Certificate of pharmaceutical product (COPP) the top most important documents in exports lets dig it for Indian Pharma manufacturing fraternity
What is COPP?
The Certificate of a Pharmaceutical Product (COPP) is an official document issued by the national regulatory authority (NRA) of the exporting country in the WHO-recommended format.
- A pharmaceutical product is approved for sale in the country of manufacture
- It is manufactured in a GMP-certified facility (Good Manufacturing Practice),
- It is safe and high quality for export to other countries.
Think of it as a “passport” for your medicine to travel and get registered in other countries.
Why is COPP Important for Manufacturer?
COPP is a key requirement for drug registration in many countries, especially those that rely on WHO standards.
It helps you:
- Enter new international markets (Africa, Asia, Middle East, Latin America, CIS countries, etc.)
- Prove that your product is genuine, safe, and GMP-compliant
- Speed up approval from foreign regulatory authorities
Without COPP, your product may not be accepted for registration or import.
📄 Types of COPP
Three types COPP based on the type of GMP certification
| Type of COPP | Based On | Issued By | Validity | Purpose / Use |
| WHO-Type COPP | WHO-GMP Certificate | CDSCO / State FDA | Up to the validity of WHO-GMP | Required for exports to countries following WHO guidelines |
| State-GMP COPP | State GMP Certificate | State Licensing Authority | Up to 2 years | For exports where WHO-GMP is not mandatory but GMP is required |
| Non-GMP COPP | No GMP requirement | State Licensing Authority | Up to 2 years | For countries that do not require GMP certification for registration |
📄 Documents Required to Get COPP from CDSCO
- Covering Letter
- Application in Form 41
- Valid Manufacturing License (Form 25/28)
- Valid GMP Certificate
- Site master file (SMF)
- Product Permission / Marketing Authorization
- Product labels, artwork, packaging
- Batch Manufacturing Record (BMR)
- Batch Analysis Report
- Stability Study Report (as per ICH guidelines)
- Product samples (if required)
- Fees Payment Proof
How to Apply for COPP in India.
Step-by-Step Process:
Option 1: Apply via CDSCO SUGAM Portal (For Central License Products) |
Option 2: Apply via ONDLS Portal(For State-License Products) |
|
Step: 1 |
Register on SUGAM Portal |
Register on ONDLS Portal |
Create a user ID as a manufacturer or authorized agent |
Register as a manufacturer or agent | |
Upload basic documents like manufacturing license and contact details |
Choose your state during signup | |
Step: 2 |
Prepare Documents all necessary documents |
Fill Application |
Select product and upload necessary documents |
Go to: “COPP → Apply New” |
|
Select product and upload necessary documents |
||
System allows you to choose type of COPP |
||
Step: 3 |
Submit Application |
Submit to State Authority |
Go to: Post Login Activities → Certificate of Pharmaceutical Product (COPP) |
Application is routed to the respective State Drug Licensing Office |
|
upload documents, and submit the application under Form 41 |
They may inspect your facility for GMP verification (if needed) |
|
Step: 4 |
Pay Fees |
Pay Fees |
Make the payment online or via challan and upload proof |
Make the payment online or via challan and upload proof |
|
Step: 5 |
Inspection (if required) |
Approval & forwarding |
CDSCO may arrange a WHO-GMP inspection if your site is not recently inspected |
Once approved at the state level, the application is forwarded to CDSCO HQ (if required) |
|
Step: 6 |
Receive COPP |
Receive COPP |
Digital COPP issued on the SUGAM dashboard |
You will receive a digital certificate on the ONDLS portal |
|
Download and print it |
Some states also offer physical COPP with stamp & seal |
|
Request physical copy if required by importing country |
||
Which Countries Accept COPP?
COPP is accepted in countries that follow WHO guidelines, such as:
- Africa: Nigeria, Kenya, Ghana, Ethiopia
- Middle East: UAE, Saudi Arabia, Oman, Qatar
- Asia: Vietnam, Bangladesh, Sri Lanka, Philippines
- Latin America: Peru, Bolivia, Colombia
- CIS Countries: Kazakhstan, Uzbekistan, Kyrgyzstan
- Others: Nepal, Myanmar, and more
These countries require COPP to register and import pharma products from India and other nations.
Validity of COPP
COPP is usually valid for 2 years from the date of issue.
It becomes invalid if:
- The product formula changes
- The manufacturing site changes
- The license or GMP certificate expires
Who Issues COPP?
In India:
- Issued by Central Drugs Standard Control Organization (CDSCO)
- After evaluation by Zonal or Sub-Zonal CDSCO offices and State Licensing Authorities (SLA)
Other issuing authorities globally:
- USFDA (USA)
- EMA (Europe, though usually provides other documents)
- MHRA (UK)
- TGA (Australia)
- Health Canada (Canada)
What Details are mentioned in COPP?
| Field | Description |
| Product Name | Brand or generic name of the drug |
| Dosage Form & Strength | e.g. Tablet 500 mg |
| Composition | Active ingredients with quantity |
| Marketing Authorization No. | License number and date from Indian authority |
| Manufacturer Name & Address | Complete manufacturing site details |
| GMP Status | Confirmation that facility follows WHO-GMP |
| Country of Origin | e.g. India |
| Date of Issue | Date on which COPP is issued |
| Issuing Authority | CDSCO with official signature and stamp |
Digital or Physical COPP?
CDSCO usually issues COPP in digital format (PDF) through the SUGAM portal & ONDLS Portal.
Digital COPP includes:
- Digital signature
- Online verifiable certificate
- Physical copies (with stamp & seal) can be requested if:
- Required by foreign country
- You need to submit it to the embassy or trade office
Always confirm with the importing country’s requirements.
⏱️ Timelines to Receive COPP from CDSCO
| Step | Approximate Time Required |
| Application Submission | 1 day |
| Document Review by CDSCO | 7–15 working days |
| GMP Inspection (if required) | Additional 7–10 working days |
| Issuance of COPP | After approval, within 5 days |
Average total time: 2 to 4 weeks depending on completeness of documents and inspection.
Conclusion:
COPP is a crucial certificate that proves your pharmaceutical product is safe and manufactured under quality standards. For manufacturer, getting COPP from CDSCO opens doors to international markets and speeds up product approval. It ensures trust between exporters and importing countries. By preparing the right documents and following the process, you can get your COPP smoothly and grow your pharma exports with confidence.
This artical has been researched, crafted and curated by the the team member Nidhi Patel from the regulatory team of Conical Pharmaceuticals.
