Patents in Indian pharmaceutical industry: Legal and ethical issues

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

B. S. Kuchekar

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

In the post-independence era, the Indian pharma market was completely dominated by multinational companies (MNCs) and most of the medicines were imported in India. The cost of medicines in India was among the highest in the world. In 1970, Indian Patents Act 1970 was passed which allowed only process patents for new molecules and chemical entities (NCEs). This law opened gates for reverse engineering of medicines thus brought down price of medicines in India to affordable level. However the post TRIPS (i.e. post 1995) era has seen the paradigm shift from generic product development to innovative R&D and basic R&D. The legal issues mainly focus on the effective enforcement of patent laws in India. If we look at the history, the Indian pharma companies have flourished due to weaker Indian patent law. However as a legal binding, Indian government being a signatory to TRIPs implemented product patent system in India. The developed nations backed by MNCs are putting pressure of Indian Government to implement strict patents laws in view of TRIPs agreement. The ethical issues highlight the access and affordability of essential medicines to Indian citizens. It is well known fact that the strict patents reduce the availability and affordability of new essential drugs in developing countries, and thereby have a negative impact on the health of poor patients. There are few legal tools available in the TRIPs such as compulsory licensing which needs to be fully exploited by Indian government.

Biography :

B. S. Kuchekar has completed his Ph.D. degree in Pharmaceutical Chemistry in 2002. He has 33 years experience in academics. He has published 135 research papers and 29 reviews. 4 books and 2 patents are to his credit. He has guided 45 postgraduate and 8 Ph.D. scholars. He did LL.B. from New Law College Pune, India and P. G. Diploma in Patents law from NALSAR University, Hyderabad. Currently he is working as a Principal and Professor at Maharashtra Institute of Pharmacy, MIT campus, Pune, India.