The Generic: What Is It?

United Nations’ Guidelines for Consumer Protection, 1985, say that protection of consumer health is one of the basic consumer rights; for whatever reasons, though, it is a right that has not come into practice in India. The Indian government does try its bit through Central Government Health

As per the US Food and Drug Administration (FDA), generics are considered identical to their branded counterparts in dose, strength, route of administration, safety, efficacy and intended use. A generic drug is also defined as ‘any drug marketed under its chemical name without advertising.’ It must contain the same active ingredients as the original formulation of the branded drug.

Generic drugs can be produced without patent infringement for drugs where: 1) the patent has expired; 2) the generic company certifies that the brand company's patents are either invalid or unenforceable, or will not be infringed; or 3) the said drugs have never held patents. A generic drug can also be made in countries where the drug does not have current patent protection. Patent lifetime differs from country to country; typically an expired patent cannot be renewed. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand-name product and the generic forms. The time it takes a generic drug to appear on the market varies. In most countries, patents give 20 years of protection. Some countries/regions – the European Union and the USA, for instance – may grant up to five years of additional protection for drugs (‘patent term restoration’).