DRUG REGISTRATION SERVICES
REGISTRATION CERTIFICATE and IMPORT LICENSE
Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs intended to be imported in India from an overseas manufacturer. CDSCO checks the safety and quality parameters of both the Product as well as the Manufacturing site from where the product has to be imported before granting a registration certificate for import of the Product.
Government fees for the Import of Drugs was Hiked as per Notification No. 1193(E)..An Importer needs to make an application in Form 40 as per the Checklist of documents Prescribed by CDSCO and submit to the CLA for processing.
The Registration certificate to an Importer is granted in form 41 for Drugs.
As a prerequisite, an Importer needs to have a License for stock and sale in Form 20 B & 21 B from the SLA.
|
Application Form |
Permission |
Government fees |
Validity |
|
Form 40 Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945 |
Form 41 Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945 |
USD 10000 for Each Plant or Site Registration USD 5000 for each product |
3 years from Date of issue, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. |
Checklist of Documents
For Ease of undertaking the information has been Divided to understand what is required from Importer and What is Required from Legal Manufacturer.
Importer
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Covering Letter
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Copy of Import: Permission for New Drug in Form 45 or 45A if applicable
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Drug License in 20B/21B
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Companies Authorisation for the bearer to submit the file
Legal Manufacturer
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Power of attorney duly apostilled or Attested by Indian embassy
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Foreign Manufacturer Authorisation nominating indian Importer
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Schedule DI and DII undertaking
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Notarized Device Master file
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Notarized Plant Master File
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Real time and Accelerated Stability Data
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Notarized Copies of COPP, Free sale certificate, Manufacturing license
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SFDA Certificate in case of China
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Certificate of Suitability from EDQM
Import License in Form 10 or Form 10 A
Import ,Manufacturing & Distribution of Drugs is regulated under Drugs and Cosmetics Act 1940.
Once a Registration Certificate is granted for a drug manufactured by an overseas manufacturer, a separate application seeking grant of impot needs to be submitted to CDSCO.
An application seeking grant of permission to Import Drugs has to be Applied in Form 8 or Form 8A for approval in Form 10 and Form 10A
Application has to be submitted on SUGAM portal of CDSCO https://cdscoonline.gov.in
|
Form applied |
Approval received |
Government fees GSR 1193 |
|
Form 8 Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 |
Form 10 Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945 |
INR 10000 |
|
Form 8A Application for licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945 |
Form 10A Licence to import drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945 |
Rs 10000 for each product Rs 1000 for each subsequent product |
Condition of Import License
The grant of import licence of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or From 10-A.
An Import licence unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
Checklist of Documents:
- Cover Letter
- Form-8/8A duly Signed & Stamped by applicant Generated by SUGAM portal
- Form 9 (Undertaking given by Manufacturer or on behalf of manufacturer) duly signed and stamped
- 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 importer.
WHY NKG FOR Drug Regulatory Services
Our team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.
NKG experts are well versed with dossiers for registration in Form 40 & Form 8 and make the process of filing and approval in Form 41 & Form 10 efficient and predictable.
in numbers from
regulatory track record
5000+
INTERNATIONAL BRANDSRegistered
100k+
Products Registered
100%
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NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
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we help you meet your compliance needs
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
