Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study - PEDA Study.
OBJECTIVE
Ensuring that medicines meet quality standards is mandatory for ensuring safety and efficacy. There have been occasional reports of substandard generic medicines, especially in resource-limiting settings where policies to control quality may be less rigorous. As HIV treatment in Thailand depends mostly on affordable generic antiretrovirals (ARV), we performed quality assurance testing of several generic ARV available from different sources in Thailand and a source from Vietnam.


METHODS
We sampled Tenofovir 300mg, Efavirenz 600mg and Lopinavir/ritonavir 200/50mg from 10 primary hospitals randomly selected from those participating in the National AIDS Program, 2 non-government organization ARV clinics, and 3 private drug stores. Quality of ARV was analyzed by blinded investigators at the Faculty of Pharmaceutical Science, Chulalongkorn University. The analysis included an identification test for drug molecules, a chemical composition assay to quantitate the active ingredients, a uniformity of mass test and a dissolution test to assess in-vitro drug release. Comparisons were made against the standards described in the WHO international pharmacopeia.


RESULTS
A total of 42 batches of ARV from 15 sources were sampled from January-March 2015. Among those generics, 23, 17, 1, and 1 were Thai-made, Indian-made, Vietnamese-made and Chinese-made, respectively. All sampled products, regardless of manufacturers or sources, met the International Pharmacopeia standards for composition assay, mass uniformity and dissolution. Although local regulations restrict ARV supply to hospitals and clinics, samples of ARV could be bought from private drug stores even without formal prescription.


CONCLUSIONS
Sampled generic ARVs distributed within Thailand and 1 Vietnamese pharmacy showed consistent quality. However some products were illegally supplied without prescription, highlighting the importance of dispensing ARV for treatment or prevention in facilities where continuity along the HIV treatment and care cascade is available.
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.
Vorapot
V
Sapsirisavat
Faculty of Pharmaceutical Sciences, Chulalongkorn University, Rama 4 Road, Pathumwan, Bangkok, 10330, Thailand.
Vorasit
V
Vongsutilers
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.
Narukjaporn
N
Thammajaruk
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.
Kanitta
K
Pussadee
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.
Prakit
P
Riyaten
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.|Department of Global Health, Academic Medical Center, University of Amsterdam, Amsterdam Institute of Global Health and Development, Trinity Building C, Pietersbergweg 17, 1105 BM, Amsterdam Zuidoost, The Netherlands.
Stephen
S
Kerr
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.|Department of Medicine, Faculty of Medicine, Chulalongkorn University, 254 Phyathai Road, Pathumwan, Bangkok, Thailand.
Anchalee
A
Avihingsanon
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.|Department of Medicine, Faculty of Medicine, Chulalongkorn University, 254 Phyathai Road, Pathumwan, Bangkok, Thailand.
Praphan
P
Phanuphak
HIV-NAT, Thai Red Cross AIDS Research Centre, 104 Ratchadamri Road, Pathumwan, Bangkok, 10330, Thailand.|Department of Medicine, Faculty of Medicine, Chulalongkorn University, 254 Phyathai Road, Pathumwan, Bangkok, Thailand.
Kiat
K
Ruxrungtham
D019380:Anti-HIV Agents / Q000191:economics / Q000627:therapeutic use*; D044966:Anti-Retroviral Agents / Q000191:economics / Q000627:therapeutic use*; D003906:Developing Countries; D016568:Drugs, Generic / Q000191:economics / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000821:virology; D006801:Humans; D061466:Lopinavir / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D013785:Thailand; D014744:Vietnam
D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D016568:Drugs, Generic; D061466:Lopinavir; D019438:Ritonavir