CDSCO is the primary regulatory body for drugs and cosmetics in India. This agency operates under the Ministry of Health and Family Welfare. The CDSCO Form 10 is important when seeking an import license for drugs to ensure that applicants possess a valid license for wholesale or manufacture. Thus, it is ensured that only genuine entities will import pharmaceutical products to India.

Understanding CDSCO (Central Drugs Standard Control Organization)?

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory authority operating under the Ministry of Health and Family Welfare for pharmaceuticals, medical devices, and cosmetics. CDSCO's major responsibilities are:

• Approving New Drugs: It checks for safety and effectiveness before marketing by evaluating the new drugs.
• Conduct of Clinical Trials: Regulating these clinical trials to observe whether they are complying or not with the ethical and safety standards.
• Quality Control: Monitoring the quality of imported drugs and coordinating with the state drug control organizations.
• Licensing: They issue licenses for blood products, vaccines, and sera, categories that are considered crucial.

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What is Central Drugs Standard Control Organization (Form 10)?

The CDSCO Form 10 is an import license issued by the Central Drugs Standard Control Organization of India, which authorizes the import of drugs and cosmetics. It ensures drugs and cosmetics imported through this license adhere to the requisite regulatory standards and quality requirements. For this import license, forms are submitted through the SUGAM portal of the CDSCO, including Forms 8 (the application), Form 9 (under the undertaking by the importer), and Power of Attorney. This license is important for legal compliance, assuring safe and effective importation of products for consumer use. This demonstrates India's strong stance on holding health and consumer goods up to very high standards.

Importance of CDSCO (Form 10)

• Regulatory Compliance: It ensures compliance with CDSCO's regulatory standards for the drugs and cosmetics imported to comply legally.
• Quality assurance: It ensures that the imported products retain the quality standards to maintain consumer health.
• Safety standards: It ensures the safety of products for usage to prevent the Indian market from admission of harmful or low-quality products.
• Market access: It provides a window for importing and selling drugs and cosmetics through legal ports in India to open the market for businesses.
• Public Health Protection: Proving that only appropriately approved and harmless merchandise will be present in the market for consumers' use.
• Transparency and Trust: Ensures confidence for the consumer to purchase products because they have been carefully scrutinized by legitimate regulatory authorities.

Read Our Blog: Understanding CDSCO Form 27 and the CDSCO MD-12 Test License

Eligibility criteria of CDSCO Form 10 application

The following criteria must be met to be eligible to apply for CDSCO Form 10, which is the Import License for drugs and cosmetics:

• Manufacturer or Authorized Agent: The application can be submitted by the manufacturer with a valid wholesale license, or by an authorized agent in India who also holds a valid wholesale license under the Drugs and Cosmetics Rules, 1945.
• Power of attorney: It must be executed and attested either in India or the country of origin, authenticated by the Indian Embassy.
• Wholesale License: The Indian agent or manufacturer must hold a valid wholesale license as per Rule 24A of the Drugs and Cosmetics Rules.
• Registration Certificate: A registration certificate for the drug or cosmetic product (Form 41).
• Indian Standards Compliance: The products should comply with specified Indian Standards and carry the Standard Mark issued by the BIS.
• Submission of Required Documents: The application shall contain Form 8 (application for grant or renewal of a license), Form 9 (undertaking by the importer), and other required documents, including the proposed draft label/package insert where applicable

Read Our Blog: CDSCO Form 8: Import License for Drugs in India

Application Procedure of CDSCO Form 10 

• Register on the CDSCO SUGAM Portal: First, open an account on the CDSCO SUGAM portal. Fill up the registration form, and then confirm your email to complete your registration.
• Prepare Documents: The list of documents required includes

1. Form 8: Import license application
2. Form 9: Undertaking accompanying the application
3. Form 41: Registration Certificate for device to be introduced
4. Power of Attorney: With consent of Power of Attorney so that any agent can act on your behalf.
5. Wholesale License: Valid license for the sale or distribution of drugs.
6. Such other relevant documents as required.

• Online Application Submission: Simply log in to the SUGAM portal and submit your application along with all prepared documents.
• Fee Payment: Pay through the online payment gateway.
• Review Process: CDSCO will review your application. If needed, it can also request additional information.
• Inspection: Be ready for an inspection of the manufacturing facility or importer's premises by CDSCO people.
• Approval: If approval is accorded, download the Import License (Form 10) from the SUGAM portal and be well-compliant with other regulations covering importation.

Conclusion

The CDSCO Form 10 is an integral part of India's regulatory requirement for the importation of drugs and cosmetics. Thereby, only qualified manufacturers and authorized agents are allowed for the importation of such products to ensure standards of the highest safety and quality in the market. The application process on the CDSCO SUGAM portal provides streamlined submissions and enhanced transparency. Through the eligibility criteria and the procedures outlined to follow, applicants can gain the mandatory license to legitimize and sustain operations within India's pharmaceutical landscape toward the protection of public health and consumer trust in imported goods.