The Indian vaccine industry began as a network of state-owned manufacturers supplying basic pediatric vaccines to the national immunization programme. In recent times, the number of private owned firms active in the sector has grown rapidly. Their success in bringing low cost vaccine solutions to the public vaccine market is an important driver behind the emergence of the sector. As the industry is becoming more sophisticated, there is an increasing focus on innovation. Across the industry, a dozen or so new vaccines are in clinical development.
The Indian vaccine industry has been gradually building its R&D capacity for at least a decade. Spurred by the prospect of sales to the Global Alliance for Vaccines and Immunizations (GAVI), firms have strengthened their capabilities in biotechnology, built collaborations with international partners, and moved from basic vaccines to more sophisticated technologies.
Industry’s Role:: Very recently, Hyderabad based Indian Immunologicals Ltd (IIL), a subsidiary of the National Dairy Development Board (NDDB), has launched Vaxtar 5, its pentavalent vaccine offering protection against Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus influenzae type B (HiB). This development has led the company to bag Rs 210-crore order from the government to supply 140 million doses of the 5-in-one pentavalent vaccine. At the same time, the company is actively pursuing work on its hexavalent vaccine which includes inactivated polio antigen. Another Hyderabad based key vaccine player Bharat Biotech was recently in the news with respect to the announcement of the National Technology Award for 2018 from the Technology Development Board, Government of India. This award on innovative technologies, successfully developed and commercialized from India was bestowed on ROTAVAC, by the President of India Ram Nath Kovind. ROTAVAC, a Bharat Biotech vaccine that protects against diarrhoea became the first indigenously developed vaccine to be incorporated in the government-sponsored immunization campaign this year. Besides, Bharat Biotech has reported that its typhoid vaccine, Typbar TCV, has shown 87 per cent efficacy in trials. Currently, the company is working on the phase I clinical trials for its chikungunya vaccine. This year also saw a strategic deal being signed between Panacea Biotec and Serum Institute of India (SII) for a fully liquid six-in-one vaccine. Under the collaboration, SII will be allowed to make and sell fully liquid Whole cell Pertussis (wP) and Salk-based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed and commercialised by Panacea Biotec, touted to be the first of its kind. Both vaccine companies intend to get this wP-IPV-based Hexavalent Vaccine introduced in the government’s National Immunisation Programme. Other developing countries are also on the radar through stakeholders, including governments, the World Health Organisation, the Global Alliance for Vaccines & Immunisation (GAVI), the Bill and Melinda Gates Foundation (BMGF) and other United Nation agencies. Back in 2017, SII had launched two new vaccine products - Rotasiil and Rabishield for rotavirus causing diarrhoea and rabies respectively. The newly developed Rabishield anti-rabies immunoglobulinis the world’s first recombinant rabies monoclonal antibody to prevent Rabies, a fatal disease which is estimated to cause two deaths every hour in India. Rabishield has been developed in research partnership with Massachusetts Medical School, USA. Rotasiil rotavirus vaccine is the world’s first thermostable pentavalent Rotavirus vaccine containing the G9 strain to help prevent the spread of rotavirus which causes diarrhoea mostly in babies. Currently, SII is working on developing vaccines against pneumonia, chikungunya and enteric diseases. Joining the league of vaccine R&D, Sun Pharmaceutical Industries Ltd has entered into a collaboration with the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi to develop a novel dengue vaccine targeted against all four serotypes of dengue virus (DENV). Sun Pharma is funding and supporting further development of the vaccine candidate while ICGEB will be granting Sun Pharma exclusive rights and licenses for development and commercialisation of this vaccine globally. Another prominent player in the vaccine market, Zydus Cadila, has recently received approvals from the Drug Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO) and the Central Drug Laboratory (CDL) to market its Tetravalent Inactivated Influenza vaccine for seasonal flu, VaxiFlu - 4. With this, Zydus Cadila will become the first Indian pharma company and second in the world to launch a Tetravalent Inactivated Influenza vaccine. The vaccine provides protection from the four influenza viruses- H1N1, H3N2, Type B (Brisbane) and Type B (Phuket).
Government’s role One of the primary forces that is stimulating the vaccine market growth in India is the increasing investments in research and development (R&D) by government funding agencies like the Department of Biotechnology, the Indian Council of Medical Research, and the Ministry of Health and Family Welfare. The Indian Council of Medical Research (ICMR) has entered into an agreement to collaborate on vaccine research and development with South Korea based international vaccine development organisation International Vaccine Institute (IVI).Through this partnership, India will commit $5,00,000 (Rs 3.20 crore) annually for a stake in IVI. The Department of Biotechnology (DBT) has made concerted efforts in the area of vaccine research and development since its inception in 1986-87 through the Task Force on Medical Biotechnology, Indo-US Vaccine Action Programme (VAP), National Technology Mission on Immunisation and National Jai-Vigyan Mission on Science and Technology for the generation of new and improved vaccines and more recently through the Vaccine Grand Challenge Programme (VGCP). DBT has also been funding research on Tuberculosis (TB) for the past two decades with focus on vaccine development, among others. A number of novel approaches for generating vaccines against TB have been identified at ICGEB, Delhi University South Campus, New Delhi, University of Hyderabad, Indian Institute of Science, Bengaluru, to name a few. For more details click: www.biospectrumindia.com