A COMPREHENSIVE REVIEW ON REGULATORY REQUIREMENTS OF PHARMA-CEUTICAL DRUG PRODUCTS IN CIS AND GCC COUNTRIESAbstract
India may have a potential in the Commonwealth of Independent States (CIS) region. Pharmaceuticals are difficult to register with the CIS region’s regulating organisation because of the turmoil among these countries. The CIS includes Russia, Ukraine, Kyrgyzstan, Uzbekistan, Tajikistan, Kazakhstan, Turkmenistan, Azerbaijan, Armenia, Belarus, Moldova, and Georgia. These call for various regulatory standards for drug registration. Based on the FDA’s recommendations, it will be problematic to have various policies in the same area- activity of exporters and producers; registration of the same product in various nations; work of manufacturers and exporters. The same documents cannot be used to implement CIS due to the lack of regulatory harmonisation. Manufacturers and exporters must submit various country-specific documents to reach these markets since these nations adhere to a country-specific document format. Both Ukraine and Kazakhstan have enacted stringent regulations and are awaiting United States Food and Drug Administration (USFDA) – level document certification. The Gulf Cooperation Council (GCC) is regarded as a “growing industry both in terms of trade agreements and drug exportation.” During 2008–2009 in certain cases, the GCC’s healthcare sector will indeed be dominated by patented medications. This article’s purpose is to assess existing regulatory frameworks of the GCC member countries (Bahrain, Oman, Kuwait, Saudi Arabia, Qatar, and the United Arab Emirates (UAE) to ascertain a coordinated approach. In addition to the GCC Team, the GCC Commission for Drug Monitoring was founded and put into action by purchasing medications as well as pharmaceuticals on its own efforts.
S. Princely Ebenezer Gnanakani *, P. Kala Sree and K. P. S. Praneetha
Department of Pharmaceutical Biotechnology, Vikas Institute of Pharmaceutical Sciences, Rajahmundry, Andhra Pradesh, India.
15 February 2023
17 May 2023
31 May 2023
01 November 2023