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Documents Required for CDSCO Loan License

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Documents Required for CDSCO Loan License

Introduction

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services and the Ministry of Health and Family Welfare of India, plays a pivotal role in the Indian pharmaceutical and medical device sectors. Established in accordance with the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, CDSCO is entrusted with the approval of new drugs, clinical trials, and the regulation of drug and cosmetic quality standards in India. This article aims to provide an in-depth understanding of the documents needed for obtaining a CDSCO Loan License, a critical component for those looking to operate in the pharmaceutical and medical device industry in India.

Table of Contents

What is a CDSCO Loan License?

Required Documents for CDSCO Loan License

Documents Needed for Formulations of CDSCO Loan License

Agencies Responsible for Approving CDSCO Loan Licenses

Application Procedure

Conclusion

What is a CDSCO Loan License?

A CDSCO Loan License is issued to applicants who do not have their own manufacturing facilities but intend to utilize available manufacturing capacities. According to the Drug and Cosmetic Act of 1940 and the Medical Devices Rules (MDR) 2017, manufacturers lacking sterilization facilities must obtain a loan license under specific conditions:

Form MD-6: For the manufacture, sale, and distribution of Class A or Class B medical devices.

Form MD-10: For the manufacture, sale, and distribution of Class C medical devices.

Required Documents for CDSCO Loan License

To obtain a CDSCO Loan License under Forms 25-A, 28-A, and 32-A, the following documents are required:

Cover Letter: A formal letter detailing the purpose of the application.

Challan for Required Amount: As per the Head of Account's instructions.

Relevant Statutory Forms: All necessary forms completed and signed.

Fees: Applicable statutory fees must be paid.

Declaration: Information about each proprietor, partner, and director of the company, provided under affidavit.

Partnership Agreement and Memorandum of Agreement: Attested copies.

Affidavit II: Notarized document certifying the identity, address, and other relevant details of individuals involved in the company's operations.

Proof of Residential Address: Copies of Ration Card, passport, Aadhaar card, or other identification documents.

Consent Letter from Parent Company: Detailing available facilities, licensing information, and previously issued CDSCO Loan Licenses.

Technical Worker Declaration: Statements from workers involved in the production process.

Statement of Previous CDSCO Loan Licenses: Information about any previously awarded licenses.

Formulation Declaration: Details of any previously inappropriate formulations or those not approved by the department.

Documents Needed for Formulations of CDSCO Loan License

When applying for a CDSCO Loan License for various formulations, the following documents are required:

List of Formulations: Including packaging information.

Specimen Labeling: Labels for all products.

Non-Pharmacopeial Product Labels: Uniform labeling across all products.

Test Procedures: For products and substances not listed in Pharmacopeia or other drug standards compendia.

Drugs Not Listed in I.P.: Monograph copies for these drugs.

Agencies Responsible for Approving CDSCO Loan Licenses

State Licensing Authorities (SLA)

The SLA, representing the state government, is responsible for issuing medical licenses and inspecting factories that manufacture Class A and Class B medical devices. They also grant production, loan, and retention licenses for these categories. The SLA has the authority to suspend licenses if they do not meet regulatory standards.

Central Licensing Authorities (CLA)

The CLA, established by the Drugs Controller General of India, handles the approval and performance standards for Class C and Class D medical devices. The CLA also manages import permits for all medical device categories and can revoke licenses for regulatory violations. They often work in collaboration with SLAs to ensure compliance with medical device regulations across the country.

Application Procedure

The application process for a CDSCO Loan License involves the following steps:

Registration: Register with the Ministry of Health and Family Welfare.

Form Submission: Submit the application form (MD-4 for Class A and B devices, MD-8 for Class C and D devices).

Sugam Portal: Upload the form and required documents to the Sugam portal, ensuring all information is accurate.

Document Submission: Upload all necessary documents.

Review: The State or Central Licensing Authority will review the application.

Approval and Issuance: If approved, the loan license will be issued using forms MD-6 and MD-10.

Conclusion

Obtaining a CDSCO Loan License is a critical step for manufacturers in the pharmaceutical and medical device industries in India. The process requires meticulous preparation and submission of various documents to demonstrate compliance with regulatory standards. By following the guidelines and ensuring all necessary documentation is in order, applicants can navigate the loan licensing process effectively. For expert assistance in obtaining a CDSCO Loan License, consult with professional services like Bizadvisors.io.