Modernization Of Cosmetics Regulation Act (MoCRA) In India [Complete Guide]

MoCRA (Modernization of Cosmetics Regulation Act) signals a new era of cosmetics regulation in India. Although it is called MoCRA, and draws its structure from US legislation, India also has its own reform with the Cosmetics Rules, 2020. which, under the Drugs and Cosmetics Act, The Modernization of Cosmetics Regulation Act was implemented in India to ensure clarity and consistency as part of the 2020 Cosmetics Rules. The objective of such rules is to enhance the safety, clarity, and consistency in cosmetic regulations that align with global regulatory approaches. In 1940, India had some regulations on cosmetics in India and aligned Indian cosmetics regulations with best practices globally.

In this complete report, we will look at what MoCRA is, why it was enacted, what businesses will have to comply with it, when it was enacted, how businesses can prepare for it, and what the benefits are for businesses selling cosmetics in India.

What Is the Modernization Of Cosmetics Regulation Act (MoCRA)?

As the title implies, and for the sake of brevity in the future, the Modernization of Cosmetics Regulation Act (MoCRA) could be defined as the modernization of the regulatory standards and practices concerning cosmetics for safety, consumer protection, and performance with respect to international regulations. The original MoCRA came into effect in the USA in 2022; however, the term MoCRA is becoming most associated with the reform efforts in India related to the new Cosmetics Rules, 2020, under the Drugs and Cosmetics Act, 1940.

Why Was MoCRA Introduced In India?

The Modernization of Cosmetics Regulation Act was enacted in India to ensure clarification and consistency with the 2020 Cosmetics Rules. The goals of such rules are to further improve safety, clarity, and consistency with the regulation of cosmetics with international regulatory approaches.

Who Must Comply With The Modernization Of Cosmetics Regulation Act?

According to the Modernization of Cosmetic Regulations Act, anyone associated with the manufacturing or sale of cosmetic products must comply with this Act. The following entities are: 

• Importers of Cosmetic Products: Foreign brands and their Indian distributors must register all products before importing.
• Manufacturers of Cosmetic Products in India: All Indian manufacturers of cosmetic products are required to have a valid cosmetic Manufacturing License or Loan License that is under the new COS forms. 
• Third-Party / Loan License Holders: All indenture holders who are manufacturing on behalf of the brand must comply with all of the MoCRA obligations. 
• Distributors / Stockists: Distributors must ensure that they are only storing and distributing licensed, labelled products as per the rules. 
• E-commerce / Online cosmetic sellers: E-commerce platforms such as Amazon and D2C brands will have obligations to ensure products comply with labelling and registering products.

Timeline And Compliance Deadlines

The Cosmetics Rules, 2020, were officially notified on 15th December 2020, and full compliance became mandatory soon after.

Date / Period	Event / Requirement
December 15, 2020	Cosmetics Rules, 2020, were officially notified and enforced.
2021	Introduction of new COS forms for import/manufacturing/loan licenses.
2022	Mandatory use of the SUGAM portal for all license and registration applications.
2023–2024	Full enforcement: product safety checks, labeling audits, and surveillance increased.
Every 5 Years	License validity period, renewal required before expiration.
At least 6 months before the license expiry	Recommended time to apply for license renewal.
Before product launch	Mandatory safety testing through CDSCO-approved laboratories.
Ongoing	Adverse event reporting and labeling compliance must be maintained at all times.

How To Prepare For MoCRA Compliance?

A few steps will ensure businesses comply with the Modernization of Cosmetics Regulation Act (MoCRA) in India (Cosmetics Rules, 2020), and it is a very simple process that is done in this sequence: 

• Classify Your Product: First, you need to verify that your product is not a drug or Ayurvedic product and is really a cosmetic.
• Use the SUGAM Portal: There is one entry point for every entry, application, and tracking approvals.
• Sequence of Compliance: You will need to have the following mandatory disclosures: the name of the product, expiry date (or shelf life), ingredients components, batch number, Labels of proposed products,  List of machinery and equipment.
• Test Your Product: You will need to use an accredited laboratory approved by the CDSCO. 
• Report Adverse Effects: Create a mechanism in your business to include a report on any adverse effects and medication effects reported from your products.
• Retain Documents: You will need a Product Information File (PIF) for your products — a record of the safety and manufacturing documents.

Benefits Of MoCRA For Brands

The Modernization of Cosmetics Regulation Act (MoCRA) provides many advantages for cosmetic companies in India & other countries like the USA, etc. 

• Increased Customer Confidence: Cosmetics that are labelled appropriately and transparent as it pertains to safety testing and practice will build confidence from a customer standpoint. 
• Faster Delivery to Market: Online licensing at the SUGAM portal will bring quicker approvals.
• Greater International Competitiveness: Following many internationally accepted standards, it also helps with exporting our goods and the ability to partner.
• Greatly Positively Effects Brand Image: Ethical practices, such as the animal testing ban, will be appealing to ethically conscience consumers.
• Reduced Liability Exposure: Clarified regulations will reduce the chances of going through a recall and regulatory issues, as well as being fined, etc.
• More Opportunity for Innovation: Modernizing the rules gives cosmetic companies a leg-up to increase their ability to legally and safely create a variety of enhanced cosmetic items for our consumers.

Need Help With MoCRA Compliance?

Compliance with MoCRA can be arduous. Don’t risk delays, denials, and penalties using incomplete or incentive compliance solutions. ELT Corporate Pvt. Ltd. can assist with:

• CDSCO license applications
• Formal documentation and labeling
• Product testing and approvals
• Timely renewals and updates

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