Raw Material Security: Supply Chain Risks for Pharma Manufacturers in India
India is globally recognised as the “Pharmacy of the World,” with a vast network of Pharma Manufacturers in India playing a crucial role in supplying life-saving medications across continents. Yet, this thriving industry faces an often overlooked but pressing challenge: raw material security.
For Pharma Manufacturers in India, especially those in the injectables segment like Armein Pharmaceuticals, ensuring an uninterrupted supply of APIs and other raw materials is key to maintaining product quality, affordability, and compliance with international standards. This blog dives deep into the supply chain risks facing Pharma Manufacturers in India, especially Injectable Manufacturer in India operations, and the strategies being implemented to mitigate them.
Why Raw Material Security Matters
Over 70% of APIs used by Pharma Manufacturers in India are imported, primarily from China. This high dependency poses serious challenges in maintaining uninterrupted manufacturing, especially for injectables.
For a WHO-GMP-certified Injectable Manufacturer, consistency in quality and timely delivery of raw materials is critical. Any disruption can impact the ability of Pharma Manufacturers in India to meet domestic and global demand.
Key Supply Chain Risks Faced by Pharma Manufacturers in India
From geopolitical tensions to port congestion and environmental regulations, the vulnerabilities in global sourcing expose Pharma Manufacturers in India to serious operational and financial risks. For example, during the COVID-19 pandemic, disruptions impacted API imports, causing ripple effects across sterile drug manufacturing units run by Pharma Manufacturers in India.
1. Geopolitical Instability
Tensions between India and key trading partners such as China can lead to sudden restrictions, tariffs, or embargoes on raw material exports. Pharma Manufacturers, particularly those producing life-saving injectables, face a high risk due to this dependency.
2. Pandemic-Induced Disruptions
COVID-19 highlighted the fragility of global pharmaceutical supply chains. Lockdowns led to factory closures, port congestions, and delayed shipments, especially of APIs and excipients vital to Injectable Manufacturers.
3. Global Price Fluctuations
Volatility in the price of solvents, reagents, and chemical intermediates often stems from supply shortages, currency fluctuations, or rising energy costs. For cost-sensitive Pharma Manufacturers in India, these changes can impact profitability and product pricing.
4. Environmental Regulations
Tighter regulations in countries like China have caused shutdowns of polluting API factories, leading to abrupt global shortages. Manufacturers relying solely on a few international suppliers face a significant supply chain risk.
5. Logistics and Port Congestion
India’s ports and inland transport systems, while improving, remain vulnerable to disruptions caused by strikes, weather, and administrative delays. For time-sensitive injectable drugs, such delays can result in missed delivery timelines and spoilage.
Impact on Injectable Manufacturers and Production
Sterile injectable products require high-purity raw materials, precision handling, and controlled environments. Any delay or compromise in materials directly affects:
- Batch timelines
- Product efficacy and shelf life
- Regulatory approvals (WHO-GMP, EU-GMP, etc.)
Injectables require higher regulatory scrutiny and greater control over input materials. Pharma Manufacturers in India producing sterile injectables face stricter compliance, and any raw material irregularities can lead to rejected batches or delayed exports.
Companies like Armein Pharmaceuticals, a globally trusted Injectable Manufacturer in India, exemplify how stringent raw material controls are necessary for uninterrupted operations by Pharma Manufacturers in India.
Role of Indian Injectable Manufacturers in Ensuring Continuity
Indian companies have started implementing multi-pronged strategies to minimise dependence and ensure continuity. Armein Pharmaceuticals, a WHO-GMP and ISO 9001:2015 certified Injectable Manufacturer, stands as a prime example.
With a robust facility located in Gujarat, Armein produces a diverse range of injectable drugs catering to anti-infectives, anti-inflammatories, and GI segments. Their infrastructure is optimised for consistency, safety, and supply assurance. By working with vetted suppliers and maintaining buffer stocks, they are better equipped to navigate global raw material shortages.
Government Support and Industry Efforts
Recognising the urgency, the Indian government launched several initiatives:
✔ Production Linked Incentive (PLI) Scheme
The government is incentivising domestic production of 53 critical APIs and KSMs under the PLI scheme, reducing import dependency.
✔ Bulk Drug Parks
Three mega parks are being developed in Gujarat, Himachal Pradesh, and Andhra Pradesh to manufacture essential APIs domestically at scale.
✔ Customs and Tax Reform
Simplification of procedures and reduced duties on pharma-related inputs aim to make domestic manufacturing more competitive.
With an aim to reduce dependence on imports, the Indian government is actively encouraging Pharma Manufacturers in India to localise API production and develop backward integration models.
Programs like the PLI scheme and bulk drug parks are designed to empower Pharma Manufacturers in India to become globally competitive.
Strategies for Pharma Manufacturers in India to Overcome Supply Chain Risks
Leading Pharma Manufacturers are adopting strategic practices to strengthen raw material security:
1. Multi-Sourcing and Local Sourcing
Diversifying suppliers across geographies and encouraging Indian vendors ensures supply chain resilience.
2. Backward Integration
Some large players are acquiring API manufacturing capabilities, reducing third-party dependence and improving cost control.
3. Vendor Audits and Partnerships
Robust qualification protocols for suppliers ensure quality consistency, especially for injectable raw materials.
4. Digital Supply Chain Management
Tools like ERP systems and blockchain integration are helping Pharma Manufacturers in India track and trace material flows in real-time.
5. Inventory Optimisation
Smart inventory planning, especially for critical excipients and solvents, helps reduce the risk of stockouts without inflating costs.
Armein Pharmaceuticals’ Strategic Approach
As a proactive Injectable Manufacturer in India, Armein Pharmaceuticals has developed an advanced procurement and quality management system. This allows it to buffer against disruptions and maintain the trust of its global clientele.
With a facility that adheres to WHO-GMP and ISO 9001:2015 standards, Armein showcases the evolving resilience of Pharma Manufacturers in India against supply chain risks.
- In-house Quality Labs: Each batch of material undergoes rigorous testing before entering the production line.
- International Footprint: Armein exports to 30+ countries, complying with stringent global regulatory bodies.
- GMP-Certified Facilities: Built to meet EU, WHO, and PIC/s standards, minimising compliance risks.
- Dedicated Warehousing: Helps in maintaining optimal storage conditions and stock levels of APIs and excipients.
- Focus on Sterile and SVPs (Small Volume Parenterals): Their specialised focus adds an extra layer of precision in managing critical inputs.
These factors reinforce Armein’s position as a trusted Injectable Manufacturer in India capable of delivering consistent results even in times of global disruption.
The Way Forward for Pharma Manufacturers
India’s pharmaceutical future hinges on a balanced strategy that emphasises both expansion and resilience. For Pharma Manufacturers in India, this means:
- Investing in backward integration.
- Building strong relationships with domestic raw material producers.
- Embracing digital transformation.
- Fostering a culture of proactive risk mitigation.
Companies like Armein Pharmaceuticals are already paving the way by demonstrating how preparedness and quality-centric models can protect and strengthen India’s global pharmaceutical leadership.
Conclusion
As the world increasingly depends on India for affordable, high-quality medicines, the onus is on Pharma Manufacturers in India to future-proof their operations. Raw material security is no longer a backend issue; it’s a frontline strategic priority.
Through smart partnerships, policy support, and self-reliant frameworks, India is moving towards becoming not just the Pharmacy of the World but also the most resilient one. Industry leaders like Armein Pharmaceuticals, a trusted Injectable Manufacturer in India, exemplify how innovation and foresight can turn supply chain risks into competitive advantages.
The journey ahead demands adaptability, transparency, and long-term thinking. But with focused action, Indian Pharma Manufacturers are poised to secure not just raw materials, but the future of global healthcare.