India to flag market access of drugs and spices with US

Indian policy makers will take up with visiting US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg all the issues ranging from the quality of products and safety standards in Indian pharmaceutical plants raised by the FDA and access of certain foods, fruits and spices to the US market, sources said.

Hamburg will meet health and commerce ministers and top officials on ongoing collaboration on food and drug programmes and strengthening cooperation between regulators of the two countries.

Currently, India is the second largest provider of finished drugs and the eighth largest exporter of food products to the US.

"I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration," Hamburg said in a statement ahead of the visit.

During the Feb 10-18 visit which will take her to Mumbai and Kochi, Hamburg will meet industry representatives to discuss quality control of medical and food products exported to the US.

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.

Drug Controller General of India G.N. Singh says that every country has different measures and "we cannot judge Ranbaxy by standards set up by the American drug regulator".

Health Minister Ghulam Nabi Azad has said India is a victim of cartelisation by developed nations which "lay down such strict parameters to bar manufacturers from developing countries from global competition."

"There is politics and business interests of multi-national companies, which find it difficult to take on competition from Indian companies," he said.

India supplies low-cost drugs to over 200 countries.

"The pharma industry has played a significant role in providing affordable drugs not only to the country but to the rest of the world, especially African nations, where the healthcare spends of governments are very less," G V Prasad, Dr Reddy's Laboratories (DRL) chairman, said ahead of next week's BioAsia 2014.

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 bedevilling 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 this week.

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.

In Kochi, Hamburg will attend the Feb 16-19 World Spice Congress. She will visit a seafood processing facility and a spices facility.

Almost nine percent of 1,057 spice shipments from India were contaminated with salmonella, the FDA said in a report last October.

The Spice Board of India is currently working directly with farmers to put additional safety practices in place and to lower the risk of contamination.