The enactment of the new patent regime in India in March 2005 will herald a new era in the country's pharmaceutical sector, according to local media sources, who expect the market to reach US$25bn in the next five years.
In 2005, the new intellectual property accords stand out as having had the greatest impact on both company revenues and structures in India. At the same time, the legislation has meant that India's generics makers have had to re-evaluate their role.
The larger companies have increasingly invested in new drug development as they look to create their own branded product portfolios. Meanwhile, the smaller players have also shifted their strategies, looking to marketing and licensed manufacturing as a way of collaborating with the innovator firms.
However, foreign drugmakers claim that India's patent protection still falls short of international norms. The Office of the US Trade Representative (USTR) has led the criticism and has opted to continue India's "priority watch" status. The agency is particularly concerned over inadequate safeguards to protect undisclosed test data.
Further, counterfeiting remains a serious problem in India. The government is hoping to address the problem with the Drug and Cosmetics (Amendment) Bill, and has promised harsher penalties for those involved in the illicit trade. However, market sources remain sceptical as to how stringently these measures can be enforced.