Policy reversal on stent pricing in Gujarat: MTaI laments misleading narratives, AiMeD backs the move

New Delhi: The Gujarat government has withdrawn its earlier order on differential pricing system for stents used to treat patients under the Ayushman Bharat – Mukhyamantri Amrutam (AB-PMJAY-MA) scheme. The order issued on April 02, 2025 had an interim pricing notification for drug-eluting stents (DES) under which stents approved by the United States Food and Drug Administration was priced Rs 25,000 per stent, and those cleared by the Indian drug regulator at Rs 12,000 per stent.

The move was strongly opposed by the local manufacturers and the Association of Indian Medical Device Industry (AIMED) which in a letter to the state’s health minister Rushikesh Patel had termed it discriminatory, unfair and exclusionary. The association also brought the issue to the notice of union health minister, JP Nadda.

AiMeD in its earlier statement had pointed out that the Gujarat government’s notification discredited 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.”

Following the outcry, the state government reversed its decision, drawing expected applauses from the domestic manufacturers. AiMed termed it a welcome move that would encourage make in India.

However, the Medical Technology Association of India (MTaI) that represents global players has termed the media coverage of the issue as a skewed narrartive that warrants factual clarification. “The portrayal of global regulatory approvals as a loophole or a tactic for manipulation is misleading and dangerous. It undermines the collaborative approach that India has adopted to ensure patient access to cutting-edge and clinically validated technologies. It also risks eroding public trust in clinicians, regulators, procurer, and manufacturers who are striving to enhance healthcare quality and ensure patient safety and affordability,” read the statement.

Reaffirming its confidence in India’s regulatory framework, MTaI argues, “The Central Drugs Standard Control Organization (CDSCO) is a robust authority that has laid down comprehensive quality and safety standards under the Medical Device Rules, 2017. These rules are harmonized with global best practices and recognize the approvals from mature regulatory bodies such as the TGA (Australia), Canada (Health Canada), Japan (PMDA), European Union countries (Respective Health Authorities of those countries) and United States (USFDA), which constitute the foundation of the IMDRF (International Medical Device Regulator Forum) working group. With India now recognized as an affiliate member of the IMDRF, the focus is on achieving regulatory convergence for medical devices. This initiative aims to establish a regulatory model that is both efficient and effective, addressing new challenges while prioritizing public health and safety. Discrediting these regulatory frameworks is highly detrimental to India’s public health.”

Backing the Gujarat government’s earlier move, MTaI calls the differential pricing policy as a well-intended move aimed at improving patient access to advancedlife-saving technologies. “Unfortunately, when the policy’s implementation did not align with the expectations of certain quarters, they shifted the dialogue to misleading and speculative commentary.”

MTaI cites the example of states like Rajasthan that it says have demonstrated that policies can evolve constructively. “After receiving legal and expert input, the Rajasthan government adopted a model grounded in real-world evidence and registry data. This data-driven approach anchored in robust clinical studies such as Randomised Controlled Trials (RCTs) and long-term outcomes supporting informed decision-making and objective evaluation of medical devices.”