Analyst: GMP standard complicates life for all pharmaceutical companies

Analyst: GMP standard complicates life for all pharmaceutical companies


MOSCOW, 16 Oct. GMP standard complicates the lives of not only Russian but also foreign pharmaceutical companies, said the head of Association of manufacturers of pharmaceuticals and medical goods (ACE) Sergey Kolesnikov.

Standard GMP (Good Manufacturing Practice — good manufacturing practice) is a basic industry standard quality and includes a wide range of indicators, must meet pharmaceutical industries. According to the law “On circulation of medicines”, the production of all Russian pharmaceutical companies must comply with the GMP standards from 1 January 2014, and next year this rule applies to all participating countries of the EAEU.

“The theme of GMP is inextricably linked with all regulatory procedures. This makes the lives of not only our producers, but also foreign, especially if accompanied by such rulings as the “third wheel” or the definition of “local manufacturer”, — said Kolesnikov.

According to him, the introduction of the GMP standard was lobbied foreign manufacturers as the way to deal with the Russian manufacturers and developers of generics.

“But then came the idea of the odd, exclusion from the concept of local production of packaging and packing. If the majority of the existing Russian production complies with the requirements of GMP, in addition, will introduce parallel importation, then the incentives for localization will be less as production becomes more expensive and longer it will take to pay off,” said Kolesnikov.

Localization may slow down

Localization of foreign companies will slow down, if passed the bill according to which the Russian Federation Packed in the medicine will no longer be considered a local product after 2016, says Kolesnikov. Earlier, the Ministry of industry and trade introduced the draft submitted to the state Duma, he is now at the stage of public discussion.

“We believe that the process of localization of production of foreign companies in Russia will slow down, if it is anticipated that packaging will not be recognized by the Russian production”, — said Kolesnikov.

“Currently, despite the “beautiful” word on localization of production of foreign companies to produce innovative products and technology transfer, these enterprises mainly engaged in filling and packaging of their products, which is imported in bulk, in sacks,” he added.

Easier to import than to invest

Now the Russian pharmaceutical industry attractive for Russian investors, but foreigners will not want to invest in both domestic producers profitable to import finished drugs, says Kolesnikov.

“At present, domestic manufacturers are attractive for Russian investors and for foreign — is unlikely to be attractive in the near future. System registration and launch into the domestic market of medicines is much more difficult than abroad”, — said Kolesnikov.

“Foreign companies are encouraged to register their drugs and are ready to trade drugs, because the Russian pharmaceutical market continues to grow despite the crisis, in contrast to Western markets,” he added.