The Central Drugs Standard Control Organisation (CDSCO), India’s main drug regulator, has recently canceled the import license for a popular hair-loss product called QR678 Neo. This action serves as a stark warning to the peptide industry and related businesses.
The issue? The product, made from plant-derived peptides, was registered and approved only as a cosmetic. However, its website made strong claims, suggesting it could treat serious medical conditions like hair loss after chemotherapy, male and female pattern baldness (androgenetic alopecia), and scalp issues (seborrheic dermatitis)¹.
This move by the CDSCO clearly shows that simply calling a product a cosmetic while promoting it as a drug is a serious regulatory violation. Companies must be super clear about what their products are meant to do and make sure their advertising matches how their product is officially registered.
To fully understand the strategic implications, a closer analysis of the regulatory framework is required.
India’s legal framework, mainly guided by the Drugs and Cosmetics Act of 1940 and the newer Cosmetics Rules, 2020, draws a very clear line between what counts as a cosmetic and what counts as a drug². You see, a cosmetic is basically any item put on the human body to clean it, make it prettier, improve its look, or change its appearance.
Think lotions, shampoos, makeup. The main idea here is that cosmetics are about enhancing or altering how you look, not about treating diseases or changing the body’s functions deep down.
On the flip side, drugs are meant to prevent, diagnose, treat, or cure diseases. They’re also used to affect how the body works or its structure. This difference isn’t just a small detail; it’s the whole ballgame. Because drugs have such a big impact on health, they have to go through tough testing and get special approvals before they can be sold.
This includes detailed clinical trials to prove they are safe and actually work. Cosmetics, though they have their own rules for safety and ingredients, don’t need to pass these same high bars for showing they treat medical problems³.
In the case of QR678 Neo, the product was registered as a cosmetic. But the company’s marketing, especially on its website, pushed it far beyond what a cosmetic is allowed to claim. They talked about treating medical conditions that cause hair loss, which instantly made the product seem like a drug. This is where the company tripped up.
The CDSCO made it clear that a product registered as a cosmetic cannot claim to be a cure or treatment for any disease. Doing so directly goes against Rule 36 of the Cosmetics Rules, 2020. This rule states, plain and simple, that cosmetics cannot make any false or misleading claims about what they do².
Rule 36 of the Cosmetics Rules, 2020, is a major piece of this puzzle. It’s designed to protect consumers from being misled by fancy words or unproven claims. The CDSCO found that QR678 Neo’s claims on its website were a direct violation of this rule.
Even though the company quickly removed the claims after getting a notice from the regulator, the damage was already done. The simple fact that those claims existed online meant the company had broken the rules for how a cosmetic product should be promoted.
This specific regulatory action isn’t just about one product; it’s a loud and clear message to the entire industry. It highlights that regulators are actively watching the online space and company websites, not just product labels. In today’s digital world, where information spreads like wildfire, what a company says about its product online is just as important, if not more, than what’s printed on the box.
For peptide researchers and startups, this event offers key lessons. Peptides are fascinating molecules with a wide range of potential uses. They can be ingredients in cosmetics, like improving skin texture, or they can be developed into actual drugs, targeting specific diseases.
The way a peptide product is regulated depends entirely on its ‘intended use.’ If you aim for your peptide product to have a medical effect – like treating hair loss or regenerating tissue – then it must go through the rigorous drug approval pathway, which includes extensive clinical trials under the New Drugs and Clinical Trials Rules, 2019⁴.
If it’s just for beautifying or enhancing appearance, then the cosmetic rules apply. There’s no middle ground where you can claim drug-like effects with a cosmetic registration.
This ruling by the CDSCO has several major implications for companies working with peptides, especially those in the cosmetic and health product sectors.
Firstly, it forces a rigorous review of all marketing materials. Every claim, every description, whether on a website, social media, or product packaging, needs to align perfectly with the product’s official regulatory classification. Companies cannot afford to be vague or imply benefits that aren’t legally supported by their product’s registration. This means legal and marketing teams must work hand-in-hand to ensure compliance.
Secondly, it underscores the need for early and accurate regulatory strategy. Before even launching a product, companies must decide if their peptide-based solution is a cosmetic, a drug, or perhaps a medical device.
This decision then shapes the entire development pathway, including the type of research, testing, and approval processes required. Trying to take shortcuts by registering a product as a cosmetic and then marketing it as a drug will likely lead to severe penalties, including license cancellations and significant financial losses.
Thirdly, this event will likely lead to increased scrutiny from regulatory bodies. Other products making similar ambiguous claims might now come under the scanner. Companies should proactively audit their own product lines and marketing strategies to ensure they are fully compliant with Indian regulations. Ignoring these rules isn’t just a minor mistake; it’s a threat to a company’s ability to operate in the market.
Ultimately, the CDSCO’s decision on QR678 Neo isn’t just a story about hair loss products. It’s a fundamental reminder about the critical distinction between cosmetics and drugs. For the peptide industry, known for its innovative potential, this distinction is particularly important.
The same peptide molecule could be a cosmetic ingredient in one formulation and a therapeutic drug in another, based purely on its intended use and how it’s marketed. Clarity, honesty, and strict adherence to regulatory pathways are not just good practices; they are essential for success and for building trust with consumers and regulators alike.
Compliance is strategy. Stay informed. ⚖️
All human research MUST be overseen by a medical professional.
