DRUG IMPORT LICENSE | FORM 10 / 10A
Import License in Form 10 is a license to Import Drugs excluding those specified in Schedule X in India or in Form 10A to Import Drugs specified in Schedule X. The Permiso team will provide comprehensive assistance, starting from the project’s paperwork through its successful completion.
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Any substance that falls into the Act’s definition of a drug (Section 3b) must be registered before being imported into the nation. The applicant has to obtained a Registration Certificate in Form 41 before applying for a Import License in Form 10 or Form 10A.
Any importer / manufacturer who wants to import drugs mentioned in schedule X or drugs excluding in schedule X has to make and application in Form 8 or Form 8A. The foreign manufacturer with a wholesale drug licence in India, or the foreign manufacturer’s local authorised agent with a manufacturing or wholesale drug licence in India, may submit the application for Import License. The Import License in Form 10 / Form 10A shall be valid for a period of three years from the date of its issue.
If the importer / manufacturer fails to comply with any of the conditions, the licensing authority may suspend or cancel the Import License for whatever period it deems appropriate, either entirely or in relation to some of the substances to which it relates.
Procedure for Obtaining a Import License in Form 10 / 10A in India:
- Obtaining Login credentials: To obtain a Import License in Form 10/ 10A, the applicant must first register in an online portal and create a Login ID and Password.
- Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
- Fees: The applicant must pay the required fees online as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945.
- Document Verification: Following the submission of documentation, the licensing authority will authenticate all the documents submitted.
- Issue of Import License: Post authentication and verification of all the documents the licensing authority will grant the Import License in Form 10 or Form 10A.
Pre - Requisites / Documents required for Import License in Form10 / 10A :
- Covering Letter: The covering letter should clearly specify the purpose of the application, list of documents attached. It should be signed by authorised signatory including his name and designation and address of the firm.
- Authorisation Letter: A signed authorisation letter from the Director, Company Secretary, or Partner of the Indian Agent firm is required, which should include the name and title of the authorised person who is authorised to sign documents on the company's behalf.
- Form 8/ 8A: To import drugs not listed in Schedule X, an application form 8 must be completed, and a form 8A is required for drugs listed in Schedule X.
- Form 9: An undertaking given by the foreign manufacturer to duly signed and authenticated by the Indian embassy of the country of origin.
- Drugs Imported: The form shall capture proper brand name, different pack size, different strength to be imported in India.
- Challan: The original and detail challan of the fees paid has to be uploaded
- Registration Certificate: A valid copy of the CDSCO Registration Certificate in Form 41 for the proposed Drug, duly authenticated by the Indian Agent
- Manufacturing / Wholesale Drug License: The foreign manufacturer or his authorised agent has to have a vali wholesale drug license in India.
- Others: The CDSCO may ask for any other documents to be furnished during the verification of the application.
The company/firm applying for a Import License in Form 10 /10A will remain liable to pay a license fee of ten thousand rupees for a single drug and an additional fee of one thousand rupees for each additional drug.
Obtaining a Import License in Form 10 / 10A can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the certificate. We reduce the likelihood of application rejection and ensure that licenses are issued quickly and without complications.
You can apply for a Fresh Import License in Form 10 or 10A / Renewal of Import License / Amendment in License / Change in Constitution / Surrender of Import License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com
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DRUG IMPORT LICENSE Registration Procedure
