A highly predictable IPR regime is needed for the pharma industry in India to develop to the level of the US or Europe, a senior executive of Swiss drug major Novartis said today.
If India wants to develop to the same framework that we have in Europe, Switzerland or US, it is very important that the environment becomes highly predictable and that IPRs are clearly defined, Novartis Pharma AG, Global Head of Development, Established Medicines Franchise, Lutz Hegemann told PTI.
If the whole data regulatory process becomes predictable in the long run, it makes investment in the country more sustainable, he added.
Novartis India Managing Director and Vice Chairman, Ranjit Shahani said: "Looking ahead there is obviously a recognition of fact that India needs to be strong in IPR and I think some of the statements made by the Prime Minister on his recent visits are encouraging."
He added: "We eagerly await translation of these into actionable items in the new IPR policy which is just being drafted out and also the rules being framed following that should provide fillip because we truly want to go from Make in India to invent in India because any economy which needs to be successful the core has to be innovation."
On the Compulsory License issue, he said the World Trade Organization has very straight forward rules as to under what basis a CL can be issued and clearly those norms must be followed.
The triggers for CL that exist in India are too many and threshold limits are pretty low and definitions of national emergency must be pretty clear so as to what is a national emergency so on those aspects it requires more clarification and this is evolving, he added.
In March 2012, Controller General of Patents Design and Trademarks, P H Kurian had granted the first-ever CL to Hyderabad-based Natco Pharma to sell a generic version of Nexavar, a patented kidney cancer drug invented by German pharma giant Bayer - a move that is seen as having changed the course of IPR history in India.
"I think it is good that apart from one CL no CL has been issued and we hope no further CL is issued unless there is a true national emergency that is well defined," Shahani said.