Generic drugs - The Indian scenario

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Authors: S. Joshi, Y. Shetty and S. Karande
Date: April-June 2019
From: Journal of Postgraduate Medicine(Vol. 65, Issue 2)
Publisher: Medknow Publications and Media Pvt. Ltd.
Document Type: Editorial
Length: 1,950 words
Lexile Measure: 2100L

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Byline: S. Joshi, Y. Shetty, S. Karande

Introduction

A generic drug is a medication created to be the same as an existing approved brand name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.[1]

Beginning of Generics

On September 24, 1984, in the 98th United States Congress, the act named The Drug Price Competition and Patent Term Restoration Act was passed, informally known as the Hatch-Waxman Act, encouraging the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.[2]

The requirement was an abbreviated new drug application (ANDA) to be submitted by the pharmaceutical companies to the regulatory authorities for getting the approval to market a generic drug. ANDA process does not require the manufacturer to carry out repeat testing of generics in animals which is often time-consuming, as their branded versions have already been tested and approved for the safety and effectiveness. They are formulated when patent and other exclusivity rights of the innovator have expired.[3]

Generic drug manufacturers do not have to spend extra money for drug discovery and preclinical and clinical trials. Generics are available at a lower cost; they provide an opportunity for savings in drug expenditure in a country.

Indian Scenario

As India is one of the highest per capita out-of-pocket expenditures' country, such generics will save a lot of money which can be used for other health issues.[4] In all the countries, use of generic drugs has increased significantly in recent years.[5],[6]

The regulations governing the approval of generic drugs are somewhat the same world over, with very few differences in developing countries, as in this part of the world it is not mandatory to undergo bioequivalence (BE) studies for getting approval for generics, and the gold standard considered for regulation in this field is United States.[3]

In 2008, the Government of India, through the Department of Pharmaceuticals, started a new initiative 'Jan Aushadhi' (a Hindi word literally translated as 'Medicine for People'). This program envisaged making unbranded quality medicines available to poor people in the country at a reasonable and affordable price through retail outlets' setup with the help of the government. It has taken ownership of setting up Jan Aushadhi stores, which are pharmacies selling only generic name medicines to the extent possible, giving preference to pharmaceutical public sector undertakings too.[7] Until March 15, 2018, 3200 Jan Aushadhi stores were operating in more than 33 states/union territories across India.[8] There are not enough Jan Aushadhi stores, possibly 3200 against more than 8 lakh retail pharmacies in existence, with many rural areas still underserved.[8]

The Medical Council of India, in an amendment to the code of conduct for doctors in October 2016, has recommended that every physician should prescribe drugs with generic names legible and he or she shall ensure that there is a rational prescription which promotes the use of generic drugs.[9] In...

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