2025-09-17

For decades, India has proudly worn the title of the “pharmacy of the world.” Its pharmaceutical manufacturing sector has been the backbone of affordable healthcare across the globe, supplying high-quality generics to over 200 countries. From life-saving HIV medicines in Africa to affordable vaccines in Asia, India’s role as a volume leader is undisputed. But the story is now evolving. The country is moving beyond scale to create value through quality, innovation, and sustainability.

India’s manufacturing strength lies in its sheer capacity. The country has more than 3,000 pharma companies and over 10,000 manufacturing units. It also boasts the highest number of US FDA-approved plants outside the United States, cementing its credibility in regulated markets. Yet, being the lowest-cost producer is no longer enough. Rising global competition, stricter regulatory demands, and the push for green manufacturing are forcing Indian companies to rethink their strategies.

In reent years, regulators such as the US FDA and EMA have tightened compliance requirements. For Indian firms, this has meant significant investment in upgrading plants, digitalising processes, and adopting global best practices. Zero-observation inspections, once rare, are becoming milestones that companies proudly announce. Quality is no longer simply about avoiding warning letters; it has become a key differentiator in winning trust from global clients.

Environmental responsibility has become central to the next phase of growth. The bulk drug industry, particularly in Active Pharmaceutical Ingredient (API) manufacturing, has faced criticism for its environmental footprint. In response, companies are adopting sustainable manufacturing practices: reducing water and energy consumption, treating effluents more efficiently, and exploring green chemistry. Bulk drug parks being developed under government schemes are designed with common effluent treatment facilities and eco-friendly infrastructure, showing that scale and sustainability can go hand in hand.

Pharma manufacturing worldwide is being reshaped by new technologies, and India is not staying behind. Continuous manufacturing, automation, and data-driven quality control are gaining ground. Artificial intelligence and machine learning are being deployed to monitor production in real-time, detect anomalies, and predict equipment failures. These technologies not only ensure consistent quality but also lower costs in the long run, reinforcing India’s competitiveness.

The COVID-19 pandemic exposed vulnerabilities in global pharma supply chains, particularly the dependence on China for key raw materials. India has since taken decisive steps to reduce this reliance. The government’s Production Linked Incentive (PLI) scheme for APIs and key starting materials is encouraging domestic manufacturing and attracting global partnerships. This shift towards self-reliance is strengthening India’s position as a resilient and trusted partner in global healthcare.

Perhaps the most significant shift is the industry’s move towards value creation through innovation. Beyond generics, Indian manufacturers are increasingly investing in biologics, biosimilars, and complex formulations. Contract development and manufacturing (CDMO) services are on the rise, catering to multinational pharma companies seeking reliable and cost-effective partners. This signals India’s intent to not just serve global markets, but to shape them.

India’s pharma manufacturing industry is at an inflection point. From being a leader in scale and affordability, it is evolving into a value-driven, innovation-oriented, and sustainability-focused sector. Quality, technology, and green practices are redefining what “Made in India” means for global healthcare. The future is clear: India is no longer just the pharmacy of the world; it is becoming a trusted architect of the next generation of medicines.