In India, the manufacturing, sale, import and distribution of drugs are controlled under the Drugs & Cosmetics Act 1940 and Rules 1945. In India, the drug industry is rapidly growing, with a massive market for drugs & personal care items. The import of drugs in India is regulated by CDSCO to ensure the safety, quality, and performance of drugs. So, for the import of drugs into India, it is necessary to obtain CDSCO Certificate for Drugs Import as prescribed under Drugs & Cosmetics Rule 1945[1]. In this article, we will focus on the CDSCO Certificate for Drugs Import to India.
What is the meaning of Drug?
Drugs mean any substance (other than food) which is used to prevent, diagnose, treat, or relieve symptoms of a disease and abnormal condition.
The Role of CDSCO for Drug Import in India
Under the Drugs & Cosmetics Act, CDSCO is responsible for the following Roles:
- The approval of Drugs,
- Laying down the standards for Drugs,
- The conduct of Clinical tests,
- Control over the quality of imported Drugs in India and
- Coordinating the activities of the State Drug Control Organizations by providing advice to bring uniformity in enforcing the Drugs & Cosmetics Act.
Who can apply for CDSCO Certificate for Drugs Import to India?
As per the Drugs and Cosmetic Act, 1945, CDSCO has listed the applicants who can apply for CDSCO Certificate for Drugs Import to India:
- Authorised Agent: If the manufacturer has an authorised agent on their behalf to import drugs.
- A subsidiary of the Manufacturer: For all foreign drugs manufacturer, the Indian subsidiary firm can apply on behalf of the foreign manufacturer for the CDSCO Certificate for Drugs Import to India.
- Manufacturer: Also, the manufacturer can apply for the grant of the CDSCO Certificate for Drugs Import to India.
- Importer: Any Importer willing to import drugs to India from a foreign manufacturer can apply for CDSCO Import Certificate or Registration.
Documents required for CDSCO Certificate for Drugs Import to India
Following are some necessary forms and documents for getting CDSCO Certificate for Drugs Import to India:
- An application seeking a grant of permission to import Drugs has to be applied in Form 8 & Form 8A for approval in Form 10 & Form 10A.
- Form 8: Application for a license to import drugs excluding those specified in Schedule X to the Drugs & Cosmetics Rule, 1945.
- Form 8A: Application for license to import drugs specified in Schedule X to the Drugs & Cosmetics Rules, 1945.
- Form 10: License to import drugs excluding those specified in Schedule X to the Drugs & Cosmetic Rules, 1945.
- Form 10A: License to import drugs specified in Schedule X to the Drugs & Cosmetics Rules, 1945.
- Cover Letter
- Form 8/8A is duly stamped and signed by the applicant Generated under CDSCO Sugam Portal.
- Form 9 duly stamped & signed Undertaking is given by the manufacturer or on behalf of the manufacturer.
- Notarised copy of manufacturing license or wholesale license
- Labels
- Copy of registration certificate on Form 41 duly attested by the Indian importer or agent.
- Copy of approval under rule 122A (application for approval to import new Drug) if the new Drug is in the importer’s name.
Procedure for CDSCO Certificate for Drugs Import to India
Following are the steps procedure for CDSCO Certificate for Drugs Import to India:
Step 1: Determination of Drugs Classification: When a manufacturer wants to register their drugs in India, the manufacturer needs to check the Gazette Notification of CDSCO before finalising a device’s regulatory classification and status.
Step 2: Appointment of an Indian Agent: The foreign manufacturer should appoint an authorised Indian agent to interact with the CDSCO. The Indian agent will grant a power of attorney to assist in drug approval & manage registration and import in India.
Step 3: Fill out the Application form for CDSCO Drug Import Registration: Once you appoint the Indian Agent, you have to fill out the application form for the CDSCO Certificate for Drugs import along with submitting all the significant documents and paying of prescribed fee on the CDSCO Portal.
Step 4: Issuance of CDSCO Certificate for Drug Import to India: After filling out the application form and submitting the vital documents and paying the prescribed fee on the CDSCO Portal, the DGCI Registration Department may send a query via a letter of inquiry to the manufacturer or from the certified agent of the importer. After the authority is truly satisfied with the application form and all the documents you submitted, and then they issue a CDSCO Import Certificate for Drugs.
Note: according to the Drugs & Cosmetics Rules Import License shall be valid for three years.
Conclusion
After discussion, it is clear that the CDSCO Import Certificate is essential for those who want to Import Drugs into India.
Read our Article:CDSCO Medical Devices Manufacturing Registration Requirement
