Union Minister for Road Transport and Highways Nitin Gadkari on Thursday launched the Purple Building Certification Scheme, a new national framework developed by the Andhra Pradesh MedTech Zone (AMTZ) to evaluate and certify infrastructure used in medical device manufacturing and biomedical facilities. The initiative, introduced at an event in New Delhi, seeks to strengthen quality, resilience, and sustainability standards across India’s rapidly growing medical technology ecosystem.

Gadkari said the certification system is designed to promote global best practices and improve safety across buildings that house sensitive medical operations. The scheme is expected to support India’s goal of expanding domestic manufacturing in critical health sectors, reduce import dependence, and foster international competitiveness.

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Aimed at Modernizing Biomedical Infrastructure

A New Standard for Buildings Critical to Health Systems

The Purple Building Certification Scheme provides guidelines for assessing medical device manufacturing units, laboratories, diagnostic centers, and other biotech-related infrastructure.

Officials said the rating system evaluates a building’s compliance on parameters such as:

• Structural and operational safety

• Fire and chemical hazard preparedness

• Energy efficiency and environmental sustainability

• Biomedical waste management practices

• Advanced ventilation and sterility controls

• Disaster resilience and emergency readiness

AMTZ Managing Director Dr. Jitendra Sharma said the scheme represents a “first-of-its-kind” certification model tailored specifically to the medtech sector. “The goal is to ensure that biomedical facilities meet the most rigorous standards so that quality, safety, and reliability become non-negotiable,” he said.

Addressing Gaps in Infrastructure Quality

While India has expanded medical device manufacturing in recent years, industry leaders have long highlighted issues related to inconsistent infrastructure quality. Many smaller units do not meet global norms for material handling, temperature control, or contamination prevention.

Gadkari said the certification scheme is an attempt to fill these systemic gaps. “We cannot afford lapses in medical device quality. This framework ensures that infrastructure itself becomes an enabler of excellence,” he said.

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India’s Medical Device Industry on a Growth Path

Government Push to Reduce Import Dependence

India currently imports nearly 70–80 percent of its high-end medical devices, according to government estimates. The Centre has prioritized the sector under the Make in India initiative and established dedicated medical device parks to promote domestic manufacturing.

AMTZ, based in Visakhapatnam, is one of the largest such parks in Asia. It provides testing labs, manufacturing units, and regulatory support to medtech companies.

“AMTZ has already demonstrated how infrastructure can catalyze industrial growth,” Gadkari said. “The Purple Building framework takes this mission forward by ensuring excellent standards nationwide.”

Demand for MedTech Infrastructure Rising

The COVID-19 pandemic exposed weaknesses in global medical supply chains, prompting countries to build local capacity.

Industry estimates suggest India’s medical device market may reach USD 50 billion by 2030, driven by rising domestic demand, an expanding healthcare sector, and export growth.

Analysts say the introduction of a specialized building certification system aligns with this trajectory, giving companies a clear compliance roadmap and improving investor confidence.

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How the Certification Works

Multi-Level Rating System

The Purple Certification framework incorporates multiple tiers of rating, similar to international green building standards.

Buildings are evaluated under categories such as:

• Basic Compliance (Purple 1)

• Enhanced Safety and Quality (Purple 2)

• Advanced Medical Grade Infrastructure (Purple 3)

• Global Excellence Level (Purple Platinum)

AMTZ officials said the rating reflects not only structural specifications but also operational processes, including adherence to biomedical norms, cleanroom protocols, and maintenance quality.

Voluntary but Strongly Encouraged

The certification is currently voluntary, though officials expect it to become a preferred industry benchmark. Banks and investors may also use it to assess infrastructure stability and risk levels for medtech projects.

“Certification is not mandatory, but companies striving for global markets will see it as a major advantage,” Sharma said.

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Industry Response Positive but Cautious

Experts Welcome Push for Standardization

Industry leaders and healthcare experts reacted positively to the launch, noting that the sector has long lacked a unified infrastructure benchmark.

“The medical device industry operates in an environment where microscopic errors can lead to public health consequences,” said Dr. Asha Reddy, a Hyderabad-based biomedical engineer. “A building certification tailored to our needs is overdue.”

Concerns Over Compliance Costs

Some small- and medium-scale manufacturers expressed concern about the expense of upgrading infrastructure to meet the standards.

“Certification will add credibility, but the cost of retrofitting older buildings may be high,” said a Pune-based device manufacturer who requested anonymity. “The government may need to consider subsidies or support.”

Gadkari acknowledged the concern and said the government is open to exploring incentives that encourage long-term adoption.

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Strengthening India’s Regulatory Architecture

Part of Larger Efforts to Modernize Health Manufacturing

The Purple Building Certification Scheme ties into broader regulatory reforms, including the proposed Medical Devices (Amendment) Rules and efforts to streamline licensing processes.

Officials said improved infrastructure standards can reduce quality violations, enhance product reliability, and make Indian manufacturers more competitive internationally.

The scheme may also help reduce India’s reliance on imported testing and certification facilities, many of which remain located overseas.

Boost for Export Competitiveness

Countries importing medical devices—from Europe to Southeast Asia—often require proof of compliance with advanced safety infrastructure.

“If India wants to be a global medtech hub, our infrastructure has to match the world’s best,” said Dr. Reddy. “Purple Certification could help bridge that gap.”

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Looking Ahead: Adoption and Implementation

Rollout Across States Expected

AMTZ is expected to work with state industrial departments, health ministries, and regulatory agencies to promote adoption. Awareness workshops, training programs, and technical support are likely to accompany the rollout.

Industry associations, including the Association of Indian Medical Device Manufacturers (AiMeD), have indicated interest in collaborating.

Potential Expansion to Hospitals and Laboratories

Officials hinted that the scheme may later extend to hospitals, diagnostic labs, and clinical research facilities. These sectors also depend heavily on sterile environments, safety systems, and advanced engineering controls.

“While the first phase focuses on medical manufacturing, the principles apply across the healthcare infrastructure spectrum,” Sharma said.

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A Step Toward a Stronger MedTech Ecosystem

Government Sees It as a Long-Term Investment

Gadkari concluded the launch by emphasizing that infrastructure excellence is essential for building a globally competitive healthcare manufacturing sector.

“As India aims to become a leader in medical technology, initiatives like Purple Certification send a strong message: we are committed to the highest standards,” he said.

Industry observers say the initiative signals India’s intention to position itself as a reliable and high-quality medical manufacturing hub, with infrastructure playing a central role.