A RETROSPECTIVE REVIEW OF PHARMACEUTICAL PREQUALIFIED APPROVED DRUGS FROM 2015 TO 2022

Dr. K. Jesindha Beyatricks*, Chandan, Dixit, Harshini, Mayuri and Santhosh B.

ABSTRACT

Efficient regulation of pharmaceutical products is crucial in ensuring that the medicines within a specified territory meet the stipulated standards of quality, safety and efficacy. The process of drug registration requires submission of a dossier in Common Technical Dossier (CTD) format which essentially contains all administrative, quality, clinical and non-clinical information about the product. This study is a retrospective review of Pharmaceutical prequalified approved dossiers from the period starting 2015 to 2022. The aim of this study was to carry out a retrospective review of pharmaceutical prequalified approved product dossiers from period starting 2015 to 2022. To compare the prequalified approved dossier with their dosage form, number of prequalified approved, applicant of the different countries and their therapeutic categories between 2015- 2022. The sample size of 373 files selected and studied, the prequalified approved dossiers in 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022 are 18, 35, 57, 54, 64, 51, 51, 41 numbers. According to the therapeutic use of the drugs in 2019, more number HIV/AIDS (31%) drugs are approved for prequalified compare to other years and in 2017 more number of tuberculosis (55%) drugs are approved for prequalified, in 2018 more number of malarial drugs 21% went for prequalified approval, in 2020 more number (16%) of reproductive health drugs are preapproved compare to other year. By comparing between the applicants and the number of prequalified drugs approved between 2015 to 2022, India submitted dossier has be approved by comparing with other country applicants. India dossiers approved more medicines (40 medicines) in 2019 compare to other years. Next to India, China is the next applicants for more number of prequalified drugs to be approved. According to the dosage form, the most frequently submitted dosage form was film coated tablets at 44.23%, followed by tablets at 33.51%. In this review of generic product dossiers submitted to the WHO Prequalification of medicines Programme during 2015 to 2022, there were considerably more quality-related deficiencies in TB, MA and RH dossiers compared to HIV dossiers, especially in the categories specification of APIs, development pharmaceutics, manufacturing method and FPP specifications. This may be related to the applicant’s experience of interacting with SRAs, availability of information on comparator products, availability of pharmacopoeial monographs and the age of the product.

Keywords: ICH, dossiers, CTD, prequalified.