What are Generic Drugs?
Source: PIB
GS II: Health
Overview
- News in Brief
- What are Generic Drugs?
Why in the News?
Providing relief to patients with rare diseases across India, the Union Health Ministry has made available generic drugs to support care and treatment.
News in Brief
- Four ailments: TyrosinemiaType 1, Gaucher Disease, Wilson’s Disease, and DravetLennox Gastaut Syndrome.
- This means that the cost of these drugs will be slashed by between 60 and 100 times of their current market value.
- The ministry is also in the process of making available drugs for rare diseases.
- To bring in these drugs a special initiative was taken, and discussions were held with academia, pharma industries, organisations, the Drug Controller, and the Department of Pharmaceuticals.
- Thirteen rare diseases were prioritised.
What are Generic Drugs?
- Generic drugs are medications that are equivalent to brand-name drugs in terms of dosage, strength, route of administration, quality, and intended use, but they are usually sold under their chemical or scientific name rather than a brand name.
- In other words, generic drugs are copies of brand-name drugs and have the same active ingredients, safety, efficacy, and intended use.
- When a pharmaceutical company develops a new drug, it is granted a patent, which gives the company the exclusive right to sell the drug for a certain number of years.
- Once the patent expires, other manufacturers can produce and sell generic versions of the drug.
- These generic versions must demonstrate bioequivalence to the original brand-name drug, meaning they have the same rate and extent of absorption of the active ingredient into the bloodstream.
- It’s important for patients to discuss with their healthcare providers and pharmacists if they have any concerns about switching from a brand-name drug to a generic version.
- Overall, generic drugs play a crucial role in providing affordable and accessible healthcare by offering equivalent alternatives to brand-name medications.
Key points about generic drugs
- Active Ingredients: Generic drugs have the same active ingredients as their brand-name counterparts. The active ingredient is the chemical substance responsible for the drug’s therapeutic effect.
- Safety and Efficacy: Generic drugs are required to meet the same rigorous standards for safety, efficacy, and quality as brand-name drugs. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) in the United States, review and approve generic drugs to ensure their equivalence to the brand-name versions.
- Cost Savings: Generic drugs are typically less expensive than their brand-name counterparts. This can lead to significant cost savings for consumers and healthcare systems, making essential medications more affordable and accessible.
- Appearance and Packaging: While generic drugs have the same active ingredients, they may look different from the brand-name version. This includes differences in colour, shape, size, and packaging. However, these differences do not affect the drug’s safety or efficacy.
- Regulatory Approval: Generic drugs must go through a regulatory approval process to demonstrate their bioequivalence to the brand-name drug. This involves showing that the generic version is absorbed into the bloodstream at the same rate and extent as the original drug.
- Availability: Once a drug’s patent expires, multiple generic versions may enter the market, increasing competition and further lowering prices.
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