Generic Drugs Are Safe

Is really Generic Drug’s safety a worried issue?

A generic drug is a drug which is produced and distributed without patent protection. A generic drug must contain the same active ingredients as the original formulation. A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at very low affordable prices as compared to branded drugs.

FDA approves the quality of these generic drugs. Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. The major difference between the FDA approval of a brand drug and a generic drug is that the manufacturer of the generic drug is not required to duplicate the original medical studies proving the safety and efficacy of the chemical compound where as the manufacturing standards remain same. These differences have no effect on the medical action of the drug. They are created simply to distinguish the appearance of one drug from another. Since the medical safety and effectiveness of the brand name drug has already been determined, only bioequivalence/therapeutic equivalence testing is required for a generic drug.

To gain FDA approval, a generic drug must:

• contain the same active ingredients as the innovator drug(inactive ingredients may vary)
• be identical in strength, dosage form, and route of administration
• have the same use indications
• be bioequivalent
• meet the same batch requirements for identity, strength, purity, and quality
• be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products

Generic drugs can be legally produced for drugs where:

• The patent has expired
• The generic company certifies the brand company’s patents are either invalid, unenforceable or will not be infringed
• For drugs which have never held patents
• In countries where a patent(s) is/are not in force
• The expiration of a patent removes the monopoly of the patent holder on drug sales licensing.

Generic drugs are marketed under a non-proprietary or approved name rather than a proprietary or brand name. Because of their low price, generic drugs are often the only medicines that the poorest can access.

Generic drugs are frequently as effective as, but much cheaper than, brand-name drugs. For example, paracetamol is a chemical ingredient found in a number of brand-name painkillers, but is also sold as a generic drug (not under a brand name). Because of their low price, generic drugs are often the only medicines that the poorest can access.

Despite being much cheaper than brand name drugs, why do we hesitate to use generics? Here are some of the reasons that I heard-

• Concern about quality:
  There is a concern that generic medicines are not of same quality as brand names. Not many people know that generic medicines need to be approved by FDA just like brand name drugs.
• Visibility factor:
  People tend to trust a name that they have heard of more than the one they have never heard of.
• Anything less expensive must be lower quality:
  This is Human nature. We tend to think that more expensive must be better. We apply this principle to medicines too.
• People think that generics are of inferior quality?
  Actually, when a company develops a new drug, it gets it patented.The patent protection gives the company exclusive right to produce that drug for several years. Once that patent expires, many different companies get to manufacture that drug. That is when drug is said to have gone generic. The cheaper price of generic drug is due to competition and not due to lower quality of the product.
• How can you tell that effect from a generic is not just a placebo effect?
  In other words, how can we be sure, for example, that a generic aspirin pill contains aspirin and not some sugar powder? Before they are allowed to produce generics, the manufacturers have to meet standards set by FDA. As for placebo effect, some studies suggest that up to 30% of effects of all drugs could be due to placebo effect.

Summary

Generic Drugs are safer to use as these drugs are FDA approved. Being cheaper, these drugs are affordable to a common man’s pocket and can further serve even those who find it hard to purchase the branded versions. So Need to worry about the quality of these drugs. If required Go and Purchase them with no fear. But do not forget to check the FDA approval certificate of these drugs at the time of purchase.