Emergent BioSolutions Inc. announced that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection.
Emergent BioSolutions has signed a marketing agreement with Biological E. Limited for the marketing of BioThrax in India. BioThrax is the only vaccine for the prevention of anthrax infection licensed by the US Food and Drug Administration (FDA).
The BioThrax market authorization for India follows the publication in 2008 of the National Disaster Management Guidelines by the Indian National Disaster Management Authority (NDMA), which is the government body that oversees disaster management. In that document, the government of India provided guidance with respect to the management of biological disasters and stated that there is a need to have a supply of readily available anthrax vaccines to be administered rapidly in the event of an outbreak. The report goes on to state that all first responders will be vaccinated in an impending disaster situation.
Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, "The Government of India has been explicit in expressing its commitment to protect its population from the continuing threat of bioterrorism. We are certainly pleased that BioThrax will be a valuable countermeasure available to the Government of India to achieve that goal. Today marks a pivotal milestone in Emergent's efforts to expand globally and further our mission of protecting life."
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis and contains no dead or live bacteria. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During that time period, nearly 8.4 million doses have been administered to more than 2.1 million military personnel. BioThrax cannot cause anthrax infection.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immune-related biologic products, consisting of vaccines and therapeutics that assist the body's immune system to prevent or treat disease.
Biological E Limited a 50 years old private sector biological products company in India is the pioneer in preventive medicine. The company was originally incorporated as Biological Products Private Limited in 1953, is a significant player in the world vaccine market.