Last Updated on January 5, 2024 by The Health Master
Quality and Regulations in the Global Pharma Industry
In a video message delivered at the Eighth Global Pharmaceutical Quality Summit, S Aparna, the Union Pharma Secretary, emphasized the significance of regulations and quality standards in the pharmaceutical sector.
She highlighted that regulations pose the most significant barrier to market access worldwide and encouraged Indian companies to prioritize quality.
Aparna also stressed the need for innovation in line with evolving disease profiles and other factors.
Regulations as a Barrier to Market Access:
Aparna acknowledged that the pharmaceutical industry operates within a highly regulated global landscape.
She emphasized that regulations act as the primary obstacle hindering market access.
Recognizing the broad spectrum of players in the Indian manufacturing sector, Aparna stressed the importance of fostering a culture of quality across all levels.
Innovation and Adaptation:
Given that the Indian pharmaceutical industry is primarily oriented toward generics, Aparna urged companies to focus on innovation to keep up with changing disease profiles and other factors.
She noted that Indian pharmaceuticals possess advantages in terms of scale, cost, and quality, which have allowed them to establish a strong presence and gain market share worldwide.
However, she cautioned against relying solely on cost competitiveness for sustained growth, emphasizing the need for continuous innovation.
Challenges and Initiatives:
Aparna acknowledged the industry’s challenges in areas such as technology, resources, and skills.
She emphasized the importance of overcoming these hurdles to create a unified and homogeneous quality ecosystem.
The government has taken steps to address these challenges through the launch of the pharma technology upgradation assistance scheme, which specifically targets small businesses, supporting them in their innovation endeavors.
Quality as a Driver of Growth:
Highlighting the paramount importance of quality, Aparna stated that it serves as the key parameter for the future growth of the Indian pharmaceutical industry, both in domestic and global markets.
She emphasized that the responsibility for ensuring quality lies with the manufacturers themselves.
Additionally, Aparna called upon the industry lobby group, the Indian Pharmaceutical Alliance (IPA), to actively contribute to maintaining and enhancing quality standards.
Conclusion:
S Aparna, the Union Pharma Secretary, addressed the challenges and opportunities in the pharmaceutical industry during her video message at the Eighth Global Pharmaceutical Quality Summit.
She emphasized the significance of regulations as the primary barrier to market access and emphasized the need for the Indian pharmaceutical industry to focus on quality.
Aparna highlighted the importance of innovation, overcoming challenges, and fostering a unified quality ecosystem.
By prioritizing quality, the Indian pharmaceutical industry can ensure sustainable growth both domestically and internationally, contributing to the overall advancement of the sector.
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