The widely accepted definition of a generic drug/medicine is that used by the US FDA. “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”. WHO’s definition of a generic drug is that “a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights”. The innovator company of a new drug is granted patent in compliance with international patent law for a period of 20 years to protect its sole right to sell the drug. The patent protected drug, known as brand (innovator) drug, allows the company to recover its development costs along with a profit. A generic medicine may also be called a multisource pharmaceutical product. A Generic medicine is marketed under the drug’s non-proprietary approved name or under a different brand (proprietary) name. Included in the group of generic market is generic product with its own brand name, known as branded generic. Generic medicine provide a less expensive alternative to brand medicine. Generic medicines are usually much less expensive than brand medicines. The average price difference between brand and generic medicines ranges from 20 to 90%. The issue of access to essential medicines is thus addressed by using generic medicine as a cost effective alternative. The principal reason for the reduced cost of generic medicines is that these are manufactured by pharmaceutical companies which do not invest in research and development into new medicines. Apart from price, differences between generic and a brand medicines are their name, appearance and manufacturer.
Generic medicines in India: India is the single largest producer of generic medicine in the world. The growth of generic medicines in Indian pharmaceutical market is attributed to export of generic medicines. Before the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement, India had not recognized product patent protection in medicines for 35 years till December 2004. India’s patent act of 1970 granted patents on processes that allowed Indian pharmaceutical manufacturers to produce generic versions of medicines patented in other countries. Multiple generic pharmaceutical producers manufactured medicines till December 2004 in the absence of product patents, driving the prices substantially low for both the brand medicine and its multiple generic forms. To comply with TRIPS, India amended its patent law (act of 1970) in January 2005 and started to grant patents on medicines. As a result, today Indian pharmaceutical manufacturers are not allowed to produce cheaper generic versions of medicines whose patents are granted in other countries.
In India, private community pharmacies are the main sources of medicines. However, there is no guideline on how generic substitution should be undertaken at private pharmacies. The main opportunity for pharmacists or drug retailers to substitute generic medicines is when they encounter clients who walk in pharmacies and obtain medicines for their self-limiting symptoms. The use of medicines in India is dictated by the prescribing doctors who are influenced by pharmaceutical companies and commercial sources of information. Doctors, in the private sector, prescribe and dispense medications directly to patients. Pharmacy services are often inadequate and therefore patients are unaware important information on medicine use including on issues pertaining to generic substitution.