Why the generics are not accepted wholeheartedly and confidently by medical fraternity and as well as patients in spite of ruling by the GOI & NMC?
1. Inactive Ingredients: Generic drugs may include different inactive ingredients (excipients), such as fillers, binders, or preservatives. These ingredients can affect the drug's formulation, stability, absorption, and overall effectiveness, although the active ingredient remains the same.
2. Manufacturing Processes: The methods and technologies used in manufacturing generics may differ from those used for innovator drugs. Variations in production techniques can lead to differences in the drug's bioavailability (how well and how quickly the drug is absorbed) and pharmacokinetics (how the drug behaves in the body).
3. Drug Formulation: Even though the active ingredient is the same, the formulation of the drug (e.g., tablet, capsule, liquid) and its design (extended-release, immediate-release) might differ. These differences can influence how the drug is released and how the body processes it.
4. Quality Control Standards: Both generics and innovator drugs are subject to regulatory oversight, but differences in quality control processes can lead to variations in the final product. Manufacturers of generic drugs must prove that their product is bioequivalent to the brand-name drug but may achieve that through different methods.
5. Clinical Efficacy and Safety: While generics are required to demonstrate bioequivalence to the innovator drugs, there can still be variations in how different patients respond to them. This can be due to differences in formulation or manufacturing. Some patients may notice differences in efficacy or tolerability, especially if the inactive ingredients interact differently with their bodies.
6. Regulatory Approval: Generic drugs must go through a different regulatory approval process than innovator drugs. While they do not need to undergo the same level of clinical trials as the original brand, the approval process does ensure that they are safe and effective based on their similarity to the innovator product.
7. Consumer Perception: Patients and healthcare providers may perceive generic drugs differently due to familiarity with brand-name drugs. This perception can sometimes influence their experience with the generic version.
Overall, while generic drugs are designed to be equivalent to innovator drugs in terms of active ingredients, these other factors can lead to differences in performance and patient experience.
While the active ingredient in both generic and innovator drugs may be identical, a closer look reveals a complex tapestry of differences ranging from inactive ingredients to manufacturing processes that can significantly impact drug performance and patient response.
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