MTaI’s Statement On Stent Pricing In Gujarat: Misleading Narratives Targeting Clinicians, Regulators, Procurers, And Manufacturers.

Spread the love

Gujarat, 9th of April 2025 : The Medical Technology Association of India (MTaI) has been closely following recent events regarding the interim pricing notification for drug-eluting stents (DES) under the Ayushman Bharat – Mukhyamantri Amrutam (AB-PMJAY-MA) scheme in Gujarat. Recent media coverage on this issue, particularly regarding price differentiation between domestically and internationally approved stents, has unfortunately presented a skewed narrative 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.

At the outset, MTaI strongly reaffirms its confidence in India’s regulatory framework. 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.

The introduction of the differential pricing policy was 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. Claims framing the rollback as a “victory over wrongdoing” distort the purpose of the policy and risk undermining the very stakeholders striving to make quality healthcare more accessible. Such narratives do a disservice to patients and the ecosystem at large.

Encouragingly, states like Rajasthan 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. It enables governments to prioritise products with proven safety and efficacy, ultimately advancing public health and improving patient outcomes.

India’s regulatory and reimbursement landscape must continue to be driven by science, clinical evidence, and transparency. We encourage all stakeholders to avoid divisive rhetoric and work collaboratively towards frameworks that uphold patient safety, reward innovation, and maintain the integrity of our healthcare system. MTaI and its members are committed to contribute constructively to this process.