A. Background

We also refer to the related Important HRQCs in trail, blue, italic and double Line (a) 28 of 6.4.25 about Medical expenses issue: YPA exposed DRAP’s corruption, etc (b) 25 dated 16.2.24 about Medical expenses will increase Significantly and Way forward.

B. Updated Commentary

1. Further to the KQU 3609 of 20.10.25, being an important matter, we would inform you about Mandatory Sourcing Requirements for Active Pharmaceutical Ingredients (APIs)/Drug Substances (DS) Imported for Product Development, Stability Studies and Commercial Manufacturing (Attachment 68.1).

To ensure compliance with national laws and international best regulatory practices, all pharmaceutical firms are hereby directed to adhere to the following mandatory requirements for the import of APls/drug substances for the aforementioned purposes:

i. Only APIs/drug substances of pharmacopoeial grade and in case of non-availability in pharmacopoeia, the APIs/drugs substance shall be of pharmaceutical grade only.

ii. One of the following documents (either submitted as hard copy or verifiable from online database of the relevant regulatory authority), for granting permission to import of API/Drug substance:

a. Valid Drug Manufacturing License issued by the relevant regulatory authority of country of origin.

b. Valid Good Manufacturing Practice (GMP) certificate of the Drug Substance manufacturer issued by relevant regulatory authority of country of origin.

c. Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) issued by EDQM (European Directorate for the Quality of Medicine & Healthcare).

d. GMP certificates issued by any of the Reference Regulatory Authorities adopted by the Registration Board in its 275th meeting.

iii. All such consignments must obtain official endorsement and as an evidence for sourcing of API for application dossiers.

C. Further Details & Services

Should you require any clarification or explanations in respect of the above or otherwise, please feel free to email Mr Amsal at amsal@kasbati.co with CC to info.kasbati@professional-excellence.com