BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES IN INDIA: A GENERIC OVERVIEW

In India generic drugs are distributed to public by retail shops as “JANAUSHADHA”. Generics are the drugs which are not branded but they are proven to be bioequivalent to branded drugs. Generic drugs must show similarity with its reference drug in terms of dosage form, strength, API and route of administration. Need of generic drugs in market is high as they are available at reasonable cost, the prime importance is to make the good quality drugs available at lower cost to public. The main objective of the study is to know the process of approval of generics, type of products eligible for BE study and the regulatory aspects for generic approval in India. The regulations for conduct of BA/BE studies in India is set up by Central Drugs Standard Control Organisation (CDSCO). The various regulatory aspects for the development of generic drugs, study design and parameters considered during study and the documentation required the concerned authority has been discussed. The new drug and clinical trial rules 2019 have bought new set of rules which is helpful in conducting BA/BE studies and clinical trials in support with ethical aspects. There is need of more specific guidelines for conduct of BA/BE studies in India for more reliability on generics.