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Kerala - Apply for Neutral Code Certificate

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Procedure[edit]

Apply In-Person:

  1. Applicant shall approach the office of the respective range / district / zonal drugs control officer under whose dominion the applicant is operating.
  2. Link for contact details: link1 AND link2
  3. Go to the respective office and consult with the designated authority to know the updated applying procedure, if any. Please collect the application form or write on a plain A4 sheet as advised.
  4. Application form can be downloaded using the following link In this form please mention “Neutral Code” against “6. Type of Application :”.
  5. Applicant shall get all the required documents as advised. If there is a shortfall in document requirement, the application won’t be processed.
  6. Complete the application form. Attach all the documents as per our “Required Documents” section of this page along with the fees (DD/ Challan / as per applicable norms) and submit it to the designated authority in five sets.
  7. After receiving the application, authorities will check the application set and if found complete in all respects, the authority will allot a unique registration number for the correct and complete application in the order of their receipt and assess the inspection fees and other charges.
  8. The fee can be made through treasury challan/demand draft (DD)/bank draft/pay order/cash as applicable to the authority or at the respective fee counter as advised.
  9. Once the fee is paid, the authority will make appropriate entries in the application. Authorities will register these applications in the manual record or electronically using a computer.
  10. Applicant will be provided with a receipt of acknowledgement and attested photocopy of the application as an acknowledgement for the receipt of the application.
  11. Please collect it and keep it safe for future reference.
  12. Authority will attach a separate checklist to the application to keep a track of the processing of the application for neutral code certification. This application will be forwarded to the designated authority for further processing.
  13. ”SMS” triggered update on application status will be sent to the applicant’s mobile.
  14. Applicant will get notification about the tentative date for inspection of the goods from the department.
  15. On the scheduled date, the inspection team will visit the premises. The inspection shall be carried out in accordance with the list of products, combination of the finished product and other details furnished by the applicant while applying.
  16. The inspection team will generate the inspection report in the prescribed format at the time of the inspection and the copy of the same shall be given to the applicant.
  17. This inspection report along with the remarks will be forwarded to the concerned drug inspector – FDA or the designated authority for further processing. From here, this application will be forwarded to the sanctioning authority with a detailed letter for approval.
  18. From this point onwards, the sanctioning authority will take call on the approval of the application from the recommendations as stated above.
  19. The status, viz. Approval or Rejection if any will be conveyed to the applicant through an SMS or through email or as per applicable norms.
  20. The neutral code sanction letter will be signed along with the seal of the sanctioning authority.
  21. If approved, the neutral code sanction certificate will be hand delivered or sent through post to the address mentioned while applying or issued as per applicable norms.
Note:The fee payment for this certificate is accepted in different formats like challan/DD/cheque/cash as applicable. Applicants are advised to take the consultation with the respective drug control authority for your area to prepare fees requirements.


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Required Documents[edit]

  • Application form.
  • Covering letter indicating the purpose of a neutral code certificate.
  • Copies of manufacturing licence.
  • List of products meant for export.
  • Application for export NOC on company’s letter head duly signed.
  • Valid export order on the foreign buyer’s letter head clearly mentioning quantity and name of the drug to be exported.
  • A letter from foreign buyer on his letterhead mentioning the specific requirement of a special code number.
  • In the case of the export of banned drugs, a valid registration certificate from the Ministry of Health of the importing country is to be provided.
  • Covering letter addressed to the director of drugs control or as per advised authority, along with Rupees.2/- court fee stamp for each licence.
  • Demand draft for the advised amount.
  • Authorization of the signatory of the application form as per requirement.
  • Company PAN card
  • Record related to quality measures adopted by the business
  • Aadhaar card of directors
  • Self-declaration
Note:Apart from the above listed documents, authorities may ask for additional information or documents. Please provide them for smooth processing.



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Office Locations & Contacts[edit]

Office of the Drugs Controller,
Red Cross Road, Vanchiyoor PO,
Thiruvananthapuram – 695035.
Phone: 0471-2471896
Email ID: [email protected]
Contact link

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, India.
Phone: +91-11-23216367(CDSCO)/ 23236975
Fax: +91-11-23236973
E-mail: [email protected]
Contact link

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Eligibility[edit]

  • Manufacturer or a formulator of pharmaceutical products with a valid licence of manufacture, for export is eligible to apply.
  • The manufacturer of those drugs that are not classified under schedule F, F(1) and X, blood products, narcotics and psychotropic substances also, those manufacturers who don’t want their name and address on the label shall apply for this certificate.


Fees[edit]

  • Rupees 1,000/- per certificate or as per authorities quote.
  • Applicant shall pay the applicable Inspection charges and other charges as authorities quote.


Validity[edit]

The issued certificate shall be valid for the inspected consignment that are meant for export or as per the period mentioned on the certificate.

Documents to Use[edit]

Application form can be downloaded using the following link In this form please mention “Neutral Code” against “6. Type of Application :”.

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Sample Documents[edit]

Please attach sample completed documents which would help other people who would like to follow this procedure.


Processing Time[edit]

The whole process can be completed within 7 working days of receipt of application


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Related Videos[edit]

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%22 Video ID is "Y0US7oR_t3M".


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Instructions[edit]

  • Don’t forget to take all the originals of the document along with a copy for applying.
  • Ensure that the application is complete before submission.


Required Information[edit]

  • Name of the company
  • Address of the company
  • Names of the drugs
  • Prototype packing material including Labels, Cartons, leaflets, Blister foil etc. mentioning the specific code
  • Date of application
  • eEmail ID
  • Mobile number
  • Company letterhead


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Need for the Document[edit]

The manufacturer of drugs who desires to export drugs without indicating their name and address on the label shall obtain the neutral code approved by the respective drugs controller.

Information which might help[edit]

The neutral code is the abbreviation of the state followed by the word DRUGS and the drug manufacturing licence number.


Other uses of the Document/Certificate[edit]

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


External Links[edit]

Place some external links which might help.


Others[edit]

More information which might help people