A recently released white paper, MedTech Sector in India: Challenges & Opportunities, published by the Association of Indian Medical Device Industry (AiMeD) and Consocia Advisory, highlights the urgent need for policy reforms and strategic interventions to strengthen domestic medical device manufacturing and reduce India’s reliance on imports.
The paper places the medical technology sector at a pivotal juncture and has the potential to become a global manufacturing powerhouse while ensuring healthcare security for its citizens.
Despite initiatives like Make in India and Start-up India, the country continues to import nearly 70% of its medical device needs, with ventilators alone accounting for ₹950 crore in annual foreign exchange outflow. This needless dependence creates economic vulnerabilities and risks for healthcare resilience, particularly during global crises like the COVID-19 pandemic.
Key findings of the paper are as follows:
· Economic Impact: India’s MedTech imports reached $8.2 billion in FY24, while exports stood at $3.8 billion. With the right policy support, exports could escalate to $15-20 billion by 2030, as projected by the Confederation of Indian Industry (CII).
· Domestic Manufacturing Capacity: India has the capability to produce over 39,600 Invasive ICU ventilators annually—far exceeding the country’s demand of 9,000-12,000 invasive units per year and they meet national standards, however, we still continue to depend on imported ventilators due to bias towards imported products.
· Regulatory Barriers: Weak enforcement of Public Procurement (Preference to Make in India) Order, 2017 viz. DPIIT’s report dated 5th Nov 2024 states identified 1,502 tenders (worth ₹63,911 crore) as non-compliant with local preference rules, out of 3,590 tenders reviewed (total worth ₹1.74 lakh crore), and the inclusion of medical devices which have domestic capacity such as ICU ventilators in the Global Tender Enquiry (GTE) exemption list continue to favour foreign suppliers over Indian manufacturers.
· Certification and Standards Recognition: While Indian regulators (CDSCO, BIS) have defined standards for ventilators, Indian manufacturers often struggle to obtain international certifications like CE (Europe) or FDA (USA) approvals due to the high cost associated with them, which many hospitals perceive as a quality benchmark though these are regulatory approvals and not quality certification. There is a lack of government-supported mechanisms to validate and showcase the quality of domestic ventilators based on indigenous Voluntary Quality Certification like ICMED Plus (Indian Certification for Medical Devices) from the Quality Council of India.
Urgent policy reforms are needed to help the sector achieve its potential. These include:
1. Source internally: Remove domestically manufactured medical devices such as ICU Ventilators from the GTE Exemption List and prioritise local procurement for critical care equipment.
2. Align Standards with Global Frameworks: Facilitate Mutual Recognition Agreements (MRAs) for Indian certifications or to ease international market access.
3. Making Indian Standards Mandatory: For medical devices for which Indian standards are available, those should be made mandatory
4. Increase R&D and Certification Support: Provide tax incentives, grants, and subsidized certification schemes to help Indian MedTech firms meet global standards.
5. Import Advantage and Cost Structure: Many medical devices have lower import duty compared to duty on their components, thus favouring import of finished products over local manufacture.
6. Promote Infrastructure Development: Establish common testing and manufacturing facilities in MedTech parks to support innovation.
Mr Rajiv Nath, Forum Coordinator, AiMeD, said, “Becoming Aatma Nirbhar and reducing import dependence is a strategic necessity… A well-structured policy push will enable India to emerge as a leading global MedTech hub, benefiting both the economy and public health”.
If India reduces its import reliance from 70% to 35% by 2030, as projected in the National Medical Device Policy 2023, this shift could generate over 1.5 million jobs, and position the country as a significant exporter of medical devices.
