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Imagine this scenario. You have cracked the formula for an Ayurvedic face serum. The packaging is amazing. Your ideal consumer base is right there waiting. But before you deliver a single package, the government wants to know who you are, where your product was manufactured, what goes into it, and whether it is safe for use by Indians.
This is where CDSCO steps in.
As a brand owner or entrepreneur, if you wish to manufacture skincare, hair care, oral care, and baby care products in India through private label or your manufacturing plant, the CDSCO regulations cannot be ignored. Hence, this is the basis on which everything stands.
Here’s a closer look at what that means.
What Is CDSCO and Why Does It Matter for Cosmetic Manufacturers?
CDSCO refers to the Central Drugs Standard Control Organization. They work under the Indian government’s Ministry of Health and Family Welfare and act as the main body regulating cosmetics and pharmaceuticals in India.
Cosmetic manufacturers in India have to seek approval from CDSCO before getting their products into the Indian market. It handles all issues related to imports, safety standards, and post-market regulations.
These three main laws regulate the cosmetic industry:
1) The Drugs and Cosmetics Act, 1940 — the original legislation covering manufacture, import, and sale
2) The Drugs and Cosmetics Rules, 1945 — procedural guidance on licensing, labeling, and compliance
3) The Cosmetics Rules, 2020 — a modernized framework introducing updated safety and manufacturing requirements
For your brand to comply with Indian regulations, all products must meet the above laws.
Who Regulates What? Understanding the Three-Authority Structure
The regulation of products in India is distributed among three authorities. It is important to know what each authority controls to avoid confusion.
- CDSCO (Central Authority)
Deals with imports and the regulatory regime at the national level. A Registration Certificate is mandatory for any cosmetic that has been imported.
- State Drug Control Authorities (SDCAs)
The SDCAs regulate cosmetics manufactured within India. They inspect manufacturing units, enforce good manufacturing practices, and keep an eye on all state-level activities. This regulation will be directly applicable to the cosmetic manufacturers in Punjab and other states.
- Bureau of Indian Standards (BIS)
BIS is responsible for developing and maintaining mandatory quality standards of specific categories of cosmetics, including things like creams, shampoos, and toothpaste. In case your product belongs to any such category of cosmetics that is mentioned in the Ninth Schedule of the Cosmetics Rules, you must meet these Indian Standards.
Labeling Requirements Under Rule 34: What Your Product Packaging Must Show
Rule 34 of the Cosmetics Rules, 2020 pertains to all aspects regarding your label. It’s a crucial area wherein many companies, especially start-ups, go wrong.
Labeling Requirements
All cosmetic products available in the Indian market shall have the following information on their labels:
- Name of the cosmetic
- Name and complete address of the manufacturer
- If the product is not made in the owner’s manufacturing plant, the name and location of the real manufacturer, along with the country of manufacture, should be indicated on the packaging
- Batch number or lot number
- Use-before date or date of expiry
- Manufacturing license number
- Registration Certificate number (for imported products) and the name and address of the RC holder
- List of ingredients from most concentrated to least concentrated
- Directions for use and cautionary statements where applicable
Here’s something a lot of brands overlook: you can’t put phrases like “Antiseptic,” “Antibacterial,” “Cellular Renewal,” or anything about “Treating diseases or disorders” on cosmetic labels. The CDSCO doesn’t allow these kinds of claims for cosmetics. If your label uses this language, they’ll just reject your application.
Also, every imported cosmetic has to meet Rule 34, sub-rule 9. That means your label needs to show the Registration Certificate number and the name and address of the RC holder before the product comes into India. No shortcuts.
GMP Compliance: The Standard Your Manufacturing Partner Must Meet
It doesn’t matter if you run your own production unit or partner up with a private-label manufacturer; Good Manufacturing Practices aren’t optional. The Cosmetics Rules, 2020, make it clear: every facility must follow GMP standards that match what’s accepted worldwide.
ISO 22716 sets the global standard for cosmetic GMP. It’s what everyone looks to for rules about production, control, storage, and shipping. The standard covers everything from personnel and technology to handling raw materials, quality checks, and even admin work. India’s rules stick closely to this international model.
This would mean that your manufacturing partner should:
1) Have well-maintained and organized facilities that have well-defined SOPs
2) Carry out batch testing and keep batch records either in paper form or electronically
3) Utilize competent technical staff
4) Adopt quality management systems that can stand up to regulatory inspection
Safety Testing: What You Need to Submit
Safety assessments and lab tests on cosmetics made in India are necessary to be performed in either the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratories or CDSCO-approved labs. The important tests include:
- Toxicity test on ingredients
- Microbiological test
- Stability testing
- Dermatological safety assessments
- Heavy metal testing – The Cosmetics Rules state that there should be a declaration stating adherence to limits of heavy metals such as Lead (Pb), Arsenic (As), and Mercury (Hg)
Animal experimentation for cosmetics is also banned in India in accordance with global standards. All imported products should have a declaration stating that they were not tested on any animal.
What Changed with the Cosmetics Rules, 2020?
The 2020 Rules were a major revision. Before the 2020 Rules, cosmetic products had been governed by the same set of guidelines as drugs, leading to a lack of clarity. The new regulations brought about various changes in the cosmetic manufacturing industry in India:
1) Complete segregation of cosmetics regulations from drug regulations
2) Simplified licensing procedures through the online SUGAM portal
3) More stringent safety assessments
4) Compulsory GMP regulations
6) Post-marketing surveillance procedures
Recently, the Cosmetics (Amendment) Rules, 2025, have brought about more modifications, which include better terminology on labels, improved record-keeping standards, requirements for batch records (including ingredients and test data), and a new clause on license suspension/cancellation, along with an option for appeal before the State Government within 90 days.
What This Means If You Want to Launch Your Brand
If you are a cosmetic manufacturer in Punjab or any other state who wants to introduce a skincare, haircare, Ayurvedic, or baby care product into the Indian market, this is how the regulatory structure will impact your business:
Product Manufactured in India: Your manufacturer should be licensed under the State Licensing Authority and should have GMP facilities, along with access to NABL-accredited laboratories.
Product Imported into India: You should have the import certificate from the CDSCO. Missing data about the safety of ingredients is the main cause for rejection of import registration forms.
In Case of Use of Private Label/White Label Manufacturing: Ensure that the manufacturing companies are properly licensed and have full knowledge of their regulations. Request GMP certification and license details before starting business negotiations.
Positive Development: The Indian cosmetic regulations are gradually becoming closer to ASEAN and EU cosmetics regulations. Hence, if your manufacturer is compliant with CDSCO rules, it makes things easier for you, too!
Start Your Own Brand with Cizy Biocare
Creating a compliant, ready-to-market cosmetic brand in India need not be a daunting task for anyone. This is because, at Cizy Biocare, we handle the manufacturing aspect, which includes creating Ayurvedic formulas and private-labeling cosmetics for skin, hair, oral, and baby care products.
If you are new to the industry or are already operating a wellness business and want to grow your product range, then the regulatory information provided above should be exactly the foundation of our collaboration.
Frequently Asked Questions
Q1. What is Rule 34 of the Cosmetics Rules?
Rule 34 under the Cosmetics Rules, 2020, deals with labeling requirements for cosmetic products available in India. The rule highlights the information that needs to be provided on the label of the product, like its batch number, expiry date, manufacturing details, ingredients used, and for imported products, the Registration Certificate number.
Q2) What is the 1% rule in skincare?
1% rule is an ingredient labeling law. All ingredients above 1% must appear on the product packaging from highest to lowest. Ingredients less than 1% can be listed in any order below those above 1%.
Q3) What is the 60-second rule in skincare?
The 60-second rule does not have anything to do with any rules or regulations, but it is related to a method used in skin care. This rule means that you need to wash your face using your fingertips for 60 seconds using a gentle cleanser.
Q4) What is the ISO guideline for cosmetics?
The ISO 22716 standard is the international Good Manufacturing Practices (GMP) for cosmetics. It deals with manufacturing, controlling, storing, and distributing cosmetics. The ISO 22716 standard was developed jointly by the USA, Europe, Canada, and Japan in 2007 to regulate the manufacturing of cosmetics.
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