Generic drugs are safe, effective but need to undergo stringent tests–experts

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Generic drugs are safe, effective but need to undergo stringent tests–experts
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Every September, the Department of Health observes “Generics Awareness Month” to promote the use of generic medications and to commemorate the passage of Republic Act 6675, also known as the “Generics Act of 1988.” RA 66754 ensures that inexpensive and effective drugs are made available to all Filipinos.

In the photo are, from left, Brian Posadas, President of GIPDEX Inc.; Willison John E. Luna, Food and Drug Regulation Officer of the Food and Drug Administration; Dr. Benjamin Co, President of BioAnalytica and Chief Medical Officer of Metro Pacific Health; Dr. Bu Castro, past President of the Philippine Medical Association and Medical Director of CEDRES Inc. ; and Atty. Irineo Galicia, President, CEDRES Inc.

“To safeguard public health, we recommend that doctors should verify if the generic products they prescribe have undergone testing by FDA-approved and ISO-accredited clinical research organizations, Bioavailability or Bioequivalence Testing Centers and Bioanalyitical Laboratories,” said Atty. Irineo M. Galicia, President of the Center of Excellence in Drug Research and Studies Inc. or CEDRES Inc. CEDRES champions the universal right to safe, effective and quality medicines.

Bioequivalence testing is a measurement of how closely different drugs trigger the desired biochemical pathways and clinical outcomes. For a generic drug to be bioequivalent to a name-brand version, the drug manufacturer must get FDA’s stamp of approval. The drug company must prove the generic is pharmaceutically equal to the name brand version. There are also different bioequivalence standards depending on whether the drug is taken as a pill, injection, patch, inhaler or through another method.

“Through the seminar, we want to equip participants with the knowledge and tools necessary to ensure the highest standards of quality, safety and efficacy of pharmaceutical products,” Galicia said. “Before substituting a generic product, physicians and other decision makers should consider the potential clinical and pharmaeconomic consequences of overtreatment, undertreatment, adverse effects, additional expenses, and cost savings,” he said.

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