₹1,500-crore Biopharma Mission may focus on dengue, HPV vaccines

Developing home-grown vaccines to prevent dengue, human papillomavirus and pneumococcal infection, and biologics for diseases such as cancers and rheumatoid arthritis, are among the identified focus areas for the recently launched ₹1,500-crore National Biopharma Mission.

The final decision on national identified priority products will be taken at the first meeting of a specially constituted scientific advisory committee, consisting of experts from India and abroad, in the next 15 days, said a Department of Biotechnology (DBT) official.

Renu Swarup, Managing Director of Biotechnology Industry Research Assistance Council (BIRAC), a public sector undertaking under the DBT, said the aim of the mission is to accelerate early leads through the product development pipeline to ensure they reach the market in a time-bound manner. BIRAC will be the implementing agency for the mission, which is also supported through a World Bank loan.

An official statement from the government said the Mission is part of an attempt to push India’s share in the global biopharmaceuticals market from the current 3 per cent to 5 per cent by 2022.

“We expect the rollout to begin by October,” Swarup told BusinessLine .

“This mission is not for new discovery, but for creating infrastructure to move important early leads, which are in different stages, through the pipeline, and come out with products.

“We do not expect 100 or 200 applications as we do not have so many at such a stage. We anticipate 5 or 10 players to come forward. But once an ecosystem is in place, a large number of start-ups may benefit subsequently,” said Swarup.

The mission will follow a consortium-based approach, wherein academia and industry working in an identified area will be encouraged to work together. The government will handhold them through various regulatory processes so that product development can be hastened, she added.

The processes followed in developing the first indigenously developed rotavirus vaccine, Rotavac, could serve as a model for the mission, Swarup said.

Rotavirus vaccine research first commenced at the All Indian Institute of Medical Sciences (AIIMS), in New Delhi, in the 1990s, and subsequently at the Society of Applied Studies, Christian Medical College (CMC), Vellore, and Translational Health Science and Technology Institute (THSTI), Faridabad, which is under the DBT. Finally, the vaccine was successfully transferred to Hyderabad-based public sector undertaking Bharat Biotech International Limited.

The development of the rotavirus vaccine suffered from many procedural delays. “From Phase I trials in 2003 to final Phase III clinical trials in 2015, it took a long time,” said Gagandeep Kang, Executive Director of THSTI, who was instrumental in developing the vaccine when she was at CMC.

“We will help them in expediting some regulatory clearances as they are working on nationally important priority products,” said Swarup.

Apart from vaccines and biosimilars, the five-year mission will also support development of newer platform technologies for medical devices and diagnostics.

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