Roche Products (India) Pvt Ltd & Ors vs Drugs Controller General Of India And ... on 25 April, 2016
168. This Court in Bayer Corporation and another v. Union of
India and Others, (2010 (43) PTC 12 (Del) (DB)), has rightly held that
Appendix IA to Schedule Y of the Drugs Rules applies to generic
versions of a patented drug. The manufacturer of a generic version of
a patented drug is only required to satisfy defendant No.1 that its drug
is bioavailable and bioequivalent to the patented drug (as required
under Appendix IA).