Regulatory Provision for Cosmetics Registration in India

Under the drugs and cosmetics Act definition - “A cosmetic refers to anything that is intended to be sprayed, rubbed, sprinkled and poured on or introduced or applied, to the human body or another part, for cleansing, promoting attractiveness, beautifying or changing the appearance. It also includes anything that is intended to be used as a component of cosmetics.”

The demand for cosmetic products has been rising at an increasing rate globally. Even in India, the demand for varied cosmetic products has been increasing at a faster rate because of several reasons like high income, good purchasing power of the middle class, the enhanced influence of western culture and the desire of people to look more attractive. But the cosmetic sector is under strict regulatory provision to ensure customers interest.

Cosmetic regulation in India

All the cosmetic products in India are under the control of Drugs and Cosmetics Act 1940 and 1945 and the labelling declarations proposed by the BIS. All the standards for cosmetics are set by BIS for products that are listed under schedule "S". Under the cosmetic regulation, there is a restriction on the use of cosmetics that contains dyes, pigments and colours along with lead and arsenic. Moreover, those cosmetics that contain mercury compounds are prohibited from manufacture as well as import.

Regulations regarding cosmetics registration in India:

All the cosmetic products that are to be imported for sale in India should be registered with the Central Drugs Standard Control Organisation (CDSCO), the licensing authority for these regulations. Registration was made mandatory to regulate illegal Cosmetic Import India

 by traders and restrict the sale of sub-standard cosmetic products.

Chapter III of the drug and cosmetic act deals with the import of drugs and cosmetics. However, the import of certain cosmetics is prohibited under section 10 of the act and rules 134A, 135, 135A of Drug and Cosmetic Rules 1945.

Some basic characteristics of such prohibited cosmetics are:

�-�       Any cosmetic of sub-standard quality

�-�       Any cosmetic that is mis-branded

�-�       Cosmetics whose import is banned by law or contains ingredients that are harmful or unsafe to use

�-�       Cosmetics which contain hexachlorophene, lead or arsenic as ingredients or any mercury compounds

These categories have been elaborated further in detail to specify the exact composition and content of ingredients.

 

The process of Cosmetic Registration in India

The trader with no manufacturing unit in India but an intention to sell his products by importing through some noted importers/ distributors in India, is required to get a registration certificate to market his products. For this, a registration application along with all required documents is required to be submitted to the Drugs Controller General, CDSCO in New Delhi.

Some of the documents needed include request letter by the applicant, form 42, proof of payment, power of attorney, original or copy of the label, marketing authorisation, manufacturing license, the detail specification of the product, test protocols, package inserts etc.

Pertaining to the complexity of the cosmetic registration process it is advised to get help from an authorized Pharma Regulatory Consultant India.

The registration certificate is issued within six months of putting up the application and remains valid for three years from the date of issue.

It is also important to note that the import of cosmetics is allowed in India only through specific ports as mentioned in rule 43A. These include Firozpur cantonment and Amritsar railway station. Ahmedabad, Chennai, Delhi, Hyderabad, Kolkata, and Mumbai by Air. Chennai, Kolkata, Mumbai, Cochin, NhavaSheva and Kandla by Sea route and Raxaul by Road/Railway lines connecting in India.

That concludes the complete process of cosmetic registration in India. Eventually, it is always better to seek the help of a professional consultant to evade the hassle involved in the process.

 

 

Author's Note

The registration certificate is issued within six months of putting up the application and remains valid for three years from the date of issue.