In a recent survey, domestic API manufacturers, finished dose manufacturers and CDMOs were asked what factors are holding back biotechnology and manufacturing in India.
Of the 433 respondents in the 'CPhI India Pharma Insights survey,’ 38% said there has not been enough government support, while a further 33% placed the problem with a lack of early stage funding from angel investors. Lack of biomanufacturing expertise in the country was also cited as a problem.
“For a majority of the Indian pharma industry, their growth story is led by small molecule generics and biopharma is the new emerging growth engine for them,” a spokesperson from Biocon – one of the few Indian large-scale biopharma players – told Biopharma-Reporter.
“Considering that biopharma is a highly capital intensive sector, bio-manufacturing in India has been sub-optimal due to limited access to capital, lack of fiscal incentives, inadequate infrastructure and complex, ever evolving regulatory requirements.”
Furthermore, “the scale up for biologics manufacturing is complex, expensive and fraught with challenges.”
Make in India
The Indian firms surveyed were also asked whether they were investing or planning to invest in biomanufacturing capabilities over the next three years.
Just under 30% said they were, something Biocon attributes to the fact biotechnology has been identified as a key focus area in the Indian government’s 'Make in India' programme – launched in September 2014 intended to encourage investment in the country.
“India has laid down a strategic roadmap for creating an optimal ecosystem that encourages bio-manufacturing through industry-friendly policies, smart regulations, world class infrastructure and relevant skill development initiatives,” the spokesperson said.
“These initiatives have the potential to transform India into a cost-effective global bio-manufacturing hub and a global partner for making affordable biologics for the world.”
According to the roadmap, the government intends for the Indian biotech industry to be worth $100bn by 2025 and is laying down policies to encourage this, including clarifying regulatory guidelines and offering “funding, mentoring, handholding and infrastructure support.”
The programme also overhauled foreign investment policies earlier this year, giving overseas companies an easier approval route to invest in brownfield pharma projects.