Indian vaccine manufacturers are facing challenges to develop new vaccine technology to replace the conventional ones. Majority of the vaccines in the country are old. The new vaccine formulations are complex and scale-up is not easy.

There is a huge demand for vaccines globally and India is the largest supplier for international immunization programmes. All that it needs is to develop new vaccines and upscale production. Only new manufacturing technology can help faster scale-up which could bring down the cost. With the onset of advances in novel delivery options through nasal and dermal patches and product trends like pentavalent vaccine replacing trivalent vaccine to be soon substituted by hexavalent versions, Indian companies need to chalk out their future growth plans, stated Dr Subhra R Chakrabarti, head, manufacturing sciences, Shantha Biotech.

India is a global hub for vaccines. But there are many challenges to move forward to maximize the opportunities in the space. There is lack of expertise in large scale manufacturing. Further there are regulatory bottlenecks making it difficult to even change a vaccine and the only option seen is to continue the conventional ones that are seen to have a high acceptance in the medical centres. But, the country will need to speed up technology transfers with global companies. The existing Indian manufacturers will need to look to cost-effective production methods to offer globally competitive prices in the world market, he added.

Providing a snap shot of the vaccine scenario, Dr Chakrabarti, said, “There are 31 vaccines listed in the WHO- prequalified list with 27 manufacturers and 21 countries. India manufactures 20 vaccines and Serum Institute is the largest manufacturer in the country. There are 11 vaccines which no Indian company manufacturers. Therefore there is ample scope for more players to enter the fray.

Among the latest vaccines in the country is for cholera manufactured by Shantha Biotech, a Sanofi Company. While the demand for this vaccine is  50 million doses and we make available 10 million doses. The shortfall cannot be sustained by just one company giving scope for more companies to manufacture, said Dr Chakrabarti.

Product trends are that pentavalent vaccine has  replaced the trivalent vaccine. By 2015-17, hexavalent version will substitute the pentavalent version. The new vaccine combinations reduce the number of shots and are seen to be cost effective. Post 2017-18 would also have the entry of injectables polio vaccine (IPV) replacing polio drops. These next generation vaccines are also being researched by Indian companies. However, collaborations with multinational companies like the Shantha Biotech with Sanofi could speed up efforts. In addition, in-licensing deals would provide a boost to vaccine development, said Dr Chakrabarti while speaking on vaccine manufacturing challenges and opportunities at the Merck Millipore event.

Further Indian vaccine companies need to track global epidemics to be ready with the innovative versions. India needs to move away from its  legacy practices by sticking to old processes which needs to be transformed and  embark on newer vaccines. Now the advantage for India is that it is armed with the expertise in vaccine production and cold chain management. All that it needs is government support and involvement with the global vaccine companies, he said.