The "Indian advantage" has been the ability to do clinical trials and manufacture drugs for global export at perhaps a tenth of the cost that drugmakers in the West face. But with actions by the FDA and Western regulators forcing plants from exporting to those markets and a need to move to higher-margin drugs, some Indian drugmakers are giving up that edge in an effort to raise profits.
India's troubled Wockhardt is again expanding its voluntary recall of metoprolol succinate extended-release tablets, a generic of AstraZeneca's hypertension drug Toprol XR. This is Wockhardt's third recall of the drug in about four months.
Nilesh Gupta, managing director of India's Lupin, told Bloomberg that his company gave Wockhardt a financial sizing up recently before deciding it didn't represent a good M&A target.
India's drug business has taken a big financial hit in the last years as the FDA has stopped some of its top players from shipping drugs to the U.S. But experts still see big potential in the industry, saying it will grow faster than other Indian industries, particularly if players shed their conservative approach and get involved in the global M&A mix that their larger competitors are benefiting from.
The drugmaker says it disagrees with the U.S. Consumer Product Safety Commission's allegations and is talking things over with the CPSC. But the Department of Justice is also investigating a complaint related to the same matter under the Federal False Claims Act.
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.