Deciphering the role and impact of India's pharmaceutical industries and its regulatory compliance

Abstract

The pharmaceutical industry faces exceptionally high R&D costs, with the US research-based sector investing about 17% of sales into R&D. The cost of bringing a new compound to market was estimated at $802 million in 2001, up from $138 million in the 1970s and $318 million in the 1990s, necessitating stringent regulations. This study aims to determine the role and impact of India's pharmaceutical industry and its regulatory compliance. Personnel from organizations established between 1884 and 2004, with turnovers ranging from Rs. 25 crore (US $5.3 million) to Rs. 5500 crore (US $1.2 billion), were surveyed. Out of 150 companies approached, 73 responded, with 70 complete responses analyzed. Ongoing interactions with regulatory agencies helped companies better understand the regulatory system. Three key areas emerged as priorities: awareness of intellectual property rights (IPR) and patents, fostering a suitable environment for research and development, and implementing Good Manufacturing Practices (GMP), considered more critical than price control. The findings underscore the importance of regulatory compliance in promoting innovation and maintaining quality within the pharmaceutical industry, ensuring its competitiveness and ability to meet global standards.