Transcript Strengthening national drug regulatory capacity

Strengthening national drug
regulatory capacity
Valerio Reggi
11 October 2007
1 TBS Oct 2007
WHO - HTP
The three key statements on DRAs:
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2 TBS Oct 2007
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
WHO - HTP
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Manufacturers
Products
Government
Regulatory
authority
Importers/Wholesalers/Retailers
3 TBS Oct 2007
Experts
Prescribers
Medicines
Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Manufacturers
Products
Government
Regulatory
authority
Importers/Wholesalers/Retailers
4 TBS Oct 2007
Experts
Prescribers
Medicines
Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Manufacturers
Products
Government
Regulatory
authority
Importers/Wholesalers/Retailers
5 TBS Oct 2007
Experts
Prescribers
Medicines
Patients/Consumers
WHO - HTP
Drug regulation is a multi- faceted activity at
the centre of complex interactions
Manufacturers
Products
Government
Regulatory
authority
Importers/Wholesalers/Retailers
6 TBS Oct 2007
Experts
Prescribers
Medicines
Patients/Consumers
WHO - HTP
Drug regulation comprises all the legal, administrative
& technical arrangements meant to ensure that:
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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
WHO - HTP
What is quality?
8 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
9 TBS Oct 2007
WHO - HTP
Questions
Wrong sample?
Wrong test?
Wrong results?
children?
Wrong worms?
Wrong
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WHO - HTP
Answer
11 TBS Oct 2007
WHO - HTP
The study
Two 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
12 TBS Oct 2007
WHO - HTP
Results
Drug
Albendazole 400 mg
Batch N
Quantity
(mg/tablet)
% Active
Ingredient
Disintegration
time (minutes)
%
Dissolution
Zentel 400
(GSK)
48907G10
0
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
13 TBS Oct 2007
Dissolution
WHO - HTP
Results
Drug
Albendazole
400 mg
Ascaris
Trichuris
Hookworms
14 TBS Oct 2007
N
Day 0
% Pos
EPG a
Day 21
% Pos
EPG
CR
ERR (95%CI)
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)
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
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
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
COST (US$)
15 TBS Oct 2007
Extra COST
Curex
81,600
Royal Drug
115,600
34,000
GSK
136,000
54,400
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.
16 TBS Oct 2007
WHO - HTP
What is quality?
Quality is suitability for purpose!
All three products are of
acceptable quality then?
Let's discuss
17 TBS Oct 2007
WHO - HTP