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GENERIC MEDICINE

Generic medicines are cost effective option of their branded counterparts. Both are similar in quality and composition. Whenever a pharmaceutical company launches a new medicine in the market, it has gone through costly procedures of development, research, marketing and promotional activities for the medicine. A right of exclusivity known as ‘Patent’ is granted to that company; it can sell that drug as long as the patent is in effect. After the expiration of the patent, the innovator company can get permission from the FDA (Food and Drug Administration, US) to make and market generic versions of the drug. In this procedure there is no requirement for testing and advertising which reduces the cost generic medicine. Competition exists among various manufacturers for selling the same generic product; it further lowers down the cost of generic medicine.

According to FDA guidelines, a generic drug must be identical to its branded counterpart in following aspects:

  • active therapeutic ingredient (inactive ingredients may vary)
  • Strength, dosage form and route of administration
  • Indications of usage
  • Bioequivalent
  • Follow the same strict standards of Good Manufacturing Practices regulations given by FDA during manufacturing and processing.
  • Comply with same batch requirements for quality, identity, strength and purity.

An abbreviated new drug application (ANDA) is submitted by drug companies to get marketing approval of a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, bring the concept of generic medicine in the lime light. For the approval of ANDA, the drug sponsor does not require repeat costly animal and clinical research on medicines already approved as safe and effective. The drugs first marketed after 1962 come under these regulations.

A very famous myth about generic drugs is that they are inferior and poor quality products just because they are available at lower prices. Manufacturing and research of both generic and branded medicines comply with norms of FDA. Generic medicines act in a similar way to the branded one. Sometimes, generic versions of a medicine differ in colours, flavours, appearance or composition inactive ingredients than their branded counterparts this is because for the sake of trademark laws in the United States which do not grant permission for the identical appearance of generic and brand-name preparation, however the active ingredients must be the same in both preparations to assure same therapeutic effects.

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