The Indian cosmetics market is governed by the Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020, which modernize previous regulations. These rules ensure the quality, safety, and standardization of cosmetics manufactured, imported, and sold in India.

Understanding the Regulatory Framework

Key Regulatory Authorities and Their Roles

• Drugs and Cosmetics Act, 1940, and Cosmetics Rules, 2020
  These form the core of cosmetic regulation in India, updating and superseding previous guidelines to align with international standards.
• Central Drugs Standard Control Organization (CDSCO)
  The CDSCO, under the Ministry of Health and Family Welfare (MoHFW), regulates cosmetics at the national level. The Drugs Controller General of India (DCGI) oversees amendments to regulations, grants import registration certificates and ensures compliance for cosmetic imports.
• State Licensing Authorities (SLAs)
  The SLAs implement the Act and Rules at the state level, issuing manufacturing licenses, conducting inspections, and monitoring compliance for domestic cosmetic manufacturers.
• Bureau of Indian Standards (BIS)
  While BIS is not a dedicated cosmetics regulatory body, it sets quality standards for specific cosmetic products, such as skin creams, hair dyes, and sunscreen. Compliance with BIS standards is mandatory for certain categories, while voluntary for others.

Key Regulatory Considerations for OTC Cosmetics

Definition of Cosmetics in India

According to the Drugs and Cosmetics Act, a cosmetic is any article intended to be rubbed, poured, sprinkled, sprayed, or applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.

Manufacturing License

• Companies manufacturing cosmetics in India must obtain a manufacturing license from the respective State Licensing Authority (SLA).

There are two types of manufacturing licenses:

1. 1. Own Premises License – For those manufacturing in their own facility.
   2. Loan License – For those using third-party manufacturing facilities.

Import Registration

• Any cosmetic imported into India must be registered with the CDSCO before being marketed.
• Registration covers pack size, variants, and manufacturing premises.
• No cosmetic can be imported unless registered under the Cosmetics Rules, 2020.

Quality and Safety Compliance

• All cosmetics (imported or manufactured in India) must comply with:
  • Ninth Schedule of the Cosmetics Rules, 2020.
  • Any other applicable Indian or international safety standards.

Navigating the Regulatory Pathway with Maven

Maven offers comprehensive regulatory support to help businesses navigate India’s evolving cosmetics landscape. Our services include:

Regulatory Compliance Support

Regulatory Overview & Product Classification – Identifying the correct regulatory         category and pathway for your product.
 Ingredient and Additive Compliance – Ensuring all ingredients meet Indian regulatory standards.
 Claims Review – Reviewing and substantiating product claims to comply with regulations.
 Labelling Review – Ensuring product labels align with CDSCO and BIS requirements.
 Product Registration/Notification – Managing the entire registration process for cosmetic products.

Market Entry & Strategic Support

Go-to-Market Services – End-to-end support for launching cosmetics in India.
Ongoing Compliance Assistance – Continuous monitoring of regulatory amendments for market continuity.

Maven’s team has global expertise in health authority regulations and specializes in product compliance, registration, and risk assessment across various cosmetic categories.

Challenges and Considerations

 Keeping Up with Amendments – The regulatory landscape is dynamic, and businesses must stay updated with changes in Cosmetics Rules, 2020.

 Ensuring Product Quality – Both manufacturers and importers must ensure compliance with Indian quality and safety standards.

 Proper Product Classification – Determining whether a product falls under "cosmetics" or "therapeutic" categories (e.g., medicated cosmetics) is critical, as misclassification may lead to regulatory challenges.

 Timeline for Approvals –

• Manufacturing licenses typically take 60-90 days for approval.
• Import registration certificates can take 6-9 months, depending on dossier       completeness.

Conclusion

Entering the Indian cosmetics market requires a strong regulatory strategy. Maven ensures a smooth pathway to compliance, allowing businesses to confidently launch and expand their cosmetic products in India.

With Maven’s expertise, you can navigate regulations efficiently, ensuring your cosmetic products are safe, effective, and market-ready for Indian consumers.