Introduction

The Central Drugs Standard Control Organization (CDSCO) is a key regulatory body in India's pharmaceutical and medical device sectors, operating under the Directorate General of Health Services and the Ministry of Health and Family Welfare. Formed under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945, CDSCO is responsible for new drug approvals, clinical trial oversight, and regulation of drug and cosmetic quality standards in India. This article provides a comprehensive guide on the documentation required for obtaining a CDSCO Loan License, essential for engaging in the Indian pharmaceutical and medical device industry.

Table of Contents

1. What is a CDSCO Loan License?
2. Required Documents for CDSCO Loan License
3. Documents Needed for Formulations of CDSCO Loan License
4. Agencies Responsible for Approving CDSCO Loan Licenses
5. Application Procedure
6. Conclusion

What is a CDSCO Loan License?

A CDSCO Loan License is granted to those without their own manufacturing facilities but who wish to leverage existing manufacturing capabilities. Under the Drug and Cosmetic Act of 1940 and the Medical Devices Rules (MDR) 2017, manufacturers lacking sterilization facilities must acquire a loan license under specific provisions such as:

• Form MD-6: Pertains to the manufacture, sale, and distribution of Class A or Class B medical devices.
• Form MD-10: Pertains to the manufacture, sale, and distribution of Class C medical devices.

Required Documents for CDSCO Loan License

To secure a CDSCO Loan License under Forms 25-A, 28-A, and 32-A, applicants must provide the following documents:

• Cover Letter: A formal application letter explaining the intent.
• Challan for Required Amount: As per Head of Account guidelines.
• Relevant Statutory Forms: Properly completed and signed forms.
• Fees: Payment of applicable statutory fees.
• Declaration: Information regarding every proprietor, partner, and director via affidavit.
• Partnership Agreement and Memorandum: Attested copies required.
• Affidavit II: Notarized identification and address confirmation documents.
• Proof of Residential Address: Such as Ration Card, passport, or Aadhaar card.
• Consent Letter from Parent Company: Detailing the facilities and prior licenses.
• Technical Worker Declaration: Statements from production workers.
• Statement of Previous CDSCO Licenses: Previous license details.
• Formulation Declaration: Information regarding any non-approved formulations.

Documents Needed for Formulations of CDSCO Loan License

For formulations, the following documents are required:

• List of Formulations: Including packaging details.
• Specimen Labeling: Product labels.
• Non-Pharmacopeial Product Labels: Consistent labeling for all products.
• Test Procedures: For products not in Pharmacopeia.
• Drugs Not Listed in I.P.: Relevant monograph copies.

Agencies Responsible for Approving CDSCO Loan Licenses

State Licensing Authorities (SLA): SLAs, representing state governance, issue medical licenses and inspections for Class A and B devices. They also grant production, loan, and retention licenses and can suspend licenses for non-compliance with standards.

Central Licensing Authorities (CLA): The CLA, under the Drugs Controller General of India, approves and evaluates Class C and D device standards, manages import permits, and can revoke licenses for breaches. Collaboration with SLAs ensures national compliance.

Application Procedure

The CDSCO Loan License application process involves:

• Registration: With the Ministry of Health and Family Welfare.
• Form Submission: Submitting the appropriate forms (MD-4 for Class A and B, MD-8 for Class C and D devices).
• Sugam Portal: Uploading forms and documents on the portal, ensuring accuracy.
• Document Submission: Ensuring all documents are uploaded.
• Review: By the State or Central Licensing Authority.
• Approval and Issuance: Granted via MD-6 and MD-10 forms if approved.

Conclusion

Securing a CDSCO Loan License is essential for manufacturers in India's pharmaceutical and medical device industries. The process demands comprehensive preparation and correct documentation to meet regulatory compliance. By adhering to guidelines, applicants can effectively obtain their licenses. For expert guidance, consider consulting professional services like Bizadvisors.io.