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EU GMP certification helps Indian drug manufacturing plants to align with global quality standards: Arpit Bhatia
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Shardul Nautiyal, Mumbai
October 30 , 2025
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The European Union Good Manufacturing Practice (EU GMP) certification has helped Indian drug manufacturing plants, processes, documentation, and quality systems to align and comply with rigorous global quality standards and expectations, says Arpit Bhatia, director, Laborate Pharmaceuticals.
An EU GMP certificate confirms that a pharmaceutical manufacturer complies with the EU's stringent quality, safety, and efficacy standards for medicinal products. It is issued after a successful inspection by a European competent authority and is necessary for a company to access the European market. The European Medicines Agency (EMA) oversees this process and maintains a public database of certificates.
Founded in 1985 in Panipat, Haryana, Laborate Pharmaceuticals is among India’s top three pharmaceutical manufacturers with a revenue of over Rs. 1,600 crore. It has a wide portfolio of affordable medicines and recently secured EU-GMP certification to expand its global exports.
Bhatia adds that for buyers and regulators in Europe and other regulated markets, EU GMP has reduced perceived risk and shortened the trust gap. Practically, it has opened the door to dossier submissions, tenders, and long-term supply contracts that were not previously accessible.
He further adds that EU GMP has moved the conversation from capacity to credibility. It has also driven a culture shift internally. Once you are operating to an EU GMP framework, the disciplines of data integrity, serialisation, change control, and continuous process verification become day to day habits rather than projects.
Commenting on EU GMP standards influence on India’s pharmaceutical exports and competitiveness, Bhatia says, “Compliance changes both product strategy and market strategy. On product strategy, you build dossiers with stronger comparability data, robust stability, and lifecycle management from the outset. That makes the portfolio export ready rather than retrofitted for different regions. On market strategy, EU GMP improves our eligibility for procurement, whether hospital tenders in the EU, institutional buyers in Latin America, or public health programmes in Africa. It also improves our negotiating position with distributors and partners because the quality conversation is settled. Over time, this translates into better realisation, longer contracts, and more predictable demand. The knock-on effect is investment confidence. When the compliance base is strong, you can justify new lines, new forms, and technology upgrades that keep you competitive across geographies.”
While India is known as the pharmacy of the world, reseach and development (R&D) investment remains comparatively low. Certain structural changes or incentives could help Indian pharma move from volume led to innovation led growth.
Bhatia suggests that three shifts will make a material difference. First, restore and strengthen predictable fiscal incentives for in-house research, including weighted deductions tied to genuine R&D rather than capital expansion. Second, build shared preclinical and early formulation infrastructure through public private partnerships so that mid-sized firms can access good lab practice (GLP) facilities, bioequivalence centres, and platform technologies without duplicating cost. Third, create outcome linked grants for complex generics, 505 b 2 pathways, and novel delivery systems where milestones are tied to dossiers filed and approvals secured. Alongside these, faster review timelines for high need therapies and clear data exclusivity frameworks would de-risk development. The objective is simple. Decrease the cost of scientific risk while keeping the bar for quality and evidence high.
While commenting on how can mid-sized Indian manufacturers balance the cost of maintaining EU GMP facilities with the need to allocate resources towards long term R&D and formulation innovation, he says that we should prioritise platform approaches in manufacturing and development so that one investment supports multiple products. Examples include common granulation platforms, modular packaging with serialisation ready lines, and analytical methods that can be validated across families of molecules. On R&D, we should focus on complex but adjacent technologies where our existing know how gives an execution edge. Co-development and risk sharing with specialist partners helps stretch budgets without diluting standards. Finally, we should phase validation and capacity additions against firm demand signals from target markets.
Bhatia further says that India’s strength in high quality, high volume manufacturing is now meeting a new wave of formulation science, device integration, and data enabled development. I see three convergences. First, quality by design becoming the default, with digital systems that connect shop floor data to development decisions in real time. Second, greater collaboration between academia, start-ups, and mid-sized companies to move ideas from lab to line faster, especially in drug delivery and combination products. Third, capital becoming more patient where pipelines are credible and governance is strong. As this matures, India will not only supply the world efficiently but will also originate more complex generics, differentiated formulations, and incremental innovations that improve adherence and outcomes. The ecosystem is moving from proof of capacity to proof of capability.
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