Cosmetics BANNED in India: The Salicylic Acid Shockwave
You Need to Know About!
Hey Skincare Fam!
Ever wonder how the beauty products you love make it onto
store shelves? There's a whole world of regulations behind them designed to
keep you safe! And recently, India's top drug regulatory body, the Central
Drugs Standard Control Organisation (CDSCO), dropped some major news that's
causing ripples in the cosmetics industry. If you use products with Salicylic
Acid, you have to read this!
Key Highlights:
- The
Big News: The CDSCO has cancelled the registration of several cosmetic
products imported by M/s. Spectra Medical India Pvt. Ltd.
- The
Culprit Ingredient: The issue revolves around Salicylic Acid.
- The
Rules: India's Cosmetics Rules, 2020, set strict limits on Salicylic
Acid concentration: 3% for rinse-off hair products and 2% for other
cosmetics.
- The
Violation: The cancelled products contained Salicylic Acid at alarming
concentrations ranging from 7% to 30%.
- Company's
Response: M/s. Spectra Medical India Pvt. Ltd. agreed to surrender the
non-compliant products after receiving a show-cause notice.
- Why It Matters: This action underscores the importance of regulatory compliance for consumer safety and product quality.
Detailed Article: Unpacking the Salicylic Acid Scandal
We all love a good skincare product, especially those that
deliver visible results. Salicylic Acid, in particular, is a hero ingredient
for many, celebrated for its ability to tackle acne, exfoliate, and keep pores
clear. But like any powerful ingredient, there's a fine line between effective
and excessive. And that's exactly what the Central Drugs Standard Control
Organisation (CDSCO) has cracked down on.
The Regulatory Watchdog Steps In
On May 20, 2025, the Government of India's Directorate
General of Health Services, Central Drugs Standard Control Organisation
(Cosmetics Division), issued a significant order. The target? M/s. Spectra
Medical India Pvt. Ltd., a company that had registered cosmetic products for
import into India. Their Registration Certificate, RC/COS-003211, endorsed on
July 17, 2023, was valid until May 31, 2027. However, things took a turn.
The Heart of the Matter: Salicylic Acid Concentrations
The core of the problem lies in Rule 39 of the Cosmetics
Rules, 2020. This crucial rule states that no cosmetic shall be imported or
manufactured unless it complies with specific quality and safety standards. When
it comes to Salicylic Acid (CAS No. 69-72-7), the rules are very clear: it's
allowed as a cosmetic ingredient at a maximum of 3% concentration for
rinse-off hair products and 2% for other products. These limits are
based on recognized standards like IS 4707 (Part 2): 2017.
Upon scrutiny of the application submitted by M/s. Spectra
Medical India Pvt. Ltd., several cosmetic products were found to be in direct
violation of these permissible limits. Take a look at these alarming
concentrations:
- Mesoestetic-
Mesopeel Periocular(64): 7% Salicylic Acid
- Mesoestetic-
Salicylic; variant 10%(66): 10% Salicylic Acid
- Mesoestetic-
Salicylic; variant 20%(51): 20% Salicylic Acid
- Mesoestetic-
Salicylic; variant 30%(67): 30% Salicylic Acid
- Dermamelan
Intimate Gel(7): 15% Salicylic Acid
- Dermamelan
Mask(31): 15% Salicylic Acid
- MESOPEEL
MODIFIED JESSNER(63): 14% Salicylic Acid
As you can see, these concentrations are significantly
higher than the permitted 2% for general cosmetic products.
The Road to Cancellation
Given these clear violations of Rule 39 and condition number 03 of the Registration Certificate (which requires withdrawal of non-compliant products from sale)
, the Licensing Authority issued a show-cause notice to Spectra Medical India Pvt. Ltd. on April 7, 2025.
Crucially, the firm responded to this notice, expressing
their willingness to surrender the products containing salicylic acid beyond
the prescribed limit.
The Final Order
Keeping in view the violations and the firm's response, Dr.
Rajeev Singh Raghuvanshi, the Drugs Controller General (India) and Central
Licensing Authority, ordered the cancellation of registration for these
specific products. This cancellation is effective from the date of the order,
May 20, 2025.
What Does This Mean for You?
- Consumer
Safety is Paramount: This action is a strong reminder that regulatory
bodies like the CDSCO are actively monitoring the market to ensure the
safety and quality of products available to consumers. High concentrations
of active ingredients, while potentially effective in professional
settings, can also lead to adverse reactions if not properly regulated and
used.
- Be
an Informed Consumer: Always check the ingredient list and
concentration of active ingredients in your cosmetics, especially if you
have sensitive skin or specific concerns.
- Professional
vs. OTC: This incident highlights the difference between
over-the-counter cosmetic products and professional-grade treatments.
Products with higher concentrations are often intended for controlled use
by professionals in clinical settings.
- Trust
in Regulation: While it might seem like a small detail, these
regulations are vital for maintaining standards in the beauty industry and
protecting public health.
This move by the CDSCO sends a clear message: compliance with safety and quality standards is non-negotiable. It reinforces the importance of knowing what you're putting on your skin and trusting that the products you use meet stringent regulatory requirements.
What are your thoughts on this cancellation? Has this
changed how you look at ingredient lists? Share your comments below!
