Renewal applications are only available to importers.
The Applicant must follow the following process:
Selection of authorized Indian Agent |
Generation of SUGAM credentials |
Applying for a Registration Certificate in Form 40 by filling in an online form, uploading documents in PDF formats |
Submitting the Government fee. |
Submission of Application |
Form 41from Central Drugs Standard Control Organisation
9
MonthsAccording to the experts:
The company needs to confirm that the manufacturing site for which they are applying has never before received a registration certificate.
The manufacturer is responsible for verifying that all regulatory documents are still valid. 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.
No, in situations where only transportation is required, a registration certificate is not required.
The complicated regulatory environment, strict documentation requirements, controlling expenses and time restrictions, guaranteeing compliance with Indian biotech product rules, and accurate interpretation of guidelines are some of the major obstacles in the Drugs medication registration process.