The Hindu Business Line : Biocon insulin likely to be in market soon

Armed with the approval from the Genetic Engineering Approval Committee (GEAC) to manufacture and market the diabetes drug, Biocon will now start manufacturing it.

The company has set up what it says is the country's first and Asia's largest insulin plant at Bangalore. It may take at least three months to launch it, according to the Biocon CMD, Ms Kiran Mazumdar-Shaw.

It has put clinical trial data pertaining to its three insulin formulations on the company's Web site, making Biocon the first Indian company to share such data online, a company release said on Saturday.

While pharma and pharma biotech companies are not mandated to disclose their drug trial details, GlaxoSmithKline was the first to do so.

"In India, we want to be transparent about our clinical trials and set a strong code of conduct," Ms Mazumdar-Shaw told Business Line.

Biocon's entry into the Rs 200-crore domestic insulin market dominated by MNCs will make it the fifth player after Eli Lilly, Novo Nordisk, Aventis and Wockhardt, which launched its Wosulin a few months ago.

The GEAC gave its approval on July 14 to the three insulin formulations - regular, NPH and bi-phasic isophane (with quick, slow and medium-paced action respectively).

Biocon's trials were conducted on 400 patients compared to the DCGI-mandated 30 patients for validating a drug.

It has created an online database to pool information from clinical studies conducted by the company and provide summaries of trial protocols and results.

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