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Applied Drug Research, Clinical Trials and Regulatory Affairs


ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

Systematic Review Article

Indian Pharmaceutical Industries Current Status and Togetherness to Overcome Speed Breakers in Term of Quality Issues to make India as a Global Pharma Destination

Author(s): Vikas Rathee, Kapil Pihwal, Neelam Pawar*, Sheikh Aamir, Mohammad S. Alam and Kavita Bahmani

Volume 8, Issue 1, 2021

Published on: 15 September, 2020

Page: [19 - 31] Pages: 13

DOI: 10.2174/2213476X07999200915160423

Price: $65


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 the pharmaceutical industry of any 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, and 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 and 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 top 10 pharmaceutical companies in 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.

Keywords: Regulatory affairs, Regulatory authorities, CDSCO, DCGI, Regulatory system, Indian pharmaceutical industries.

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