From active pharmaceutical agents for making key medicines to enzymes needed for developing biofuels, and reagents needed for manufacturing biofertilizers — the government under its BioE3 policy plans to set up around 16 biomanufacturing hubs across the country to ensure that India starts making the components for which it is largely dependent on imports. The government has already listed 1,000 such products for which there is a need to develop indigenous manufacturing facilities, which will be put on a website soon.
There has been a push towards manufacturing within the country since Covid-19 pandemic, with government policies such as performance-linked financial incentives to drug manufacturers. The department has been somewhat successful in scaling-up manufacturing of some of the drugs, but fermentation-based products still remain a challenge for the country.
With plans of setting up large fermenters of around 500 litres or 1,000 litres, these hubs can help push the manufacturing of not just fermentation-based medicines but also other products such as biofuels. “Creating these hubs helps pool the resources; meaning start-ups and small companies do not have to make big capital investments initially,” said an official from the department, on condition of anonymity.
These biomanufacturing hubs, in addition, will also look at scaling up innovative solutions such as novel monoclonal antibody treatments, new technologies for carbon capture, or smart proteins to improve nutrition developed under the programme from proof of concept to market ready products.
The Department of Biotechnology has already supported a set up of six biofoundries — a specialised facility that helps to develop and conduct the initial tests on such novel projects — at National Agri-Food and Bio-manufacturing Institute (NABI), Mohali (for sustainable food and nutrition), Tata Memorial Centre (for new drugs), International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi (for synthetic biology to make microbial cells for manufacturing enzymes, testing new biofuels, enhancing carbon capture efficiency), Translational Health Science and Technology Institute (THSTI), Faridabad (for monoclonal antibody therapies), Institute of Pesticide Formulation Technology (IPFT), Gurugram (for biopesticides), and National Centre For Cell Science (NCCS), Pune (for enzymes and metabolites).
“Once a proof of concept has been developed and tested at the biofoundries, it can be taken for manufacturing at these biomanufacturing hubs,” the official added.
BioE3 policy push
With the biomanufacturing hubs under the programme, critical ingredients for medicines, reagents needed for various products such as biofuels, bioproteins, and other chemicals for which India depends on imports, will be manufactured within the country. The Department of Biotechnology has undertaken a survey to finalise a list of 1,000 such products, which start-ups and companies may develop processes to manufacture within the country.
The biomanufacturing hubs will be set up in research institutes, private companies that specialise in a particular form of manufacturing, or near existing knowledge hubs for specific industries.
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The facilities can be accessed by government and private research institutes, universities, and colleges, along with start-ups and other companies. While the private companies will be charged, mainly to cover the cost of consumables, human resources, and other overhead charges.
As per its policy, the start-ups will be charged a maximum of 5% over the actual costs while companies may be charged up to 15% over the cost. The policy also states that the facility will not claim any intellectual property rights.
