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CPhI released Part 1 of its annual industry report focused on innovation in the market.
CPhI Worldwide released the first part of its second annual report, which included three industry experts discussing the importance of innovation and predictions for the market. The experts include Vijay Shah, executive director, COO, and expert in green technologies at Piramal Enterprises, a global pharmaceutical company specializing in inhalation anesthesia and custom manufacturing; Dilip Shah, CEO and expert in intellectual property rights (IPR) at Vision Consulting, a professional services organization that provides healthcare information technology services; and Girish Malhotra, president and expert in QbD at EPCOT International, a company offering consulting services to improve manufacturing quality, efficiency, environmental impact, and innovation.
According to the report, the pharmaceutical industry is a $990 billion industry that continues to grow at a steady rate of 5% per year. Patients depend on the evolution and growth of products, as well as innovation in the pharmaceutical industry, to keep them healthy and safe. However, there are some factors that need to be addressed by companies that want to continue to flourish in this developing market, and these involve widespread regulatory changes.
The pharmaceutical industry is dependent upon innovation, yet as Dilip Shah explains, “Innovation is a culture, a way of life. IPR is a barrier, a way of doing business. One flows automatically and through generations. The other is imposed.”
International IPR regimes need to be reduced in early stages of development to control increasing legal monopolies and decreasing opportunities for free trade, noted the report. Intellectual property laws prolong a drug’s monopoly and protect high prices, stifling innovation, asserts Shah. Shah argues that despite the TRIPS agreement, which was forged to establish intellectual property standards, “Strong IPR are preventing new technologies from disseminating to less developed and developing countries..” He concludes that governments in developing countries need to balance IPR with needs of public health to promote growth.
Revisions also need to be made to standards to allow companies to move from regulation-centric approaches of quality to process-centric approaches, according to Girish Malhotra. Pharmaceutical manufacturing and business strategies focused on quality by analysis (QbA), rather than quality by design (QbD), inhibits innovation. Malhotra continues by stating there could be 20-25% savings in global revenue due to increased efficiency, quality products, and lower costs if companies adopt a QbD mentality.
Similarly, Vijah Shah explained that the government needs to revise its regulations to make it easier for companies to adopt green strategies. Green chemistry, which is expected to be a $100 billion industry by 2020, cannot be ignored as a strategy to reduce costs and increase efficiency. He projects that $65 billion could be saved with the adoption of green chemistry, improving the overall ROI for the industry. “For an industry where the development of new drugs is expensive, time -consuming, and has a falling rate of market approval, developing greener and more efficient methodologies for existing processes can help improve cost efficiencies,” Vijah Shah stated in the report. Shah reasoned that if the government were to revise certain standards and regulations, they could offer incentives for meeting specific goals. If companies were offered incentives, green practices could become a priority.
Girish Malhotra outlined the two main objectives of the pharmaceutical industry: To maximize profits through invention, and to market safe drugs while complying with expected performance and regulatory standards. Changes in government regulation may promote companies to adopt greener technologies, facilitate a QbD approach to development, and drive innovation, allowing the pharmaceutical industry to meet these objectives more effectively.