Russian pharmacists say shortages of foreign medicines are coming

New certification requirements for foreign drugs may mean new medicines will not be allowed into Russia, says Association of International Pharmaceutical Manufacturers Director Vladimir Shipkov.

Since January 1, new medicines are required to receive the Russian equivalent of the international Good Manufacturing Practices (GMP) certificate. This new regulation may lead to problems with supplies of new drugs, says Shipkov. Since this regulation came into force, not a single certificate has been awarded, and there is no legal basis supporting the issuance of certificates.

At present, the Russian GMP certification is only required for new medicines. Beginning in 2017, however, it will be necessary for all foreign drugs. For the moment, these certification rules have become an insurmountable barrier for foreign companies, says Shipkov.

Already, certification issues have affected vaccines for whooping cough, tetanus, and diphtheria. 

According to accepted international practices, GMP certificate checks are required only for drugs from developing countries. Governments in Europe have agreed to the joint recognition of GMP certificates, and thereby save time and money on checks.

The value of the Russian pharmaceutical market in 2015 was about $13.2 billion (1 trillion rubles). Foreign companies account for more than half of market value.

In December 2015, the Russian government issued an order to limit government purchases of foreign drugs. According to this decision, the purchase of a foreign drug is prohibited if at least two Russian equivalents of the drug are available.