Ms Mahima Datla, MD, Biological E
During the fiscal year 2013-14, Biological E clocked an estimated Rs 420 crore in sales from its biologics business. This is almost a 19 percent jump from its previous year's revenue of Rs 353 crore. It was the third largest supplier to UNICEF in 2013, with over $50 million vaccines sent to the international agency. Biological E recently entered into a long term $200 million supply agreement with Vacsera (and its subsidiary Egyvac), an Egyptian vaccines company under the Ministry of Health of Egypt, for the pentavalent vaccine manufactured by Biological E. Vacsera, the sole vaccine procurement agency of Egypt, is likely to procure 8 million doses annually.
The company, which has significantly increased its market share in the pentavalent vaccines and TT vaccines segment, had launched its inactivated Japanese Encephalitis (JE) vaccine in 2012. During this period, Biological E also received OHSAS 18001 accreditation for occupational health and safety management systems. It also accomplished the ISO 14001 certification for an environmental management system. Acknowledging its performance, Biological E was presented the "Outstanding Exports Award" for its exports performance in Asia, Middle East and the African region for 2012-13 by Pharmexcil, the Pharmaceuticals Export Promotion Council, based in Hyderabad.
The company sees the Indian regulatory environment becoming more complex. There is an increased interest in R&D in the country but uncertainties regarding the regulatory environment and clinical trials is disconcerting. As a manufacturer of vaccines that are mostly used by the pediatric segment, the top most priority for the company is to ensure delivery of high quality vaccines at affordable prices. In this background, the government's support for clinical development and trials would go a long way in supporting the industry's drive to launch affordable vaccines in time.