Updated on 7 January 2013
Why is the rate of approval of biologics declining in India?
The biopharma sector, which contributes about 60 percent of the Indian biotechnology industry, has been witnessing a compound annual growth rate (CAGR) of 21.63 percent in the last 10 years. The sector witnessed fall in the growth rate in the recent years as compared to the early part of 2000. This is mainly attributed to drop in number of new products launched and also decline in the prices of biologicals due to price war among the Indian manufacturers and multinationals.
Until September this year, about 10 companies have launched biotech products and products related to biotechnology. Five companies in bioinformatics space, four from diagnostics and one from the biopharma area have announced the launch of their products in 2012. In bioagriculture space, 33 companies got approval from Genetic Engineering Approval Committee (GEAC), the apex body constituted under the Ministry of Environment and Forests for marketing 213 Bt cotton hybrids during May 2012 season.
The biopharma sector, specifically in vaccine space, witnessed launches of a few products in 2012 as compared to previous years. In the last three to four years, the number of product launches have fallen from 10 biologicals in 2009 to eight products in 2010, five in 2011 and to just three as of August 2012, according to the Central Drugs Standard Control Organization (CDSCO). The Drugs Controller General of India (DCGI) has given approval to 11 companies for marketing 26 biologicals excluding therapeutic products since 2009 till August 2012.
Three companies have launched their products in biologicals space, during 2012. Ranbaxy Lab, which has acquired Biovel Life Science, a biotechnology company from Bangalore in 2010 has launched haemophilus influenzae type B (Hib) conjugate lyophilized vaccine and Vi capsular polysaccharide Salmonella typhi (Typhoid) vaccine in March for active immunization against haemophilus influenzae type B infection in children of the age group of six weeks-to-five years and for active immunization against typhoid fever for adults and children older than two years of age respectively. In June, Bharat Biotech International got the approval from DCGI for marketing inactivated Japanese encephalitis vaccine. Even Biological E launched inactivated JE vaccine in September.
Identifing a possible disease or disorder
Coming to diagnostics space, the DCGI has till August 2012, has given approval for 76 kits from Indian manufacturers (includes 36 HIV diagnostic kits, 21 HBsAg diagnostic kits used in the detection of hepatitis B virus mutation within "a" determinant and 19 diagnostic kit of hepatitis C virus (HCV) for blood bank use. The number of diagnostics kits allowed by DCGI to import and market in India for a similar disease was higher as compared to the local manufaturers (62 kits for HIV, 55 for HBsAg and 46 for hepatitis C virus (HCV). In all India has about 25 companies involved in manufacturing of diagnostic kits, reagents etc.