During the 2021 race in developing Covid-19 vaccines, the CEO of a prominent Indian pharmaceutical organisation openly called on the US to facilitate the availability of key raw materials. The message was clear: despite having the scientific breakthrough and capacity to manufacture and the orders for the product, the firm still had the challenge of input availability. The story is one behind the next China+1 option. Not only does it revolve around manufacturing the finished tablets, vials or API in one place. But it is also about the invisible chain behind the development of such products: the single-use bags, sterile tubing, filters, connectors, sensors and fluid management systems, which help move the biologics from the production process.
India has solid fundamentals on which to build. Pharmaceutical exports were at $ 30.47 billion for FY2024-25, marking a 9.4% growth compared to the previous year. Indian medicines have entered over 200 markets, with more than 60% of export destinations being those with strict regulation. In terms of its broader bioeconomy, India has seen $ 195.3 billion revenues in 2025, constituting some 4.8% of the GDP, backed by more than 11,800 biotech startups.
Biologics are a different story when it comes to industrial operations. Cultivated, purified, transferred and filled through controlled processes, they require materials for every single step where any contact takes place. Single-use technologies have come to define this process. According to BioPlan’s 2024 biopharma industry survey, 87% of biopharmaceutical manufacturing plants used single-use technologies, with 87.6% using bags and connectors and 86.6% using tubing. These are recurring inputs, needed for each successive batch manufactured. They play their role in sterility assurance, contamination control, flexibility of the production process and time it requires to shift between products.
The Government of India has established a credible base. The National Biopharma Mission (NBM), implemented by BIRAC, has been responsible for supporting 101 projects with the involvement of more than 150 organisations and 30 MSMEs. BioE3 Policy, endorsed in 2024, has put high-performance biomanufacturing at the core of the Indian biotechnology policy and prioritised the area of precision biotherapeutics. This policy plans Bio-AI hubs, biofoundries and biomanufacturing hubs in order to accelerate technology transition through development of interdisciplinary talent.
{{/usCountry}}The Government of India has established a credible base. The National Biopharma Mission (NBM), implemented by BIRAC, has been responsible for supporting 101 projects with the involvement of more than 150 organisations and 30 MSMEs. BioE3 Policy, endorsed in 2024, has put high-performance biomanufacturing at the core of the Indian biotechnology policy and prioritised the area of precision biotherapeutics. This policy plans Bio-AI hubs, biofoundries and biomanufacturing hubs in order to accelerate technology transition through development of interdisciplinary talent.
{{/usCountry}}Further impetus came in Union Budget 2026-27 with the announcement of Biopharma SHAKTI that would spend ₹10,000 crore in five years on the development of indigenous biologics and biosimilars ecosystem. The plan comprises creation of three new NIPERs, upgrades of seven existing NIPERs, more than 1,000 clinical trial sites accredited and strengthening of CDSCO with scientific review cadre. But these are just the first steps. The next step has to be more focused. That will be a Bioprocessing Inputs and Qualification Pillar under Biopharma SHAKTI.
The problem lies not in the question of whether India can manufacture bags, connectors or filters, but in whether a global or Indian biologics producer can utilise the products in a validated manufacturing process with confidence. Technical justification of manufacturing changes in case of biological medicines should show no negative influence on quality, safety and effectiveness of the product. Therefore, switching suppliers of pharmaceutical products becomes an expensive and risky business. The solution lies in creating a programme for de-risking the qualified second sources in India without lowering global standards of quality.
India needs joint testing facilities for evaluation of extractables and leachables, material characterisation, sterilisation and filter integrity. This could include to co-fund first-qualification projects between its Indian component producers and biologics manufacturers, which would involve financing for validation runs, documentation, and comparability activities while allowing industry to retain responsibility for quality and implementation. This will turn a laboratory component into a legitimate supply source. This can be backed by incentives that favour reliability and not simply localisation. They can include factors such as traceability, an auditable quality system, on-time deliveries, technical applications support and customer qualification. The goal of India should be to be a reliable second source for the world and not a protected first source domestically.
Moving beyond China will not be gained through shifting the very dependencies from one geography to another, but through the creation of resilient networks of qualified capabilities. India has already achieved the name of pharmacy of the world. The next step will be making the world’s most complex medicines possible.
(The views expressed are personal)
This article is authored by Sachin Joshi, founder, PharmNXT Biotech.