{"id":32663,"date":"2019-04-07T21:46:31","date_gmt":"2019-04-07T16:16:31","guid":{"rendered":"http:\/\/www.altnews.in\/english-clone-2026\/?p=32663"},"modified":"2019-04-07T21:47:44","modified_gmt":"2019-04-07T16:17:44","slug":"iit-delhi-startup-sanfe-falsely-claim-fda-approval-and-ayush-ministry-certificate-for-their-product","status":"publish","type":"post","link":"https:\/\/www.altnews.in\/english-clone-2026\/iit-delhi-startup-sanfe-falsely-claim-fda-approval-and-ayush-ministry-certificate-for-their-product\/","title":{"rendered":"IIT-Delhi startup Sanfe falsely claim FDA approval and AYUSH ministry certificate for a pain relief roll-on"},"content":{"rendered":"

On 8th of March 2019, four IIT-Delhi entrepreneurs launched<\/a> a product ‘Sanfe Period Pain Relief Roll-On’ that claimed to help women with menstrual pain. The start-up group who launched the product consists of two textile engineering students (Archit Agarwal & Harry Sehrawat ), a faculty of economics (Dr Seema Sharma), and a professor in the department of design (Prof Srinivasan Venkataraman) at IIT-Delhi.<\/p>\n

As reported by the Times of India<\/a><\/em> on the 11th of March, the Tech student Archit Agarwal stated that 24-hour long research for almost seven months was required to finalise a composition that helped them acquire the FDA approval.<\/p>\n

Several news outlets such as Indian Express<\/em><\/a>, NDTV<\/em><\/a>, Times of India<\/em><\/a>, The Economic Times<\/em><\/a>, India Today<\/em><\/a>, DNA India<\/em><\/a>, reported as per the Official IIT Delhi website<\/a> release.<\/p>\n

Claims:<\/h2>\n

As per the archived version of the Sanfe<\/em> article<\/a>, <\/em>reportage by major news outlets as listed above, and during a phone conversation with Sanfe<\/em> co-founder Archit Agarwal, it was collectively claimed that:<\/p>\n

    \n
  1. It has received \u2018FDA approval claiming no side-effects\u2019<\/li>\n
  2. It has received an \u2018AYUSH ministry certificate of safety\u2019 instead<\/li>\n
  3. It is developed, medically tested in collaboration with AIIMS Delhi<\/li>\n<\/ol>\n

    Fact Check:<\/h2>\n

    The claim of FDA approval <\/h3>\n

    The Food and Drug Administration (FDA), USA, examines and approves a broad range of treatments for medical use including drugs and medical equipment. Although, FDA can approve drugs from international manufacturers, it is to ensure the safety of such products for Americans.<\/p>\n

    FDA approval of treatments is public information. After checking with two online databases here<\/a>, (Drugs@FDA<\/a> and Orange Book<\/a>), it was found that Sanfe was not approved by the FDA.<\/p>\n

    A cross-check via email to the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research (druginfo@fda.hhs.gov). The FDA CDER confirmed that \u2018Sanfe Period Pain Relief Roll-On\u2019 is not a U.S. FDA approved drug product (see screenshot of email response below).<\/p>\n

    <\/p>\n

    When we established our 1st<\/sup> phone contact with Archit Agarwal, the co-founder of Sanfe, he confirmed that Sanfe doesn\u2019t have the American FDA approval, but actually acquired the approval from FDA, Haryana.<\/p>\n

    During our 2nd<\/sup> phone contact, also with Archit Agarwal, he suggested they hadn\u2019t acquired any FDA approval but instead had a safety certificate from the AYUSH ministry, Haryana by the manufacturers called Space Organics, <\/em>Haryana.<\/p>\n

    Upon confronting the reason behind their misleading adverts of FDA approval, he elaborated that the AYUSH certificate was \u2018FDA like\u2019 and hence was advertised that way.<\/p>\n

    2. The claim of AYUSH ministry safety certificate <\/h3>\n

    During our 2nd<\/sup> phone contact with Archit Agarwal, he claimed that an AYUSH ministry certificate was acquired by the manufacturer Space Organics<\/em>, Haryana, to determine the safety of the Sanfe roll-on.<\/p>\n

    Thereafter, we contacted the owner of Space Organics<\/em> Mr Bhupender Nagpal. He stated that his company manufactured Ayurvedic treatments in collaboration with a sister company called Space Life Sciences, <\/em>led by his son. Mr. Nagpal clarified that neither the FDA approval nor the AYUSH ministry approval exists for the \u2018Sanfe roll-on\u2019.<\/p>\n

    3. The claim of clinically tested in collaboration with AIIMS Delhi<\/h3>\n

    The previous version (archived here<\/a>) of the Sanfe website, also claimed that it was tested in 79 people in conjunction with AIIMS, Delhi. The owner of Space Organics<\/em> Mr Bhupender Nagpal who manufactured Sanfe<\/em> roll-on clarified that no \u2018clinical\u2019 or \u2018medical\u2019 testing was conducted as a part of safety and toxicity tests. The reason given was that it wasn\u2019t cost-effective for a business to test a product in the market that has a lower purchase value per product in comparison to the cost of the clinical testing.<\/p>\n

    Research databases such as PUBMED also provided no studies referring to the specific Sanfe<\/em> product.<\/p>\n

    Conclusions<\/h2>\n

    All the claims listed above, i.e. FDA approval, AYUSH ministry safety certificate as well as clinical testing in collaboration with AIIMS, Delhi were not substantiated by the Sanfe<\/em> founders.<\/p>\n

    Fact-checks from FDA and the Sanfe manufacturers called Space organics<\/em> also confirmed that the treatment had no official approvals or any ongoing clinical testing.<\/p>\n

    After our phone calls to Sanfe<\/em>, the information about FDA approval and clinical testing in AIIMS promptly deleted at official IIT-Delhi website<\/a> but can be compared with the archived version available here<\/a>.<\/p>\n

    However, major media outlets had reported that Sanfe<\/em> was released after an FDA approval and none of those articles had been retracted. Archit Agarwal, the Sanfe <\/em>founder also stated that the FDA claim was a \u2018mistake\u2019 and they have published a corrigendum in major newspapers but no such corrigendum have been published so far.<\/p>\n

    The infographics on Sanfe<\/em> have also been changed to remove the \u2018mistakenly\u2019 added FDA approval.<\/p>\n

    \"\"<\/p>\n

    These claims collectively made by members of leading government institutions such as IIT-Delhi is grossly misleading to include tags such as FDA, AYUSH and AIIMS to market the product as a private company.<\/p>\n

    Finally, major leading news outlets reproduced the press release without any cross-verification and added significantly to spreading the misleading, deceitful marketing for the Sanfe<\/em> brand.<\/p>\n","protected":false},"excerpt":{"rendered":"

    On 8th of March 2019, four IIT-Delhi entrepreneurs launched a product ‘Sanfe Period Pain Relief Roll-On’ that claimed to help women with menstrual pain. The start-up group who launched the product consists of two textile engineering students (Archit Agarwal & Harry Sehrawat ), a faculty of economics (Dr Seema Sharma), and a professor in the […]<\/p>\n","protected":false},"author":42,"featured_media":32741,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[121],"tags":[],"an_content_type":[],"coauthors":[628,122],"class_list":["post-32663","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-science","fact_checks_claim_type-economics"],"blocksy_meta":[],"yoast_head":"\nIIT-Delhi startup Sanfe falsely claim FDA approval and AYUSH ministry certificate for a pain relief roll-on - Alt News<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IIT-Delhi startup Sanfe falsely claim FDA approval and AYUSH ministry certificate for a pain relief roll-on - Alt News\" \/>\n<meta property=\"og:description\" content=\"On 8th of March 2019, four IIT-Delhi entrepreneurs launched a product ‘Sanfe Period Pain Relief Roll-On’ that claimed to help women with menstrual pain. 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