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.
For the second time in recent months, Pfizer is having to recall hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet. Pfizer says a single 100 mg tablet of Pristiq Extended Release was found in a 50 mg bottle but the drugmaker is taking no chances and is recalling four lots of the the antidepressant drug.
Bristol-Myers Squibb in April quit making injected Coumadin, the form used in the rare cases when patients can't take the oral formulation. But there is still product in the market and and the company is having to recall some of it.
Thinking it needs to change the spin on the story, an industry group in India has hired a Washington, D.C., consulting firm which is launching a campaign it hopes can do that.
Federal authorities have torn down another pillar in a wide-ranging business that sourced foreign-made cancer and other drugs and sold them to U.S. doctors at a discount. Some of the meds were cold-chain drugs that were sometimes left unrefrigerated in Pakistan.
In the face of FDA actions against some of India's biggest drugmakers and a barrage of criticism of its regulators, the Indian government and industry have already responded with a PR campaign, and now India says it will spend more than $500 million to double its inspection staff and upgrade capabilities.
Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.
Teva Pharmaceutical Industries is one of half a dozen drugmakers that have been rolling out generics of Eli Lilly's top-selling blockbuster Cymbalta. The others are going to roll past the Israeli drugmaker after it recalled more than 1 million bottles of the antidepressant.
Tivicay, a combo HIV drug from GlaxoSmithKline, Pfizer and Shionogi that is pegged to become a blockbuster, was only approved last summer, but the companies are having to recall a small portion of it because of cross-contamination.
Rapidly expanding Indian generic drugmaker Lupin has stumbled, having to recall 5 lots of the antibacterial med Suprax (cefixime) because it failed purity tests.