Navigating Indian Cosmetics Regulations: Essential Tips for New Brands

As of April 2023, India has become the most populous country in the world, surpassing China, with a population exceeding 1.44 billion. This growth presents significant economic opportunities, including an expanding cosmetics market. According to the report by Custom Market Insights, the Indian cosmetics market was valued at $8.1 billion (approximately ₹570 billion) in 2023 and is projected to reach $18.4 billion (around ₹1,300 billion) by 2032, with a compound annual growth rate (CAGR) of 3.2%. Key factors driving this growth include rising disposable incomes among the emerging middle class, increased product innovation, and a growing preference for organic cosmetics.

Regulatory Authorities for Cosmetics in India

To navigate the Indian cosmetics market, it’s essential to understand the regulatory framework. The main regulatory body is the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health & Family Welfare. The CDSCO is responsible for:

1. Import registration and licensing
2. Amending the Drugs & Cosmetics Act and Rules
3. Banning unsafe cosmetics
4. Oversight and market surveillance

Key Regulations Governing Cosmetics

There are three primary regulations that govern cosmetics in India:

1. The Drugs and Cosmetics Act, 1940: This foundational law establishes the basic framework for drug and cosmetic regulation in India.
2. The Drugs and Cosmetics Rules, 1945: These rules provide specific guidelines for implementing the 1940 Act.
3. The Cosmetics Rules, 2020: This regulation focuses specifically on cosmetics and outlines the latest compliance requirements.

Definitions of Cosmetics

India classifies cosmetics into two categories:

1. Cosmetics: Defined by the 1940 Act as any product intended for cleansing, beautifying, promoting attractiveness, or altering appearance.
2. New Cosmetics: According to the 2020 Rules, these are cosmetics containing novel ingredients not previously recognized for use in cosmetics globally.

Importing Cosmetics into India

To import cosmetics into India, follow these steps:

1. Import Process:
   • Apply for an Import Registration Certificate.
   • Obtain an Import Registration Number.
   • Import the products.

   For new cosmetics, you must secure an import license before importing.

2. Application for Import Registration Certificate:
   • This can be applied for by the manufacturer, an authorized Indian agent, or an Indian importer.
   • Submit your application online at the CDSCO website and provide the necessary information as per the Guidance Document on Common Submission Format for Import Registration of Cosmetics in India.
3. Import Registration Number:
   • This number can be applied for by the importer and requires details about the cosmetics and contact information.
4. Validity:
   • The Import Registration Certificate is valid indefinitely unless canceled, but a retention fee must be paid every five years.
   • The Import Registration Number is valid for three years.
5. Prohibited Cosmetics for Import:
   • Cosmetics tested on animals after November 12, 2014.
   • Products banned in their country of origin.
   • Cosmetics with a shelf life of less than six months.
   • Products containing hexachlorophene.

Managing Cosmetic Ingredients

The Bureau of Indian Standards (BIS) has established lists for cosmetic ingredients:

1. Positive List: Includes safe colorants and preservatives.
2. Negative List: Lists ingredients that are not allowed unless specific conditions are met.

Additional Regulations

1. Ban on Animal Testing: Since October 13, 2014, cosmetics tested on animals are prohibited for import.
2. Organic and Natural Certification: Consumers increasingly prefer eco-friendly products. The BIS has issued guidelines for natural and organic cosmetics based on international standards.

Conclusion

Understanding the regulatory landscape is crucial for foreign enterprises looking to enter the Indian cosmetics market. Familiarizing yourself with these regulations will help ensure a smooth import process.

Make your own COSMETICS BRAND with names and pictures

If you plan to do private label cosmetics products, please contact us. We are here to assist you step by step, and we can provide the necessary legal documents for your registration in India.

Reach out to us at [email protected].