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Background: The CIS region has an enormous growth potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which required different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization & it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also getting strict & expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

: Regulatory is the heart of the Pharmaceutical Industries which acts as an interface between the industries and government authorities for the growth and development of pharmaceutical industry system of their respective country. In 2017, India was a pharmaceutical country valued at USD (United States Dollar) 13 billion and accounting for 20 percent of worldwide exports, making the country the main supplier of generic drugs worldwide. Ministry of Chemicals and Fertilizers, the Department of Pharmaceutical Products said that the national pharmaceutical market's gross revenue reached approximately US $ 18.12 billion in 2018 (Rs 129,015), growing 9.4% year-on-year and export retention in 2018 was US $ 17.88 billion. 19.14 billion US$ in 2019. The Union Ministry of Health and Family Welfare has increased by 13.1 percent to Rs 61,398 crore (US $ 8.98 billion) in the Union Budget 2019-20. The Indian pharmaceutical market is facing many difficulties such as central and state regulatory compliance, data integrity, ethics committee in clinical trials, governmental control over the price of medicine, lack of research and so on. We are discussing in our article that top 10 pharmaceutical companies are doing business, their turnover in 2020 and challenge in today's era. We discuss future plans and solutions to problems, so that they can be ranked first in the world.