Pharmaceutical Regulatory Affairs: Open Access

Suryakanta Swain

Publications

• Review Article
  Pharma Regulations for Generic Drug Products in India and US: Case Studies and Future Prospectives
  Author(s): Suryakanta Swain, Ankita Dey, Chinam Niranjan Patra and Muddana Eswara Bhanoji RaoSuryakanta Swain, Ankita Dey, Chinam Niranjan Patra and Muddana Eswara Bhanoji Rao
  
  Among the developing nations of the world, India has already carved out a special niche for itself in many business verticals of the pharmaceutical industry and is currently being recognized as the ‘pharmacy of the world’ for the generic drug products. The Indian generics market is growing day by day with Indian pharmaceutical companies seeking more Abbreviated New Drug Application approvals (ANDAs) in US. Generic medicines are formulated when patent and other exclusivity rights expire. To ensure the therapeutic efficacy of generic products, it must be pharmaceutically interchangeable and bioequivalent to the originator product. The contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high i.e. about to 35%. To sustain competition from developed world Indian generic manufacturer should plan the market strategy and regulato.. Read More»
  DOI: 10.4172/2167-7689.1000119

  Abstract PDF