Generic Drugs and IPR
Generic Drugs and IPR
Date: December 30, 2014
GENERIC DRUGS vs BRANDED DRUGS
A Branded is the trade name given by the manufacturer to the medicine produced by his enterprise while a generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.
When a company discovers a drug it gets patent right for 20 years i.e. the other pharmaceutical companies may not sell this substance without permission from the developing company during that time.It will also get brand name and then it will supply the drug in the market with the brand name but branded drugs will be costlier because company invests heavily in research infrastructure.
Actually, generic drugs are cheaper because the manufacturers have not had the expenses of developing and marketing a new drug.When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug.it is not the case with Generic drugs.
The generic drug may differ from branded drug terms of in color, shape, taste, inactive ingredients, preservatives and packaging.Generic drugs should prove that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product.
INDIA – A GLOBAL POWER IN THE PRODUCTION OF GENERIC MEDICINE- India leads the world for non-branded drugs, and produces close to 20 percent of the world’s generic volume because there are many available skilled young workers, who are educated and English-speaking. In fact, it is the third largest scientific and technological manpower in the world belongs to India. Generic drugs account for almost 90% of the total drug sales value in India. Since the drugs will be bought in bulk, this will reduce the government’s annual cost and the state will pay for 25% of the free drugs, while the central government covers the rest.
Intellectual Property Rights-
Intellectual property rights are the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.
Intellectual property rights are customarily divided into two main areas:
(i) Copyright and rights related to copyright-
The rights of authors of literary and artistic works (such as books and other writings, musical compositions, paintings, sculpture, computer programs and films) are protected by copyright, for a minimum period of 50 years after the death of the author.
Also protected through copyright and related (sometimes referred to as “neighbouring”) rights are the rights of performers (e.g. actors, singers and musicians), producers of phonograms (sound recordings) and broadcasting organizations. The main social purpose of protection of copyright and related rights is to encourage and reward creative work.
(ii) Industrial property
Industrial property can usefully be divided into two main areas:
One area can be characterized as the protection of distinctive signs, in particular trademarks (which distinguish the goods or services of one undertaking from those of other undertakings) and geographical indications (which identify a good as originating in a place where a given characteristic of the good is essentially attributable to its geographical origin).The protection of such distinctive signs aims to stimulate and ensure fair competition and to protect consumers, by enabling them to make informed choices between various goods and services. The protection may last indefinitely, provided the sign in question continues to be distinctive.
Other types of industrial property are protected primarily to stimulate innovation, design and the creation of technology. In this category fall inventions (protected by patents), industrial designs and trade secrets.The social purpose is to provide protection for the results of investment in the development of new technology, thus giving the incentive and means to finance research and development activities.A functioning intellectual property regime should also facilitate the transfer of technology in the form of foreign direct investment, joint ventures and licensing.
The Government has recently decided to invoke the flexibility under the World Trade Organisation (WTO) agreement on trade related Intellectual Property Rights for compulsory licensing of patented drugs to ensure availability of patented drugs at affordable prices. In essence, under compulsory license, an individual or company seeking to use a patent can do so without seeking the patent holder’s consent, and pays the patent holder a set fee for the license.
Recently India used the Compulsory licensing provision of WHO to make Generic version of NEXAVAR, an anticancer drug. Because it was costlier so poor are dying of cancer without the ability to buy anti-cancer drugs.
Suggested question for mains-
1-What are Generic Drugs? Do they fall under Intellectual Property Rights? also DIscuss India's position in world market of generic drugs. [200 WORDS]
GS PAPER 3 – HEALTH & NUTRITION + ISSUES RELATED TO INTELLECTUAL PROPERTY RIGHTS