India’s “Make in India” initiative is a vital step toward building self-reliance and resilience in manufacturing. In the medical technology space, this national vision is increasingly shaping public procurement decisions, where local manufacturing is not just encouraged but prioritised. As someone who works at the intersection of healthcare delivery, government procurement systems, and regulatory policy, I support this ambition wholeheartedly but with a word of caution drawn from field realities.

The principle of national self-sufficiency must not eclipse the promise of patient safety and clinical effectiveness. In the pursuit of origin-based procurement, we must ask: Are we unintentionally creating inequities in access and outcomes within our own health system?

Policy Intent vs. On-the-Ground Impact
The Government of India, through the General Financial Rules (GFR) and the Public Procurement (Preference to Make in India) Order, 2017 (PPP-MII), provides clear directives: preference must be given to domestically manufactured goods with a minimum of 50 per cent local content. The intent is clear: nurture indigenous manufacturing, reduce import dependence, and make healthcare more accessible over time.

This framework has delivered early gains. MedTech start-ups are gaining traction, domestic capabilities are steadily expanding, and innovation is emerging in segments once dominated by imports. However, at the level of public hospitals, this strategic ambition often translates into overly simplified procurement practices, where decisions are guided more by checkboxes such as price, basic technical compliance, and local content declarations than by nuanced evaluations of clinical performance or patient safety.

This simplicity is problematic when the products involved are not commodity items but complex, high-risk medical technologies such as stents, ventilators, infusion pumps, or diagnostic platforms, where safety, efficacy, and long-term performance are critical. In such cases, procurement decisions based solely on manufacturing origin risk undermine the quality of care delivered in public hospitals.

A Widening Equity Gap in Access and Quality
India’s rise as a global medical tourism hub is well-recognised. International patients are increasingly visiting the country for specialised and elective procedures, drawn by advanced clinical expertise, modern infrastructure, and competitive pricing. These patients are treated almost exclusively in private hospitals, which are equipped with the autonomy and resources to procure the best available medical technologies, often from global manufacturers.

Private healthcare providers, serving both affluent Indians and foreign nationals, operate without the procurement constraints that bind the public system. Their decisions are guided by clinical outcomes and patient expectations, enabling them to continuously invest in world-class infrastructure and cutting-edge devices.

Meanwhile, public hospitals tasked with delivering essential care to the majority of the population face systemic procurement limitations. Their access to medical technologies is governed by local content rules, price ceilings, and compliance filters, often at the cost of quality and clinical relevance.

If these trends continue, India risks deepening a structural divide: where foreign nationals and the privileged access the best technologies for elective care, while Indian citizens, reliant on public hospitals, struggle to access safe and effective tools for basic, life-saving treatments. This is not just a policy imbalance, it is a public health contradiction we can no longer ignore.

Recognising Progress
The government has introduced exemptions for certain critical and lifesaving medical devices from local content provisions, which did not have adequate manufacturing capacity in India. Under this order, administrative departments may request exemptions from local content requirements or purchase preference margins, subject to justification and formal approval.

This policy reflects a nuanced understanding that in healthcare, clinical criticality must occasionally take precedence over procurement uniformity. It ensures that patients who depend on government institutions can benefit from global innovations, where local manufacturing capacity is still evolving.

However, such exemptions are currently case-based and require departmental approval, which limits their practical utility. A more sustainable, public health-centric approach would involve clearer criteria, faster approval timelines, and better integration with a clinical risk assessment framework so that the exemptions serve as a proactive safety net, not just a procedural fallback.

Strengthening Without Displacing: Guardrails for Equitable Growth
The intent behind Make in India is not in question, it is visionary and necessary. But intent must be matched with robust implementation mechanisms, especially when public health is at stake.

Rather than revisiting foundational principles, the opportunity lies in reinforcing the framework with safeguards that protect clinical quality while promoting domestic capability. A well-calibrated approach can ensure that our drive for self-reliance goes hand-in-hand with patient safety and evidence-based decision-making.

Here’s how we can strike that balance:
•    Risk-Stratified Procurement Evaluation: Medical devices should not be evaluated with a one-size-fits-all lens. Products that are invasive, high-risk, or life-sustaining require a higher threshold of scrutiny than low-risk consumables. A stratified evaluation model based on clinical risk, regulatory complexity, and patient impact can ensure that procurement safeguards mirror the clinical context of use.
•    Stakeholder-Driven Clinical Appraisal Panels: Procurement decisions should be supported by expert inputs from cross-functional panels comprising clinicians, biomedical engineers, public health professionals, and regulatory experts. These panels can guide procurement entities on device appropriateness, contextual fit, and clinical reliability, offering qualitative insights that go beyond mere compliance documentation.
•    Performance-Based Incentivisation for Domestic Players: Domestic manufacturers who demonstrate evidence of product safety, long-term performance, and user satisfaction should be prioritised through weighted evaluation criteria. This approach encourages continuous improvement in product quality while ensuring that procurement remains standards-driven rather than geography-driven.
•        Proactive Post-Market Surveillance Integration: Strengthening feedback mechanisms is crucial. The Indian Pharmacopoeia Commission’s Materiovigilance Programme should be embedded into procurement platforms to ensure that safety data and field experiences inform future purchasing decisions. Procurement agencies must treat post-market surveillance not as an afterthought but as a central component of lifecycle management.
•    Procurement Transparency and Technical Audits: Regular, independent audits of procurement outcomes, evaluating both product performance and user satisfaction, can provide insights into system-level impact. Making audit findings publicly available (where feasible) would build greater transparency, foster accountability, and reinforce trust in government purchasing systems.

Towards a More Inclusive ‘Make in India’
The true objective of Make in India in healthcare should not be to merely replace imported devices with locally made alternatives, it should be to elevate standards across the board. That means ensuring that every medical device used in Indian hospitals, whether domestic or imported, is safe, effective, and outcome-driven.

Procurement, in this context, is far more than a financial transaction. It is a powerful public policy tool, one that shapes clinical ecosystems, influences innovation pathways, and ultimately determines the quality of care delivered to millions.

Yet, when procurement frameworks prioritise manufacturing origin over medical merit, we risk distorting the incentives that matter most. Without adequate checks and balances, we risk institutionalising a two-tier healthcare system, one where market forces reward clinical performance, and another where public procurement rewards geographic origin over medical merit. To avoid this, we must shift the Make in India narrative from one focused solely on industrial output to one anchored in clinical excellence and equity. This requires three decisive shifts:
1.    From price-based selection to performance-based evaluation
2.    From blanket preferences to risk-calibrated safeguards
3.    From policy mandates to patient-centred accountability

India’s public hospitals are lifelines for millions. For patients on dialysis, undergoing chemotherapy, recovering from trauma, or relying on diagnostic interventions, the quality of a device is not a matter of compliance; it is a matter of survival.
The success of Make in India in healthcare will not be defined by how many devices we produce, but by how many lives those devices help save, improve, or protect. It will succeed not because it is mandated but because it is trusted. Not because it is cheaper, but because it delivers better outcomes.

That is the standard we must set and the future we must build.
 

BW Healthcare