The Pharmaceutical Research and Manufacturers of America (PhRMA), one of the top bodies representing American pharmaceutical and biotechnology companies, said in an annual report that India's intellectual property rights protection is weak and the group added India to its "priority watch list."
The country's legal and regulatory systems "pose procedural and substantive barriers at every step of the patents process," the group said, according to a report by Livemint.
"Not only is this a concern in the Indian market, but also in other emerging markets that may see India as a model to be emulated," PhRMA said in its report.
The group also said that since 2012 about 25 products "have had their patent rights undermined in India" and that "in 2015 alone, at least six products have faced issues due to the continued denial of applications" under India's patents act.
Products also saw "infringement due to state-level marketing authorization for generic versions of on-patented drugs, and the threat of compulsory licenses, all of which demonstrate that there have been no concrete policy improvements in India," it said, according to the Livemint report.
PhRMA also said high tariffs and taxes in India on APIs and finished products were a huge challenge for the industry and that India "collects more in taxes on pharmaceuticals than it spends on medicines."
PhRMA also said in its report that foreign drugmakers are discriminated against under the country's drug price control regulations because new medicines developed by "indigenous research" are exempt from price controls.