FDA Warns Sun Pharmaceutical of Quality Problems

Sun Pharmaceutical Industries is a larger drugmaker in India. It supplies many generic drugs to the US market .. But the giant is once again in trouble with US regulators.

FDA Warning Sun Pharmaceutical:

Administration

The Food and Drug Administration has issued another warning letter to the company because one of its main manufacturing plants has fallen short in control quality. The problems the FDA said in its latest communication are very similar to those mentioned in a letter sent earlier this year.

Sun Pharmaceutical bought another large manufacturer of generic drugs from India, Ranbaxy, which also had problems with the FDA about quality control problems. Ranbaxy agreed to pay $ 500 million in fines May 2013 after pleading guilty to making false statements and violating the laws of drug safety.

More problems in India:

Another manufacturer of generic drugs from India, Dr. Reddy’s Laboratories, has also been the subject of scrutiny by the FDA. The company received a warning letter last month because of quality control problems, especially data integrity.

Indian drug manufacturers provide at least 40 percent of Americans take generic drugs each year. This is not the first time we have written about problems with poor quality control in certain manufacturing plants in India. You can read more here and here .

The FDA and foreign-made drugs:

The message we hear repeatedly from the FDA on generic medicines is that the agency has everything under control and there is nothing to worry about. However, we read about violations in India and other countries. Unfortunately, the FDA rarely reveals what medicines have been affected.

there is no “country of origin” label on the medicine bottle so you have no way of knowing if your drug is made in China, Thailand, Brazil and West Virginia. And you have no way to know if the pills you are taking for high blood pressure, depression, cholesterol control or acid reflux were made in a pharmaceutical company first class with excellent quality control or a facility where cleanliness is not such a high priority and workers fudge data.

We all want affordable medicine but also want an absolute guarantee that our pills are carried out under appropriate conditions and perform exactly as the name of the brand name drug. The last problem in India does not instill confidence that this is the case.

Reader Stories:

Leo, a pharmacist with years of experience:

“I am a registered pharmacist and I have worked in the generic and brand name pharmaceutical industry for 31 years. I think that the rules for the integrity of drugs have changed. I am currently working at a pharmacy chain and I’ve seen drugs on the shelves that come from around the world ;. why, because they are cheap and that’s what we want in this country I have drugs from :. Island of Malta, Slovenia, Croatia, India, China, Taiwan and Poland just to name a few

“it’s a joke to believe that the FDA has been in these countries to actually carry out inspections of manufacturing plants.

“Pharmaceutical companies production to India, China and other countries for economic reasons due to the fact that no EPA or OSHA, and minimal, if any moved, supervision of any regulatory government group.

“If supermarkets are required to label fish, poultry and meat, the country of origin, then it also should require labels prescription. This can help to inform the public of what is really going on. The FDA is understaffed, overloaded and ineffective to do an effective job “

This comes from a patient in New Mexico.

“I used Coreg for 15 years to control my blood pressure and heart condition and I loved it. They put me in the carvedilol because Medicaid would not pay for Coreg. The generic immediately showed that it did not work. I have complained about a year.

“My insurance company has refused to agree with my doctgor ​​me back Coreg brand. Today. I was told to try at least one more generic for Coreg. No there is another generic only other vendor. generics from India.

“Tomorrow begins a generic again. Hopefully the bad results show quickly and may require Coreg get my back. These insurance companies are working. “

Eileen in Missouri:

” Wellbutrin XL 300 mg – was changed to generic Bupropion – horrible reactions. Insurance no longer pay for the brand name.

“Luckily I found one, with licensed Canadian pharmacy reputation – need a prescription as in the US – and now I’m getting tablets 90 brand names by lot less than $ 200, which for me is a source of 3 months. it would be way more than $ 1,000 if you had to pay out of pocket in a pharmacy US. This pharmacy was reliable and is the same brand that I like to have in the U. S “.

How sad is that Americans have to buy branded products from Canada to save money because they can not depend on imported generic drugs from India and other countries.

Share your own experience and thoughts below in the comments section and please vote in this article at the top of the page.

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