一、CDSCO的介绍        

CDSCO（Central Drugs Standard Control Organization&中央药品标准控制组织）It belongs to the Directorate General of Health Services under the Ministry of Health and Family Welfare of the Government of India and is the national regulatory authority of India. CDSCO is a licensing authority responsible for issuing import licenses for drugs, medical devices, and cosmetics imported into India, with its headquarters in New Delhi.

Explanation of the Attributes of CDSCO Certification in India

II. The responsibilities of CDSCO include:

1. Approving new drugs and clinical trials;

2. Implementing CDSCO registration and licensing (cosmetics, pharmaceuticals, and medical devices);

3. Licensing blood banks, vaccines, and certain medical devices;

4. Revising the Pharmaceuticals and Cosmetics Act and regulations;

5. Participating in the World Health Organization's GMP accreditation program;

6. Granting testing licenses, individual licenses, and NOC export licenses;

7. Conducting drug testing in central laboratories.

III. How to Obtain Indian CDSCO Cosmetic Certification?

Step 1: Determine if your imported product falls within the certification scope.

All cosmetics "imported" for "sale and distribution in India" are included. The Indian Cosmetic Act provides a broad definition of cosmetics: any article used to wipe, pour, spray, or dab, introduce, or otherwise apply to the human body or any part thereof for cleansing, beautifying, enhancing attractiveness, or altering appearance, including any used as a component of cosmetics.

Step 2: Manufacturer Appoints Indian Representative

Indian law requires foreign manufacturers to have an authorized Indian representative company to handle all certification applications. This authorized representative company does not necessarily have to be affiliated with the manufacturer; it can be their Indian agent, responsible for participating in the application process and reporting on market activities.

Step 3: Applicant Submits Relevant Documents According to Form-Cos-1

When submitting the certification application, the application fee and a commitment letter in Schedule-II format must also be paid. The following documents are required:

1) Covering letter by the applicant;

2) Form-Cos-1 (Applicant Information Form);

3) Treasury Challan (Payment Record);

4) Power of Attorney (Authorization Letter);

5) Schedule II (Commitment Letter);

6) Original or copy of the Label;

7) Free Sale Certificate (FSC) / Marketing Authorization letter / Manufacturing license, if any;

8) Product specification and testing protocol;

9) List of countries where market authorization, import permission, or registration was granted;

10) Pack insert, if any, instruction manual;

11) Soft copies of the information about the brands, products, and manufacturer (electronic version). Step 4: Obtaining Certificate Form-Cos-2

After submitting all relevant documents, the CDSCO system will directly contact the Indian representative and issue the first clarification letter. Upon receiving a response, CDSCO will decide whether a second clarification is necessary. One applicant can import cosmetics from one manufacturer, across multiple brands and countries of origin, using a single certificate.

Step 5: Tracking and Reporting in the Indian Market

After obtaining the certificate and import permit, the products can be imported into India. If there are any changes in the import situation, or if product recalls or adverse events occur, the local Indian representative must promptly and truthfully report to the Central Drug Administration.

IV. What information must be included on the labels of imported cosmetics entering India?

1) Name and Address of the actual manufacturer;

2) Name of the country where the product has been manufactured;

3) Use Before;

4) Directions for Safe Use/Caution;

5) Batch No.;

6) Manufacturing License No. (If any);

7) Registration Certificate No. (India CDSCO Certificate Number)

V. Costs and Processing Time for CDSCO Certification Application for Cosmetics

CDSCO fees vary depending on the type of cosmetic product.

For a detailed fee schedule, please contact the professional engineer at Weitest responsible for CDSCO certification.

VI. Why Choose Microchip Testing? What are the advantages of Microchip Testing?

1) Direct cooperation with CDSCO, resulting in a 40% cost reduction compared to traditional subcontracting models used by other organizations in the market;

2) 5 years of experience in CDSCO cosmetic registration, experts in resolving CDSCO certification issues;

3) We have a wholly-owned subsidiary in India, with a representative solution office in New Delhi;

4) We provide a complete set of document templates, ensuring speed, convenience, and high efficiency.