Lex Witness will hold the 3rd annual edition of The Pharma Legal & Compliance Summit. The summit, which will be held on September 19, 2014 in Mumbai, will have brainstorming sessions with the leaders and veterans of the industry.
The summit will have four-focused panel discussions broadly for; Compliance and Best Practices; M&A & FDI; IPR – Wining the Wars | Challenge the Challenges; Comprehending Regulations to Drive Strategic Moves– NPPA DPCO 2013 and Clinical Trials.
The Indian Pharma industry is struck hard by the regulators’ stringency. The commotion in industry is mostly because of lack of understanding of various pharmaceutical players in the country towards increasing regulations and strictness towards such regulations. Both domestic and international regulators are keeping a stringent watch on pharma regime.
With 100 per cent brownfield and greenfield investments in Indian pharma; the market stands to see an enormous growth in times to come; this growth seems to be promising enough keeping in mind what the European Commission and US FDA have opined recently. It has also raised the scopes of M&A & FDI to the heights that once seemed uncertain. These transactions seem to be promising a lot of international interest which at the same time calls for a lot of housekeeping for the India players, right from legal best practices to marketing strategies. There also remains a need for a clear understanding of check points for acquiring assets overseas.
While being compliant was still a challenge the increasing complications that the industry has been facing, the US FDA’s increase in issuing notices; has further stressed upon its dire need. The NEW COMPANIES ACT 2013 has further added on to its intricacies. A close watch on all trade and product promotion practices has become yet another vigil act amidst the pharma players.
Various aspects of IPR still has a lot of grey air around it. Ever greening of patents remains a debate. Moreover, increasing compulsory licenses and increasing need of patent linkage has created more uncertainty in the industry.
EP News Bureau – Mumbai
