|
 Indian pharma’s global presence in generic medicine exports among others like biosimilars will indicate a strategic shift towards further expansion in the international markets particularly the US. To this end, the guidance from the US FDA on formulation development serves as a crucial enabler for Indian pharma companies in this pursuit.
The draft guidance on formulation development outlines the regulatory requirements and best practices for developing drug formulations, especially those intended for the US market. Adhering to these guidelines not only ensures compliance but also enhances the quality and efficacy of pharmaceutical products. For Indian pharmaceutical firms eyeing global expansion, such guidance provides a roadmap for developing high-quality formulations that meet international standards, thereby bolstering their credibility and competitiveness in the global arena, said Indian pharma industry experts.
This comes at a time when a recent news report indicated that the US is encountering shortage of 233 drugs across 22 categories. The same report has quoted the India Ratings and Research study noting that regulatory costs, complexities in filing and price erosion has led to low pricing with stiff competition which was resulting in stopping production of medicines in the US market.
Now the guidance for the pharmaceutical development by US FDA is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guidance also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
Further, the global regulatory guidelines do not apply to contents of submissions for drug products during the clinical research stages of drug development. However, the principles in this guidance are important to consider during those stages as well. The objective aim of pharmaceutical development guidance is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experience provide scientific understanding to support the establishment of the design space, specifications, and manufacturing controls, said the global regulatory authority.
India is home to 741 US FDA plants and accounts for US contribute about 30% of India's total pharma exports. The industry is also seen to receive faster Abbreviated New Drug Applications (ANDAs).
By leveraging the US FDA guidance on formulation development, Indian pharma companies can streamline their research and development processes, optimize formulation techniques, and accelerate the time-to-market for new drugs. This, in turn, enables them to seize emerging opportunities in the global pharmaceutical market, particularly in the lucrative US market, said Archana Dubey, executive vice president, international sales, Bal Pharma Limited.
Moreover, compliance with US FDA guidelines enhances the reputation of Indian pharmaceutical manufacturers for reliability and quality, which is crucial for gaining market acceptance and building trust among healthcare providers and patients worldwide. As Indian pharma firms continue to invest in research and development, manufacturing capabilities, and regulatory compliance, they are well-positioned to maximize their global presence and capitalize on the growing demand for affordable and high-quality pharmaceutical products, she added.
|