In the second half of 2001 the issue of counterfeited drugs attracted particular attention of Russian Ministry of Health officials. A series of internal ministerial meetings, as well as open discussions were held. In the course of this public campaign certain weaknesses in national drug regulatory system were admitted, such as absence of pharmaceutical inspectorate, outdated pharmacopoeia, in efficient certification procedure. It seems that this autocriticism become feasible only following the replacement of the Head of Russian DRA. The current certification procedure in the Russian pharmaceutical sector is based on batch testing in the distribution channels. To the best of the author's knowledge it is not used in any other country. At the same time other QA mechanisms, e.g. licensing procedures, GMP inspections etc. Are underutilized.