's been writing at IndianWeb2 since 2007. Apart from blogging he had a professional career of software developer, Ux developer and search engine marketer in past. His vision of IndianWeb2 has been laid down so as to showcase, encourage and propagate Indian startups, innovation and entrepreneurship ideas.

To Boost the Startups platform BSE Ties with HDFC Bank

Previous article

Indian Startup Wobot Wins Innovation Prize at Seedstars Global 2019

Next article

More in startups

Comments

Comments

This site uses Akismet to reduce spam. Learn how your comment data is processed.