How recent Regulatory changes will impact Cosmetics Registration in India?

Cosmetic items fall under the purview of the Ministry of Health and Family Welfare in India. The overarching Drug and Cosmetics Act 1940 and the Rules 1945 (last amended on 01.12.2016) regulate the drug and cosmetic industry.

Who regulates the cosmetic segment?

Cosmetics specifically are regulated by the Central Drug Standard Control Organization (CDSCO) while the guidelines on standards for ingredient usage in cosmetics is issued by Bureau of Indian Standards (BIS).

According to the law, with effect from 1st April 2013, all cosmetics imported into India must be registered. The registration is done with Drug Controller General of India (DCGI).

We specialize in helping cosmetic importers gain registration in India.

Domestic cosmetics do not need to be registered although, the manufacturing facilities must be audited as per guidelines.

What is “import” of cosmetics?

There are 2 main conditions under which cosmetics are imported:

1. Directly imported from a foreign manufacturer to be sold in India (either by an Indian entity like a trader or a subsidiary of the foreign manufacturer)
2. Indian trader or manufacturer who gets the cosmetic item manufactured abroad for the sole purpose of importing and selling it in India

In both the cases, the cosmetic “brand” must be registered. The government has listed 28 cosmetics which need to conform to Indian standards before being registered.

To know more about the registration process, connect with us.

What is the meaning of “brand” in cosmetic registration?

To register any imported cosmetic, the product is seen as a brand. A brand encompasses all the variants like pack sizes, shades, colors etc.

For example: You have a shampoo that comes in 5 flavors each having different color packs. The product is packaged and sold in 50 ml, 100 ml and 200 ml containers. All of them together will comprise a single brand from the perspective of registration.

This helps applicants like you to file a unified application and streamlines the process.

The certificate is valid for 3 year unless re-registered. Also, it is mandatory to print the registration number on the labels.

We will discuss more on labels in an upcoming blog post.

What is the objective of registration of imported cosmetics?

The Indian regulatory system has 5 key objectives for enforcing registration of imported cosmetics.

1. Consumer protection and safety. This is enforced through a stringent set of guidelines for labelling and declaring specific details like license, manufacturer name and ingredients
2. To restrict the sale of any item that has been banned elsewhere in the world (country of origin of the product). To protect from dumping of such goods into the Indian market
3. To monitor the content of heavy metals, especially lead, arsenic and compounds of mercury in the cosmetic products. Cosmetics with hexachlorophene are prohibited from sales.
4. To monitor and restrict sales of misbranded products including those which declare incorrect ingredients in their labels. Items without “use before” or “use by” dates are prohibited too.
5. To weed out spurious products or “fakes” which are made and sold at a lower price to the gullible consumers by the retailers

The Drug and Cosmetic Rules are undergoing further amendments as per notification dated 26.02.2019. There are 71 articles mentioned in it.

We are monitoring the changes suggested and the implications for manufacturers and importers. Please follow our blog as we will be discussing the impact in our future blog posts.