The Hindu Business Line : Biotech cos all set for commercial production

BIOTECH biggies Biocon India, Bharat Biotech and Shantha Biotechnics seem to be on the journey of commencing commercial manufacture of their new discoveries.

The Genetic Engineering Approval Committee (GEAC), which gives clearances to proposals in the sector, has given it permission to conduct Phase III trials of its products. When contacted, officials in the Ministry of Environment and Forests confirmed, "The GEAC met on July 14, and has approved most of the phase III clinical trials taken up in the meeting."

Industry sources said that since several companies have sought post-facto clearances, this implies that they are well into the third phase of clinical trials.

"Once the Phase III trials are completed companies would have to file new drug application before commercialising the product," said sources.

The companies, which have sought clearances ex post-facto include the Ahmedabad-based Intas Pharmaceuticals, the Hyderabad-based Shantha Biotechnics and the Bangalore-based Biocon.

Companies are looking to launch a whole range of products for treatment of diabetes, anaemia and hepatitis vaccine among others.

For instance, the Hyderabad-based Bharat Biotech had sought permission for Phase III clinical trials of r-human insulin while another company, Indian Immunologicals Ltd, had sought permission for phase III clinical trials of r-human Hepatitis vaccine.

Biocon, meanwhile, had sought an ex-post facto approval for conducting phase III clinical trials and permission to manufacture and market r-insulin. Shantha Biotechnics had also sought ex-post facto approval for conducting phase III clinical trials of r-erythropoietin. Simply put, r-erythropoietin, used for treatment of anaemia, is a protein formed in the kidneys and stimulates the body's production of red blood cells.

Clearance from the GEAC is just one of the several approvals required by biotech companies before they commercialise a product.

Other agencies including the Drug Controller General of India, the Department of Scientific and Industrial Researchand the Department of Biotechnology have to give their nod as well.