A Certificate of Pharmaceutical Product proves three administrative facts and nothing more: that one specific product holds a marketing authorisation in the exporting country, whether that product is actually sold there, and that the site making it has been inspected against WHO GMP. It says nothing about the batch in your container. If you are registering an Indian product for the first time, understanding that boundary will save you a rejection and a wasted authentication cycle at your embassy.
One product, one certificate
The WHO guidance is explicit that the certificate “is for a single product only since the manufacturing arrangements and approved information for different dosage forms and different strengths can vary.” A 500 mg tablet and a 250 mg tablet of the same molecule are two certificates. A twelve-product order is twelve certificates.
This is where most first enquiries go wrong. Buyers ask a manufacturer to “send your COPP”, expecting a single document covering the factory. That document exists, but it is a different one — the WHO-GMP certificate, which covers the site and the categories of product licensed there. The CoPP is the product-level certificate built on top of it. Ask for both, and ask for the CoPP product by product against the exact strengths and pack presentations you intend to register.
The three lines an overseas regulator reads first
The WHO model certificate runs to several numbered boxes, but a reviewing assessor goes straight to three of them.
Box 1.3 asks: “Is this product authorized by the certifying authority to be marketed in the certifying country or within the jurisdiction of the certifying regional authority?” A “No” here is not automatically fatal, but it moves the file into a different queue.
Box 1.4 asks: “Is this product actually on the market in the certifying country?” — with Yes, No or Unknown as the permitted answers. This is the box that surprises importers. Plenty of Indian-made products are manufactured for export only. Under the CDSCO export No Objection Certificate route, the manufacturer undertakes that “the entire quantity… shall be exported and no part of it will be diverted for domestic sale in India”, and the pack is labelled “For export only – Not for domestic consumption.” That is a lawful, documented arrangement — but it produces a “No” in box 1.4, and some importing authorities treat that answer as a reason to ask for more.
Box 3.5 asks whether “the facilities and operations of the manufacturer of the FPP conform to good manufacturing practices (GMP) as recommended by WHO.” This is the line the certificate exists for. Read it alongside the site’s WHO-GMP certificate and the date of the last inspection.
Who issues it, and how long the process takes
CDSCO administers the WHO certification scheme in India in coordination with the State Licensing Authorities. For a plant in Himachal Pradesh, the application is made to the State Licensing Authority and the inspection is a joint one, carried out by CDSCO zonal or sub-zonal officers together with state representatives.
How long it stays valid — two answers, not one
The WHO guidance leaves validity to the issuing authority: “A period of validity can be provided by the authority on the certificate.” There is no universal expiry.
In Indian practice, WHO-GMP certificates and CoPP have carried a three-year validity since 2018, when the Drugs Controller General extended it from two years. That figure has moved before — in May 2020 CDSCO extended certificates expiring between March and August 2020 by a further six months — so verify the dates printed on the actual document rather than assuming the rule.
The validity that constrains you, though, is usually the importing regulator’s. NAFDAC, for example, requires that the certificate be issued by the health or regulatory body in the country of manufacture, conform to WHO format, and be authenticated by the Nigerian Embassy or High Commission in the country of origin — with a Commonwealth or ECOWAS mission acceptable where no Nigerian mission exists. The accompanying cGMP certificate must be “valid at the time of submission.” Authentication takes weeks. A certificate with eight months left on it can still be too old by the time your dossier is assessed.
What a CoPP does not prove
It does not certify the consignment. WHO deals with individual consignments through a separate instrument — the batch certificate, which “refers to an individual batch” and is described as a vital instrument in the procurement of medicines. The CoPP is for registration; the batch certificate and certificate of analysis are for the shipment. Treating a CoPP as a quality release is a category error, and it is the one that most often shows up in a first-time importer’s file.
It also does not attest bioequivalence, stability in your climatic zone, or suitability of the pack for your market. Box 4 asks only whether “the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product” — a statement about that authority’s satisfaction, not a technical opinion you can use in place of data.
Reading a WHO-format CoPP: the boxes that matter
| Box | What it asks | What to do with the answer |
| 1.3 | Is the product authorised to be marketed in the certifying country? | If “No”, go straight to box 2.B for the reason before anything else |
| 1.4 | Is the product actually on the market there? (Yes / No / Unknown) | “No” is normal for export-only products — ask for the export NOC and a specimen of the “For export only” label |
| 2.A.1 | Marketing authorisation number and date of issue | Check it matches the exact strength and dosage form you are registering, not a sister product |
| 2.B | If not authorised, the reason: not required / not requested / under consideration / refused / withdrawal for commercial reasons / withdrawal for sanitary reasons | “Refused” or “withdrawal for sanitary reasons” ends the assessment. The others do not |
| 3.5 | Do the facilities conform to WHO-recommended GMP? | Pair with the site WHO-GMP certificate and the date of the last inspection |
| 4 | Does the applicant’s submitted information satisfy the certifying authority? | A “No” here is rare and material — ask what was outstanding |
How Salus approaches this
Salus Pharmaceuticals manufactures at a WHO-GMP and ISO 9001:2015 certified facility in Baddi, Himachal Pradesh, and has done so since 2005. Certification documents are issued product by product through the State Licensing Authority route described above, and export documentation for Nigeria, Bangladesh and Sri Lanka is prepared against each destination regulator’s own authentication and currency requirements rather than as a single standard pack.
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