COPP certificate in India explained for medicine exporters
A COPP certificate records one medicine's regulatory and GMP status for export. A regulator issues it, not WHO. Check the Indian route before you file.
A COPP certificate is a certificate of pharmaceutical product for one medicine. WHO calls the same document a Certificate of a Pharmaceutical Product, or CPP, under its voluntary Certification Scheme. A national regulatory authority issues it. WHO does not.
In India, start with your state or union territory authority and the ONDLS certificate service that fits the product. Ayurvedic medicines need a separate route check. Don't copy a conventional-drug filing pack across.
What does a COPP certificate contain?
The WHO model certificate records the medicine's regulatory status and manufacturing information. It includes:
- Product name, dosage form, ingredients and quantities.
- Whether the product is licensed and actually marketed in the exporting country.
- Licence-holder and manufacturer information.
- Inspection and good manufacturing practice, or GMP, information.
- Details of the certifying authority.
The WHO model treats the certificate as specific to one product, because manufacturing arrangements and approved information can differ between dosage forms and strengths, so a certificate for one strength does not cover another strength or a different dosage form. For an export file, match the certificate to the product you will ship.
A CPP does not always prove marketing authorization in the exporting country. The model has a section for products with that authorization and a section for products without it. Read the status on the certificate.
COPP versus a GMP certificate
A COPP combines product regulatory status with manufacturing and GMP information. It is not simply a factory GMP certificate. The WHO model asks about the individual medicine as well as the manufacturing arrangements.
The ONDLS services page lists WHO-GMP and COPP as separate services. Ask the importing regulator which document it wants. The names are not interchangeable.
How to approach a COPP application in India
India moved to an ONDLS framework through CDSCO notices in 2025. Check the current CDSCO and state instructions before you file. If your product is awaiting licence approval, confirm its eligibility with the authority.
Identify the authority and product
Start with the medicine, the manufacturing site, the state or union territory regulator and the documents the destination market asks for. ONDLS was developed with CDSCO and state/UT drug regulatory authorities. Don't send every application to CDSCO headquarters.
The 25 June 2025 annexure refers to applications to state authorities for WHO-GMP/COPP certificates.
CDSCO's 3 March 2020 circular describes review and joint inspection by CDSCO zonal or sub-zonal officers and the State Licensing Authority, focused on quality compliance for the product and the manufacturing process. Don't read it as a current processing-time guarantee. Use the live service for your state.
Select the relevant ONDLS service
The live certificate-services page separates COPP with inspection from COPP without inspection. The with-inspection description covers new WHO-GMP/COPP products.
Without-inspection descriptions include products obtaining WHO-GMP through ONDLS, products already holding COPP for other countries and a category labelled brand endorsement. Those labels are short. They are not a complete eligibility test. But a without-inspection label does not remove GMP oversight. Use the state selector and take the document list from that service.
Prepare information for review
The WHO sample shows the product and manufacturing information the certificate records. It does not list every supporting document for an Indian application. Get that list from the portal service or the authority.
Follow the regulator's document review and inspection route. Before you use the certificate abroad, check whether the destination regulator accepts it. A CPP is not permission to sell in the importing country. WHO sends questions about authenticity and validity to the certifying authority.
Are Ayurvedic medicine applications different?
Yes. Confirm the route before you assemble the file. The Ministry of Ayush Drug Control Cell coordinates with state licensing authorities and drug controllers, and it works with CDSCO on WHO-GMP/CoPP, export, import and quality certification.
A 2017 CDSCO delegation document says Ayurvedic manufacturer inspections for COPP involve personnel from the AYUSH Ministry and the State AYUSH Authority, alongside CDSCO's related issuance work. Confirm current inspection responsibilities, the filing channel and the checklist with the relevant AYUSH/CDSCO authority. Don't use a general AYUSH licensing notice as a COPP checklist.
Where can you find a COPP sample or PDF?
Use the WHO model Certificate of a Pharmaceutical Product as the official sample. The notes explain the fields. You cannot complete it and issue it yourself. The scheme page links implementation guidelines dated 10 October 2021. For the Indian document list, use the portal or ask the authority.
What are the COPP certificate fees and validity?
Ask the issuing authority for the Indian fee, validity, renewal term and processing time before you file. The WHO sample does not set those terms. For authenticity or validity questions, the scheme page points you to the certifying authority.
RegAffairs AI's answer on COPP applications in India includes a follow-up on Ayurvedic medicines.
What does CPP mean for FDA exports?
The US FDA issues electronic Certificates of Pharmaceutical Product. Its eCPP page, current as of 16 September 2024, says they follow the WHO format and describe US marketing status and manufacturer compliance. FDA does not issue them for human drugs that are not exported from the United States. The same page states a 24-month validity for those US certificates. That period is an FDA rule, not the validity of an Indian COPP.