CDSCO Registration Document Checklist for Pre-Screening of Application

With a sizable market for cosmetic and personal care products, India’s cosmetic & drug business is expanding quickly. CDSCO Registration for cosmetic imports includes two levels of assessment. The first is the application, and the second is document assessment, also known as pre-screening. The Central Drug Standard Control Organization^[1] scrutinises your application and documents. The core of its assessment is the correctness of the documents you submitted. This blog provides you with a CDSCO Registration Document Checklist for pre-screening of applications.

CDSCO Registration Document Checklist: Role and Responsibilities of CDSCO

The central authorities approve new drugs, conduct clinical trials in the nation, establish drug standards, monitor the quality of imported drugs, coordinate state drug control organisations’ efforts, and offer professional advice to ensure consistency in the application of the Drugs & Cosmetics Act. On the other hand, the state authority is in charge of regulating drug production, sale, and distribution. They do this by issuing licences to laboratories that test for drugs, approving drug formulations for production, conducting pre- and post-licensing inspections, and monitoring the production process for drugs produced by specific state units and those markets in the state. The Drug and Cosmetics Act & Rule established these powers.

Functions undertaken by the Central Authority (CA) can be summarised as follows:

1. Laying down standards of cosmetics, drugs, diagnostics & devices.
2. To regulate market authorisation of the new drugs.
3. Laying down regulatory measures and amendments to Acts & Rules.
4. To regulate clinical research in India.
5. To regulate the students of imported drugs.
6. To approve licenses to manufacture specific categories of drugs as central License approving Authority, i.e. for Blood Banks, large volume pre-enteral & vaccines and sera.
7. Testing of drugs through the Central Drugs Laboratory.
8. Works relating to the Drugs Technical Advisory Board (DTAB) & Drugs Consultative Committee (DCC).
9. Publication of Indian Pharmacopeia.

Functions undertaken by the state authority can be summarised as follows:

1. Licensing of drugs manufacturing & sales establishments;
2. Approval of drugs formulations for manufacture;
3. Investigation & Prosecution in respect of a contravention of legal provisions;
4. Pre & post licensing inspection;
5. Administrative actions;
6. Monitoring of quality of drugs and cosmetics manufactured through respective state units & those marketed in the state.
7. Licensing of drugs testing laboratories.
8. Recall sub-standard drugs.

CDSCO Registration Document Checklist

Following is the CDSCO Registration Document Checklist for Grant of Registration Certificate in Form under the Provisions of Drugs & Cosmetics Rules:

• Covering Letter: It should entail your purpose behind applying CDSCO Registration Certificate. You must be clear, concise, and convincing when drafting this document.

•  Application Form

1. Duly filed, stamped and signed the original application through the Manufacturer/ importer/ Indian Agent.
2. The details of the cosmetic product include product name, product variant, actual manufacturer details, and the categorisation of the product.
3. Name of your authorised Agent, applying on your behalf.
4. Name & Address of the factory premises.

•  Fee: TR-6 Challan: You need to provide this specifying the fees for CDSCO Registration. Don’t deposit this vital document in case your challan does not have the following:

1. Bank’s Stamp;
2. Address of the manufacturing premises;
3. Name of the product;
4. Head of the fee information.

Note: The categories of applied products & manufacturer’s name shall be mentioned in TR6 Challan.

• Power of Attorney

1. Name & Address of the Indian Agent
2. Name & Address of the manufacturer and its manufacturing site according to Form;
3. Name of product, variants (if any), and the product’s actual manufacturer to be registered. The categorisation of the products should be according to Column 3 of the cosmetics guidelines.
4. Duly conjointly signed, stamped, and dated with the name & designation of the signatory by both the Indian Agent & the manufacturer.
5. The period for which POA is valid must be mentioned in a power of attorney.

Note: All the pages of power of attorney, including the list of products duly apostilled or notarised and authenticated through the country of origin, or it should be the tamper-proof seal.

• Labels of Proposed products: Legible label of the product circulated in the origin country. Legible original label for proposed products and their variants (in case any) according to Drugs & Cosmetics Rules, 1945, which includes the following:

1. Name of Products;
2. Name of manufacturer & Address of the location where the products are manufactured.
3. Direction for safe use or Caution;
4. Use Before;
5. Batch No.
6. Registration Number and Name & Address of Importer;
7. Manufacturing License no.
8. Other details (if any);
9. List of Ingredients with information of concentration of all ingredient used in the product composition duly signed through competent QC person by the manufacturer.

• Regulatory Certificates :

1. Authenticated copy of manufacturing licenses or registration or marketing authorisation in respect of applied products granted through regulatory Authority from a country of origin.
2. In case it is not issued by National Regulatory Authority by the country of origin. Other competent organisations or Associations duly authenticated from the Indian embassy of the country of origin must be submitted.
3. Original Free Sale Certificate (FSC) issued through the National Regulatory Authority of Country of origin for the applied products.

• Chemical Details of Products:

1. Test protocol for testing cosmetics
2. Specification
3. Test report including the result of Pb, As, Hg & microbiological test. (Wherever applicable)

Note Testing protocol, Specification and Test Report duly signed by a competent QC person from the manufacturer.

• Plant Master File;
• Master File;
• Copy of the valid License: Copy of valid Wholesale or Manufacturing License for the Indian Origin manufacturer.
• Product Registration Certificate;
• Pack insert (in case any);
• Soft copies of the details (MS Word and MS Excel) about product name & category, pack size and actual manufacturing premises;
• List of countries where market authorisation/ import permission or registration was granted;
• One product sample pack shall be submitted after its first import;
• Other documents (in case any).

Note: These are essential CDSCO Registration Document Checklist which are compulsory to submit for Pre-Screening of Application.

Conclusion

There should be rules to guarantee the high quality, safety, and efficacy of cosmetics imported into India. Imports of cosmetics are subject to two levels of examination under CDSCO Registration. Pre-screening, also known as CDSCO Registration Document Checklist, comes first. The Central Drug Standard Control Organization examines your application and supporting documentation at this stage.

Read our Article:Documents needed for CDSCO Loan License