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Kamal Sharma
Tiny Nair
Manoj Chawla
Sanjay Kalra
Manash Baruah
Mangesh Tiwaskar
Vijay Kher
Prafulla Kerkar
Unnikrishnan A G
Alan Almeida
Umapati Hegde
Binayak Sinha


generics, innovator, equivalence, clinical efficacy


Generic drugs with active ingredients are generally developed and marketed following the expiry of the patent and the other exclusivity rights of the innovator drug. Generic drugs are given preference due to better affordability in many instances. Many health agencies and governments encourage the use of generic drugs due to cost parameters; however, not much data are available about the quality of generics. Generics do not undergo complete clinical development as the original innovator drug; hence, there have been differences in the effects of generic drugs in the real world. The study of properties such as stereoisomerism is important, as the shape of the drug molecule (especially in generics) not only impacts the desired biological activity but also influences the potential adverse effects (AEs). Generic drugs are considered therapeutically equivalent if they are pharmaceutically equivalent and have similar pharmacokinetics. However, the bioavailability of the drug is a prime concern among generics. Additionally, bioequivalence does not assure similar therapeutic responses and AEs as that of the reference drug. In addition, concerns related to the effect of excipients have also been raised. Nevertheless, generic drugs are considered an alternative to address the increasing cost of healthcare in developing countries where most patients pay for healthcare out of their pockets. However, generic drugs should meet the same standards of quality, safety, and efficacy as those of innovator drugs as they are prescribed widely. Hence, it is important to implement generic switching policies with caution until the quality, efficacy, and safety of generics are convincingly at par with innovator drugs.

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