Indian pharma: Raising barometer of success beyond generics

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Ritul Bapna, B. P. Nagori, Vipin Mathur

Posters: Pharmaceut Reg Affairs

Abstract :

Emergence of the Indian pharmaceutical industry on the global landscape as one of the biggest generic drug supplier was due to the Indian Patents Act, 1970 which allowed only process patents and no product patents for food, drugs and medicines. India being a member country of WTO signed TRIPS agreement and consequently amended its patent law in 2005 to allow product patenting in all fields of technology including pharmaceuticals. Post TRIPS era of product patentability has posed both opportunities and challenges in front of Indian pharma companies. In this new scenario, it takes away the freedom of Indian pharma companies to introduce generic versions of new chemical entities (NCEs) in the normal course before the drug?s product patent expiry. However, since world?s 10 biggest selling drugs are going to be off patent soon, it is going to create an estimated $250 billion worth of generic drug market till 2015. Although the generic industry will benefit in the short term but it will also see a slowdown in revenue growth after 2015 since R&D pipeline has dried up to a great extent and the number of NCEs has come down significantly. To cope up with these future pressures, Indian pharma companies definitely require to look beyond generics and should try other business options like building joint ventures, investing in lower risk research areas, developing skills in biotechnology based drug production, exporting to unregulated markets etc. This presentation analyses the impact of product patenting on Indian pharmaceutical industry and suggests some measures to tackle the possible challenges that the industry is expected to face in near future.

Biography :

Ms. Ritul Bapna is presently pursuing M. Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of Science & Technology, Pharmacy Wing, Jodhpur, India.