WHO Approves India’s Vaccine Regulatory System

Indian vaccine market reaches $ 900 million

India has made a significant contribution to Vaccine development. India produces 60 per cent of the world’s vaccines and account for 60-80 percent of annual UN vaccine purchases. The current Indian vaccine market is estimated at around $ 900 million and targets $4.6 billion revenue by 2017. It recorded growth rate of 23 per cent during 2011-2012.

India’s contribution in mid level vaccine innovation coupled with an improvement in biopharmaceutical R&D capacity and capability is noteworthy. India has indigenously developed novel vaccines that today are either commercialised or are near commercialization for diseases like: Meningococcal Meningitis; Rotavirus; H1N1 & Japanese B Encephalitis.

New schemes such as Small Business Innovation Research Initiative (SBIRI) & Biotechnology Industry Partnership Program (BIPP) which have been started by Department of Biotechnology (DBT) and have provided an impetus to the innovation cascade and encouraged new players.

Decade of Innovation

2010-2020 has been declared as “Decade of Innovation. India’s growing focus on funding for scientific education and encouragement to our scientists returning from foreign shores in the form of efforts like DBT-Wellcome Trust Fellowships & Ramalingaswami Fellowships have helped in the success in the field of vaccine production.

Key elements enabling an innovation-friendly environment in place are a balanced contribution for high risk projects by the public and private sectors, academia-industry collaboration within the country and with global non-profit agencies, efficient regulatory system and vast network with international collaborations including South-South engagements.

India innovated vaccines for big killer diseases like HIV, TB, Malaria, Dengue etc. India’s scientists at the DBT-supported International Center for Genetic Engineering and Biotechnology (ICGEB) are working in malaria and dengue. R&D in vaccines against HIV and TB is improving.

The establishment of Translational Health Science and Technology Institute (THSTI) at Faridabad and the International AIDS Vaccine Initiative (IAVI) partnered HIV vaccine Design Centre is an important milestone in this area. Global partnerships with agencies like the IAVI, National Institute of Health, Bill & Melinda Gates Foundation has helped in mobilizing global talent and working together of best scientists. Greater efforts are yet needed for Vaccines for Cancer and Non Communicable diseases.

The low pricing has been possible due to social innovation, Public Private Sector Partnership programs and competition amongst the Indian and other Developing country manufacturers. Bharat Biotech’s Rotavirus vaccine and Serum Institutes Meningococcal Meningitis Vaccine was developed is as an example of this arrangement. The National Rural Health Mission efforts are beginning to show results with steady increases in coverage of routine EPI vaccine.

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