Certificate of Pharmaceutical Product (COPP) for Exporters
A COPP certificate is the WHO-format document that importing countries ask for before they register an Indian medicine. CDSCO issues it to licensed manufacturers after checking WHO-GMP compliance, often with a joint inspection, and applications are now filed only on the ONDLS portal.
What it is
A Certificate of Pharmaceutical Product (COPP) confirms, product by product, that a medicine is licensed for manufacture in India and is made in a plant that follows WHO Good Manufacturing Practices. It follows the format of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce. Importing regulators rely on it to register your product.
In India, the Central Drugs Standard Control Organisation (CDSCO) issues the COPP through its zonal and sub-zonal offices, working with the State Licensing Authority that granted your manufacturing licence. The procedure comes from a DCGI notice of March 2020, and since mid-2025 every WHO-GMP and COPP application goes through the Online National Drugs Licensing System (ONDLS). A COPP depends on your plant’s GMP certification under revised Schedule M and WHO-GMP, so the two usually move together.
Who it applies to
You make and export medicines
Units holding a drug manufacturing licence that want to register their products in another country.
You are adding export products
Plants that had a joint WHO-GMP inspection within the last two years and now need COPPs for more products.
You bid in overseas tenders
Suppliers to overseas health ministries and agencies, whose tender documents often list the COPP as a mandatory paper.
Why it matters
Get products registered abroad
Regulators that follow the WHO scheme expect a COPP certificate with each product’s registration dossier.
Prove your WHO-GMP standard
The certificate tells foreign buyers that an Indian regulator has inspected the site against WHO GMP.
Certify more products on one inspection
Once a site has had a joint inspection, additional products within two years can be certified without another one.
Documents required
About the site
- Application from the manufacturer
- Site Master File in the WHO format
- Copy of the manufacturing licence and list of approved products
- Manufacturing layout
About the products
- List of products applied for COPP
- Stability data for three batches
- Process validation for three batches
- Product Summary Sheet with batch history and validation status
About the quality system
- List of SOPs and standard testing procedures
- List of equipment and instruments
- Details of technical staff
- Water and HVAC schematics, kept current
How it works
Check GMP readiness
We check that your licence covers the products and your plant is on revised Schedule M. In practice, a unit that finished its upgrade recently should file only once its validation batches are complete.
Assemble the dossier
We build the Site Master File, product summary sheets and supporting lists with your quality team, in the format CDSCO expects.
File on ONDLS
We submit the WHO-GMP/COPP application online to the CDSCO zonal or sub-zonal office for your area.
Face the joint inspection
For a first-time applicant, CDSCO and State officers jointly inspect the site against WHO guidelines. We help you close any deficiencies they list.
Receive and use the COPP certificate
Once recommended, the COPP is issued product-wise within five days, and we keep track of new products to add within the two-year window.
COPP, WHO-GMP and export NOC compared
| COPP | WHO-GMP certificate | Export NOC | |
|---|---|---|---|
| What it covers | A specific product and its licensing status | The manufacturing site | Export of unapproved, new or banned drugs |
| Who asks for it | The importing country’s regulator | Buyers and regulators abroad | Indian law, before shipment |
| Issued by | CDSCO with the State Licensing Authority | CDSCO with the State Licensing Authority | CDSCO zonal office on SUGAM |
Here is the catch. Say a Haryana tablet maker has a strength approved in an African market but not in India. A COPP alone will not do. It also needs a drug export NOC from CDSCO before the goods leave.
Timelines
21 working days
To scrutinise an application where no joint inspection is needed, such as additional products from a site inspected within two years.
28 working days
Where a joint inspection is required, mainly for first-time applicants.
1 January 2026
Revised Schedule M became mandatory for small and medium manufacturers, so a COPP site now needs to meet it in full.
What happens if you do not have a COPP
Registration stalls abroad
Picture a Faridabad exporter with a buyer waiting in East Africa. Until the COPP arrives, the regulator there holds the dossier and the order waits.
Your tender bid is incomplete
Overseas tenders that list a COPP as mandatory treat a bid without it as incomplete.
Deficiencies hold the certificate
If the joint inspection finds deficiencies, the COPP waits until they are closed and accepted.
Frequently asked questions
Who issues the COPP certificate in India?
CDSCO issues the COPP through its zonal and sub-zonal offices, together with the State Licensing Authority that licensed your plant. First-time applicants go through a joint inspection by CDSCO and State officers before the certificate is recommended. Since mid-2025, applications are accepted only on the ONDLS portal, and physical files are no longer taken. A complete dossier on the first upload is the fastest route.
How long does it take to get a COPP?
CDSCO’s guidance allows 21 working days to scrutinise an application without a joint inspection and 28 working days where a joint inspection is needed. The COPP then follows within five days of the recommendation. Time spent closing inspection deficiencies comes on top. A site that is already on revised Schedule M and has its validation data ready sees the fewest queries.
What is the difference between COPP and WHO-GMP?
WHO-GMP certifies the manufacturing site; a COPP certifies a specific product made at that site and its licensing status in India. Importing regulators ask for the COPP when they register each product. Both come out of the same CDSCO application and inspection process on ONDLS. In practice, once your site clears WHO-GMP, adding a COPP for each new product becomes much simpler.
Is a fresh inspection needed for every new product?
No. If the site has had a joint inspection within the last two years, COPPs for additional products can be issued without another joint inspection, and CDSCO scrutinises those in 21 working days. You still file the product documents, including stability and process validation data for three batches. Planning new products into that two-year window saves both time and an inspection.
Which documents matter most in a COPP application?
The Site Master File, stability data for three batches and process validation for three batches matter most. CDSCO also wants the manufacturing licence, list of approved products, SOP and testing procedure lists, equipment list, technical staff details, layouts, water and HVAC schematics, and a Product Summary Sheet. Gaps in validation data are the commonest reason for delay. We review the full set before it goes on ONDLS.
Who can apply for a COPP?
A manufacturer holding a valid drug manufacturing licence in India can apply, for products covered by that licence. The site must meet WHO-GMP, which CDSCO and the State Licensing Authority verify through a joint inspection for first-time applicants. The application lists the approved products and the products for which COPPs are sought. If your licence is in order, the rest is preparation, and we handle that with your quality team.
Do I need revised Schedule M before applying for COPP?
Yes, in practice. Revised Schedule M applied to large manufacturers from 28 June 2024 and became mandatory for small and medium manufacturers from 1 January 2026. Inspectors check WHO-GMP against a plant that must meet Schedule M anyway, so a non-compliant site will struggle. If your upgrade is still in progress, we will plan the COPP filing around your completion date.
Does a COPP let me export an unapproved drug?
No. A COPP certifies a product’s status; it does not permit export of a drug not approved in India. For unapproved, new or banned drugs, you need a separate export NOC from the CDSCO zonal office, filed on SUGAM, which since March 2025 is valid for one year. We can handle the COPP and the export NOC together so your shipment and registration timelines line up.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Any CDSCO or State fee depends on the application and is paid online on ONDLS. Your plant’s own costs, such as validation studies and upgrades for Schedule M, are separate.
Ready to begin?
Send us your product list and target countries, and we will prepare and file your WHO-GMP and COPP application on ONDLS.