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==Procedure==
'''Apply Online ''' 
#To Apply for Pharmaceutical Manufacturing License, the applicant has to make the application online via [https://statedrugs.gov.in/SFDA/Homepage link]
#The applicant has to click the “Sign In/Up” button.
#Without registering the applicant can be done through the OTP format.
#Enter the mobile number and click the “Get OTP” button.
#The applicant will receive the OTP from the entered mobile number.
#Enter the OTP and click “Validate & Proceed”.
#To log in with a username and password click the “Sign in with Username and Password”.
#Enter the details with the captcha code and click “Validate & Proceed”.
#The applicant has to select the application form from the menu list and click the “Submit” button.
#Enter all the details in the application form and click the “Next” button.
#And upload all the necessary documents that are mentioned in the “Required Documents” section of this page and click the “Proceed” button.
#To review once, the applicant can view all the details in the application form and click the “Save & Proceed” button.
#Pay the prescribed amount fee in online mode.
#The applicant has to pay the prescribed fee as requested by the authority and fees range from 1000 to 7500.
#Once completed with all the details click the “Submit” button.
#After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
#Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
#Once the process gets completed, the applicant gets a call from the office regarding the application.
#Licensing Authority will conduct an inspection of your manufacturing premises to verify compliance with the regulations.
#If the inspection and verification process is successful and all requirements are met, you will be issued the Pharmaceutical Manufacturing License.
#The license will specify the scope of your manufacturing activities and any conditions or restrictions.
#This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.
 
'''Apply In Person ''' 
#To Apply for Pharmaceutical Manufacturing License, the applicant has to approach the State or Central Drugs Standard Control Organization [https://statedrugs.gov.in/SFDA/ondls-institute-list.html link]
#An application form will be provided to the applicant by the concerned officer.
#The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
#Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
#The applicant has to attach the photocopies of the required documents along with the application form while submitting.
#Submit all the documents with the completed form to the concerned officer.
#The applicant has to pay the prescribed fee as requested by the authority and fees range from 1000 to 7500.
#After receiving the application, the concerned authority will check the submitted application and document set. If all are in place, the application will be accepted.
#An acknowledgment receipt will be provided. Please save it for future reference.
#Then the application will be processed further. All the updates on the application status will be sent via SMS to the applicant’s mobile number.
#Once the process gets completed, the applicant gets a call from the office regarding the application.
#Licensing Authority will inspect your manufacturing premises to verify compliance with the regulations.
#If the inspection and verification process is successful and all requirements are met, you will be issued the Pharmaceutical Manufacturing License.
#The license will specify the scope of your manufacturing activities and any conditions or restrictions.
#This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.
 
==Required Documents==
*Application form
*ID proof (birth certificate, PAN card, Aadhar card, etc)
*Address proof – (Driving license, passbook, utility bill, etc)
*Proof of ownership or lease agreement for the manufacturing premises
*Site plan, building layout, and specifications of the manufacturing facility
*Detailed manufacturing process and Standard Operating Procedures (SOPs)
*Quality control procedures and specifications
*List of manufacturing equipment and their calibration certificates
*Details of the technical staff and their qualifications
*Documents related to the storage and transportation of raw materials and finished products
*Safety and environmental control measures
*Fee receipt
*Any other documents (If required)

 
==Office Locations & Contacts==
'''Central Drugs Standard Control Organization''' 
Ministry of Health and Family Welfare, 
Directorate General of Health Services, 
Government of India FDA Bhavan, 
ITO, Kotla Road, New Delhi -110002 
Contact – 1123216367 
Email - EGOV-CELL@CDSCO.nic.in 
Contact [https://statedrugs.gov.in/SFDA/contact-us.html link] 
Regional Office [https://statedrugs.gov.in/SFDA/ondls-institute-list.html link] 
 
==Eligibility==
'''The eligibility criteria for applying for a pharmaceutical manufacturing license in India are as follows:''' 

*The applicant must be a legal entity, such as a company, partnership firm, or limited liability partnership.
*The applicant must have valid manufacturing premises. The premises must be inspected and approved by the Drugs Controller General of India (DCGI).
*The applicant must have qualified technical staff. The staff must have the necessary education and experience to manufacture pharmaceuticals.
*The applicant must have the necessary equipment and machinery. The equipment and machinery must be suitable for the manufacture of pharmaceuticals.
*The applicant must have a quality assurance system in place. The quality assurance system must ensure that the manufactured pharmaceuticals meet the required standards.

 
==Fees==
*The applicant has to pay the prescribed fee as requested by the authority.
*The fees range from 1000 to 7500

 
==Validity==
Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

 
==Documents to Use==
Please attach documents that can be used by people. e.g. links

 
==Sample Documents==
Please attach sample completed documents that would help other people.

 
==Processing Time==
*This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

 
==Related Videos==
Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

 
==Instructions==
*Applicants must complete the application form before submitting it. Incomplete applications will not be accepted.
*Applicants must provide genuine information while applying for this procedure.

 
==Required Information==
*Name
*Address
*PIN code
*State
*Country
*Age
*Education details
*Site plan
*Quality control details
*Contact number
*Email
*Fax
*Declaration
*Date
*Signature

 
==Need for the Document==
*A Pharmaceutical Manufacturing License in India is an official authorization granted by the Central Drugs Standard Control Organization (CDSCO) or the State Licensing Authority to a pharmaceutical company or entity allowing them to engage in the manufacturing of pharmaceutical products within the country.
*This license is a legal requirement for any entity involved in the manufacturing, processing, packaging, labeling, or testing of pharmaceutical products in India.
 
 
==Information which might help==
*For more details [https://statedrugs.gov.in/SFDA/resources/app_srv/SFDA/startup/user-mannual/applicant_manuf_v1.pdf link]

 
==Other uses of the Document/Certificate==
Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

 
==External Links==
[https://statedrugs.gov.in/SFDA/Homepage Link] 

 
==Others==
*The Pharmaceutical Manufacturing License ensures that pharmaceutical manufacturing operations comply with the regulatory standards and guidelines set by the CDSCO and other applicable laws.
*It covers various aspects of manufacturing, including the premises, equipment, personnel, quality control, documentation, and adherence to Good Manufacturing Practices (GMP).

 
[[Category:India]]

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