Counterfeit Drugs

Our economic today is so dynamic that represents a greater chance of economic growth and progress. Industries, like telecommunications, food, clothing, life insurances, investments, pharmaceutical and cosmetics, realty properties and alike, are the major entities that contribute to the advancement of the economy. Pharmaceutical industry is one of the top five leading markets that contributes to the growth of the Philippine economy, not just in our country alone but also in the other parts of the world. However, it is not always to say that the pharmaceutical industry is a perfect market. There will be a fraudulence and black market within it. Usually the importation of the smuggled products that does not undergo due process is illegal. Also, the manufacture of drug products, devices, cosmetics and food that do not meet the standards and requirements, maybe adulterated, and unregistered are also illegal. These maybe classified as counterfeit products.

Counterfeit drugs/medicines according to Republic Act No. 8203 “refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to:

1) the drug itself or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;

2) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used; 

3) an unregistered imported drug product, except drugs brought in the country for personal use as and justified by accompanying medical records;

4) a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration. ”

But how would your determine if a drugs, devices or cosmetics are counterfeit? Here, I am going to give you some tips on how to determine them on the actual circumstances.

• Unknown source ( manufacturer, importer or distributor)
• Unregistered establishments that engaging in manufacturing, distributing, importing or selling drug products without the FDA approval
• Peddling or offering special offer through door-to-door
• The condition of the medicines or products when transferred are non-stable, easily to break and cheap, caking, do not suspend for suspension, inconsistent, odorous, crystalling, cracked and other conditions that identify under substandard. But there is an exemption. Products that registered to the FDA but do not meet the storage condition causing some problems in contents.
• No Batch no. or Lot no.
• No drug registration no. (DR), device registration no. (DVR), or other product registration no. is present in the label/s that approved by the FDA.
• No Manufacturing date and expiration date
• No Certificate of Registration Product for imported drugs, devices and cosmetic products.
• Labels and packaging are authentic but the content is adulterated
• Labels and packaging are authentic, but came from smuggling, slipping from the registered owner and use commercially.
• Counterfeit products are easily identified by observing the labels and packing that are imitation of the original.
• Sometimes the product is in good fate, passed the quality control and right labels and packaging, but does not registered to FDA, which reported by the pharmaceutical company as unregistered and not allowed to be sold. This happens due to slipping of products from registered company and distribute in the market illegally.
• Smuggled drugs and devices that circulate in the market.