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What is a COPP Certificate (Certificate of Pharmaceutical Product)?

A COPP — short for Certificate of Pharmaceutical Product — is an official document issued by a country’s national drug regulatory authority (in India, that is CDSCO) in the format recommended by the World Health Organization (WHO). It confirms that the pharmaceutical product is approved for sale in the exporting country, manufactured in a GMP-certified facility, and that the manufacturing site undergoes regular regulatory inspection. The COPP is mandatory for pharmaceutical exports and drug registration in over 80 countries worldwide. In India, as of July 15, 2025, all COPP applications must be submitted digitally through the ONDLS (Online National Drugs Licensing System) portal — physical files are no longer accepted.

What is COPP in Pharma — and Why Does It Matter?

If you manufacture or export pharmaceutical products from India, the Certificate of Pharmaceutical Product is not optional. It is the first document most importing countries ask for before they even open your dossier.

COPP Full Form

COPP stands for Certificate of Pharmaceutical Product. It is also commonly referred to as CPP (Certificate of Pharmaceutical Products) or WHO-COPP – all three terms refer to the same WHO-format export certification document.

COPP = Certificate of Pharmaceutical Product
CPP = Certificate of Pharmaceutical Products
WHO-COPP = WHO-certified version

The COPP certificate is issued by the Drugs Controller General of India (DCGI) through CDSCO, in the exact format recommended by the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

Think of it as a “passport for your medicine” — without it, your pharmaceutical product simply cannot enter the regulatory review pipeline in most importing countries. Countries in Africa, Southeast Asia, the Middle East, and Latin America routinely require a valid COPP before they begin evaluating any drug registration application from India.

For COPP in industrial pharmacy, the certificate covers every stage of the pharmaceutical manufacturing value chain — from active pharmaceutical ingredients (APIs) to finished formulations — and applies to allopathic, homeopathic, OTC, and even unapproved products destined for export under specific legal provisions.

At TraccGlobal, we have guided Indian pharmaceutical manufacturers through the entire COPP process — from eligibility assessment to ONDLS portal submission to inspection readiness. We know exactly where applications get delayed and how to prevent it.

WHAT A COPP CONFIRMS

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The pharmaceutical product is legally approved for sale (or export) in India

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The manufacturing facility holds a valid WHO GMP certificate and meets GMP standards

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The manufacturer is licensed and regularly inspected by CDSCO

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The product's quality, safety, and efficacy meet regulatory standards of the exporting country

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Drug regulatory authority inspection data and manufacturing compliance are on record

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2025–2026 Critical Update: COPP Applications Must Be Filed on ONDLS Portal Only

Effective July 15, 2025, the DCGI has mandated that all WHO GMP and COPP applications in India must be submitted exclusively through the ONDLS (Online National Drugs Licensing System) portal. Physical files and hard copies are no longer accepted at any CDSCO zonal or sub-zonal office. This is a major regulatory shift. If your consultant is still talking about offline submissions, you need a new consultant. TraccGlobal's team is fully ONDLS-trained and handles digital submissions end-to-end.

Who Can Apply for a COPP Certificate in India?

The COPP is issued by CDSCO and is available to any Indian pharmaceutical manufacturer exporting products internationally. Here’s who qualifies:

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Finished Drug Manufacturers
Companies manufacturing approved allopathic formulations — tablets, capsules, injections, syrups — that are licensed for sale in India or legally exportable.
🧪
API Manufacturers
Active Pharmaceutical Ingredient producers who need COPP documentation for their bulk drug substances being exported for formulation abroad.
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OTC & Specialty Products
Over-the-counter drug manufacturers, homeopathic product companies, and veterinary drug makers who need international market access documentation.
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Export-Only Manufacturers
Companies manufacturing products that may not be marketed domestically in India but are legally exportable under the Drugs & Cosmetics Act provisions.
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Biological / Radiopharmaceutical
Manufacturers of biologics, biosimilars, or radiopharmaceuticals who require COPP for international clinical trial or commercial supply.
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COPP Revalidation Cases
Companies whose existing COPP (valid for 2 years) is nearing expiry and need revalidation or renewal to maintain uninterrupted export compliance.

How to Get a COPP Certificate from CDSCO India (2026)

The Indian COPP process — now fully digital via the ONDLS portal — requires careful preparation. Here is exactly what happens, and where TraccGlobal supports you at every stage.

Step 1- WHO GMP Certification First

Before a COPP can be issued, your manufacturing facility must hold a valid WHO GMP certificate from CDSCO. If you don’t have this yet, TraccGlobal handles WHO GMP certification as part of an integrated engagement — so both move forward simultaneously. Only after WHO GMP data approval can the COPP application be filed on ONDLS.

Step 2- Pre-Application Eligibility Assessment

Determine whether your product falls under an approved NDA/ANDA category or qualifies as a legally exportable product. Identify which CDSCO zonal or sub-zonal office will handle your application. TraccGlobal conducts a free regulatory audit to map out your exact pathway before a single document is touched.

Step 3- Document Dossier Preparation

Compile the complete application package — manufacturing licence, Site Master File (as per WHO TRS 823), product summary sheets (Format B), stability data for 3 batches, process validation reports, HVAC/water system schematics, GMP inspection reports, and actual product labels. Incomplete dossiers are the #1 cause of COPP rejections. TraccGlobal prepares zero-error dossiers.

Step 4- ONDLS Portal Submission

Submit the COPP application exclusively through the Online National Drugs Licensing System (ONDLS) portal — no physical copies are accepted since July 15, 2025. TraccGlobal manages the full ONDLS submission workflow: portal setup, document upload, form completion, and digital sign-off.

Step 5-  CDSCO Inspection & Review

CDSCO officers review the application and conduct a joint WHO GMP inspection of the manufacturing facility. The zonal/sub-zonal officer prepares an inspection report and recommends clearance. TraccGlobal conducts mock audits to ensure your facility is inspection-ready — eliminating surprise deficiencies.

Step 6-  COPP Issuance via ONDLS/SUGAM

Upon satisfactory review, CDSCO issues the COPP digitally in PDF format through the ONDLS or SUGAM portal. The certificate is valid for 2 years from the date of issue. Total processing time: typically 2 to 4 weeks if all documents are complete. TraccGlobal tracks your application in real time and resolves queries within 48 hours.

Documents Required for COPP Application from CDSCO

Missing even one document can delay your COPP by weeks. Here is the complete checklist — TraccGlobal prepares and reviews every item before submission.

📄 Copy of Valid Manufacturing Licence
📄 Valid WHO GMP Certificate (Unit)
📄 Site Master File (as per WHO TRS 823)
📄 Manufacturing Plant Layout
📄 HVAC System Schematic (with terminal filter configuration)
📄 Water System Schematic (with circulation loop and MOC)
📄 Master Manufacturing Formula & Process
📄 Finished Product Specification & Method of Analysis
📄 Stability Study Evaluation — 3 batches (Format-A)
📄 Process Validation Report — 3 batches
📄 Analytical Method Validation Report
📄 Product Summary Sheet (Format-B)

COPP in Industrial Pharmacy: A Critical Export Enabler

In the world of industrial pharmacy, a COPP is far more than a compliance checkbox — it is the key that unlocks global market access for Indian pharmaceutical manufacturers. India is the world’s third-largest pharmaceutical producer by volume and a leading supplier of generic medicines to over 200 countries. Yet, many Indian manufacturers lose export contracts simply because their COPP documentation is incomplete, expired, or filed incorrectly.

The COPP enables national drug regulatory authorities (NDRAs) in importing countries — especially those with limited QA capacity — to rely on India’s regulatory rigour rather than conducting their own full inspections. Countries across Africa, Southeast Asia, the Middle East, Latin America, and the CIS region require a valid COPP as a precondition for drug registration. Without it, your product registration application will not even reach the evaluation stage.

TraccGlobal specialises in helping Indian industrial pharma companies navigate the WHO GMP and COPP pathway efficiently — from facility readiness to digital ONDLS submission. We handle the full regulatory lifecycle, so your export pipeline stays uninterrupted.

Countries That Commonly Require COPP from India:

NGNigeria
ETEthiopia
ZASouth Africa
KEKenya
TZTanzania
VNVietnam
PHPhilippines
MYMalaysia
SASaudi Arabia
AEUAE
BDBangladesh
MMMyanmar
RORomania
UZUzbekistan
BRBrazil

How We Helped a Mid-Size Indian Pharma Company Get Their COPP in 3 Weeks

CASE STUDY — 2025
Haryana-Based Oral Solid Dosage Manufacturer — COPP for African Markets
A Haryana-based pharmaceutical company with a WHO GMP-certified facility approached TraccGlobal after their COPP application was rejected twice — once because their Site Master File did not align with the latest WHO TRS 823 format, and a second time because their stability data was submitted in an incorrect format.
TraccGlobal conducted a full regulatory gap assessment, rebuilt the entire dossier — including updated stability reports and revised plant layout schematics — and submitted the application through the ONDLS portal.
The COPP was issued 19 working days from submission.
19
Working days to COPP issuance
6
African markets unlocked
0
Inspection deficiencies found
2×
Previous applications had failed

Why Indian Pharma Companies Choose TraccGlobal for COPP

We are not a generic compliance firm. We are deep pharmaceutical regulatory specialists who live and breathe WHO GMP and COPP processes.

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ONDLS Portal Experts
We are fully trained on India's new mandatory digital COPP submission system. Our team handles ONDLS account setup, document upload, digital signatures, and query management — end to end.
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Zero-Error Dossiers
Our 98% first-attempt approval rate comes from meticulous dossier preparation. We cross-check every document against the latest CDSCO guidelines before a single file is uploaded.
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Mock Inspection Audits
We conduct WHO GMP mock audits at your facility before CDSCO inspection — identifying gaps in real time, not after rejection. Our team has cleared 100% of inspections.
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48-Hour Query Response
CDSCO queries are time-sensitive. We resolve all regulatory queries within 48 hours — preventing delays in your COPP timeline.
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Export Market Intelligence
We advise on importing country requirements simultaneously — so your COPP application is tailored for your target markets.
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COPP Revalidation Support
A COPP is valid for 2 years. We manage your renewal pipeline proactively — giving advance notice and handling revalidation smoothly.

Frequently Asked Questions (FAQ) — COPP Certificate

What is the full form of COPP in pharma?

COPP full form is Certificate of Pharmaceutical Product. It is also abbreviated as CPP (Certificate of Pharmaceutical Products). Both terms refer to the same WHO-format document issued by a national drug regulatory authority — in India, issued by CDSCO (Central Drugs Standard Control Organisation) — confirming that a pharmaceutical product is approved for sale and manufactured under GMP conditions in the exporting country.

In India, the COPP is issued by CDSCO (Central Drugs Standard Control Organisation) under the Drugs Controller General of India (DCGI). Applications are processed through CDSCO’s zonal and sub-zonal offices, and since July 15, 2025, all applications must be submitted exclusively through the ONDLS (Online National Drugs Licensing System) portal. The zonal/sub-zonal officer is authorised to issue the COPP on behalf of the DCGI after satisfactory joint inspection.
 
A COPP issued by CDSCO is valid for 2 years from the date of issue (notarization). After this period, manufacturers must apply for COPP revalidation/renewal, providing updated export data for the last 2 years and any changes to the manufacturing facility or product. TraccGlobal recommends starting the revalidation process at least 90 days before expiry to avoid any gap in export compliance.
 
A WHO GMP certificate confirms that your manufacturing facility meets WHO Good Manufacturing Practice standards — it covers the site/plant. A COPP (Certificate of Pharmaceutical Product) is product-specific — it confirms that a specific pharmaceutical product is approved, manufactured under GMP, and eligible for export. You need a valid WHO GMP certificate first before CDSCO can issue a COPP. Think of WHO GMP as the facility credential and COPP as the product-level export credential.
 
The government fee for COPP from CDSCO is ₹1,000 per certificate copy per country (or per country annexure, validation annexure, stability annexure, etc.). An additional ₹500 per product is charged for each additional strength or formulation variant. For WHO GMP unit certificates, the fee is ₹1,000 per list of 10 products. These are CDSCO’s official fees; professional consultancy fees from TraccGlobal are separate and based on the scope of work. Contact us for a transparent fee quote.
 
If all documents are complete and the manufacturing facility is inspection-ready, the COPP is typically issued within 2 to 4 weeks from the date of ONDLS application. This includes application review, joint WHO GMP inspection, and certificate issuance. Incomplete applications, dossier errors, or inspection deficiencies can extend this to 2–3 months or result in rejection. TraccGlobal’s proactive approach — mock audits, zero-error dossiers, and 48-hour query resolution — regularly keeps timelines at the 2–3 week mark.
Yes, the COPP is mandatory for pharmaceutical exports to most countries globally. Over 80 countries require a valid COPP as part of the drug registration dossier submitted to their national drug regulatory authority. Countries in Africa, Southeast Asia, the Middle East, Latin America, and the CIS region particularly require this. Without a COPP, your drug registration application will typically not be accepted for evaluation in these markets. Some developed markets (US, EU) have their own certification systems, but a COPP is still valuable for facilitating bilateral regulatory reliance.
Effective July 15, 2025, CDSCO stopped accepting physical/hard copy applications for WHO GMP and COPP. All applications must now be submitted exclusively through the ONDLS (Online National Drugs Licensing System) portal, developed by C-DAC under the Union Health Ministry. This is a permanent shift — not temporary. All zonal and sub-zonal CDSCO offices, as well as all State and UT Drug Controllers, have been instructed to reject physical files. TraccGlobal is fully equipped to manage end-to-end digital submissions on ONDLS.
Yes, a manufacturer can apply for COPP for multiple pharmaceutical products in a single application batch, provided all products are manufactured at the same WHO GMP-certified facility. Each product’s documentation (stability data, validation reports, Format-B summary sheets, certificates of analysis) must be submitted individually. The fee of ₹500 per additional product applies. TraccGlobal typically handles multi-product COPP applications as a package engagement, ensuring consistency across all product dossiers.
The key documents include: valid manufacturing licence, WHO GMP certificate, Site Master File (WHO TRS 823 format), manufacturing plant layout, HVAC and water system schematics, master manufacturing formula, finished product specifications, stability data for 3 batches, process validation reports, analytical method validation, product summary sheets (Format-B), certificates of analysis for 3 batches, actual product labels, list of technical staff and equipment, SOPs/STPs list, and export data for the last 2 years (for revalidation). TraccGlobal provides a complete document readiness checklist during the initial consultation.
In industrial pharmacy, COPP (Certificate of Pharmaceutical Product) is an official export certification document that enables large-scale pharmaceutical manufacturers to register and market their products in foreign countries. It is the foundational document in any international drug registration dossier — confirming GMP compliance, product approval status, and regulatory oversight in the exporting country. For industrial pharma companies targeting markets in Africa, Asia, and the Middle East, a valid COPP is non-negotiable for market entry.

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