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The Medical Technology Association of India (MTaI) has said that the move by Gujarat government to introduce differential stent pricing has resulted in misleading commentaries by "certain quarters" and advised all stakeholders to avoid divisive rhetoric to uphold patient safety, reward innovation and maintain the integrity of the healthcare system.
The statement comes in response to the recent reports that the Gujrat Government has initiated efforts to introduce differential pricing for Drug-Eluting Stents (DES) under the Ayushman Bharat - Mukhyamantri Amrutam (AB-PMJAY-MA) scheme, where the stents approved by the US Food and Drug Administration (FDA) was to be priced at Rs 25,000 per unit, as against those approved by Central Drugs Standard Control Organisation (CDSCO) at less than Rs 12,000 per unit.
The Association of Indian Medical Device Industry (AiMeD), the umbrella organisation of Indian medical devices manufacturers has raised alarm over the differential pricing and wrote to Union Health Minister J P Nadda, alleging that the move is favouring multinational companies and this could result in huge loss for Indian manufacturers who contributes almost 69 per cent of the DES used under the scheme in Gujarat.
Following the protests, the State government withdrew the decision of having differential pricing. AiMeD has thanked the Government of Gujarat for repealing the differential pricing order, which may help Indian manufacturers including Gujarat-based Meril, SMT, AMS and SLTL, among others.
Commenting on the issue, MTaI said, "The introduction of the differential pricing policy was a well-intended move aimed at improving patient access to advanced life-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," stated the Association.
"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," it added.
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, procurers, and manufacturers who are striving to enhance healthcare quality and ensure patient safety and affordability, said MTaI.
It opined that the Indian drug regulatory framework, recognised as an affiliate member of International Medical Device Regulator Forum (IMDRF), which focus on achieving regulatory convergence for medical devices, and 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," it added.
MTaI also applauded the model adopted by the Rajasthan government, claiming that it is a model grounded in real-world evidence and registry data. This data-driven approach is 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, it averred.
Currently, all DES used in India for cardiac treatment are priced at Rs 35,000.
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