Amid the proliferation of fake over-the-counter (OTC) medicines, Camarines Sur lawmakers led by Rep. Luis Raymund Villafuerte sought to give more teeth to the Food and Drug Administration (FDA) on pharmacovigilance so it can crack down hard on manufacturers and dealers of counterfeit or substandard drugs.
The legislators proposed that the FDA establish a pharmacovigilance unit within its Center for Drug Regulation and Research (CDRR).
To strengthen the country’s system of pharmacovigilance or the detection and assessment of the efficacy of medicines, Villafuerte and his fellow authors likewise mandate the FDA in House Bill 3984 to develop a consumer advocacy and education program, in partnership with private organizations and relevant government agencies, on the dangers of using bogus or substandard pharmaceutical items.
The lawmakers made the pitch as the FDA has been issuing advisories warning the public to exercise care when buying OTC medicines following its discovery of counterfeit versions of assorted commonly used drugs.
FDA Director General Samuel Zacate earlier said his office found counterfeit versions of OTC medicines such as Kremil S, Alaxan FR, Biogesic, Medicol Advance, Bioflu and Tuseran Forte in the local market.
The FDA, in a follow-up warning this August, said that on top of these OTC drugs, it has also found other counterfeit medicines locally, including Solmux and Diatabs capsules.
Counterfeit medicine is defined as a product “with the correct ingredients but not in the amounts as provided, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength, or purity.”
The FDA said counterfeit products “pose potential danger or injury to consumers.”
