What is the Detailed Procedure to Import Biological Products in India?

Author : CliniExperts Pvt Ltd | Published On : 05 Apr 2024

The detailed procedure to import biological products in India involves several steps and adherence to regulatory requirements. The process involves interactions with the Central Drugs Standard Control Organization (CDSCO) and other regulatory authorities. Here is a general outline of the procedure:

1. Determine Regulatory Classification:

   Identify the regulatory category of the biological product. Different classes of biological products may have specific requirements, and understanding the classification is crucial for the import process.

2. Appoint an Authorized Agent:

   Overseas manufacturers are typically required to appoint an authorized agent in India. The authorized agent should possess a valid import license under Form 20B and 21B.

3. Preparation of Documents:

   Gather necessary documents, including but not limited to:

   - Covering letter

   - Registration certificate of the manufacturing site

   - Power of Attorney for the authorized agent

   - Undertakings specified in Schedule D-I and D-II

   - Information on the manufacturing process and formulation details

   - Stability data

   - Clinical trial data (if applicable)

   - Importer's license

   - Manufacturing license of the product

4. Submission of Application:

   Submit the application for a Biological Registration Certificate to the CDSCO. The application is usually filed through the Common Integrated Online Platform (CDSCO-CIOP).

5. Review and Approval:

   The CDSCO reviews the application, including the submitted documents. They assess the product's safety, efficacy, and compliance with regulatory standards. If the application meets the requirements, the CDSCO may grant the Biological Registration Certificate.

6. Import License:

   After obtaining the Biological Registration Certificate, apply for an import license under Form 10 for each consignment.

7. Customs Clearance:

   Once the import license is granted, the biological products can be imported into India. Ensure compliance with customs regulations for clearance.

8. Post-Market Surveillance:

   After the products are in the market, companies are typically required to monitor and report adverse events through pharmacovigilance activities.

Please note that the above steps provide a general overview, and the specific requirements may vary depending on the nature of the biological product and any updates to regulations. It is highly recommended to consult with regulatory experts or legal professionals familiar with the latest guidelines and procedures in India.