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  • 09 Oct
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Safety and Effectiveness of Generic Drugs

A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorized. It is also known as the ‘reference medicine. This has been arising as a critical issue that generic drugs are effective and safe for patients because the same active ingredient is present in multiple branded and generic drugs. Generic drugs are equivalent to brand formulation if the same active ingredient is present in it. The uses of generic drugs have been increasing progressively due to increased disease or infection or a therapeutic failure. These are also manufactured in bulk quantity in order to reduce medication price.


Generic medicines are those where the original patent has expired and which may now be produced by manufacturers other than the original innovator (patent-holding) company. The term ‘generic drug’ or ‘generic medicine’ is commonly understood, as defined by the World Health Organization (WHO), to mean a pharmaceutical product that is usually intended to be interchangeable with an innovator product, is manufactured without a licence from the innovator company and is marketed after the expiry date of the patent or other exclusive rights

Generic drugs approved by the Food and Drug Administration (FDA) through a rigorous review process. . The FDA ensures a generic medication provides the same clinical benefit and is as safe and effective as the brand-name medicine that it duplicates. They behave very similarly to their brand formulation due to the presence of same active substance, the same therapeutic indications and might have a similar bioequivalence with a bit difference found in it. The response of generic drugs are always positive and do not show a negative feedback in terms of adverse effects when switch from brand to generic formulation. They may look different in shape, size and color that do not impact how medications work. The generic manufacturer must provide studies showing the shape, size and color have not changed the quality, safety or effectiveness of the generic drug. The quality standards under which generic drugs and brand name drugs are taken is exactly the same.  The ingredients, manufacturing processes and facilities for all drugs must meet the federal guidelines for Good Manufacturing Practices. As well, all drug manufacturers must perform a series of tests, both during and after production, to show that every drug batch made meets the requirements for that product. Due to the same active ingredient of generic drug, these work in the same way with same benefits and risks associated with the brand name drugs.


What measures bring safety and effectiveness in Generic Drugs?

  1. The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
  2. The generic medicine has the same strength, use indications,  same dosage form (such as a tablet, capsule  or an injectable), and have the same route of administration (such as oral, injectable or topical) as the brand name drug.
  3. The inactive ingredients of the generic medicine are acceptable.
  4. The generic medicine is manufactured under the same strict standards as the brand-name medicine.
  5. The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine's label.
  6.  The positive feedback comes out after using of generic drugs when substitution of prescribed branded medications have introduced with less expensive generic equivalents.
  7.  Generic medicines has made to reduce the cost of prescription drugs for both consumers and the government
  8. Generic medicines tend to cost less than their brand-name counterparts because these drugs do not repeat animal and clinical (human) studies that are performed in the brand-name medicines to demonstrate safety and effectiveness.
  9. Global healthcare expenditure is increasing steadily and generic medicine utilisation is often encouraged as a cost-containment measure.
  10. Generic drugs represent 70% of the total prescriptions dispensed in the United States and saved billion of American consumers in the last decade.
  11. Each year, more than 2.6 billion prescriptions are filled in the United States using generic drugs.
  12. Generic drugs must be “bioequivalent” to the brand name drug and be as safe and effective as the brand name drug.
  13. Although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantially lower costs. When multiple generic companies market a single approved product, market competition typically results in prices about 85% less than the brand-name.


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