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.
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.
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