Approval rate for biologics drop in India

Updated on 7 January 2013

During 2012, Bhat Biotech, a diagnostic company from Bangalore has launched a dengue kit. The company noted that the kit is very sensitive and easy to use. This kit can detect both antigen and antibodies. It is fast as it is based on the lateral flow immuno-chromatography-based technology. This test can detect the infection within three days of infection. Besides, the market witnessed a soft launch of SES platform by XCyton Diagnostics from Bangalore. The company observed that the platform allows for simultaneous identification of 26 different pathogens in a single sample in a single test. It detects RNA viruses, DNA viruses, bacteria, parasites and fungi in a single sample of 1 ml of cerebrospinal fluid in a single test. Currently, existing products are uniplex PCRs and immunodiagnostics. If a battery of these tests have to be performed it will cost nearly $818-to-$909 (Rs45000-to-Rs50,000) per patient sample and takes seven-to-10 days to complete. SES on the other hand costs only one third of that for a seven hour process.

Reliance Life Sciences, one-of-the-leading life sciences companies of India from Mumbai having wide interest in biotechnology has launched Reli Stat in August 2012. ReliStat is a thrombin-based hemostatic kit for use in surgeries to control excessive bleeding and post operative oozing. Currently there are no similar products existing in the Indian market. Priced at $140 (Rs7,750) per kit, this hemostatic kit is expected to be used by surgeons in various surgeries including oncology surgeries, neuro surgeries, general surgeries as well as laparoscopic procedures. Thrombin supplied as part of the ReliStat kit is manufactured in-house in the state-of-the-art manufacturing facility in Navi Mumbai.

Acton Biotech developed a novel oral alkylating agent, Temozolomide, commonly used drug for Glioma and which has been found to be effective only in patients who have an inactive methylguanine methyltransferase (MGMT). This allows the doctors to determine if Temozolomide therapy will work on a certain patient and if not then the doctor will recommend something else.

Currently, there are 20 recombinant therapeutics, which are approved for marketing in India by the GEAC. Since 2005, the Review Committee on Genetic Manipulation (RCGM) under GEAC has approved 94 clinical trials to be conducted in India related to recombinant pharmaceutical and therapeutic products recommended by the DCGI. There are close to 100 biopharmaceutical companies actively involved in R&D, manufacturing and marketing of biologics in India. No Indian company has launched recombinant therapeutic product during 2012.

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