Lucknow’s King George’s Medical University (KGMU) has put a new financial gate around expensive imported implants for poor and Ayushman Bharat patients, requiring doctors to obtain written clearance before using them.The move also brings a larger question in publicly funded healthcare into focus — when a domestic implant is available, who decides whether the costlier imported alternative is medically necessary.The hospital has directed its Hospital Revolving Fund (HRF) not to issue foreign or high-cost implants for poor, underprivileged and Pradhan Mantri Jan Arogya Yojana (PM-JAY) beneficiaries without prior written approval from the senior hospital authorities.Under the order, Indian-made implants that meet the clinical requirement are to be used wherever suitable. If a treating faculty member or surgeon considers an imported implant necessary, approval from the chief medical superintendent, medical superintendent or deputy medical superintendent will be required. Using an imported or expensive implant without the prescribed approval will be treated as a financial irregularity.KGMU spokesperson Prof KK Singh said the measure was not intended to compromise treatment quality, but to prevent public money from being spent on expensive imported products when comparable Indian-made options were available.“High-quality implants are being made in India. They are at par with imported implants,” Singh said, adding that the move would support domestic manufacturing of medical devices.However, for patients who are paying for treatment themselves, the KGMU doctors would continue to explain the available options and their quality before a decision is made. Although the KGMU has not prohibited imported implants, it has shifted their use from being a routine clinical-procurement decision to one requiring documented justification when public-funded patients are involved.The PM-JAY largely works through bundled treatment packages, with implants and prosthetic devices incorporated into the reimbursement structure. The National Health Authority’s HBP 2.0 framework also allows implant-related variation in some procedures depending on the type and number of implants used. That means the choice of implant can have a direct bearing on how far a fixed public healthcare payment stretches.India already has a more explicit framework under the Central Government Health Scheme (CGHS). Its 2025 empanelment rules require Indian-manufactured implants of certified quality to be used, with imported implants permitted when the Indian products are unavailable. They also provide for informed consent when a beneficiary chooses a costlier implant beyond the applicable ceiling.However, there is no uniform and nationally consistent clinical-and-financial test for when an imported implant should be allowed despite a domestic alternative. The KGMU’s order effectively creates such a test locally.Besides, medical-device regulation is still uneven across categories. The National Pharmaceutical Pricing Authority currently has specific ceiling-price mechanisms for select medical devices, while its medical-device framework lists, among other things, coronary stents and orthopaedic knee implants for price regulation.The policy also raises a practical issue for patients about whether a person receiving free or government-funded treatment has the same clinically appropriate implant choices as a self-paying patient, or should public funding determine the available range.The KGMU’s position is that the restriction applies where a suitable Indian alternative exists and that imported devices can still be authorised when medically required. Therefore, the bigger question remains whether hospitals have a transparent system to establish equivalence, clinical necessity, price and patient choice before a more expensive device is rejected or approved.The move also reflects the growing role of Indian medical-device manufacturing. The Centre’s National Medical Devices Policy, 2023, explicitly seeks to improve access, affordability, quality and domestic manufacturing, while a parliamentary committee has noted that high-end medical devices remain substantially import-dependent.


