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    Drug – Import and Licence Registration

    Import of Drugs: Everything You Need to Know

    You need to go through several steps before you can start the business, the most important of which is getting a valid import license.

    Getting a Drug Import License

    In India, there are two legislations (Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945) that govern the import of drugs. The main authority responsible is the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. CDSCO is located in FDA Bhavan, ITO, Kotla Road, New Delhi -110002.
    Only a manufacturer with a valid wholesale License for sale or distribution of drugs can apply for this license. If they don’t have a valid license, they need to have an agent (importer) in India with a valid wholesale license.
    The application needs to be made to the Drugs Controller General (India), CDSCO (Central Drugs Standard Control Organization). Since 1st April 2016, all applications need to be made through CDSCO’s Sugam Portal. ● For drugs specified in Schedule X, you need to apply for the license using Form 8-A, and the license is received in Form 10-A. ● For other drugs, the application is made in Form 8, and the license is received in Form 10
    Here’s the entire list of documents that you need to apply for the license: ● A Cover Letter explaining exactly why you need the license. Any mistake in this letter can mean a flat-out rejection. ● The application form Form-8/8A Signed & Stamped by applicant ● Form 9 (Undertaking given by Manufacturer or by the manufacturer’s agent that they have a valid wholesale license) ● Notarized copy of Wholesale Licence or Manufacturing Licence ● Labels ● Copy of valid Registration Certificate (RC) on Form 41 duly attested by the Indian Agent or Importer ● Copy of permission under rule 122A (Application for permission to import new drug) in case of New Drug in the name of the importer.
    While an import license is valid for 3 years from the date of the issue, actually getting the license can be quite a painful task.
    In general cases, you cannot get an import license without having a registration certificate in place. It’s only in case of an emergency that this is allowed. In that case, Import Licenses can been issued under Rule 24 (2) “the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under Rule 27-A, for reasons to be recorded in writing”. However, this is granted very rarely, and you would be better off applying for the Registration Certificate, to begin with.
    CDSCO may issue the license in Form 10 within 2 to 3 months from the date of receipt of the application. Of course, this is subject to the condition that the application is complete and that all the documents are in place.
    Drug – Import and Licence Registration

    How to get a Registration Certificate

    Before you can get an import license to start importing drugs, you need a Registration Certificate.

    This Registration Certificate is issued by the licensing authority (CDSCO) under Rule 27A, via Form 41. Not only do you need to register the drug that’s being imported, but also the manufacturing site that will be used. Since 1st April 2016, all applications need to be made through CDSCO’s Sugam Portal.
    You need to apply for the Certificate in Form 40 with the following: ● A treasury challan with the prescribed fees ● All the relevant data that the authority requires Is it possible to submit the applications for Import License and Registration Certificate simultaneously? An applicant can apply application for import license in Form 8 to get the Import license in Form 10 only after issuance of registration certificate in form 41.
    Like an import license, a Registration Certificate is also valid for 3 years from the date of issue.
    Application for renewal of Import License should be submitted before 3 months and Renewal of Registration certificate should be submitted at least 9 months before the expiry of the certificates. You can only do this if both the importer and the Indian Agent remain unchanged.
    Drug – Import and Licence Registration
    Drug – Import and Licence Registration

    Getting the Import License and Registration Certificate can be a very long and cumbersome process. It becomes especially arduous when your application gets rejected and you’re not sure why. It’s a good idea to take the help of experts and make this process much simpler and hassle-free. If you need expert assistance, you can reach out to us at any time and we’ll be happy to help.

     

     

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