The Association of Indian Medical Device Industry (AiMeD) has raised strong objections to a recent notification issued on March 10, 2025, by the Commissionerate of Health, Medical Services & Medical Education, Government of Gujarat. The notification sets an unjust reimbursement structure, allocating ₹25,000 for USFDA-approved Drug-Eluting Stents (DES) while limiting the reimbursement for Indian-manufactured DES to ₹12,000.

In response, AiMeD Forum Coordinator Mr. Rajiv Nath has formally addressed Shri J.P. Nadda, Hon’ble Union Minister of Health and Family Welfare, Government of India, calling for an urgent intervention to reverse this discriminatory pricing policy.

Unfair Policy Undermining Indian Medical Device Industry

The Indian stent industry has witnessed remarkable growth in recent years, with domestic manufacturers commanding over 73% of the market share and exporting more than 500,000 stents annually to over 100 countries, including developed markets such as Germany, the UK, Spain, Poland, Switzerland, Italy, and the Netherlands. These countries do not impose artificial price differentiation based on USFDA approval, making the Gujarat policy an anomaly that unfairly penalizes Make in India efforts.

The notification effectively discredits Indian regulatory approvals while favoring American multinational corporations (MNCs) that have been losing market share in India due to the superior cost-effectiveness and quality of Indian stents. Such a pricing model, driven by an unjustified preference for USFDA approval, directly contradicts the Government of India’s Atmanirbhar Bharat (Self-Reliant India) vision and threatens to undermine the self-sufficiency of the Indian MedTech sector.

Threat to Make in India and Healthcare Affordability

AiMeD strongly condemns this pricing structure, arguing that it:

• Undermines Indian Medical Regulations: India has an independent, robust regulatory framework under the Central Drugs Standard Control Organization (CDSCO). The Gujarat government’s policy devalues Indian regulatory approvals, sending a wrong message that India’s standards are inferior.
• Favours US MNCs Unfairly: By incentivizing hospitals to purchase costlier USFDA-approved stents over Indian-manufactured alternatives, the policy artificially skews the market in favor of American manufacturers.
• Increases Healthcare Costs: Indian manufacturers have played a crucial role in reducing the cost of life-saving cardiac interventions. With such a pricing model, hospitals and patients may be forced to buy costlier imported stents, ultimately increasing the cost burden on the healthcare system.
• Contradicts Global Practices: Countries like Germany, the UK, and Switzerland do not discriminate between domestic and foreign regulatory approvals when it comes to reimbursement. There is no logical basis for India to implement such an arbitrary distinction.

AiMeD’s Immediate Call to Action

To expose the unethical and anti-competitive nature of this pricing mechanism, AiMeD has submitted:

1) Bills, credit notes, and other supporting documents showcasing the discriminatory pricing practice.
2) A formal letter urging the Union Health Ministry to intervene and roll back this decision.
3) A request for an urgent meeting with Hon’ble Minister Shri J.P. Nadda to discuss the ramifications of the policy on India’s medical device industry.

AiMeD’s Appeal to the Government of India

AiMeD urges the Government of India, the Ministry of Health & Family Welfare, and policymakers at both the state and central levels to:

1. Immediately withdraw the Gujarat notification that discriminates against Indian stents.
2. Reinforce the credibility of CDSCO and other Indian regulatory bodies by ensuring they are treated on par with global standards.
3. Prevent anti-competitive practices that favor foreign companies over Indian manufacturers.
4. Ensure policies align with the Make in India and Atmanirbhar Bharat initiatives to strengthen domestic manufacturing.

The discriminatory pricing policy in Gujarat threatens India’s self-reliance in MedTech and unfairly favors US MNCs over domestic manufacturers. AiMeD urges an immediate rollback to ensure fair competition, uphold India’s regulatory integrity, and protect affordable healthcare. The Government must act decisively to safeguard the Make in India initiative and prevent undue foreign dominance in the Indian stent market.