Maharashtra - Apply for Certificate of Pharmaceutical Products (COPP)

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Procedure

Apply In-Person:

1. The applicant shall approach their “Deputy drug controller (DDC) / Assistant drug controller (ADC)” of respective “CDSCO” zonal / sub zonal offices under whose dominion the applicant is operating to submit their application in person (if submission in person is accepted).
2. Link for contact details: link AND Sub-zonal office link please look for the sub zonal office contact details and if your area contact details are listed then use them accordingly.
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. Applicant shall get all the required documents as advised. If there is a shortfall in document requirement, the application won’t be processed.
5. 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 (if submission in person is accepted). Otherwise, this application set shall be submitted through mail as per the address provided under the “Office Locations & Contacts” section of this page.
6. Once the application is received, 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 allot them to the respective inspecting team for the inspection.
7. An acknowledgement is sent to the applicant on receipt of the application. Please keep it safe for future reference.
8. If there is any shortfall in the details or documents, the department sends a query letter to the applicant.
9. Authority will attach a separate checklist to the application to keep a track of the processing of the application for “COPP” certification. If all are in place, an inspection team is constituted for further processing.
10. ”SMS” triggered update on application status will be sent to the applicant’s mobile.
11. Applicant will get information about the inspection and date for the inspection.
12. On the scheduled date, the inspection will be conducted by “CDSCO” officials as per “WHO” guidelines. Inspection on sterile products, Non-sterile products and other relevant guide-lined scrutiny will take place.
13. A self-appraisal checklist should be submitted to “CDSCO” officer before the inspection.
14. The inspectors will record their finding and observations as an inspection report and the same will be briefed.
15. Once the verification and inspection is over, respective zonal /sub-zonal certifying authority prepares “Review report” based on the review of the observations of check list and written inspection report from the inspection team as per “WHO GMP” guidelines.
16. The certifying authority will evaluate all the inputs and if found satisfactory, the “COPP” certificate will be generated.
17. The status, viz. Approval or Rejection if any will be conveyed to the applicant through an SMS or email or as per applicable norms.
18. The “COPP” certificate will be signed along with the seal of the respective certifying authority.
19. If approved, the certificate will be hand delivered or sent through post to the address mentioned while applying or issued as per applicable norms.
    

NOTE:

• If in case of rejection after inspection, the firm may reapply after 5months from the date of rejection.
• 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

• Application form.
• Covering letter indicating the purpose of “COPP”.
• Copy of valid “WHO-GMP” certificate.
• Copies of master formula records maintained by firm - wherever required.
• Copies of the product approvals for applied drugs.
• Copies of manufacturing licence.
• List of products for which “COPP’s” are required.
• Copies of the product permission letters of the requested products for the issue of “COPP’s”.
• Formats of “COPP”
• Stability data (3 batches) accelerated / real time.
• Copy of the power of attorney/authorization letter.
• Master validation plan.
• Process validation for 3 batches of each product.
• Quality manuals.
• Specifications.
• List of standard operating procedures (SOP’s).
• Manufacturing layout.
• List of primary and secondary impurity and reference standards/cultures available with the firm.
• Recent organization charts.
• List of personnel along with their qualifications and training.
• Floor-plans.
• List of instrument(s)/equipment(s) including number of computers.
• Procedures being followed to maintain security and integrity of computerized data and records.
• Demand draft for the advised amount.
• Company PAN card.
• Aadhaar card of directors.
• Self-declaration.
• Self-addressed envelope with stamp.
  

Note: Apart from the above listed documents, authorities may ask for additional information or document. Please provide them for smooth processing.

Office Locations & Contacts

CDSCO, Zonal office, West zone,
4th Floor, Zonal FDA Bhawan, GMSD Compound,
Bellasis Road, Mumbai Central, Mumbai-400 008.
Phone: 91-22-23002279, 23002215, 23092971, 27823483
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

• Any person/company/partnership firm/LLP can apply for this licence.
• A pharmaceutical manufacturer with a valid manufacturing licence and “GMP” licence shall apply for this certificate in order to export their produced products to foreign countries.
• Applicant (company) having competent technical staff on roll are eligible to apply.
  

Fees

• A prescribed fee of Rs. 500/- (or the advised amount) plus service tax per “COPP” should be paid.
• A fee of Rs. 100 (or the advised amount) plus service tax for each additional copy for each product in the form of demand draft (DD) / Pay Order drawn in favor of the drug's controller for the respective state or as per the office applicable for this state.
• Applicant shall pay the applicable inspection charges and other charges as per authorities quote.
  
• Please refer page number 7 and 13 in the following link for fee details: link
  

Validity

The validity of the certificate shall be for three years from the date of grant of the Certificate or as per the period mentioned on the certificate.

Documents to Use

Please attach documents that can be used by people. e.g. links

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Sample Documents

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

Processing Time

The “COPP” is generally issued within 20 working days from the date of application or as per the prescribed timeline of the certifying department.

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%22 Video ID is "Y0US7oR_t3M".

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Instructions

• Please follow the below guidelines for “COPP” certification.
  • Establish good written procedure.
  • Maintain “SOP” documents.
  • Validate the process.
  • Facility design from start to end.
  • Maintenance of records.
  • Trained and skilled staff.
  • Maintain good hygiene.
  • Proper maintenance of production facility and equipment.
• Don’t forget to take all the originals of the document along with copy for applying.
• Ensure that application is complete before submission.
  

Required Information

• Name of the company
• Address of the company
• Names of the drugs
• Date of application
• email ID
• Mobile number
• Company letter head
  

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Need for the Document

• The certificate of pharmaceutical products (COPP) helps the regulator to ensure, that the drugs are consistently produced and are quality controlled before they leave the country.
• The Certificate of pharmaceutical products (COPP) is required by the importing country when the product in question is intended for registration (licensing, authorization) or renewal of registration, with the scope of commercialization or distribution in that country.
• The certificate of pharmaceutical products (COPP) has been recommended by “WHO” to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as prerequisite of registration or importation.
  

Information which might help

• In case of rejection, the same firm shall reapply after 5 months provided, the applicant clears earlier compliance with documentary evidences.
• Adhere to “COPP” practices and techniques.
• The “COPP” certification increases the business worth and business value.
• The “COPP” certification enhances the company reputation in the international market for doing business.
  

Other uses of the Document/Certificate

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

External Links

Please follow the link for additional information: link

Others

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