The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of the South Korean aesthetic product ‘FatX Solution’ as it was found to have claims that it could dissolve fat cells. The product is marketed by Delhi based Tekno Midas Aesthetics in India.
This demonstrates the difference between cosmetics and drugs in India. CDSCO found that the claims made on the importer’s website were not consistent with the product label and were not suitable for a cosmetic.
The cancellation notice was issued on 26 October 2026 and published on the CDSCO website on 28th October 2026. This cancels the registration certificate RC/COS-003300, which was issued on 15th July 2022 and would have expired on 14 July 2027. The cancellation order states that the registration was cancelled with effect from the date of issue of the order.
During the assessment of FatX’s registration documentation and official website, CDSCO noticed inconsistencies between the claims on the product label and the approved label.
On the website, claims were being made that the product could dissolve fat cells. These claims were seen by CDSCO as drug related claims and not suitable for a cosmetic product under the Drugs and Cosmetics Act, 1940.
The issue was not limited to the product's advertised benefits. CDSCO specifically identified discrepancies between the claims appearing on the marketed product labels and those on the approved product label. This raised concerns about whether the product was being promoted beyond the scope of its registered cosmetic classification.
A show cause notice was issued to Tekno Midas Aesthetics on 10th August 2026, as the company had breached Section 3 (aaa) of the Act and Rule 36 of the Cosmetics Rules, 2020.
The company responded on 1st September, however, the Central Licensing Authority found the response unclear and unsatisfactory. The importer requested to withdraw their certificate and it was cancelled due to the breaches.
The company also requested that the voluntary surrender of registration certificate RC/COS-003300 be accepted. However, the Central Licensing Authority proceeded with the cancellation of the certificate. The order cites Rule 21(b) as the authority under which the Licensing Authority acted.
FatX Solution was marketed as an injectable aesthetic product for the reduction of localized fat in areas such as the chin, stomach, thighs and arms.
The product contains deoxycholic acid and a proprietary Natural Anti-Inflammatory System (NAIS) complex and was claimed to help reduce fat, according to media sources.
These are claims made by the product.
The key issue was that the product was being marketed as an aesthetic product but with claims it could dissolve fat cells.
Products are classified according to their intended use.
Section 3(aaa) of the Drugs and Cosmetics Act, 1940, states that a cosmetic is any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance of the human body.
This definition also includes products introduced into the human body. Therefore, the fact that a product is injectable does not, by itself, automatically determine whether it is a cosmetic or a drug. Its intended purpose and claims are also relevant to its classification.
However, if claims are made about a product then this can impact how it is classed. Section 3(b) of the Act states that substances intended for the diagnosis, treatment, mitigation or prevention of diseases are classed as drugs. Certain substances intended to influence the structure or function of the human body are also classed as drugs.
CDSCO found that FatX contained claims about dissolving fat cells, and reducing fat cells and therefore, these were drug related claims. However, Section 3(b) was not specifically cited as the basis for cancellation in the FatX notice. The regulator cited Section 3(aaa) and Rule 36 of the Cosmetics Rules, 2020.
CDSCO also pointed out that rule 36 of the Cosmetics Rules, 2020 states that no false or misleading claims should be made about cosmetic products.
It is important to understand that drugs will have different requirements to cosmetics. If products are being marketed as having therapeutic or physiological effects, then they will need to meet the requirements of the classification.
Speaking to The Times of India, Rajan Bhatnagar of Tekno Midas Aesthetics said the product had initially received registration as a cosmetic more than four years ago. He said the authorities had changed their interpretation of the category under which the product fell.
He also said the company decided not to contest the regulator's action after receiving the show-cause notice and voluntarily requested the surrender of its registration certificate. According to him, the company did not want to enter into a dispute or challenge the notification.
The company’s position provides its perspective on the cancellation, while the CDSCO order records the regulator's findings regarding the product's marketing claims and the company's response.
FatX’s registration has been cancelled, meaning it cannot be imported into India under the registration certificate held by Tekno Midas Aesthetics. This shows that injectable aesthetic products being marketed with claims that go beyond their approved use as a cosmetic product will be subject to scrutiny.
The cancellation is specific to registration certificate RC/COS-003300. The CDSCO order does not announce a blanket prohibition on all injectable fat-reduction treatments or a nationwide recall of FatX.
The cancellation also does not amount to approval of FatX as a drug. If the product is to be marketed under a drug classification, it would need to meet the applicable regulatory requirements. The CDSCO order does not grant such approval.
This shows how important it is to ensure that products you are providing to patients are suitable for use. Ensure the product labels, marketing material and claims are consistent with the correct regulatory approval.
Consumers should also be wary of products being marketed with claims of targeted fat reduction and cell destruction. Just because a product is being marketed with these claims doesn’t mean it will be effective clinically.
This doesn’t mean that FatX caused any adverse events or that there has been an instruction to perform a nationwide recall. This is simply a cancellation of the import registration held by Tekno Midas Aesthetics.
This shows how important it is to ensure products are correctly classified. With the growing aesthetic medicine market, it is essential to ensure injectable treatments and non-surgical body contouring products have clear labelling, evidence-based claims and are compliant with drug and cosmetic regulations to protect consumers.
References:
1. Central Drugs Standard Control Organisation (CDSCO). “Cancellation of Registration Certificate No. RC/COS-003300 Issued to M/s Tekno Midas Aesthetics.” October 26, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Tekno%20midas%20notice%20dated%2026.10.2026.pdf
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