Roszdravnadzor identified 6 falsified drugs and 2 substances in 2017

| By | Drug Quality Control, Roszdravnadzor
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The measures taken by Roszdravnadzor in 2017 allowed to withdraw 915 batches of medicinal products with substandard quality, which is 0.34% of the total number of batches released into circulation in that year.

The information on the number of medicinal products withdrawn from circulation in 2017 is provided in the following table:

Medicinal Products and Pharmaceutical Substances Number of Trade Names Number of Batches
Substandard medicinal products 213 434
Medicinal products recalled by manufacturers (importers) 150 372
Falsified drugs 6 6
Falsified pharmaceutical substances 2 25
Drugs manufactured from them 4 61
Counterfeit medicinal products 9 17
TOTAL   915

In the total amount of substandard medicinal products withdrawn from circulation in 2017, the share of batches of substandard medicines manufactured in Russia was 62.7% (272 batches of 150 trade names), and share of batches manufactured in other countries was 37.3% (162 batches of 63 trade names).

The structure of non-conformity indicators with regard to the quality of medicinal products withdrawn from circulation in 2017 (by number of batches) is provided in the following table:

No. Non-Conformity Parameter Share, %
1 Quantitative determination 24.5
2 Packaging 14.7
3 Labeling 12.9
4 Description 11.9
5 Uniformity of dosage units 10.7
6 Impurities 6.4
7 Particulate matter 2.4
8 Identification 2.2
9 pH 1.9
10 Dissolution 1.7
11 Other indicators 10.7