Setting the scene: Pharma manufacturers and the FDA (part 2 of the Recall of -sartans series)

Since my previous post on the recall of -sartans, Torrent Pharmaceuticals recalled 36 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide. Over the next few weeks, I will be covering various aspects of the global drug production industry as most of us, at some point or the other, would have had utilised its outputs. And we would have done so under the impression that the product we paid for (or were administered) should work, with as little side effects as possible. For the product to work, it should comprise of a precise amount of active ingredient(s), having either no contaminants or below maximum permitted limits. Tweak this formula a bit and we are looking not only at a potential placebo, but one with side effects (some of which can be dangerous). In the recent recall of -sartans, the tweaking is mainly associated with generics.


Brand-names & generics
What are generics? Drug development and manufacturing is an extensive and expensive process, requiring capital, time, and resources. This also entails extensive research and testing of a potential drug to check its efficacy, quality, and safety. Thus, very often, this is carried out by big pharmaceutical companies (e.g. Novartis, Roche), with the outputs being patented and the patent being protected for a certain duration. Given the costs involved in this process (from formulating an idea to the product being stocked in pharmacies), drugs or active ingredients manufactured by the big pharmaceutical companies (a.k.a. brand-name drugs) tend to be priced high. When the patent protection runs out after some years, other pharmaceutical companies can avail of the patent and replicate the brand-name drugs/active ingredients - these are the generics. These are significantly cheaper than the brand-name drugs for mainly three reasons:

• Firstly, the unprotected patents can be used by anyone, leading to multiple manufacturers of generics. As there is more competition, the price of the drug decreases.
• Secondly, these new manufacturers need not spend substantial capital, time, and resources (as essentially most of the work has been done by the big pharma), apart from proving that their generic works as a good copy of the original (e.g. Novartis's brand-name Diovan and the respective generic Valsartan). 
• Thirdly, most manufacturers of the generics (drugs or active ingredients) are located in countries where the production costs are lower (e.g. China and India). 

The result is that generics are widely used.

Recalls & the US FDA
The recalls of -sartans led to more than a ripple in the global pharmaceutical industry as this was highlighted by the US Food & Drug Administration (FDA). One of the stated aims of the FDA is to ensure that drugs/active ingredients sold in the US comply with their standards for quality, safety, and efficacy. Obtaining FDA's approval involves several components, often including visits by FDA's inspectors and evaluation of data maintained by the manufacturer:

• verification that the production process/factory follows good manufacturing practices (GMP)
• verification of the properties relating to the active ingredient
• verification of the presence/absence of any contaminants

The past years have witnessed a high approval of generics in the US, with around 80% of active ingredients being sourced from non-US facilities. This high rate was for meeting the promise of Trump administration on lowering the costs for medicines.

Whilst the election promise and the FDA inspection are aimed at the ensuring the US population have access to affordable and safe drugs, my blog post next week will list the problems associated with the verification process.

Image by Remaztered Studio from Pixabay