strengthening national drug regulatory capacity
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Strengthening national drug regulatory capacity. Valerio Reggi 11 October 2007. The three key statements on DRAs:. health system counts on DRA for good, safe, and effective medicines, as well as fair rules and control on drug trade, information, and use - PowerPoint PPT PresentationTRANSCRIPT
1 TBS Oct 2007 WHO - HTP
Strengthening national drug regulatory capacity
Valerio Reggi11 October 2007
2 TBS Oct 2007 WHO - HTP
The three key statements on DRAs:
health system counts on DRA for good, safe, and effective medicines, as well as fair rules and control on drug trade, information, and use
any strategy to improve anything in the pharmaceutical area involves DRA
any problem encountered in the pharmaceutical area has something to do with the DRA
3 TBS Oct 2007 WHO - HTP
Drug regulation is a multi- faceted activity at the centre of complex interactions
Regulatory authority
Manufacturers
Prescribers
Importers/Wholesalers/Retailers
Patients/Consumers
Products
ExpertsGovernment
Medicines
4 TBS Oct 2007 WHO - HTP
Drug regulation is a multi- faceted activity at the centre of complex interactions
Regulatory authority
Manufacturers
Prescribers
Importers/Wholesalers/Retailers
Patients/Consumers
Products
ExpertsGovernment
Medicines
5 TBS Oct 2007 WHO - HTP
Drug regulation is a multi- faceted activity at the centre of complex interactions
Regulatory authority
Manufacturers
Prescribers
Importers/Wholesalers/Retailers
Patients/Consumers
Products
ExpertsGovernment
Medicines
6 TBS Oct 2007 WHO - HTP
Drug regulation is a multi- faceted activity at the centre of complex interactions
Regulatory authority
Manufacturers
Prescribers
Importers/Wholesalers/Retailers
Patients/Consumers
Products
ExpertsGovernment
Medicines
7 TBS Oct 2007 WHO - HTP
all premises, persons & practices engaged in the development, manufacture, importation, exportation, wholesale, supply, dispensing & promotion of drugs comply with approved standards, norms, procedures and requirements
drug products are safe, effective and of acceptable quality
product information is unbiased, accurate and appropriate
drugs are available
Drug regulation comprises all the legal, administrative & technical arrangements meant to ensure that:
9 TBS Oct 2007 WHO - HTP
Background• 2000, Nepal: school children mass-treatment campaign
• Locally procured albendazole
• QC tested after treatment completed, result: failed
• Campaign outcome: success
10 TBS Oct 2007 WHO - HTP
Wrong sample?
Wrong results?
Wrong test?
Wrong children?
Wrong worms?
Questions
12 TBS Oct 2007 WHO - HTP
The studyTwo locally-manufactured generic albendazole (ABZ)
products (Curex and Royal Drug) used for de-worming children in Nepal since 1999
tested against originator product (GlaxoSmithKline-GSK).
API content, disintegration and dissolution testing and a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections
1277 children examined before and 21 days after treatment
13 TBS Oct 2007 WHO - HTP
Results
DrugAlbendazole 400 mg
Batch N Quantity (mg/tablet)
% Active Ingredient
Disintegration time (minutes)
% Dissolution
Dissolution
Zentel 400(GSK)
48907G100
397.6 (USP)394.5 (IP)
99.2 (USP)98.7 (IP)
6.7 (IP) 84.8 (USP)
Passed
RDZ-400 (Royal Drug Ltd Nepal)
T-53 401.3 (USP)394.0 (IP)
100.4 (USP)98.7 (IP)
11.8 (IP) 10.3 (USP)
Failed
Azol 400 (Curex Ltd Nepal)
61 413.8 (USP)415.8 (IP)
103.5 (USP)103.9 (IP)
> 1 hour (IP) 0.27 (USP)
Failed
14 TBS Oct 2007 WHO - HTP
ResultsDrugAlbendazole 400 mg
N Day 0% Pos EPG a
Day 21% Pos EPG
CR ERR (95%CI)
Ascaris GSK 429 31.5 13 0.9 0.0 97.0 92.6 (89.2, 95.0)
Royal Drug 419 33.9 17 1.7 0.1 95.0 93.8 (90.9, 95.8)
Curex 429 36.1 19 6.3 0.6 82.6 b c 91.9 (88.0, 94.4)
Trichuris GSK 429 80.7 79 62.2 22 28.6 71.7 (64.4, 77.5)
Royal Drug 419 80.0 75 61.6 21 26.6 71.4 (64.6, 77.1)
Curex 429 78.3 60 60.6 21 28.0 63.2 (53.7, 70.8) d e
Hookworms GSK 429 49.0 13 14.2 0.9 74.3 87.1 (83.3, 90.1)
Royal Drug 419 50.1 15 24.6 2.0 53.3 b 80.8 (75.6, 84.9) d
Curex 429 47.8 12 25.9 2.4 50.7 b 73.1 (66.2, 78.6) b c
15 TBS Oct 2007 WHO - HTP
Results
• goal of mass treatment campaigns is to reduce the overall burden of infection within a population
• 6.8 million tablets of ABZ are procured every year in Nepal
Curex 81,600
Royal Drug 115,600 34,000
GSK 136,000 54,400
COST (US$) Extra COST
16 TBS Oct 2007 WHO - HTP
Results
… questions on the importance of certain criteria used for planning mass treatment campaigns with anthelminthic drugs. The extremely poor performance of Curex's ABZ in quality tests would lead to the conclusion that it is unsuitable for use in a campaign. Yet, it has shown a good degree of effectiveness that, although inferior to the other two drugs, challenges the relevance or reliability of quality testing, as currently done, as a major decision criterion for inclusion of a specific product in de-worming campaigns.