WHO Product inclusion, COPP and export orders- Vicious cycle

CURRENT SCENARIO
1. WHO product inclusion - is the process which involves submission of details (Stability data,
process validation, cleaning validation, Annual Product Review. etc), of the product to FDA in
order to include product in companys WHO LIST. Once product is included in the list, company
is entitled to get COPP in WHO format for those products.
2. This list remains valid till the expiry of the WHO GMP certificate.
3. Pharmaceutical Companies apply for re-inspection two months in advance before the expiry of
WHO GMP certificate.
4. Upon re-inspection, the officials discover that no batches were manufactured for some products
from the WHO list in the time period of two years (validity of WHO GMP certificate). Such
products are excluded from the new WHO product list which is approved at the time of reinspection.
5. Now the manufacturer has the valid WHO GMP certificate and amended WHO product list.

ISSUE
1. Manufacturer receives an urgent export enquiry which requires him to submit COPP for the
particular product. But the product is no longer in the WHO List and hence COPP in WHO
format cannot be obtained.
2.

In order to obtain COPP,

Fresh application to include the product in WHO Product list has to be made.
Inclusion process takes minimum 40 working days.
Procurement of COPP will take another 10 working days.

3. Thus, the manufacturer gets the COPP (for the product which was their once in the WHO list)
after two whole months and in that time the valuable export order is lost. This happened due to
the non-availability of valid COPP.
Now, take for example if it was one of those rare tender enquiries which comes once in every two years,
there will be no order for this product for next two years.
In next WHO-GMP re-inspection, this product will be removed from the WHO Product LIST.
. thus it is a Vicious cycle.

WHO Product inclusion, COPP and export orders- Vicious cycle

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SUGESSIONS
1. Have fast track procedure for product inclusion of those products which were already included in
the WHO LIST of manufacturer thereby reducing the timeline to 2-3 days.
2. Documentation requirement must be limited to only the proof of last valid WHO LIST with the
name of product. Waiver of extensive documentation will enable faster processing.