Ladakh - Apply for Pharmaceutical Manufacturing License

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Procedure

Apply Online:

1. To Apply for Pharmaceutical Manufacturing License, the applicant has to make the application online via link
2. The applicant has to click the “Sign In/Up” button.
3. Without registering the applicant can be done through the OTP format.
4. Enter the mobile number and click the “Get OTP” button.
5. The applicant will receive the OTP from the entered mobile number.
6. Enter the OTP and click “Validate & Proceed”.
7. To log in with a username and password click the “Sign in with Username and Password”.
8. Enter the details with the captcha code and click “Validate & Proceed”.
9. The applicant has to select the application form from the menu list and click the “Submit” button.
10. Enter all the details in the application form and click the “Next” button.
11. And upload all the necessary documents that are mentioned in the “Required Documents” section of this page and click the “Proceed” button.
12. To review once, the applicant can view all the details in the application form and click the “Save & Proceed” button.
13. Pay the prescribed amount fee in online mode.
14. The applicant has to pay the prescribed fee as requested by the authority and fees range from 1000 to 7500.
15. Once completed with all the details click the “Submit” button.
16. 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.
17. 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.
18. Once the process gets completed, the applicant gets a call from the office regarding the application.
19. Licensing Authority will conduct an inspection of your manufacturing premises to verify compliance with the regulations.
20. If the inspection and verification process is successful and all requirements are met, you will be issued the Pharmaceutical Manufacturing License.
21. The license will specify the scope of your manufacturing activities and any conditions or restrictions.
22. This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

Apply In Person:

1. To Apply for Pharmaceutical Manufacturing License, the applicant has to approach the State or Central Drugs Standard Control Organization link
2. An application form will be provided to the applicant by the concerned officer. or it can be downloaded from the following link
3. The applicant has to fill in all the necessary details in the application form. (Incomplete applications are not accepted)
4. Make sure that the applicant has attached all the necessary documents that are mentioned in the “Required Documents” section of this page.
5. The applicant has to attach the photocopies of the required documents along with the application form while submitting.
6. Submit all the documents with the completed form to the concerned officer.
7. The applicant has to pay the prescribed fee as requested by the authority and fees range from 1000 to 7500.
8. 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.
9. An acknowledgment receipt will be provided. Please save it for future reference.
10. 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.
11. Once the process gets completed, the applicant gets a call from the office regarding the application.
12. Licensing Authority will inspect your manufacturing premises to verify compliance with the regulations.
13. If the inspection and verification process is successful and all requirements are met, you will be issued the Pharmaceutical Manufacturing License.
14. The license will specify the scope of your manufacturing activities and any conditions or restrictions.
15. This entire process can be completed within 30 days or as per the timeline advised by the respective department authority.

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Required Documents

• Application form link
• 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: [email protected]
Contact link
Regional Office 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

• Application form link

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, labelling, or testing of pharmaceutical products in India.

Information which might help

• For more details 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

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).