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.
Over the first few months of 2014, Novartis quietly began laying off workers, shedding an estimated 3,000 jobs in four months. Now BioSpace has provided details of where the ax has fallen and why, with development IT teams suffering heavy job losses.
The pharma sector in India is reeling after the National Pharmaceutical Pricing Authority said it's capping prices on about 100 drugs to treat diabetes and heart disease. And the company that could suffer most isn't India-based.
FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.
Glenmark has more than a dozen manufacturing plants around the world, recently opening a mAb manufacturing facility in Switzerland to feed its pipeline of monoclonal antibodies and biosimilars. But the Indian generics maker does not have a plant in North America and figures it is time.
Rising recognition of FDA scrutiny and the cost of quality failings have prompted Indian drugmakers to double spending on compliance over the past 5 years, credit rating agency Crisil reports. And Indian investors are increasingly conscious of the value of such investments, with Shasun Pharma seeing its stock jump 16% this week after it got through an FDA inspection with just a Form 483.
India's medical device manufacturers hope the government's annual budget will address taxation that skews in favor of imported devices.
Doctor education is not a new way for pharma companies to make a name for themselves in emerging countries where methods like DTC advertising won't do the trick. But Merck has put its own spin on that doctor education with its online portal, and now it's bringing the service to India.