Generics, Patents And Quality Of Medicines
 I have been working as a pharmaceutical engineer in major pharmaceutical companies around the world for a full decade. It makes me smile when people make mistake between the notions of patent and quality certificate by FDA. Before we go further on, let’s get things straight; patents are patently different from quality aspects, and that’s it. Obviously, the two terms are not interchangeable in any way.
What is A Patent?
Let’s get a bit deeper. A patent is a formal declaration issued by the patents department to someone who made a new invention to accord him the privilege of requesting the law enforcement agencies to stop others from using, making or marketing the thus recognized invention. This legally protects the inventor’s efforts, intellectual investments and market potentials from being hijacked by competitors regardless of quality standards. In the context of pharmaceutical products, generic drugs and cheap drugs are those that are allowed to use the exact same incipient (active ingredient) but have different formulations; they can patent their formulations.
Generic Drugs Are Bioequivalent Of Brand Name Drugs
 I need to clarify a few more things before I get into quality aspects of manufacturing pharmaceuticals, both patent and generic drugs. As per regulation of FDA (or any other governing agency), generics must contain the exact same active ingredients as the original formulation to make sure of their identical nature in terms of dosage, strength, route of administration, intended use, efficacy and finally safety. Having achieved this, generics are assured to be bioequivalent of branded drugs for all practical purposes. But this alone isn’t going to ensure the quality of neither generic cheap drug nor of branded drugs. Neither it is an automatic license for generics manufacturers to produce cheap drugs.
Cheap generic drugs can’t be manufactured when the patent for a particular drug is in force. But the reason we see generics being sold in online pharmacies has other legal aspects that permit them to be manufactured and sold. Cheap drugs can be manufactured and sold either online or elsewhere upon:
1. Expiration of patents
2. Proving patents as invalid or unenforceable
3. Undertaking by generics manufacturers that patents aren’t being infringed
4. In countries where patent acts don’t apply
5. Proving that a drug had never been patented
Apparently, it sounds like the law is biased towards brand name drug manufacturers but it is necessary to safeguard the new invention as intellectual property and the mammoth cost the branded drug manufacturers incurred in inventing new drugs.
Quality Manufacturing Of Drugs
 In the context of drug manufacturing, a same set of quality control measures applies equally to both generic and branded drugs. This is the one point that should allay whatsoever apprehensions there are about cheap drugs being cheap in quality. After all, the enforcement agency being not interested in commercial aspects makes sure that a practice called as Good Manufacturing Practice (cGMP) is strictly implemented and adhered to by one and all regardless of geographical locations of manufacturers and whether drugs being manufactured as generics or patented.
CGMP is an ever-evolving set of quality procedures that defines every aspect of pharmaceutical manufacturing beginning from personal aspects of shop floor people to manufacturing ingredients, sourcing the ingredients, storing, handling and manufacturing them till the drugs are packaged and marketed. The rules don’t relax in anyway if brand name drugs manufacturers loan their manufacturing licenses to outsource from fringe manufacturers; it is rather difficult complying with stringent stipulations at all levels at a third party location for patent drug manufacturers and still be able to economize.
Why Are Generic Drugs Also Cheap Drugs?
This is not a naïve question considering the economics of drug development and cost of manufacturing. It is a different issue that online pharmacies are selling FDA approved cheap drugs all over the world because they source their stocks from generic manufacturers geographically located in countries where cost of manufacturing is fractional as opposed to US and West European countries.
As we have seen, it doesn’t matter where the generic drugs are manufactured as far as quality is concerned but it makes huge difference to their selling price. Being professionally managed, online pharmacies source their stocks in groups and in bulk, which further cuts their costs, which they pass on.
For a buyer, price matters most when it comes to life saving drugs and regular medications. |
