Medtronic has tied its long-term growth to three pillars: strong U.S. sales, double-digit growth in emerging markets and Covidien. But last quarter, the medical device giant didn't deliver on emerging market revenue growth as it encountered difficulties with distributors in India and China. It expects to return to double-digit gains in both countries this fiscal year.
Until very recently, no serious consequences had been dealt out by India's Central Drugs Standard Control Organization (CDSCO), even for Ranbaxy Laboratories, which last year pled guilty to criminal charges in the U.S. for selling subpar drugs. But CDSCO appears to be turning over a new leaf--at least a little.
When the FDA issued a Form 483 to Ipca Laboratories late last month, the Indian API manufacturer voluntarily suspended shipments to the U.S. Now the release of details about the 483 has shown why Ipca acted swiftly, with the company joining the list of Indian drugmakers accused of data falsification.
The $84,000 U.S. treatment price that Gilead Sciences is charging for its hepatitis C drug Sovaldi has elicited pleas from politicians and threats from payers, who say the U.S. healthcare system cannot bear the cost. But in India, Gilead will offer it at a discount--a 99% discount.
To aid it with marketing its oncology lineup in India, the French drugmaker has brought on local company Emcure Pharmaceuticals, PMLiVE reports.
Labor issues at a Pfizer plant in Thane, India, have led the company to lock employees out of the facility after workers were said to have tried to stop production and threatened managers.
Hospira's long troubled Rocky Mount, NC, manufacturing plant is troubled no more. CEO F. Michael Ball says a much anticipated reinspection of the plant by the FDA resulted in no observations. But now the FDA's focus has shifted to a new plant in India where manufacturing issues have caught its attention.
When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.
CRO Theorem Clinical Research has inked a deal with India's Excel Life Sciences to broaden its footprint in the country, expanding its access to clinical trial sites and bolstering its patient-recruitment capabilities.
FDA Commissioner Margaret Hamburg has urged India's drugmakers and regulators to get on board with international quality standards, while promising close cooperation from its expanded office there. But efforts are being hampered by the exit of top officials.