Are Your Medications Safe Just Because They Are Scientific?

Posted on Friday 21 August 2015 and filed under , , , , . You can follow any responses to this entry through theRSS 2.0 . You can leave a response or trackback to this entry from your site

(hla) NO MATTER how stringent the regulations are for ensuring the safety and effectiveness of medication, there are always loopholes used by pharmaceutical companies to mask potential regulatory concerns. Many have the impression that every medication consumed is safe and effective just because they have undergone many scientific studies are being overseen by regulatory bodies. However, most drugs are created to maximise the generation of profits for pharmaceuticals.

For example, Reuters reported that in 2013, Ranbaxy USA Inc. (a subsidiary of the Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, India) pleaded guilty to felony charges related to drug safety and was fined $500 million for selling substandard drugs and falsely representing various data to the FDA about manufacturing practices at its plants. It was deemed the largest drug safety settlement to date with a generic drug manufacturer.

FDA responded by banning import of drugs from all of Ranbaxy's India-based plants, which is the largest supplier of generic medicines to the United States, under a wide scrutiny of the country's $15 billion pharmaceutical industry.

Ranbaxy USA admitted to introducing into US certain batches of adulterated drugs that were produced at its Indian plant in 2005 and 2006. Former Ranbaxy executive Dinesh Thakur blew the whistle on the company's activity in 2007 when he found Ranbaxy's drugs were made for Americans with "bioequivalence" data that did not exist or made up. Generic drugs are supposed to prove that they give the same effect as the brand name. This is known as "bioequivalence".

What this means for the public is that medications can be potentially harmful products. Imagine taking Ciprofloxacin, an antibiotic given to treat infections, that is substandard in quality and that it not only does not treat the infections effectively but even worse, it can lead to resistant strains of bacteria that will not respond to Ciprofloxacin in the future. This creates a domino effect. The harm does not stop here!  Resistant strains will be passed down to the future generations as well just because of such unethical practices!

It is not surprising that the said company had other potential safety problems as well. In 2012, Ranbaxy issued a recall after finding glass particles in raw ingredients for generic Lipitor. A recall is when a particular batch(es) of products are removed from being sold to the public due to potential safety concerns. In the same year, FDA inspectors found faulty cleaning records and a failure to investigate problems in another Ranbaxy facility.

Such unethical practices do not stop with Ranbaxy. Other major pharmaceutical companies have also been found guilty to such unethical misconducts. How many other pharmaceuticals out there are unethical and use various loopholes to place profits first? How many have directly or indirectly died due to such unethical lapses?

There is certainly a need to improvise the system in the pharmaceutical industry so that such unethical lapses are prevented. The safety of medications are not truly guaranteed and properly represented despite their scientific claims and support. It is not uncommon for negative data to be played down so that they meet the stringent requirement established by regulatory bodies to proceed with production. Consumers need to be aware of how such unethical lapses can lead to even their death if it is not contained.

Author: Silambarasu Karuppiah 

Copyright © 2015 Sandhya Maarga Holistic Living Resources 
Holistic Living Annex (AUGUST 2015)

1 Response for “ Are Your Medications Safe Just Because They Are Scientific?”

  1. Carol says:

    That's why there's a conspiracy theory now about the disappearances of holistic doctors in the US. When will people learn?


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