Pharma Regulations for Generic Drug Products in India and US: Case Studies and Future Prospectives

Abstract

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 regulatory requirement needed, very quickly because for generics production large number of application will be filed and competition from domestic market will also be there. This review enlists the validated regulations for manufacturing of generic drugs in India and US. Implementation and regulation, of the pharmaceutical sector at the state level, rather than on simply introducing new regulations is call of the hour. Henceforth, the use of drugs needs to be emphasized significantly for cost savings to the government and customers, in addition to its optimistic impact on health.