CDSCO Loan Registration Service In Chennai

According to the Drug and Cosmetic Act of 1940, a CDSCO Loan License is a licence that the licencing authority may grant to an applicant who does not already have a production facility or other arrangements for production but who intends to use available manufacturing facilities.
Rule 20 and Rule 21 of the Medical Devices Rules 2017[1], often known as the MDR 2017, provide that manufacturers who have a manufacturing licence but no sterilisation facilities are required to get a loan licence in compliance with the following conditions.

• Form MD – 6 for production, sale and distribution of Medical Devices from Class A or Class B
• Form MD – 10 for production, sale and distribution of Medical Devices from Class C or Class D

Documents needed to register a CDSCO loan

For the issuance of a CDSCO Loan License in accordance with Forms 25-A, 28-A, and 32-A, the following documents are required. Along with the application form, all supporting material must be sent in duplicate.

• Cover Letter
• a challan for the required amount that follows the Head of Account's instructions
• Every Relevant Statutory Form
• Fees for applicable statutory forms that must be paid
• Declaration of pertinent information by each of the company's proprietors, partners, and directors in accordance with the affidavit
• Copies of the partnership agreement and memorandum of agreement must also be attested.
• Affidavit II requires a Notary to certify the identity, address, and other pertinent information of the relevant people involved in the Company's day-to-day operations, as well as the respective conduct of business with a photograph.
• Proof of Residential Address can be provided by sending a copy of the applicant's Ration Card, passport, Aadhaar card, or other identification document.
• A statement containing particular information about any previously awarded CDSCO Loan Licenses that are relevant
• A letter of consent from the parent company outlining all facilities that are available, the licencing information that is in possession, all drug categories, and the number of CDSCO Loan Licenses that have previously been issued for the company
• Technical workers involved in the production process have declared themselves for analysis
• Declaration of any formulation used that was previously inappropriate or that the department has not approved and that may be associated with the same or a different brand name

Documents needed for CDSCO Loan License for Usage of Bulk Drugs

The following paperwork is required in order to apply for a CDSCO Loan License for Application of Bulk Drugs:

• Detailed information about the test analysis approach is provided together with a brief description of the production process and flow chart, as well as the consumption co-efficient and effluents required for the treatment process of the drugs being applied for.

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