Gauri Patel
Karmic Lifesciences Consulting Services, India
Title: Role-play of GxP standards in growth of Indian pharmaceutical industry: Recent trends in GCP and GLP requirements
Biography
Biography: Gauri Patel
Abstract
The Indian pharmaceutical industry has achieved an eminent global position in pharma sector and has been witnessing phenomenal growth in recent years. It is well known that India is emerging as a world leader in generic pharmaceuticals production, supplying 20% of the global market for generic medicines. Indian pharmaceutical sector accounts for about 2.4 per cent of the global pharmaceutical industry and is expected to expand at a CAGR of 15.92 per cent to US$ 55 billion by 2020 from US$ 20 billion in 2015. The Indian pharmaceutical industry is one of the most attractive investment destinations in the world, with ever increasing returns, lowering risks and anticipated multifold growth. It is estimated that around 40 per cent of the generic drugs in the US come from India. Given the demanding nature of inspections, recent enforcement actions and the public scrutiny that each warning letter is subjected to, there can be no compromise with the quality requirements or regulatory necessities. Special attributes are the data integrity issues that have become a recurrent theme in the FDA’s inspection of Indian facilities. The challenge to the pharmaceutical industry is, therefore, to develop quality systems, compatible with GxP principles, that not only cover formal quality items but also ensure good scientific and technical performance. The pharmaceutical industry is one of the most regulated activity sectors. The regulation includes specific quality systems such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacture Practices (GMP). Revisiting the regulations (GCP & GLP) with focus on recent updates and their causes will definitely help pharmaceutical industry in achieving goal of delivering better medications globally.