An expert committee set up to recommend regulatory guidelines for biosimilars under the DBT is learnt to have short listed a set of guidelines including the definition and may soon submit the same for approval and further action.
Without giving the details on the exact guidelines proposed, sources said the expert panel which has been running behind the schedule has held a couple of meetings and agreed on certain parameters to be followed while making guidelines for biosimilars.
The DBT may suggest coining of some new term 'geneticeuticals' for biosimilars as there are different terms followed by different countries to indicate the biosimilars and it remained still a debating issue in the international levels, sources said.
The Dept set up the panel to study and suggest guidelines as the growing bio-pharma industry has been pressing for transparent and simplified regulations for the sector. But the finalization of a very definition itself proved to be a roadblock for long.
What baffled the core committee also was the different terms used in different countries. US was using the term 'biogenerics' while the Europe was using 'biosimilars' and the senior officials in the Dept also do not subscribe to both the terms.