Closing India’s Bulk-Drug Gap: Reducing Dependence on China
- In Mathematics, Science & Technology
- 01:19 PM, Nov 11, 2026
- Rudra Dubey
India is the pharmacy of the world for finished medicines, yet it remains structurally dependent on China for the chemical core of those medicines: active pharmaceutical ingredients (APIs), key starting materials (KSMs) and intermediates. The proposed ₹7,000 crore bulk-drug scheme announced in November 2026 is the government’s most ambitious attempt yet to reverse this imbalance. Success will take more than incentives and new capacity. India will need a radical technological shift, using AI, robotics, automation and better process science to offset its cost and scale disadvantages.
Where Indian Pharmaceuticals Industry Stands
India produces a large share of the world’s generic formulations and has built strong regulatory credentials. Domestic API capacity already meets a significant portion of overall demand, and the country is a net exporter of APIs in aggregate. Yet for critical molecules, particularly fermentation-based antibiotics, certain vitamins and high-volume intermediates, dependence on China remains 70–75% or higher by value. In some cases, it is 100%.
The existing Production-Linked Incentive (PLI) scheme for bulk drugs (₹6,940 crore outlay) attracted investment and commissioned capacity for strategic products such as Penicillin G. Production and incentive disbursals, however, lagged far behind targets. Newly commissioned Indian plants frequently face aggressive price cuts from Chinese suppliers the moment they begin commercial output, which makes running the plants uneconomical.
China’s dominance rests on decades of deliberate industrial policy: vast chemical and fermentation clusters, deep backward integration into petrochemicals and agricultural feedstocks, large fully depreciated plants, shared infrastructure for solvents and effluent treatment, and the ability to sustain low pricing once market share is secured. Indian plants, by contrast, often face higher utility costs, incomplete value chains and lower scale.
The Critical Gap
The core problem is unit economics and resilience, not just capacity. Chinese APIs are frequently 35–40% cheaper for commodity and fermentation products. Indian manufacturers struggle with:
- Incomplete upstream integration
- Lower process yields and higher solvent/energy intensity
- Batch-oriented rather than continuous manufacturing
- Limited advanced automation and real-time process control
- Vulnerability to coordinated price undercutting
Without closing this gap, new plants risk becoming underutilised assets even with incentives. Supply-chain security for essential medicines remains exposed to geopolitical or logistical shocks.
The Opportunity
The proposed scheme is better designed than its predecessor. Key features include:
- ₹5,000 crore for production incentives and ₹2,000 crore for R&D, infrastructure and capital subsidies (including a dedicated ₹500 crore R&D fund)
- A platform-based approach covering 52 molecule sets and more than 300 intermediates and downstream APIs
- Eligibility for both greenfield and brownfield projects, including existing PLI facilities
- An eight-year window with six years of incentives and the flexibility to designate two “zero” years
- Flat incentive rates and explicit support for continuous-flow equipment, retrofitting, fermentation, strain development, biocatalysis and enzyme engineering
Globally, buyers are pursuing China+1 strategies. India already possesses formulation expertise, a large talent base, improving regulatory alignment and growing CDMO capabilities. The missing piece is cost-competitive, technologically advanced, fully integrated bulk-drug capacity. The scheme, if executed with technology intensity, can bring about a lasting structural shift.
Recommendations
Adding capacity bit by bit will not be enough. Indian bulk-drug companies and policymakers need a deliberate strategy to move ahead technologically.
1. Make every new and upgraded plant a “smart platform”
Treat the 52 molecule platforms as technology testbeds. Mandate or strongly incentivise continuous manufacturing, real-time process analytical technology (PAT), digital twins and high levels of automation from day one. Brownfield retrofits should prioritise continuous-flow reactors and modular designs that can be rapidly reconfigured.
2. Use AI to design processes and optimise operations
Use generative AI and machine-learning models for route design, reaction optimisation, impurity prediction and yield maximisation. Digital twins should simulate entire plants and value chains before capital is committed. Predictive quality systems can substantially reduce batch failures. National or consortium-level data platforms (anonymised process data) could accelerate learning across the industry.
3. Adopt physical AI and autonomous manufacturing
Move beyond conventional automation to physical AI, meaning AI systems built into robots and autonomous process equipment. This includes collaborative and mobile robots for material handling, sampling and hazardous operations, lights-out or near-lights-out continuous plants for high-volume platforms, and sensor-rich environments that allow AI controllers to adjust fermentation or continuous-flow parameters in real time. Physical AI can reduce labour variability, improve consistency and support round-the-clock operation at high utilisation, which starts to match Chinese scale economics.
4. Rebuild fermentation and biocatalysis as strategic national capabilities
The R&D fund should prioritise AI-guided strain engineering, metabolic pathway optimisation and enzyme design. Partner with global and domestic biotech firms and academia to create shared strain libraries and pilot-scale continuous fermentation facilities. Agricultural feedstock integration (high-quality media components) must be developed in parallel.
5. Create circular, low-cost industrial ecosystems
Bulk-drug parks should evolve into closed-loop systems with advanced solvent recovery, energy integration, shared continuous effluent treatment and on-site renewable power. Capital support should favour technologies that cut utility and waste costs, which have historically been major disadvantages against Chinese clusters.
6. Policy and industry coordination for speed
- Fast-track clearances for continuous and automated plants.
- Link higher incentive rates or additional capital support to demonstrated technology intensity and utilisation thresholds.
- Encourage consortium models for upstream Key Starting Materials (KSMs) so that no single company bears the full risk of backward integration.
- Develop a national digital backbone for process data, regulatory submissions and supply-chain visibility.
7. Long-term vision (2030–2035)
By the early 2030s, the aim should be AI-coordinated national platforms in which digital twins of multiple plants optimise production across the network in real time, fully autonomous continuous facilities producing critical APIs with minimal human intervention, and India as the preferred global source, not only for cost but for reliable, green, high-quality bulk drugs. Physical AI robots and autonomous process units would be standard, making labour-cost differences a secondary consideration.
Conclusion
China’s lead in bulk drugs is real and comes from sustained strategy. India’s new scheme provides the policy window and financial support to respond. What matters most is whether industry and government treat this as another capacity-building exercise or as an opportunity for a technological step change.
By combining the platform approach with aggressive adoption of AI, physical AI, continuous manufacturing and advanced bioprocess engineering, India can move from import substitution to global competitiveness. The goal should be more than matching Chinese prices. It is to build a resilient, efficient and sustainable bulk-drug ecosystem that supports India’s position as the pharmacy of the world, from molecule to medicine. The policy opening is here, and how quickly and ambitiously it is executed will determine the outcome.
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