Toward better quality of anticancer generics in India.

Abstract:

:Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.

journal_name

Indian J Cancer

journal_title

Indian journal of cancer

authors

Gota VS,Patial P

doi

10.4103/0019-509X.146723

subject

Has Abstract

pub_date

2014-07-01 00:00:00

pages

366-368

issue

3

eissn

0019-509X

issn

1998-4774

pii

IndianJournalofCancer_2014_51_3_366_146723

journal_volume

51

pub_type

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