Generic Drug Products: Are They Safe?

Nowadays, generic drug products are stapling in the pharmaceutical market and industrial world, because of the enacted laws which allow people to choose and access generic products freely and should directly prescribe, introduce and suggest by health professionals.

Manufacturers and traders are to apply license to operate to FDA, and such, cGMP should be met and practiced before production is made. But most of manufacturers are unknown or untrusted, others are from countries abroad.

Generic drug products are questionable in their safety, quality and efficacy, although, they can be very low cost and widely available in the market, we cannot be sure about the risks they can bring to consumers' health.

Some of the issues facing of the generic drug products are the following:

1. Substandard and adulterated active ingredients
2. Easily to break, crack, chip, crystallize, cake, not suspending for suspension or unstable.
3. Questionable drug active ingredient and quality of production.
4. Pharmacokentically unresolved issues such as onset of time to reach blood plasma, half-life and elimination in the body.
5. Slow drug's action and fast drug's elimination leading to short effect in the body and does not maintain in the blood plasma.
6. Drug's action is compromised and desirable effect is not achieved compare to the branded drugs.
7. Production does not meet the Current Good Manufacturing Practice and sanitary problem is raised.
8. Physicians actually prescribe them but do not necessarily recommend them to their patients.
9. When bioassay is done and FDA tests , they do not meet the USP/NP or other pharmacopoeias.

However, these drug products have licensed to distribute in the market to reach consumers and utilize for treatment of illness, but government agencies assume that these are bioequivalently equal to the branded drugs, even though, they are not really evaluated much. There are three kinds of drug products in the market that classifies them as branded, branded-generics and generic drug products. Branded as we know are registered for their trade name and often costly because of some compensations for registration, taxation, high quality production and marketing strategies. Branded-generics are products that do not have registered name but has to hold the manufacturer's name that identifies them and market them easily. Example of these are Pharex products and Ritemed products. Lastly, the generic products which carrying the non-proprietary name of the the drug and usually sold in the market at very cheap and low price.

We, pharmacists should be neutral regarding this issue, because we know how the production of drugs are and their other features. But sometimes, we come to contemplate and realize that branded drugs are far more better that generic drugs. For an instance, a patient took a two capsules of Mefenamic Acid 500mg and his headache does not relieve after 30 minutes, but when he takes a certain brand of Mefenamic Acid 500mg capsule, only one capsule, the relief is reached within 10-15 minutes and the effect reaches up to four hours which must be. This is also the same with other branded drugs versus generic drugs.

I am not to branded drugs or to condemn the production and marketing of generic drugs, but I just want to emphasize that if we want to help people to achieve wellness and optimum health, production of low cost generic drugs should be standardized, under the cGMP method, quality and effective, safe, and most of them all is to manufacture for such gain while compromising others' health and life.