The Indian Council of Medical Research, which had drafted the existing guideline for the biomedical research using human subject, is likely to recommend certain revisions to norms related to biopharmaceutical products. The move follows the recent industry feed back on the current lacunae in the approval procedure for clinical research and research scale manufacturing of biotechnology drugs that involves multiple agencies.

Currently, for conducting clinical trials of biopharmaceutical products, the companies/investigators need separate clearances from multiple agencies including Department of Biotechnology (DBT), Genetic Engineering Approval Committee (GEAC) and the Drug Controller General of India (DCGI).

However, due to lack of clarity in the procedures to be followed in seeking these clearances and also with the overlapping of the roles of each agencies, the investigators have been facing procedural delays as well as other practical difficulties while applying for the clearance.

Even after the introduction of ICMR's Biomedical Research Guideline a couple of years ago, there were several controversies taken place in the country regarding conduct of clinical trials and manufacturing biopharmaceutical products.

According to informed sources, the ICMR recommendation is in tune with the Department of Biotechnology and the DCGI to streamline the procedures. The sources added the current move, if it is approved by the government, would streamline the application procedures by setting up a single agency that can look into all the related aspects. The details of the single point clearance are yet to be worked out, the sources informed.

The sources added that this is a need-based revision in the currently followed procedures s to encourage and help building up the biotechnology industry in the country. According to industry sources, since India has much potential in the area of biotechnology both for pharmaceuticals and agriculture, the government is now looking at this sector with a wider perspective and so are the positive revisions on the basis of the industry feed back.