Medical Technology Association of India (MTaI) has voiced strong concerns over what it describes as a misleading portrayal of recent developments surrounding the interim pricing notification for drug-eluting stents (DES) under the Ayushman Bharat – Mukhyamantri Amrutam (AB-PMJAY-MA) scheme in Gujarat.

The association warned that skewed narratives circulating in sections of the media are casting unwarranted doubts on clinicians, regulators, procurement authorities, and manufacturers—stakeholders integral to delivering affordable and high-quality healthcare.  At the centre of the controversy is the implementation of a differential pricing policy for domestically manufactured and globally approved imported stents.

Media reports have questioned the integrity of global regulatory approvals, characterizing them as loopholes for price manipulation. MTaI strongly refuted these claims, calling them “misleading and dangerous,” and emphasized that such narratives jeopardize the collaborative, evidence-based approach India has embraced to enhance patient access to cutting-edge medical technologies.  “The portrayal of global regulatory approvals as manipulation tactics undermines the integrity of India’s healthcare ecosystem,” said a statement from MTaI.

“It threatens to erode public trust in the clinicians and policymakers working diligently to ensure patient safety, access, and affordability.” 

The association reiterated its confidence in the Central Drugs Standard Control Organization (CDSCO), India’s national regulatory authority, which enforces quality and safety standards through the Medical Device Rules, 2017. These rules align with global best practices and recognize approvals from established international regulators such as the USFDA (United States), PMDA (Japan), TGA (Australia), Health Canada, and the European Union. These regulatory bodies are all part of the International Medical Device Regulators Forum (IMDRF), of which India is an affiliate member. 

“The convergence of India’s regulatory framework with global standards aims to create a system that is both effective and adaptive,” the statement noted. “Discrediting this framework is detrimental to public health progress.”  The controversial policy, aimed at improving access to advanced life-saving technologies through differentiated pricing, has been the subject of criticism after it failed to meet the expectations of certain quarters. MTaI cautioned against framing the policy rollback as a “victory over wrongdoing,” asserting that such interpretations misrepresent the policy’s intentions and malign the efforts of those working to democratize access to high-quality medical devices.  Citing Rajasthan as a constructive example, MTaI highlighted how the state has revised its policy by relying on real-world evidence and expert consultation.

The Rajasthan government adopted a clinical data-driven approach, utilizing randomized controlled trials (RCTs) and long-term outcome studies to support informed policy decisions and ensure the selection of devices with proven safety and efficacy.  The association emphasized that India’s regulatory and reimbursement frameworks must continue to be driven by science, transparency, and clinical evidence, rather than divisive rhetoric or speculative commentary.

  “We urge all stakeholders to work collaboratively toward a regulatory environment that prioritizes patient safety, supports innovation, and maintains the credibility of our healthcare system,” MTaI concluded. “As always, MTaI and its members remain committed to supporting this process constructively.”