The experts of FSI «SID & GP» took part in the meeting of Indian manufacturers and suppliers of the pharmaceutical industry with Russian colleagues
The meeting held in Moscow on 22 November was initiated by the Council for promoting the development of export by Indian pharmaceutical manufacturers (PHARMEXCIL) with support from the Ministry of Commerce and Industry of the Government of India. It involved representatives from 25 top Indian pharmaceutical companies. The primary objectives of the event were to consider the possibility of building joint enterprises, to share technologies and to stimulate strategic cooperation with the Russian pharmaceutical industry.
The Russian Inspectorate was represented at the meeting by the Lead Expert of Drug Manufacture Inspections Department of FSI “SID & GP” Ivan Gulyaev. He informed Indian colleagues on the changes made to the Federal Law No. 61 «On Drugs Circulation» which were put into effect this year. Besides, Ivan Gulyaev provided examples of the most frequent non-conformities found during inspections of manufacturing sites.
Ivan Gulyaev explained that the most widely spread serious non-conformities which can impact the quality of medicinal drugs are violations of the requirements of the registration file and the requirements regulating product release.
In part of violation of the drug registration file, that is execution of certain manufacturing steps at the sites not listed in the registration file, a different composition and/or drug manufacturing technology as compared with registered ones, as well as the use of drug quality control methods non-compliante with the requirements of the registration file.
In terms of product release, here the majority of non-conformities are related to the release of drugs to be sold within the Russian Federation territory without the full range of tests listed in the drug normative documentation, absence of proper cooperation and traceability of information exchange between different manufacturing sites in case they are all involved in drug manufacture.
As emphasized by PHARMEXCIL representatives, this information is of great advantage for the companies which are planning to enter the Russian market, and it will allow them to better prepare their manufacturing sites for inspections.