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THE PHARMA REVIEW (MARCH - APRIL 2013)

Impact of Compulsory Licensing on Indian Generic Drug Industry

Anantha Naik Nagappa1, Asim Priyendu1, Uday Venkat Mateti1, Swapna S2 & Vaishnavi Naik1

Introduction: Generic drugs are identical or with an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties according to the U.S. Food and Drug Administration (FDA)1. Generic medicines in India are not defined like in developed countries where the pharmacokinetic and pharmacodynamic equivalence is a mandatory issue to call any medicine as generic medicine. Generic medicines are usually labeled by generic name and are packed in a basic carton and are not promoted by pharmaceutical industries as compared to branded medicines. Further generic medicines of companies are similar and can be interchanged by the pharmacist on demand of the consumers. Whereas in India generic medicines are determined by label and not by any other features described above. Generic medicines are usually available in the market at a cheaper price. Prescribers, pharmacists, nurses and some of the patients consider them as second grade drugs of poor quality and substandard drugs. On the contrary generic medicines are manufactured under valid license by competent manufacturers and they are also certified as quality medicines as per the pharmacopoeial standards. The tug of war between generic versus branded medicine is gaining momentum as many government and regulatory agencies like Medical Council of India (MCI). One is openly asking the prescribers to use generic medicines instead of branded medicines. The controversy of branded is unclear as what special attributes they have in comparison to generic medicines. The main competent of a branded medicine in the pharmaceutical industry has collided with doctors and persuade them to write medicines of their own company (which are usually expensive in comparison to the generic medicines) to improve its market segment.

 

 

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