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Generic DrugEvery September, the Philippines observes Generics Awareness Month in accordance with Republic Act No. 6675 of 1988. A program led by the Department of Health (DOH) intends to "promote and ensure the distribution, usage, and acceptance of pharmaceuticals and medicines designated by their generic name." It also wants to "raise knowledge about generic drugs that provide safe, effective, and low-cost quality medicine."

What is a Generic Drug?

Generic medicines are replicas of name-brand medicines. They must adhere to bioequivalence standards, which guarantee that generic medications function similarly to brand-name medications and offer the same clinical benefits and safety. The same active components, dose, efficacy, safety, strength, administration route, quality, and performance must all be shared across them.

When the exclusivities and patents granted to the original developer of a drug expire, other businesses are then permitted to produce and market generic versions of the drug.

Since the ingredients and dosage forms for generic drugs have already received FDA approval, they are not required to undergo additional clinical testing.5 However, they must still go through a rigorous approval process with the FDA to demonstrate that the generic drug is an equivalent replacement for the brand-name medication.7,10 This includes a careful examination of data regarding its ingredients, manufacturing, and performance.

What justifies observing Generics Awareness Month?

Caused by the high cost of medications, the isolation and remoteness of some regions, and the public's opinion that brand and price are good indicators of a product's quality, which is affected by pharmaceutical marketing and promotions.

Drug store owners are advised not to buy generic medications from suppliers with shady reputations. A case had been brought against a drug store owner in Central Visayas for allegedly selling fake paracetamol or a muscle relaxant, according to FDA Regulation Officer Sarah Oriol. A cease-and-desist order was issued against the owner of another drug store because it was selling medications that didn't have the required amount of active components.

As more people learn about generic medications, they are encouraged to purchase these affordable, high-quality medications, which raises public approval and demand for the aforementioned product.

Therefore, it's crucial to inform the general public of the similarities and differences between branded and generic medications as well as their right to select whichever they prefer.

The following actions are required of the government in order to enhance the aforementioned laws' implementation:

  • Keep track of how often medical practitioners include the generic names of medications in their prescriptions.
  • By offering generic medications at the lowest price feasible, you can ensure the accessibility and affordability of the supply of generics, and
  • By banning the production and sale of fake medications and restricting the use of medications that can result in hazardous drug interactions, you can support the promotion of drug safety.

PDO I Kimberly Tanador, RND 

 

References:

GENERICS AWARENESS MONTH

https://docs.google.com/document/d/1TxtIPg8gYJ361meWUKFeJZ5fwi9HUUtnCISu6F7cyLg/edit

Generic Drugs Facts

https://www.fda.gov/drugs/generic-drugs/generic-drug-facts