Can develop generics only by referring to an India-approved innovator biologic drug

Companies such as Biocon, Panacea Biotec and Avesthagen will now have to follow a fresh set of norms while seeking marketing approval for their biotech products in India. The new norms mandate that companies can develop a biosimilar or a biotechnology generic drugs only by referring to an innovator biologic drug approved in India. The guidelines, though, fail to address the issue of testing of such drugs with no details on patient size for clinical trials.