COPP Certificate in India: Certificate of Pharmaceutical Product (COPP) and WHO-GMP for Pharma Exports

COPP Full Form and What a COPP Certificate Is

The COPP full form is Certificate of Pharmaceutical Product. A COPP is an official certificate, issued by the regulatory authority of the exporting country, that tells the importing country three things about a medicine: that it is licensed for sale in the exporting country (or why it is not), that the manufacturer is licensed to make it, and that the manufacturing site is regularly inspected and complies with good manufacturing practice as recommended by the World Health Organization.

The certificate of pharmaceutical product COPP format comes from the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, which WHO set up in 1969 and has revised several times since. Under the scheme, the importing country's regulator relies on the exporting country's regulator to vouch for the product and the site, instead of inspecting every foreign factory itself. That is why so many importing countries, especially in Africa, Asia, Latin America and the Commonwealth of Independent States, ask for a COPP before they will register an Indian medicine.

For manufacturers in India, the COPP certificate is the gateway document for export registration. It is product-specific and usually issued for a named importing country, and it rests on the site's WHO-GMP status. Without it, most export dossiers cannot even be submitted.

COPP at a glance

Why Importing Countries Ask for a COPP

Regulators in many importing countries do not have the resources to inspect every overseas factory. A COPP lets them register a product on the strength of an assessment already done by the exporting country's regulator. In practice, a COPP certificate is used to:

• Register the product with the importing country's medicines regulator
• Take part in tenders run by health ministries, hospitals and international procurement agencies
• Confirm GMP status of the site without a separate inspection by the importing country
• Show market status, that is, whether the product is approved and actually sold in India
• Support renewals of existing registrations abroad, which often need a fresh COPP

Each importing country decides what it accepts. Some want the COPP issued in their name, some want it legalised by their embassy, and some set a maximum age for the certificate at the time of submission. Checking the importing country's requirements before you apply saves a second application later.

Markets that commonly ask for a COPP

This is a general guide only; each country's requirements change. Highly regulated markets such as the USA, the EU and Japan generally rely on their own approvals and inspections rather than a COPP, although a COPP may still be asked for in some filings.

Who Issues a COPP in India?

In India, the WHO-GMP certificate and the COPP are handled jointly by two regulators. The State Licensing Authority, which granted the manufacturing licence, and CDSCO, through its zonal or sub-zonal office for that region, work together under a procedure set by the Drugs Controller General of India. For a site in India, that means the State Drug Licensing Authority.

Under CDSCO's procedure, the CDSCO zonal or sub-zonal office reviews the application and, where needed, plans a joint inspection of the site with officers of the State Licensing Authority. The joint team assesses the site against WHO good manufacturing practice, and the CDSCO office then recommends issue, further compliance or rejection to the State Licensing Authority. For first-time applicants, the COPP is issued only after any deficiencies found at inspection have been corrected.

Since 15 August 2025, applications for WHO-GMP and COPP are accepted only online on the Online National Drugs Licensing System (ONDLS); CDSCO's zonal offices were told not to accept physical files after that date. State Licensing Authorities verify and approve product lists on the same system.

WHO-GMP Certificate and COPP: How They Fit Together

The WHO GMP certificate and the COPP are often mentioned together, but they are different documents:

In practice, the WHO-GMP status of the site comes first, and COPPs are then issued for the products made there. When a new product is added, the site's earlier joint inspection can often support it: CDSCO's procedure allows firms that were jointly inspected within the previous two years, and found compliant, to add products without a fresh inspection.

Eligibility for a COPP Certificate

To apply for a COPP certificate, a manufacturer in India needs:

1. A valid drug manufacturing licence (Form 25 or Form 28, or a loan licence on Form 25A or 28A) covering the product
2. Product permission: the product must be approved for manufacture in India; a new drug needs CDSCO's permission first
3. A site that complies with WHO-GMP, demonstrated through the joint inspection or a recent compliant inspection
4. Validation and stability data for each product, normally for three batches
5. A Site Master File and quality system documents in the WHO format

Products made only for export and not sold in India can still receive a COPP, but the certificate will show that the product is not on the Indian market and the reason, which some importing countries treat differently. Plan this before you choose an export-only formulation.

Planning exports product by product

It is tempting to list every product in the first COPP application, but a focused list usually works better. Start with products that have complete validation and stability data, a steady manufacturing history and clear demand in your target markets. For hot and humid markets, check that the stability studies cover the right climatic zone, typically Zone IVb conditions of 30 °C and 75% relative humidity for much of Africa and Southeast Asia, because importing regulators will ask for it. Products without that data can be added later, once the studies are complete, using the two-year inspection window. A smaller, well-documented first list moves faster through review and inspection and builds a good record with the regulators.

Revised Schedule M and COPP

India's revised Schedule M, notified at the end of 2023, brought domestic good manufacturing practice much closer to WHO-GMP, with new requirements for a pharmaceutical quality system, quality risk management, product quality reviews, validation and computerised systems. After phased deadlines for large and small manufacturers, it now applies across the industry. For exporters, this is good news: a site that genuinely complies with revised Schedule M is far better prepared for a WHO-GMP joint inspection, and the gap between the two standards is smaller than it used to be. Regovex reviews your site against both before you apply.

Building an Export-Ready Quality System

A COPP is only as strong as the quality system behind it. Before applying, make sure the site can show:

• A pharmaceutical quality system with clear quality policy, management review and defined responsibilities for the quality unit
• Quality risk management applied to changes, deviations and supplier decisions
• Product quality reviews for each product, at least annually, with trend analysis
• Process validation for three batches of each product, and a plan for continued verification
• Cleaning validation for shared equipment, with justified limits
• Stability programmes that support the shelf life and storage claims, including for the export climate zone
• Deviation, change control and CAPA systems that are used and closed on time
• Out-of-specification investigations carried out to a documented procedure
• Data integrity in the laboratory and production, with audit trails on computerised systems
• Supplier qualification for active ingredients and critical materials
• Training records showing that staff are trained on the procedures they follow

Many sites that pass domestic inspections still find gaps in data integrity, cleaning validation and stability for hotter climate zones when they first prepare for WHO-GMP. Addressing these early prevents major observations at the joint inspection.

COPP Documents Required

The COPP documents CDSCO's procedure lists for grant, revalidation or addition of products usually include:

• Application from the manufacturer on ONDLS, with the products and importing countries
• Site Master File in the WHO format
• Copy of the manufacturing licence with the approved product list
• List of products already approved for WHO-GMP and products now applied for
• Product permissions or approval letters for each product
• Composition, specifications and methods of analysis
• Stability data for three batches of each product
• Process validation for three batches of each product
• Product summary sheet covering batches, stability and validation status
• Lists of SOPs and standard testing procedures
• List of equipment and instruments
• List of technical staff with qualifications, and the organogram
• Layout plan of the site, and water and HVAC system schematics
• Labels and packaging for the products

The documents CDSCO reviews most closely are the Site Master File, the validation and stability data and the product summary sheets, because they show whether the site can make each product consistently.

The Site Master File: what to include

The Site Master File is the first document the CDSCO office reads, and it shapes the whole inspection. Following the WHO format, it should describe the company and the site, the quality management system, personnel and training, premises and equipment, documentation, production, quality control, distribution and complaints, recalls and self-inspection. Include site and floor plans, water and HVAC schematics and a list of products made. Keep it factual and current: inspectors compare it with what they see, and a Site Master File that describes processes the site no longer follows creates observations by itself. Update it whenever the site, equipment or product list changes, so it is ready for each new COPP documents set.

COPP Application on ONDLS: Step by Step

The COPP application process runs in this order:

1. Gap check. Review the site, the quality system and each product's data against WHO-GMP and revised Schedule M.
2. Prepare the Site Master File and product files, including the product summary sheets.
3. Register and apply on ONDLS or your state drug licensing portal for WHO-GMP and COPP, listing the products and the importing countries.
4. Document review by the CDSCO zonal or sub-zonal office.
5. Joint inspection of the site by CDSCO and State Licensing Authority officers, where required.
6. Compliance report. Close any observations with corrective and preventive actions and evidence.
7. Recommendation by the CDSCO office to the State Licensing Authority.
8. Issue of the COPP for each product and importing country.

Preparing for the joint inspection

The joint inspection is where most COPP applications succeed or stall. Inspectors look at the whole quality system, not only the export product: batch records, deviations and change controls, out-of-specification investigations, validation, cleaning validation, water and HVAC systems, data integrity in the laboratory and the training of staff. Run a mock inspection first, close the gaps, and make sure the people who will face the inspectors can explain their own procedures. Observations are graded by seriousness, and critical or major findings must be closed before the COPP is recommended.

What inspectors typically find

Observations at WHO-GMP joint inspections tend to repeat across sites. The most common are:

• Batch records that are incomplete, corrected without explanation or completed after the event
• Deviations and out-of-specification results closed without a real root cause or effective CAPA
• Cleaning validation missing for shared equipment, or limits without justification
• Laboratory computerised systems without audit trails, shared passwords or deleted data
• Stability studies that do not cover the shelf life claimed, or missing climatic-zone data
• Water system and HVAC monitoring with gaps or out-of-limit results not investigated
• Training records that do not match the procedures staff actually follow
• Supplier qualification for active ingredients based only on certificates of analysis

Each of these can be fixed before the inspection with a focused internal review. Regovex's mock inspections are built around this list.

COPP Timelines

Under CDSCO's procedure for WHO-GMP and COPP, timelines run from receipt of a complete application:

These are regulatory timelines, not total project time. Preparing the Site Master File, validation and stability data, and closing inspection observations usually take longer than the official steps, so start well before the export deadline.

A typical COPP project timeline

For a site that is already compliant, the whole process can be completed within two to three months. For a site preparing for its first WHO-GMP inspection, the preparation work usually decides the total time.

COPP Validity and Revalidation

COPP validity is stated on each certificate and is tied to the site's WHO-GMP status: when the WHO-GMP cycle ends or the site's status changes, COPPs based on it need revalidation. Importing countries also set their own rules; many accept a COPP only if it was issued within a set period before the dossier is submitted, so a certificate that is still valid in India may be too old for a particular importing country. Track both the Indian validity and each importing country's age limit, and apply for revalidation in good time, using the same ONDLS route.

COPP fees

Government fees for WHO-GMP and COPP are charged according to the current schedule on the portal, and depend on factors such as the number of products and countries. Confirm the amount payable on ONDLS when you apply. Regovex gives a written estimate of government and professional fees before work begins.

After the COPP: Keeping Export Status Current

Getting the first COPP is the beginning, not the end. To keep exporting smoothly:

• Track WHO-GMP and COPP validity for every product and country, and start revalidation well before expiry
• Keep the WHO GMP certificate and the site's quality system current, because every COPP depends on them
• Add new products to the site's WHO-GMP status before they are needed for export, using the two-year inspection window where it applies
• Report significant changes to the site, equipment or processes, which may need a fresh inspection
• Maintain product quality reviews and stability data, which importing regulators may also ask to see
• Keep export documents consistent, with the same product names, strengths and site details across the COPP, free sale certificate and the importing country's registration

Regovex keeps a validity calendar for every COPP and certificate we handle, so renewals and revalidations are filed before they hold up a shipment or a tender.

COPP Format: What the Certificate Says

The COPP format follows the WHO model certificate of a pharmaceutical product. Importing regulators read it field by field, so every entry must be accurate:

The status of the holder matters for contract and loan manufacturing: a brand owner with a loan licence, and a product made at a host site, must be shown correctly, and the site details must match the WHO-GMP inspection.

COPP vs Free Sale Certificate vs Other Export Documents

Importing countries often ask for several documents at once. They are easy to confuse:

A free sale certificate is simpler and quicker to obtain, but it does not carry the GMP assurance of a COPP, which is why most regulated and semi-regulated markets insist on the COPP. Plan the full set of documents for each importing country together, so they show the same product names, strengths and site addresses.

The COPP inside a full export dossier

A COPP opens the door, but importing regulators usually want a complete registration dossier too. Depending on the country, this can include a dossier in the Common Technical Document format, the active ingredient's Drug Master File or certificate of suitability, bioequivalence studies for generics, stability data for the country's climatic zone, samples, labels and leaflets in the local language, and a local agent's authorisation. Prepare these alongside the COPP, so that the certificate does not age while the dossier is still being written. Keeping the product name, strength, composition and site details identical across the COPP, the dossier and the labels is the single most important consistency check.

Legalisation and Apostille of a COPP

Many importing countries require the COPP to be authenticated before they accept it. India is a member of the Hague Apostille Convention, so for member countries the certificate is usually apostilled through India's Ministry of External Affairs, after any attestation the issuing state requires. Countries outside the Apostille Convention generally require legalisation by their embassy or consulate in India, sometimes with prior attestation by the Ministry of External Affairs or a chamber of commerce. Requirements change and differ by country, so confirm the route with the importing country's regulator or your local partner before the certificate is issued, and allow time for it in your export plan.

COPP for Different Exporters

• Manufacturers with their own plant apply for WHO-GMP and COPP for products made at their site.
• Loan licensees can obtain COPPs for products made under their loan licence at a WHO-GMP compliant host site, with the host and the loan licence shown correctly on the certificate.
• Merchant exporters who do not manufacture usually rely on the manufacturer's COPP for the product they export, with the manufacturer's agreement.
• Export-only products can receive a COPP stating that the product is not marketed in India, which some importing countries accept and others do not.

Loan licence and contract manufacturing: getting the details right

When a product is made under a loan licence or by a contract manufacturer, the COPP certificate must show the relationship accurately, because importing regulators check it against the dossier and the label. The product licence holder, the holder's status (manufacturer, packer or neither), the actual manufacturing site and the site's WHO-GMP status all appear on the certificate of pharmaceutical product. A brand owner that holds a loan licence at a host site is usually shown as the licence holder, with the host site as the place of manufacture; a brand owner that only markets a product made under the manufacturer's own licence is not the licence holder at all.

Before applying, agree with the host or contract manufacturer who will apply, whose name will appear where, and who keeps the Site Master File and inspection records up to date. Put this in the manufacturing agreement, including what happens to export registrations if the arrangement ends. Our Loan License page explains how loan licences work, and Regovex can coordinate the COPP application between the brand owner and the host so the certificate matches both licences.

Common Mistakes in COPP Applications

• Applying before the site is genuinely ready for a WHO-GMP joint inspection
• Missing or incomplete validation and stability data for the products listed
• A Site Master File that does not match the site as it actually operates
• Product names, strengths or compositions that differ between the licence, the COPP application and the export dossier
• Not checking the importing country's age limit and authentication requirements
• Forgetting to revalidate COPPs when the WHO-GMP cycle ends
• Filing physical applications after online-only filing on ONDLS became mandatory

Checklist Before You Apply for a COPP

• Manufacturing or loan licence valid and covering every product to be listed
• Product permissions in place, including CDSCO permission for any new drug
• Gap assessment against WHO-GMP and revised Schedule M completed and gaps closed
• Site Master File current and in the WHO format
• Three-batch process validation and stability data available for each product
• Product summary sheets prepared
• Equipment, staff and SOP lists, layout and water and HVAC schematics ready
• Importing countries' COPP, age-limit and authentication rules confirmed
• ONDLS account active with an authorised signatory
• Mock inspection carried out and observations closed

Working through this list before applying is the most reliable way to keep your COPP application within CDSCO's 21 or 28 working-day recommendation period.

How Regovex Handles Your COPP Certificate in India

1. Free export readiness check. We review your licence, products, target countries and each country's COPP and authentication rules.
2. Gap assessment of the site and quality system against WHO-GMP and revised Schedule M.
3. Site Master File and product files, including validation, stability and product summary sheets.
4. Mock inspection and help closing gaps before the joint inspection.
5. Application on ONDLS or your state drug licensing portal with the products and importing countries.
6. Inspection support and compliance reports for any observations, with query replies within 24–48 hours.
7. Issue, authentication and revalidation tracking for every COPP, plus the free sale and other export certificates you need.

Why Exporters Choose Regovex as Their CDSCO Registration Consultant

• Manufacturing licence and COPP together. As a drug license consultant that also handles manufacturing and loan licences, we see the whole chain the inspectors will check.
• Inspection readiness, not just paperwork: Site Master Files, validation reviews and mock inspections.
• Export market awareness, with document sets planned for each importing country.
• State FDA approval and CDSCO experience across Delhi NCR and Uttar Pradesh, as a CDSCO registration consultant and drug regulatory consultant in India.
• Clear pricing, with government and professional fees shown separately in writing.
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback.

COPP Certificate Services in India and Nearby Areas

Regovex supports pharmaceutical manufacturers, loan licensees and exporters in India with WHO-GMP, COPP and export certificates. Documents are prepared with your quality team, and applications are filed on ONDLS or your state drug licensing portal. Our office is in Aligarh, and we work with clients across Delhi NCR, Uttar Pradesh and the rest of India.

We also serve exporters in .

Related services:

• Drug Manufacturing License in India
• Loan License (Drug, Cosmetic, Medical Device)
• CDSCO Registration in India
• Drug Test License
• Drug License in India

What Our Clients Say

I got my Drug Wholesale License through Regovex Consulting, and Devansh and his team provided complete end-to-end support, from premises selection to timely approval. — Bilal Ahmed Khan, Founder, Medwell Pharma