The Department of Biotechnology (DBT) is planning to have a high level meeting with the Drug Controller General of India (DCGI) and the stakeholders to discuss on the new developments in the Similar Biologics 2011 Guidelines. Through this meeting, DBT intents to make final changes in the clinical trials section of the guidelines which was a point of contention among many.

The DCGI had in the last week of February forwarded his views on the subject of clinical trials whereas the rest of the matter remains the same. This meeting is expected to be held somewhere in the second week of March with an aim to sensitise the stake holders about the changes that is expected to be made in the final draft following the suggestions from the CII, ABLE and DCGI.

Dr K K Tripathi, advisor, DBT, informed that though there was a general consensus on the provisions of guidelines for similar biologics there was some confusion and concern among the industry over some points of clinical trial for biologics.

He said, “At present, we are working towards making those changes in the clinical trial section of the guidance with the help of the suggestions made by the DCGI's office, CII and ABLE. These changes are important to be made as it is for the harmonisation and benefit of the industry at large. That is why we want the stakeholders also to be present at this meeting.”

Through this close door dialogue the DBT intents to inform the industry about the changes that they are going to make in the final draft before releasing it. Dr Tripathi said, “We want to organise this meet with the DCGI and the industry, so that while making the final changes everyone is duly informed about it, especially the industry as this is being drafted for them. Its a huge step that finally we will be able to bring out this guidelines with relevant changes made according to the demands of the industry.”

Once the final changes are made, the copy of the guidelines will be sent for printing so that it can circulated among the stake holders for reference. It is expected that the final guidelines will be available to  the stakeholders by March this year.