“I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration,” Hamburg said in a statement ahead of the visit.
India-US cooperation has been wide-ranging, from sharing information on the conduct of clinical trials to jointly addressing product safety issues that have an impact on consumers in the two countries. Hamburg’s visit is taking place at a time when India-based drug companies are coming under stringent US regulatory scrutiny on “good manufacturing practices”. Last month, the FDA inspected Ranbaxy’s active pharmaceutical ingredient (API) manufacturing facility at Toansa, Punjab, and decided to bar the plant from supplying to the US. Earlier three other Indian factories of Ranbaxy, at Mohali, Paonta Sahib and Dewas, were stopped from supplying to the US. Also, other Indian companies like Wockhardt, RPG Life Sciences and Agila Specialities have come under the FDA lens. India supplies low-cost drugs to over 200 countries.
And in the US, demand for generics is rising as the Obama administration is trying to reduce healthcare costs. Also, according to IMS Health, India’s $14 billion-a-year drugs market is expected to be worth $22-32 billion by 2017. Western multinationals such as Pfizer Inc, Novartis AG, Roche Holding AG and Sanofi SA are eyeing a larger share of the growing drugs market in India.
Issues of Intellectual Property Rights (IPR) are bedeviling the drugs trade. A recent report by the US Chamber of Commerce ranked India at the bottom of 25 countries in protection of IPR, which has been questioned in India. “I would very honestly describe it as scare-mongering tactics and, frankly, I don’t think it’s helpful,” Ambassador to the US S. Jaishankar said.
He was reacting to Senator Orrin Hatch who accused India of allowing “rampant piracy and counterfeiting” for the benefit of its own industries. In an address to the Aspen Institute U.S.-India Dialogue, National Security Advisor Susan Rice Friday raised US concerns related to intellectual property.
India is currently on the U.S. government’s Priority Watch List – countries whose practices on protecting intellectual property Washington thinks should be monitored closely. India has said its IPR regime is based on “comprehensive laws, detailed rules to back them up, and strong enforcement mechanisms, including for dispute resolution”.
The FDA activities in India include increased inspections of relevant high-risk facilities and working with private and public sector entities that wish to engage with agency on third-party certification efforts regarding these products. The FDA last year put Indian basmati rice on import alert saying that a fungicide, tricyclazole, was detected in some consignments. The US also has issues with “contaminated” shipments of spices exported by India.