Safety concerns lead to halt of prescription drug imports from two Indian manufacturing facilities

Posted
by Michael Heygood

Your prescription drug is “FDA approved,” but what does that mean? For starters, where was that pill actually made? Who monitored or inspected the drug manufacturing facility? Who tested the quality, purity and safety of the pill you’re about to swallow? Did anyone?

About one-fourth of generic drugs sold by volume in the U.S. come from facilities in India, according to a report by Bloomberg’s Ketaki Gokhale and Adi Narayan, Flies Found By FDA Threaten Indian Town Built on Generics. The FDA is obviously is unable to effectively monitor the production of drugs throughout the entire world. However, in January, the FDA made a surprise visit to a drug producing facility in Toansa in a rural area north of New Delhi, India. The results of that visit and inspection are important to anyone who will have to trust that the next “FDA approved” pill they swallow has been properly produced.

The owner of the factory complex that the FDA inspected in Toansa is Ranbaxy Laboratories Ltd.. Ranbaxy is one of India’s largest drugmakers and has for years produced ingredients for dozens of pharmaceuticals sold to Americans, including AstraZeneca Plc’s top-selling heartburn medication Nexium, as well as its own generic copies of drugs including Pfizer Inc.’s Lipitor.

The FDA’s inspection identified “significant” violations of FDA’s current Good Manufacturing Practices. According to the FDA, the violations included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications in order to produce acceptable findings, and subsequently not reporting or investigating these failures. The FDA found broken equipment, windows stuck open and flies “too numerous to count,” according to the FDA’s report of its inspection.

On January 23, the FDA notified Ranbaxy that the company is prohibited from manufacturing and distributing active pharmaceutical ingredients from its facility in Toansa for FDA-regulated drug products. Following that ban, Ranbaxy announced it was voluntarily stopping production at a second facility, a plant in Dewas, India. The Dewas facility was the subject of an FDA warning letter in 2008 that expressed concern that penicillin-based and non-penicillin-based antibiotics could become mixed due to lax cleanliness standards shown by workers there.

Last year, Ranbaxy agreed to a $500 million settlement in the U.S., in which it admitted it sold batches of drugs that were improperly manufactured, stored and tested. It also pleaded guilty to four felony counts of knowingly making false statements to the FDA.

The Bloomberg report notes that Indian companies sold about $5 billion worth of generics to the U.S. in the year that ended March 2013. Drug manufacturing in India costs about half as much as in Western industrialized countries and India’s wage costs are about one-fifth of the level in the U.S., according to Bloomberg. Although Ranbaxy supposedly requires a month of training for workers who handle chemicals, Gokhale and Narayan quote workers who received only a few days of training before performing such work.

There are more than 11,000 FDA-regulated drugs on the market and nearly one hundred more approved each year. If you think the FDA has tested these drugs and determined the drugs are safe and effective before approving them, think again.

FDA approved drugs have actually been tested only by the same drug companies that plan to profit from selling the drugs they test. The FDA does not test the drugs. One more time: the FDA does not test the drugs. You can read more about “The Myth of ‘FDA Approved’ and Drug Safety” here.

At Heygood, Orr & Pearson, we believe when a drug company sells a drug or medical device that is dangerous and unsafe they should be held responsible for the damage caused by doing so. We have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. From dangerous fentanyl pain patches to defective hip and knee implant devices to dangerous prescription drugs such as Yaz, Actos, Avandia and Accutane, we have made it a career priority to hold drug manufacturers accountable and responsible for their actions.

The lawyers at Heygood, Orr & Pearson are trial attorneys in the truest sense. We are as comfortable before a judge and jury as we are drafting a legal brief. In fact, every one of our attorneys has trial experience, ranging from auto accident cases to commercial fraud cases to pharmaceutical liability cases. Our attorneys have tried over 200 cases to verdict and we have achieved verdicts and settlements for our clients totaling more than $200 million. Most importantly, we are all committed to bringing the highest standards of ethics and a passion for justice to every client and every case.

Heygood, Orr & Pearson has the resources and experience to protect your rights against irresponsible pharmaceutical companies and medical device manufacturers. If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible for such and deserve proper compensation. Contact us for a free consultation to find out more about your legal options.