The Bangalore-based biotechnology major Biocon India will be launching its much-awaited recombinant human insulin in January 2004 after the successful completion of the multi-centric trials in December, 2003. The marketing approval from the Drug Control General of India (DCGI) is expected shortly thereafter.

The company's new production facility, which is already scaled up for the commercial production, would have the capacity of 500 kgs of bulk. Currently, the country's total market requirement is 1,20,00,000 vials and this is mainly catered by the two multinationals Novartis and Eli Lilly.1 kg of bulk can be converted into approximately 60,000 vials. However, Biocon would target the export markets for more than 40 per cent of its production initially.

As the lion's share of recombinant human insulin, marketed locally is now imported, Biocon's launch will really kickstart the entry of indigenous human insulin in India. Though Wockhardt has recently launched the product in the country, their production facility is yet to be scaled up for the commercial market as the company expected.

According to Kiran Mazumdar Shaw, chairperson and managing director, Biocon India, presently the company is all set to launch the product. The trials have been successfully completed and the marketing approval is awaited. The production facility is also fully scaled up, she added.

She said that though the price of its recombinant human insulin is almost on par with the international price, the quality is competent to the best in the world now.

Though the 50-50 joint venture company Biocon-Shantha Biotech was planning to come out with the product early this year, the multi-centric trials could not be completed by the time as it was planned, it is learnt.

Recombinant therapeutics/biologicals market in India is valued at Rs 400 crore and the global value is put at Rs. 33,040 crore and the growth rate of this sector in India is pegged at 15 per cent.