Manufacturing License in India - 24, 24A, 24B, 24C, 24D, 24E, 24F & 25, 25A, 25B, 25C, 25D, 25E
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Manufacturing License – Overview
Manufacturers intending to produce drugs for sale or distribution, excluding homeopathic medicines, must obtain a manufacturing license. This license can be obtained through the State FDA/State Licensing Authority.
An overview of the entire process is given below:
- Begin by confirming the application submission process, which can differ from state to state.
- Prepare the application following the checklist issued by the state FDA.
- Fulfil the government fee requirements specified in the drugs and cosmetic rules of 1945.
- Submit the application in either hard copy or through the online portal, as per the specific requirements of the state FDA.
Who Can Apply?
Any company registered in India under the Company Act is eligible to submit a license application
How To Apply?
The Applicant must follow the following process:
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Application submission methods differ from one state to another, so it's advisable to confirm with the respective state authorities whether they accept hard copy or online submissions.
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Ensure that the application is meticulously prepared following the checklist issued by the state FDA.
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Pay the government fees specified in the drugs and cosmetic rules of 1945.
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Submit the application either in hard copy or through the online portal, following the state FDA's specific submission requirements.
Validity
The license remains valid for five years from the date of issue, and it can be extended after submitting the retention fee.
Fee Involved
The fee required to obtain the license is INR 6000, with an additional INR 1500 for inspection.
Important Documents
The essential documents needed to acquire licenses are as follows:
- Calibration Validation Certificate
- Identification documents of the applicants
- Experience certificates for the individuals responsible for Manufacturing, Testing, and Quality Assurance
- A compilation of SOPs
- Submission of the SMF and Power of Attorney
Timeline to get
25, 25A, 25B, 25C, 25D, 25E
from Central Drugs Standard Control Organisation
45 to 60
BUSINESS DAYSEssential Tips
These are some of the key prerequisites required when applying for the license:
- The company is required to have formal registration as a business entity.
- The premises should be located within an industrial area.
- Roadblocks These are potential obstacles that individuals may encounter during the license application process:
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