Even as the indirect attempts by the multinationals to equate Indian generics with counterfeit drugs failed at WHO, the United States has once again raised the issue by expressing concern on the 'weak intellectual property rights protection and enforcement' in India.
The 'Special 301' Report by the Office of the United States Trade Representative (USTR), which placed India on the priority watch list, has called for better and effective system to check counterfeit drugs.
"The manufacture and distribution of counterfeit pharmaceuticals is a growing problem that poses special concerns for consumer health and safety. The United States notes its concern with the proliferation of the manufacture of counterfeit pharmaceuticals in Brazil, China, India, Indonesia, and Russia, and the sale and distribution of counterfeit pharmaceuticals in many countries. A significant contributing factor in this problem is the unauthorized use of bulk active pharmaceutical ingredients (APIs) to manufacture counterfeit pharmaceuticals," the report said.
"India has made progress on improving its IPR infrastructure, including through the modernization of its IP offices and the introduction of an e-filing system for trademark and patent applications. Further, the IP offices have started the process of digitization of intellectual property files. In addition, the Indian ministerial committee on IPR enforcement has supported the creation of specialized IPR police units. Customs enforcement has also improved through the implementation of the 2007 IPR (Imported Goods) Enforcement Rules as well as by seizures of unlicensed copyrighted goods intended for export," the part of report part referring to India said.
"The United States remains concerned about weak IPR protection and enforcement in India. The United States continues to urge India to improve its IPR regime by providing stronger protection for copyrights and patents, as well as effective protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approval for pharmaceutical and agrochemical products. Piracy and counterfeiting, including of pharmaceuticals, remain a serious problem in India. India's criminal IPR enforcement regime remains weak. Police action against those engaged in manufacturing, distributing, or selling pirated and counterfeit goods, and expeditious judicial dispositions for IPR infringement and imposition of deterrent-level sentences, is needed," it said.
The report however lauded the recent passage of the Drugs and Cosmetics (Amendment) Act 2008 that will increase penalties for spurious and adulterated pharmaceuticals. The US also urged India to strengthen its IPR regime and stands ready to work with India on these issues during the coming year.
"We are encouraged that the Administration has taken steps to highlight the deficiencies of China, Russia, India, Indonesia, Pakistan and some other countries. China, for instance, continues to circumvent its obligations to protect safety and efficacy data generated by innovative companies and India is no closer to implementing such fundamental protection. PhRMA appreciates USTR's recognition of the severity of the IP concerns for pharmaceutical companies in these countries," the Pharmaceutical Research and Manufacturers of America (PhRMA) said while reacting to the report.