2026-04-21

As India’s pharmaceutical sector shifts from volume-driven growth to global-grade quality and compliance, Arpit Bhatia, Director, Laborate Pharmaceuticals, discusses evolving manufacturing standards, regulatory credibility, technology adoption and self-reliance in APIs, with Pharma Industrial India. He also highlights sustainability, transparency and innovation as key pillars shaping India’s ambition to become the pharmacy of the world.

Q. How has India’s pharmaceutical manufacturing landscape evolved over the past decade, and what factors have driven this transformation?

Arpit Bhatia: Over the past decade, India’s pharmaceutical industry has matured in both scale and responsibility. Earlier, the goal was to produce affordable medicines in large volumes, but now the emphasis is firmly on regulated market quality and scientific precision. The introduction of incentive schemes, the rise of skilled manufacturing talent and growing export confidence have accelerated this shift. Companies are investing more in research, data integrity and automation because they understand that credibility builds long-term value. The mindset has changed from simply meeting demand to maintaining global-grade consistency. It is a positive and necessary evolution, showing that Indian pharma is ready to match the world in both standards and reliability.

Q. In a highly competitive market, how can Indian manufacturers maintain global-grade quality while keeping production costs affordable for domestic consumers?

Arpit Bhatia: Balancing affordability and global-grade quality has always been India’s strength. The key lies in efficiency, not compromise. When processes are standardised and monitored closely, quality improves without raising costs. Investments in automation, cleaner technology and skilled training reduce errors and waste. Many Indian manufacturers now understand that disciplined operations are the most effective cost control. Medicines must remain accessible to every income group, and that requires steady focus on efficiency at every level. The companies that manage to maintain this balance will define the next phase of Indian pharma’s success.

Q. What role do certifications such as EU GMP and WHO GMP play in enhancing the credibility and export potential of Indian pharma companies?

Arpit Bhatia: Global certifications such as EU GMP and WHO GMP serve as proof of trust and reliability. They confirm that Indian manufacturing facilities follow the same scientific and procedural rigour as any in Europe or the United Kingdom (UK). These certifications open doors to regulated markets and build confidence among international partners. More importantly, they create a discipline that benefits domestic operations as well. Once a team learns to function within globally approved systems, that culture of compliance becomes second nature. The real value of certification lies in the behaviour it inspires across every stage of production.

Q. How are new-age technologies like Artificial Intelligence (AI), automation and data analytics reshaping efficiency and compliance in pharma manufacturing?

Arpit Bhatia: Technology is gradually changing how quality is managed. Automation ensures precision, while data analytics provides real-time insights into every stage of production. AI is helping predict equipment maintenance and detect irregularities before they become risks. These tools reduce dependency on manual checks and allow teams to focus on process improvement. Compliance becomes easier when the data itself tells a story of transparency and control. This shift is not about replacing people with machines. It is about using technology to build systems that are more reliable, efficient and traceable, which is exactly what regulators now expect.

Q. What are the biggest challenges manufacturers face when scaling from regional operations to global markets, particularly in terms of regulation and supply chain management?

Arpit Bhatia: Expanding to global markets requires a complete change in perspective. Each country has its own regulatory framework, inspection standards and documentation protocols. Managing all of that while keeping production consistent is demanding. Supply chains also become more layered, involving temperature-controlled logistics, local packaging rules and constant audits. The challenge is to create systems that can adapt quickly without losing integrity. Manufacturers who invest in people trained in international regulation and quality assurance tend to navigate this better. It takes discipline, patience and detailed planning to grow sustainably at that level.

Q. How important is self-reliance in raw material sourcing, especially considering India’s dependency on Active Pharmaceutical Ingredients (APIs) from countries like China?

Arpit Bhatia: Self-reliance in sourcing raw materials has become critical to the future of Indian pharma. The pandemic highlighted how external disruptions can affect continuity. Reducing dependency on imported APIs is not just about cost, it is about security of supply. India is now developing domestic API parks and encouraging local production, which is a strong step forward. Companies are also diversifying their sourcing to ensure stability. Self-reliance should not mean isolation from global trade. It simply means being prepared for uncertainty and ensuring that production continues smoothly under all circumstances.

Q. How can mid-sized pharmaceutical companies balance expansion with sustainability and green manufacturing practices?

Arpit Bhatia: Sustainability is now part of responsible manufacturing. It can no longer sit outside business growth. Mid-sized companies are in a good position to adopt energy-efficient systems, improve waste management and reduce their environmental footprint without heavy restructuring. Many operational changes, like reusing solvents and optimising power consumption, bring both ecological and financial benefits. Green practices are not just good ethics, they are good economics. When manufacturers see sustainability as part of their efficiency strategy, not a separate initiative, they naturally move towards long-term stability and credibility.

Q. What investments are being made in R&D and testing infrastructure to ensure consistency, safety and innovation across product lines?

Arpit Bhatia: There has been a clear increase in research and testing investment across the industry. Indian manufacturers are setting up advanced analytical laboratories, digital validation systems and stability testing facilities. These upgrades are vital to meet evolving global regulations and to ensure that formulations remain consistent across climates and geographies. Innovation is often about improving reliability rather than inventing something entirely new. By investing in scientific infrastructure and skilled personnel, companies are ensuring that safety and quality stay at the heart of every product. This focus on R&D builds resilience and future-readiness for the entire sector.

Q. With increasing scrutiny on drug quality and pricing, how do you see the role of transparency and testing evolving in the next few years?

Arpit Bhatia: Transparency will define the next chapter of Indian pharma. As regulators and consumers demand clearer accountability, every batch will need traceable testing and documented proof of quality. Routine audits will move towards continuous digital validation. The companies that share information openly and embrace data integrity will earn the most trust. Testing will become more integrated with technology, enabling faster yet more reliable quality checks. Over time, transparency will shift from being a compliance requirement to a core brand value. It will separate those who aim for short-term gain from those who believe in long-term credibility.

Q. How do you foresee India’s pharma manufacturing sector contributing to the country’s broader ambition of becoming the ‘pharmacy of the world’?

Arpit Bhatia: India’s strength lies in its ability to combine affordability with large-scale, quality-driven production. As the world continues to depend on accessible healthcare, Indian manufacturers are becoming key contributors to global medicine supply. The future, however, will demand more than scale. It will require continued commitment to regulated market quality, sustainable production and transparent practices. If the industry keeps evolving in this direction, India can confidently call itself the pharmacy of the world not just in name, but in trust and dependability. That is the vision shared across the sector today.