A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries.
OBJECTIVE
Studies were undertaken to assess the capability, competence and capacity of manufacturers of oral and injectable hormonal contraceptives in lower- and middle-income countries.


METHODS
A qualitative study on 41 companies, which comprised in-depth interviews and facility observations, was undertaken. Also an in-depth quantitative study of 14 companies was undertaken, of which 3 have not been included in the first study. Following review of a questionnaire and other documentation, a visit was undertaken to each factory to assess staff competence, manufacturing facilities, manufacturing processes, quality management, worker safety and environmental protection.


RESULTS
Of the 44 companies from 15 countries, less than 30% would meet the current Good Manufacturing Practice requirements of the World Health Organization (WHO), the Pharmaceutical Inspection Cooperation Scheme or any stringent regulatory authority; a further 20% could comply with investment and improvements in quality management. Few companies are able to develop adequate registration dossiers.


CONCLUSIONS
There is a limited number of companies that are capable of manufacturing high-quality generic products and which can provide a complete registration dossier for use outside their home markets. It is essential that, in the future, procurement agencies only use suppliers that are prequalified by WHO for the procurement of hormonal contraceptives.
Hall
Peter E
PE
Concept Foundation, Thailand Science Park, Pathumthani 12120, Thailand. phall@rhalliance.org
Oehler
Joachim
J
Woo
Phillip
P
Zardo
Humberto
H
Chinery
Lester
L
Singh
Jyoti S
JS
Jooseery
S Harry
SH
Essah
Nana M
NM
D003271:Contraceptive Agents, Female / Q000600:supply & distribution*; D003906:Developing Countries; D004345:Drug Industry / Q000592:standards*; D016568:Drugs, Generic / Q000600:supply & distribution; D005260:Female; D006801:Humans; D016912:Levonorgestrel / Q000600:supply & distribution*; D017258:Medroxyprogesterone Acetate / Q000600:supply & distribution*
D003271:Contraceptive Agents, Female; D016568:Drugs, Generic; D016912:Levonorgestrel; D017258:Medroxyprogesterone Acetate