The Role of Regulatory Compliance and It's Impact on Pharmaceutical Companies

Abstract

Introduction: The industry also plays an important role in technological innovation, which may reduce costs of economic activity elsewhere but the industry is greatly affected by the issues related to safety and quality of drugs throughout the world. Aim and Objective: This study was designed to explore the regulatory environments that govern the pharmaceutical industry. The Indian pharmaceutical industry is impacted by regulations promulgated by various regulatory agencies such as the US Food and Drug Administration (USFDA), the European Agency for the Evaluation of Medical Products and Indian Pharmacopeial commission. Methods: The pharmaceutical products are under continuous analysis for benefits and the risks associated with it. Many countries have introduced cost containment policies such as reference pricing, limiting the number of prescriptions, withdrawing reimbursement, cost sharing, budgetary restrictions, delisting and restrictive formularies.  With the globalization of R&D and the markets, as well as the transfer of a growing amount of pharmaceutical manufacturing to the developing world, the regulators of such countries will become increasingly important. There is a growing demand for regulatory inspections of overseas pharmaceutical manufacturing by different buyers associations in US and Europe. Results and Discussion: The Indian pharmaceutical industry faces audits from regulators (both domestic & international) as well as audits by buyers. These organizations export both drug products as well as drug substances. The continuous interaction of the industry with regulatory bodies helped them to form perception about regulatory system. When extrapolated to percentage, a total of 74.32% agreed on the listed intentions of the pharmaceutical regulatory system. Conclusion: A drug regulatory system is considered to be adequate if the regulatory frame work is well resourced for both i.e. implementation and monitoring (91%). Only 3% of the respondents considered that availability of resources for monitoring will make the drug regulatory system as adequate.