Recent years have seen a huge growth in the beauty and healthcare industries. This has also resulted in a surge in cosmetics exports from India. There are several natural remedies for various skin problems and issues that can be found in Ayurveda, which originated in India. With the global trend towards wellness and beauty, taking a more holistic and natural stance, Ayurveda has been gaining popularity in the west. The Drugs and Cosmetics Act of 1940 helps the government regulate the sale of cosmetics inside India and abroad. Exporters need to file Form 43 if they wish to import cosmetics to India. Let us now take a look at Form 43-1, and why it is mandatory.
Introduction
Cosmetics are any items that are applied, rubbed, sprinkled, sprayed, poured, or introduced to any part of the human body to beautify, clean, or alter one’s appearance. This is the formal definition as specified by Section 3aaa of the Drugs and Cosmetics Act, 1940. Additionally, any ingredient or component used as a part of a cosmetic also falls under this broad definition. The vast interlinking of countries and continents due to advanced transportation has led to India gaining access to such products worldwide. Hence, in recent years we have witnessed an influx of such cosmetic products from all over the world.
Are Cosmetics Regulated in India?
Yes, like with all other products used directly by Indian citizens, the import of cosmetics to India is regulated by the government. These regulations fall under the Drugs and Cosmetic Rules, 1945 and the Act of 1940. The regulations regarding the import of cosmetics may be found in Gazette Notification 426E. Since Indians apply these cosmetics directly on their skin or hair, they must regulate and control to ensure that they are safe and hygienic. Hence, such products must undergo rigorous quality checks and assurance at every stage of production. Consumers’ safety depends on such quality checks, prompting the government to regulate their import and use within the country.
Who Handles the Regulation for the Import of Cosmetics into India?
The Central Drugs Standard Control Organization (CDSCO) website has a copy of Gazette Notification GSR 426 (E), which details the process of importing cosmetics into India. The website also features a copy of the Drugs and Cosmetics Act and Rules to help exporters and importers understand the guidelines they must follow. The following organisation helps regulate the import of cosmetics in India.
Drugs Controller General
CDSCO HQ,
Directorate General of Health Services,
Ministry of Health and Family Welfare,
FDA Bhawan, ITO,
Kotla Road,
New Delhi -110002.
What is Form 43 for the Import of Cosmetics?
Individuals or companies who wish to import cosmetics into India must first register with the CDSCO. The application for registration occurs via Form 42, and the registration certificate will be issued as Form 43. Hence, while Form 42 serves as an application form for registration, Form 43-1 serves as the registration certificate that enables companies to import cosmetics into India. Moreover, the following individuals can apply for a registration certificate and carry out the import of cosmetics in India.
- Manufacturers
- Authorised agents of manufacturers
- Subsidiaries of manufacturers
Individuals must send their registration applications to the Drugs Controller General of India, whose address has been mentioned above. Applicants will also have to pay a processing fee amounting to 250 USD for each category of cosmetics. This processing fee must be paid when applicants file Form 42. The payment may be done with the help of challans to designated branches either in USD or INR. Moreover, the challans must pay to Bank of Baroda branches under Head of Account 0210 – Medical and Public Health, 04 Public Health, 104 Fees and Fines. Applicants can also make the payment online through the SUGAM portal using the Bharatkosh payment gateway. After online payment, the applicants must submit a copy of the challan or acknowledgement slip along with their application.
Documents Required for Form 43
- Covering letter containing details of products, category, and manufacturer
- Power Of attorney authenticated before an Indian Magistrate (First Class), Indian Embassy, or Apostille
- Duly filled Form 42
- The categorisation of the cosmetic product as per Column 3 of Registration Guidelines for Import of Cosmetics
- Letter of Authorisation if the manufacture of products occurs outside India
- Duly filled Schedule D III
- List of Ingredients and composition used in the product
- Labels of proposed products
- Specification and testing methodology used
- Manufacturing licenses from the country of origin.
- Free sale certificate
- Non-animal testing declaration
- Declaration regarding heavy metal and hexachlorophene content
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Things to Know About Form 43
- According to Rule 129C of the Drugs and Cosmetics Rules, 1945, if the application is complete, then the authority will issue a registration certificate within six months.
- However, in certain exceptional circumstances, the certificate may issue in three months after recording the reasons for it in writing. This is in accordance with the timeline that targets by the CDSCO, which is 90 days.
- Form 43 for the import of cosmetics, once issued, remains valid for three years from the issuance date. However, applicants must submit a fresh application if there is any change to the following; the legal constitution of the manufacturer, company name, company address; whereas changes regarding Indian agents are minor and do not require a fresh application.
- In case the exporter wishes to register additional products in their Form 43, they may do so by applying for the endorsement of their existing certificate. They will also have to provide the supporting documents and pay the required processing fees for the same. Moreover, the validity of such an endorsement will be the same as the principal registration certificate.
- Suppose an application for a fresh certificate is not for at least six months before the expiry of the existing certificate. In that case, it will remain in force until orders pass regarding the application.
Conclusion
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Read more,
- What Do I Need to Know Before Exporting?
- Which Are the Documents Required for Import in India?
- What Is the Purpose of an Export Certificate?
