DNewsCafe : ‘Sanfe Period Pain Relief Roll-On’ is a pain reliever product to help with menstrual pain.  Sanfe Period Pain Relief Roll On is launched by a start-up group named Redroom Technology Private Limited run by 4 IIT-Delhi Entrepreneurs.

Sanfe Period Pain Relief Roll On Reviews

Accordint to packing of Sanfe Sanfe roll-on is approved by AYUSH.  Sanfe, consists of 100% natural oils, causes no side effects.  As per the packaging It targets the source of pain without having to take ‘pain killers’.

After our investigation, Sanfe formulation is packed with several compounds used as pain-killer medications, as well as other compounds that increase the absorption of such pain-killers, which should be evaluated in toxicity and dosage studies before marketing and administration similar to any other drugs.

Thus, under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945, it can be considered as attempts to misbranding the product as defined.

Any remedy that affects will, evidently, have unwanted side effects. Hence, the dosage is studied to extract the most desired effect with the maximum tolerable adverse effect. It is false to claim that herbal drugs will be completely free of side effects just because they are ‘natural’. Some of the most potent drugs in medicine have been derived from natural substances which also carry the same adverse effects as any other laboratory synthesized compounds.

The use of medicinal plants and oils as a form of topical pain treatment has been widely studied, where detailed adverse effects have been described (Bakkali et al. 2008). Prolonged use of any of the Sanfe’s ‘natural’ ingredients, standalone or in combination, can lead to strong unwanted adverse reactions.

Sanfe roll-on consists of 6 components, and there is no prescribed method to limited the frequency of its use. Apart from the described oils (see the manufacturing licence), reportedly, lavender, gandhipura (wintergreen), nilgiri (eucalyptus), rosemary and base oil, the strongest active ingredient is an extract of the mint in the crystal form. While the packaging shown in the image below doesn’t mention crystalline Menthol (mint) as one of the ingredients, the Space Organics certificate above does. Since mint in the herbal form does not contain high quantities of this active ingredient, a crystalline form of the compound menthol is used which can act on the cold receptors in the skin to give pain relief. This is a low-cost compound synthetically manufactured in the lab and is not safe or natural, if not used correctly.

Mint essential oil can contain up to 40-90% menthol which is a potent pain killer acting on the cold receptors in the skin. Several topical anesthetics and nasal decongestants such as Vapour-Rubs also contain menthol.

Additionally, menthol also enhances the penetration of other transdermal drugs, which means that the absorption of other compounds is increased when mixed with menthol. Drug development companies should issue expert advice on consumption of menthol based compounds as it may be toxic and sub-lethal in higher doses starting from 50-500mg per kg of body weight.

The claim of suggesting it as devoid of traditional pain-killers, which target the source of pain.
The Sanfe formulation contains several ‘pain killer’ compounds in the form of essential oils that is equivalent (in specific dosage) to over the counter pain killers. For example, an American patent describes a mixture of wintergreen oil, olive oil and/or eucalyptus oil as a topical pain killer.

Although Sanfe doesn’t directly claim that its composition has no pain killers, it is contended that pain is reduced without having to take pain killers. Using this roll-on is equivalent to a topical application of consuming a ‘pain killer drug’, provided it gets absorbed into the system in the required dosage.

Wintergreen oil (8% in Sanfe roll on) contains about 98% of methyl salicylate, a compound closely related to acetylsalicylic acid, or aspirin- which is a class of ‘pain killers’. Also, if used excessively, wintergreen oil can lead to toxicity from ingestion of methyl salicylate compound. This toxicity varies for different age groups and is the most harmful in small children. For example, 5 ml of methyl salicylate is equivalent to 5 aspirin tablets (325 mg each). Various toxicity studies have confirmed that while low dose skin application was safe or can cause mild-acute irritation to the skin, dosage over 7 gm for a 70 kg adult can result in severe neurological disturbances (Chin et al. 2007).

Other ingredients of Sanfe, such as eucalyptus, lavender, and rosemary have shown limited pain-relieving effects, but have known to cause several skin related, systemic problems and other adverse effects similar to an anaphylactic reaction in higher doses (Darben et al. 1998, Pozadski et al. 2012, Ulbricht et al., 2010). Use of rosemary is also dangerous for anaemics and pregnant women.

Lastly, the claim that it penetrates deep into the source of pain is made without understanding the research in pain mechanisms. Pain during menstruation arises deep within the muscles, while this roll-on is applied only on the skin. The muscle and the skin is separated by several other layers of tissue that do not allow deep penetration of topical drugs unless the drug is in systemic circulation through the bloodstream. Hence, the effect of pain relief with Sanfe may be not be attributed through deep absorption through the skin. This claim shows the developers of Sanfe’s meagre understanding of pain emergence during menstruation.

Is IT FDA Approved

Sanfe Period Pain Relief Roll On is claimed to have an FDA approval.  Several news outlets such as The Indian Express, NDTV, The Times of India, The Economic Times, and India Today have published it with FDA Approval.  But its not true.

It is notified for iformaticin that RedrooniTechriology Private Limited, an NT Delhi incubated startup, on the occasion of International Women’s Day had launched Sanfe Period Pain Relief Roll On.  It has been mentioned On the press release and at several other platforms that “Product is FDA approved”, Since it is an Ayurvedic product it is not governed by FDA in India. The product comes under the Ministry of Ayush, Haryana and so has been approved by Minisfry of Ayush, Haryana. It is manufactured by Space Organics in Sonipat, Haryana, with manufacturing license number 665-ISM- HR. The manufacturer has all the necessary certification and license for safe manufacturing. Wherever, it has been mentioned that Sanfe Period Pain Relief Roil On is a FDA approved product, it should be considered as Ministry of Ayush, Haryana approved product. It is also to be noted that this product was developed by an IIT Delhi incubated startup and not by IIT Delhi.

Is It Ayush Approved

The founders of Sanfe, used government institutes such as AYUSH to promote drugs without any background research or understanding of menstrual pain.  Sanfe’s founders have claimed to have an approval certificate which, through our investigation, turned out to be a manufacturing licence from AYUSH.

The Ministry of AYUSH in a document lists ethical principles to be followed during a clinical trial for Ayurvedic drugs, the launch of the Sanfe product did not seem to follow those guidelines.

The co-founder of Redroom, Archit Agarwal has accepted that it was a mistake that Sanfe is FDA Approved on 28th March, 2019. They also claimed that the formula was clinically tested before release.  And according to them its safe for use.

According to AYUSH ministry, Haryana’s Dr Satish Khatkar, the certificate is given for manufacturing the product, not for the safe formula.  Its the duty of manufacturer to test the formula.  As per AYUSH, this safety certificate was backed by the ancient Ayurvedic text Bhavaprakasha Nighantu (B.P.N).

Dr Khatkar from AYUSH, also suggested that the certificate meant those individual components of the product may be effective and safe according to the ancient textbook of Ayurveda, Bhavaprakasha Nighantu (B.P.N), which had not been approved as a combined specific formula that Sanfe roll-on is.

Moreover, the certificate or manufacturing licence is given after a confirmatory test by AYUSH that the product has only the individual components as per the claim of the manufacturer and that no other safety tests are conducted by AYUSH.

Khatkar also suggested that the responsibility of conducting these safety and toxicity tests was upon the manufacturer.

According to the founders the research have been done on 79 women.  This document was not a peer-reviewed published document, did not contain any data, nor it was tested for safety in various conditions. These type of research is to be a market survey where a group of women are given the product and later verbally asked to report efficacy. This unsystematic measure of efficacy cannot be considered as clinical research.