Permission of repacking under Rule 37 of D & C Act in India - Rule 37
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Feeling the squeeze of delayed timelines as your product launch date approaches? CliniExperts Regulatory Services offers a powerful solution to ensure you get your imports of proprietary medicines into the country on time. We specialize in navigating the complexities of repackaging imported medicines for retail sale, ensuring significant cost savings and superior efficiency.
Rule 37 – Overview
As per Rule 37 Drug and Cosmetic Act 1945 (permission to repackage the imported bulk to sale in the Indian market): This is a service related to importing any drug in bulk form and planning to repackage it for retail sale in the Indian market. The applicant must be holding a valid manufacturing license for a manufacturing/packaging facility. The very first step to start the process is to get a registration certificate in Form 41 from the CDSCO. After obtaining the Registration certificate the next step is to obtain an import license in form 10. These both can be processed through the online SUGAM portal. Now the applicant may apply for the permission to repackage the imported bulk to sale in the Indian market through offline/ Physical submission.
Following are the checklist for documents required for submission:
- A cover letter clearly explaining the purpose
- Copy of manufacturing license for the activity performed like filling/ packing /labelling
- A copy of valid Registration Certificate
- A valid Form 10 license for import of drug in bulk quantity
- Original labels for bulk container
- Original labels for primary and secondary packaging of finished product
- Hold time stability data to justify the hold period/ transportation duration
Who Can Apply?
Any Indian importer on behalf of a foreign manufacturer can apply for this license.
How To Apply?
The Applicant must follow the following process:
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After obtaining the Registration certificate Form 41 and Import license Form 10 via online procedure. The Indian applicant may apply through offline procedure via physical submission of a cover letter clearly mentioning the purpose of the application along with all the document given above.
Validity
The import should be done within twelve months of the date of issue. The validity of the Registration Certificate is three years.
Fee Involved
Not ApplicableImportant Documents
The following documents are required for the permission of patent or proprietary medicines into India.
- A letter explaining the purpose
- Copy of manufacturing license for the activity performed like filling/ packing /labelling
- A copy of valid Registration Certificate
- A valid Form 10 license for import of drug in bulk quantity
- Original labels for bulk container
- Original labels for primary and secondary packaging of finished product
- Hold time stability data to justify the hold time
Timeline to get
Rule 37
from Central Drugs Standard Control Organisation
3
MonthsEssential Tips
Below listed are the primary considerations that are required while preparing and submitting this license application:
- A letter addressing the purpose of repacking patent or proprietary medicines imported in bulk for retail sale in India
- Submission of all required documents as per Rule 37 D & C Act
Expert Advise
According to our experts, the following points should be considered for a quick license receipt:
- The manufacturer needs to confirm that the manufacturing site for which they are applying has never before received a registration certificate.
- The product samples that are sent to the government laboratory for testing ought to be in adequate numbers and well within the product's shelf life.
- The manufacturer is responsible for verifying that all regulatory documents are still valid.
Frequently Asked Questions
What does repackaging of imported bulk medicines entail?
Repackaging involves taking bulk quantities of patent or proprietary medicines imported from abroad and dividing them into smaller, retail-ready packages with appropriate labelling.
Rule 37 permission is also applicable for drug manufactured in India?
No.
What is the amount of fees for application of Repackaging under Rule 37?
There is no govt. fee for repacking activities under Rule 37.
Is there any specific Import License for import of drugs for repackaging under Rule 37?
No. The import license is issued under Form 10; However, the Registration Certificate and Import license both depicts phrases such as ‘in bulk container’ or ‘in bulk for repacking’, etc., alongside drug name.
Is there permission required from state also to perform repacking activities under Rule 37?
No.
What does repackaging of imported bulk medicines entail?
Repackaging involves taking bulk quantities of patent or proprietary medicines imported from abroad and dividing them into smaller, retail-ready packages with appropriate labelling.
Who can perform the repackaging of imported bulk medicines?
Only companies with a valid manufacturing license for repackaging and permission under Rule 37 of the Drugs and Cosmetics Act (D&C Act) can perform this activity.
What licenses and permissions are required for repackaging imported bulk medicines?
The following points should be considered for license and permissions for repackaging imported bulk medicines:
Import License: You'll need a license to import the specific bulk medicines you intend to repackage.
Rule 37 Permission: You'll require permission from the Central Drugs Standard Control Organization (CDSCO) under Rule 37 of the D&C Act.
Manufacturing License: A valid manufacturing license for repackaging medicines is mandatory.
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