Policymakers have unveiled measures to reduce healthcare prices for patients but while the intent is commendable, will they be sustainable, given the reality of India’s healthcare system?
For example, the capping of trade margins on 137 anti-cancer medicines at 30 per cent and more recently the prohibition of reuse of single-use devices (SUDs) have patients’ interest at heart but could end up doing more harm in the long run.
No one questions that the October 16 directive from the Directorate General of Health Services (DGHS) prohibiting the reuse of single-use medical devices (SUDs) and disposable surgical items across public and private healthcare facilities is a long overdue step towards infection prevention and control measures. If implemented properly, it will combat Healthcare-Associated Infections (HAIs), and enhance patient safety across the country. The DO specifies that this directive had already been issued to CGHS empanelled hospitals a decade back, in December 2016.
The reuse of properly sterilised equipment brings down the procedure costs but this is rarely disclosed to patients or passed on in the final billing. As the DGHS DO points out, the DGHS has observed that patients, or the government in the case of reimbursement schemes, are charged the full cost even when resused/resterlised items are used during procedures.
Industry associations of medtech companies welcome the decision but there are concerns on its enforceability and liabilities. As Medical Technology Association of India’s (MTaI) position statement on the prohibition on reuse of SUDs cautions, the directive’s effectiveness will now depend on consistent enforcement by state authorities, regulators and healthcare institutions. Equally important is raising patient awareness, empowering them to understand and assert their rights to safe and ethical care.
While the Association of Indian Medical Device Industry (AiMeD) welcomes the directive, Rajiv Nath, Forum Coordinator, AiMeD points out, “Where a product is used contrary to its labelled instructions, such as being reused, any failure or harm cannot be attributed to the manufacturer. Responsibility must rest with the person or establishment that reused it. We ask that this be clearly reflected in enforcement and in any liability framework.”
AiMeD’s recommendations include strict, regular inspections of healthcare establishments, with traceable records of device use and disposal; clear action under the Medical Devices Rules, 2017 and the Clinical Establishments Act, 2010 against reuse; awareness and training of hospital staff on infection prevention and biomedical waste handling; a clear statement that manufacturers are not liable for failures arising from reuse contrary to labelling; and support for safer and more affordable single-use alternatives, so that cost is no reason to reuse.
Besides monitoring and enforcing the SUD directive, healthcare experts point out that policymakers will need to take into account the environmental cost of SUDs, as the volume of biowaste will increase exponentially. The increased demand for new devices is also sure to strain the resources supply chain over time.
As a practising surgical oncologist working on the ground, Dr. Sandeep Nayak, Chairman of Oncology, MACS-Renova Oncology Institute, KIMS Hospital, Bengaluru, sees a fundamental tension between these two mandates. In his view, on one hand, policymakers want to drastically lower healthcare costs for families; on the other, they are outlawing controlled practices that currently keep high-end, advanced surgical care within financial reach.
As an example, he points out that high-end surgical instruments – such as an advanced vessel sealer, ultrasonic shears, or specialised robotic accessories— are crafted from durable surgical alloys and engineered polymers that withstand validated reprocessing without structural or functional degradation. When proper, standardised sterilisation procedures are executed, these complex instruments can be reused safely multiple times.
Similarly Dr Nayak explains that capping trade margins on non-scheduled immunotherapies and targeted drugs reduces overall hospital bills by 5 per cent to 25 per cent, but strictly enforcing a single-use policy on ₹80,000 energy devices or robotic tools could mean that equipment costs alone could exceed the entire surgical fee.
Dr Nayak cautions that the ban on SUDs might push doctors and hospitals toward cheaper, inherently lower-quality equipment labelled as “reusable” or low-cost single-use alternatives, to keep surgical bills viable for patients.
He recommends that instead of an absolute prohibition, a pragmatic compromise exists—one already demonstrated by leading medical technology innovations: multi-use validation directly from manufacturers. If medical device manufacturers are incentivised or required to validate and label advanced instruments for a certified number of uses rather than applying a blanket “single-use” label to protect commercial turnover, hospitals could maintain strict safety guarantees while offering affordable access.
Dr Nayak cites the example of how certain robotic surgical platforms operate: instruments come built with integrated tracking chips and are validated by the manufacturer for a specific, safe number of uses (e.g., 10 or 20 procedures) before auto-disabling.
Importantly, he points to where the true risk lies: substandard sterilisation protocols. Instead of absolute prohibition, he recommends that India needs a practical regulatory approach spanning category-based regulation, manufacturer-defined multi-use limits and mandatory sterilisation audits.
The October 16 DGHS directive is thus a start but the direction needs to come from a collaborative approach, with inputs from medical device manufacturers and the clinical and hospital management fraternity. Together all stakeholders need to find a balance between India’s socio-economic and clinical realities, aiming for patient safety, affordability, access, and environmental sustainability.
VIVEKA ROYCHOWDHURY, Editor
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