The Central Drugs Standard Control Organisation, which is also known as the CDSCO, is established as a National Regulatory Authority for assisting the Indian Pharmaceuticals and Medical Devices that fall under the authorisation of the Directorate General of Health Services and the Ministry of Health and Family Welfare of India. The CDSCO also has the authorisation for approval of new drugs introduced in the Indian market and for conduction of Clinical Trials in India in accordance with the Drugs and Cosmetics Act,1940 and the Drugs and Cosmetic Rules, 1945. The CDSCO also has the authorisation for implementing standards for drugs and controlling the quality of drugs and cosmetics being imported into the country, along with enforcing and maintaining uniformity in the maintenance of the applicable Acts and Rules.
What is the CDSCO Loan License?
A CDSCO Loan License, in accordance with the Drug and Cosmetic Act, 1940, is defined as a license in which the licensing authority has the right for issuance of the license to the applicant that does not have their own production facility or any arrangement for production but has the intention to avail the needed manufacturing facilities.
According to Rule 20 and Rule 21 of the Medical Devices Rules 2017[1], also known as the MDR 2017, the producers who are in the possession of the manufacturing license but do not have a sterilisation facility have to mandatorily obtain a loan license in accordance with –
- 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 for CDSCO Loan License
The following documents are needed for the grant of a CDSCO Loan License in accordance to Form 25 – A, Form 28 – A and Form 32 – A. A copy of all the documentation also needs to be submitted with the application form.
- Cover Letter
- Challan of the needed amount in accordance with the Head of Account
- All Applicable Statutory Forms
- Required Fees of applicable Statutory Forms
- Declaration of necessary information of all the Proprietors, Partners and Directors of the company in accordance with Affidavit – I
- Copies of Partnership Deed and MoA also need to be Attested in Affidavit – I
- A Notary with the name, address and other necessary details of the required personnel involved in daily affairs of the Company along with the respective conduct of business with a photograph needs to be attested in Affidavit – II
- Proof of Residential Address, such as submitting a copy of the respective applicant’s Ration Card or Passport or Aadhaar Card, etc.
- A Consent Letter from the Parent Company that declares all the available facilities and the license details in possession that indicates all the categories of drugs and the number of CDSCO Loan License already issued for the Company
- Declaration of the technical personnel involved in the production process for analysis
- Declaration with specific details of any applicable previously issued CDSCO Loan Licenses
- Declaration of any formulation applied that was not applicable previously or not permitted by the department that may either be in association with the same or different brand name
Documents needed for CDSCO Loan License for Formulations
For the application for a CDSCO Loan License for various formulations, the following documents are necessary –
- List of Formulations along with the packing particulars in a consolidated manner
- Labels of all Specimen
- Labels of all the products that are similar for all Non-Pharmacopeial Products
- Methods of the tests conducted for the product and the ingredients used that are not mentioned in Pharmacopeia or any other Compendia of Drug Standards
- Monograph Copy for drugs that are not mentioned in I.P.
Documents needed for CDSCO Loan License for Usage of Bulk Drugs
For the application for a CDSCO Loan License for Application of Bulk Drugs, the following documents are necessary –
- Brief on the Production Procedure and the Flow Chart with the consumption co-efficient and effluents needed for the purpose of the treatment procedure of the drugs being applied for with the detailed information of the procedure of test analysis.
Conclusion
All companies involved in the business of importation and exportation of drugs and cosmetics or involved in the conduction of R & D activities that includes drugs, importation of drugs for testing, Bioavailability (BA) and Bioequivalence (BE) Studies in drugs for exportation, that is in need of a production or testing facility, need to obtain a CDSCO Loan License in accordance with the laws set by CDSCO.
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