US ups its pressure on India over generics industry
The US is to step up its pressure on the Indian generic drug industry following criticism from Pfizer of the country's intellectual property (IP) standards.
On a recent visit to India, US Secretary of State John Kerry is believed to have discussed the Obama administration's opposition to the country's generic drug policies, which analysts have warned could discourage pharma from investing in the country.
Indian patent laws, which do not consider new forms of a known substance to be innovative unless it improves efficacy, have stirred much controversy in recent years, following a number of high-profile cases of revoked patents. In April this year, Novartis' cancer drug Gilvec was denied patent protection; a case that followed similar defeats for Roche's hepatitis C drug Pegasys, Merck's asthma treatment Singulair, Gilead's HIV drug Viread and Pfizer's cancer drug Sutent.
During a subcommittee of the House Energy and Commerce Committee last week, chair Lee Terry outlined his concerns over India's IP policies, which he described as a “unfair and discriminatory” and a "threat" to the trade relationship between the US and India.
Speaking at the meeting, Pfizer's chief IP officer, Roy Waldron, argued that India's "unfair practices" have undermined Pfizer's "ability to innovate, create jobs and provide faster access to life-saving medicines". He claimed that the patent laws have had negative effect on Pfizer's ability to recoup R&D costs, "often exceeding $1bn".
"Since early 2012, India's policies and actions have undermined patent rights for at least nine innovative medicines. Many of these medicines have received patent protection in most countries across the world, suggesting that India is an outlier in recognising and enforcing patent rights. This is not only creating significant uncertainty in the market but it also undermines our ability to compete fairly in India, and our willingness to invest there."
Public health experts have argued that India's inexpensive generic drugs are vital to providing life-saving treatments around the world. Democrat Henry Waxman said: “Indian policies regarding IP and access to medicines can genuinely advance public health”, adding that the US's AIDS-relief programme PEPFAR relies heavily on Indian generics to supply medicines in the developing world.
In a move to address concerns, Indian ambassador to the US, Nirupama Rao, has offered US lawmakers an opportunity to discuss the issue of pharmaceutical IP.
"My senior colleagues at the embassy stand prepared to come and meet with your key officials or your constituents to engage in a friendly and substantive exchange of views so as to promote deeper understanding, and to seek mutually satisfactory solutions, in a spirit of friendship," said Rao in a letter to the US legislators, according to The Times of India.
"India has […] a well-settled, stable and robust intellectual property regime. The three main pillars of this regime are comprehensive laws, detailed rules to back them up, and strong enforcement mechanisms, including those for dispute resolution. In India, the IP framework is rooted in law.
"The full complement of our laws on patents, designs, trademarks and geographical indications is in place and these are in compliance with the Trade Related Intellectual Property Rights (TRIPs) of WTO,” she said.
US ups its pressure on India over generics industry - PMLiVE
India's generic drug industry safe and strongly regulated: Government
NEW DELHI: Government defended its lucrative generic drug industry as safe and strongly regulated after the nation's biggest drug firm pleaded guilty to US charges of making adulterated medicines.
In a bid to defend its generic export sector, the government also charged that "isolated reports" of spurious drugs found in global markets and alleged to be from India were "desperate attempts" by other countries hurt by "the strength of the Indian pharma industry".
India's "pharmaceutical sector is a highly regulated one and the exports are heavily guided by various regulatory regimes of the importing countries", the government said in a statement.
The statement came after New Delhi-based Ranbaxy Laboratories, India's largest drug company by sales, pleaded guilty in the United States to criminal charges of making adulterated medicines and agreed to a $500 million settlement.
The fraud, investigated over eight years by US authorities, was brought to light by a whistle-blowing ex-employee, who said Ranbaxy created "a complicated trail of falsified records and dangerous manufacturing practices".
India built a reputation as the "pharmacy to the world" for its production of life-saving generic versions of medicines for poor nations that cost a fraction of brand-name versions.
But analysts have warned that Indian drugmakers may find it tough to win new contracts in their main US market, with the case involving New Delhi-based Ranbaxy raising questions about the safety and quality of Indian-made drugs.
Generic drug firms in India have been a major supplier of copycat medicines to treat diseases such as cancer, TB and AIDS for those who cannot afford expensive branded versions.
The country "has proven international quality standard capabilities", the government said.
It said India enjoys "a unique position of low-cost manufacturing and the highest quality medicine, the best of both the worlds".
India's drug exports totalled $14.6 billion in the financial year to March 31, marking growth of nearly 11 percent from the previous year.
Japanese drug company Daiichi Sankyo which bought Ranbaxy in 2008, has since alleged that the Indian firm's former owners hid vital information about US regulatory inquiries at the time of the $4.6-billion purchase.
The charges have been strongly denied by the billionaire Singh family which used to control the company.
India has long alleged that some complaints about the quality of its generic medicines originate with rival brand-name manufacturers unhappy about the growing use of cheaper knock-off drugs as developed nations tackle soaring health care costs.
India's generic drug industry safe and strongly regulated: Government - Economic Times