«Medicines Quality Assessment from Retail
Market using Mini-Lab Kits »
14/04/2020 Medicines Transparency Alliance 1

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An estimated 30% of medicines are imported illegally and most of the population is inclined to the self-treatment.
 No surveys have been conducted at the retail level for assuring quality of medicines in the Kyrgyz Republic.

Despite the efforts undertaken by the National DRA the illegal trade of medicines still exists in the black market in the country
(eg. Osh bazar, Dordoy bazar in Bishkek where some people seek cheap medicines sources).

The National DRA is the only body which has mandate to ensures quality of medicines.
 There is a contradiction in the regulatory management between obligations of the DRA on ensuring medicines quality and judicial powers. For example, DRA inspectors are not permitted to carry out unannounced inspections in the pharmacies and wholesale drugstores without prior 10 days notice and given permission of the Public Prosecutor’s Office and Ministry of Economic
Regulation.
14/04/2020 Medicines Transparency Alliance 2

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Two mini-labs were procured (GPHF- minilab ®) within MeTA activities

The USP trainers trained 9 people on using mini-labs, including lab assistants of the DRA QC Lab and a private QC Lab
“Pharmacia”, and a teacher of Pharmaceutical Department of the
Kyrgyz State Medical Academy

The medicines samples were gathered in:
Bishkek (capital) – 227 samples (84 + 143)
Karakol town – 82
Osh city – 100
Djalalabat town – 138
Totally – 547 samples
14/04/2020 Medicines Transparency Alliance 3

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6 INN were selected:
1. Amoxicillin
2. Ciprofloxacin
3. Metronidazole
4. Acetylsalicylic acid
5. Aminophyllin
6. Paracetamol
Medicines Transparency Alliance

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…«It should be noted that there are examples of drugs that do not match the following criteria:
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- labeling (Acetylsalicylic acid, Amoxicillin) - the same manufacturer, but the addresses and phone numbers are different, the color of packs are the same, but shades are of different intensity, sometimes the manufacturer is not specified;
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- appearance - samples are contaminated in bottles (Aminophyllin), and are not uniform in color (blotches of darker shades);
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- for some samples the TLC-analysis was altered up to 3 times (three different tablets), because the intensity of emission comparing with the standard differed significantly; we assumed that the samples were not homogeneous in content of active substances within the series, (or one package), this is mainly about the samples of Paracetamol and
Acetylsalicylic acid;
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- many samples of acetylsalicylic acid were disintegrated in 30-50 seconds already .»
Medicines Transparency Alliance

INN No. samples
N,
Problems with
Quality &,
Quantity
(TLC, Rf)
No.
Proble ms
Labelli ng
No.
Expired date
No.
Suspicio us tablets’ apperan ce
No.
Satisfact ory samples
Amoxicil lin
104 6 23 1 4 70
% of satisfact ory samples
68%
1 3 1 73 71% Ciproflo xacin
Aminop hyllin
104
53
26
1
Metronid azole
102
Acetylsa licylic acid
Paraceta mol
91
93
15
9
7
Totally 547 64
Medicines Transparency Alliance
0
3
3
0
30
0
0
0
0
4
2
15
0
3
25
50
69
79
83
424
95%
68%
87%
90%
78%

Survey Findings
30
25
20
15
10
5
0
Am ox ici llin
Ci pr of lo xac in
Am in op hy llin
Met ro ni daz ol e yl sa licy lic ac id
Par ac et am ol
Acet items
To tal ly
Medicines Transparency Alliance
Problems with
Quality&Quantity:TLC, Rf
Problems Labelling
Expired date
’Suspicious tablets
,apperance:inclusions crumbling, different shapes

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The results are indicative of need to amend and improve current legislation, for example:
– Enhancing authority/power of inspectors/DRA
– Development of post-marketing surveillance over drug quality

The country has acquired a new method for testing Quality of medicines in the market
 Additional skills have been acquired by way of trained personnel other than DRA staff to apply the Mini Labs for testing Quality of
Medicines

The Pharmacia Department of the Kyrgyz State Medical
Academy has skills on using mini-labs and can train the students

Statistical data on the number and location of pharmacies inside and near to the Family Medicine Centers of Bishkek have been accquired as a result of the Survey

The samples of illegally sold medicines have been gathered (Osh
8

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There is no separate data on the pharmacies located in every administrative district in Bishkek (capital city)

The addresses of the pharmacies included into a DRA
Reference Book do not correspond to the factual locations

Many pharmacies do not have cash registers, making it difficult to provide financial statements for the purchased samples оf medicines

QC Laboratory/DRA was not convinced of the advantages / benefits to use the mini-labs to assess the quality of medicines. This led to significant delay in getting the test results
14/04/2020 Medicines Transparency Alliance 9

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Post marketing Surveillance is essential for assuring Quality of medicines circulating in the market

Weaknesses in Legislation do not allow the DRA to perform its regulatory role efficiently and effectively
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Only 78% of samples collected met the quality requirements hence it is evident that quality of medicines in the market is unreliable

Currently the following questions should be solved:
- who will be using the mini-labs after completion of MeTA activity? (quite expensive chemicals and USP standards)
- who will be getting the samples, how often and how many as it is the issue on expenditures related to buying samples in the pharmacies
- who will be paying expenditures involved into full analysis of the
“questionable quality” medicines?
- coverage? Urban areas, rural areas, regions?
Medicines Transparency Alliance



Strengthen regulatory control of medicines and enforcement by national DRA to prevent and detect counterfeit/substandard medicines (through improvement of current legislation, see above).
A range of stakeholders – not just health professionals is needed. The aim is to involve a range of stakeholders in collaborative efforts to protect people from buying and taking counterfeit/substandard medicines.

Make all findings with regards to actions held by NDRA publicly available.

Regular Public media campaigns to raise public awareness on public health risk of the self-treatment and buying medicines from non-regulated outlets, where the incidence of substandard drugs is likely to be higher.
Medicines Transparency Alliance

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Prepared by: Kyrgyz MeTA Secretariat

Email: kg_meta_council@googlegroups.com
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Phone number: 996 (312) 900-411
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Skype: asuluke
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Website: www.metakg.org
14/04/2020 Medicines Transparency Alliance 12