Highlights
- Medical Devices Industry push back against bill to regulate their products.
- Corporate Hospital Cry Foul over price cap on room charges: “eat the cake & have it too” attitude.
- Parliamentary Committee for 6 monthly kidney tests > 20 years: UHO expresses concerns as the strategy lacks evidence and would be resource intensive.
- Critical appraisal against the evidence
- The opportunity cost for India is substantial
- Screening without treatment capacity could create harm
By Dr. Amitav Banerjee, Chairperson of the Universal Health Organisation (UHO)
Medical Devices Industry push back against bill to regulate their products.
Medical devices are tools and technologies used in healthcare to diagnose, monitor, prevent, or treat medical conditions and improve patient care. Unlike medicines, they generally work through physical, mechanical, or technological means rather than by chemical action in the body.
Examples of medical devices include:
- Simple devices: Bandages, thermometers, tongue depressors, syringes, and surgical gloves.
- Diagnostic devices: Blood glucose meters, pregnancy test kits, ECG machines, ultrasound scanners, and MRI scanners.
- Treatment devices: Infusion pumps, ventilators, dialysis machines, and laser therapy equipment.
- Implantable devices: Artificial joints, heart valves, pacemakers, stents, and dental implants.
- Assistive devices: Hearing aids, wheelchairs, prosthetic limbs, and mobility aids.
- Medical software: Software that analyzes medical images, monitors patients, or helps healthcare providers make clinical decisions (when regulated as a medical device).
Medical devices are often grouped by the level of risk they pose to patients:
- Low risk: Bandages, examination gloves.
- Moderate risk: Contact lenses (debatable can become high risk if adversely affects eyesight), infusion pumps.
- High risk: Pacemakers, artificial heart valves, implantable defibrillators.
The exact classification system varies by country, but higher-risk devices generally require more extensive testing and regulatory review before they can be marketed.
According to a report in the ET Healthworld, the Medical Devices companies are opposing the Draft Drugs, Medical Devices and Cosmetic Bill, 2026, arguing that treating medical devices like pharmaceuticals and imposing criminal penalties for regulatory lapses could hurt manufacturing, investment and innovation. Several other groups including traders, manufacturers, healthcare providers and patient groups have joined written to the Union Health Minister to reconsider the draft bill as it will be a barrier to India becoming a major hub of the medical device industry.
UHO is of the opinion that the dispute raises an important and legitimate concern about India’s proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The medical-device sector is right to point out that devices are fundamentally different from pharmaceuticals: they are engineering products with different technologies, risk profiles, manufacturing processes and life cycles. A regulatory framework designed primarily around drugs may therefore create unnecessary compliance burdens and discourage innovation and domestic manufacturing. (ETHealthworld.com)
However, the industry’s argument should not be interpreted as a call for lighter regulation. Medical devices can directly affect patient safety, particularly implants, diagnostic equipment, life-support systems and software-driven devices. The better approach would be risk-based and proportionate regulation, with strict penalties for fraud, unsafe products and negligence, while treating minor documentation or technical non-conformities through corrective actions and administrative penalties. The concerns about applying one-size-fits-all criminal provisions are particularly worth examining. (ETHealthworld.com)
Overall, the government should reconsider the pharma-centric elements of the draft while preserving strong patient-safety safeguards. A dedicated medical-device regulatory framework, supported by specialist technical expertise, robust post-market surveillance and clear accountability, could better balance patient safety, innovation and India’s ambition to become a global medical-device manufacturing hub. (fortuneindia.com)
Corporate Hospital Cry Foul over price cap on room charges: “eat the cake & have it too” attitude.
Apollo Hospitals MD, Ms Suneeta Reddy cautioned that the government’s recommendation of price caps on room rents in private hospital will adversely affect innovation and expansion of India’s healthcare infrastructure.
The recommendation is part of the Parliamentary Standing Committee on Health and Family Welfare Report on the affordability and accessibility of healthcare facilities in the public and private sector. The panel has suggested that basic room charges at private hospitals in large metropolitan cities should not exceed the average room tariff prevailing at 3-star hotels in the peripheral areas or vicinity of the hospital. Apollo Hospital MD, Ms Reddy expressed strong reservations to this stating that one size fits all approach of the government would not be the right way forward.
She added that healthcare is at the core of a developing economy and is a vital contribution to infrastructure, employment, foreign exchange earnings, and creation of a productive of a healthy and productive work force.
UHO rues the “eat the cake and have it too” attitude of the corporate hospital. Apollo hospital acquired land at subsidized rates with an understanding that it will reserve 40% of its treatment capacity for poor patients who will not be charged. The hospital defaulted on this and the Supreme Court had to order an investigation on this issue.
The court noted that the hospital is located on land that was leased to the Indraprastha Medical Corporation by the government at a token rent of Re 1 per month in March 1994.
As per the lease deed, Indraprastha Apollo Hospital was obligated to provide free treatment to poor patients “to the extent of [a third] of its bed strength and 40% of its outdoor patients”, the top court noted.
“Unfortunately, the hospital management refused to adhere to the said obligation,” the Supreme Court noted on Tuesday (March 25), adding that this had led to the Delhi high court issuing directions to ensure the provision of treatment to poor patients.
“Despite lapse of more than 15 years there has been hardly any implementation of the conditions of the agreement providing for free treatment to indoor and outdoor patients,” the Delhi high court had said in 2009.
The Apollo Hospitals Group and the Delhi Government hold a 25% and 26% shares each of the Indrapastha Medical Corporation. On this the Supreme Court noted that if the Delhi government is earning profit from the hospital instead of providing for care of poor patients, it is most unfortunate.
Parliamentary Committee for 6 monthly kidney tests > 20 years: UHO expresses concerns as the strategy lacks evidence and would be resource intensive.
The Parliamentary Standing Committee on Health and Family Welfare has recommended 6 monthly kidney function test for people over 20 years of age which will be free of cost to all below the poverty line and at a subsidized cost for others.
UHO expresses concerns that this strategy is not evidence based, is too broad based and will entail wasteful use of resources. A more evidence based and targeted approach should yield better health returns as described in the following paragraphs.
The Parliamentary Standing Committee’s recommendation is directionally sensible but excessively broad in its current form. The article reports a proposal for mandatory kidney-function testing every six months for everyone aged 20+, while recommending annual screening for high-risk groups and appropriate follow-up. (ETHealthworld.com)
Critical appraisal against the evidence
The case for earlier CKD detection is strong.
CKD is often clinically silent, and early identification matters because effective interventions now exist to slow progression and reduce cardiovascular and kidney-failure risk. The 2024 Kidney Disease Improving Global Outcome (KDIGO) guideline provides a structured approach using eGFR and albuminuria, rather than relying simply on a generic “kidney function test.”
So, the committee is right to move policy away from waiting until patients present with advanced kidney failure. Its criticism that existing screening is too dependent on people turning up at health facilities is also reasonable. (ETHealthworld.com)
But “everyone aged 20+ every six months” goes considerably beyond the evidence.
Now for the weakest part of the recommendation. There is not convincing evidence that an asymptomatic, low-risk 20-year-old benefits from biochemical kidney testing twice every year. Even the emerging evidence supporting population-wide CKD screening does not establish a six-month interval beginning at age 20.
A 2024 cost-effectiveness analysis found population screening potentially cost-effective, but its preferred strategy was screening from age 55 and every five years, in combination with effective CKD treatment. (JAMA Network)
This study is based on US data and therefore cannot simply be transplanted to India. Nevertheless, it illustrates an important principle: the existence of a benefit from screening does not automatically justify very frequent universal screening.
The recommendation conflates “screening” with “monitoring.”
A person with established CKD, diabetes, hypertension, significant albuminuria or declining eGFR may appropriately require repeated monitoring. But a healthy person without risk factors is a different clinical population.
KDIGO’s approach is essentially risk- and disease-based, with testing and monitoring intensity determined by kidney function, albuminuria and overall risk rather than applying one interval to everybody.
The committee’s own recommendation for annual screening of high-risk people therefore arguably has a stronger evidentiary foundation than the universal six-month requirement.
The choice of test also needs clarification.
“KFT” is too vague as a population-health policy. A meaningful CKD screening strategy should specify at least serum creatinine/eGFR and urine albumin assessment, particularly because albuminuria can suggest kidney damage even when eGFR is relatively preserved. The committee explicitly recommends eGFR and urine albumin/protein assessment for high-risk people, which is much more consistent with contemporary CKD practice. (ETHealthworld.com)
There is also an important diagnostic issue: one abnormal result does not necessarily establish CKD. CKD requires persistence of abnormalities over time. Over-testing therefore creates a downstream obligation for repeat testing, clinical assessment and appropriate referral.
The opportunity cost for India is substantial
This is particularly important in the Indian context. Universal six-month testing of everyone
over 20 would involve an enormous number of tests every year. The cost is not simply the laboratory test: it includes sample collection, quality assurance, reporting, repeat testing of borderline results, physician review, confirmatory testing, medicines and nephrology referral.
We recommend that instead of mass population screening, the strategy should be:
- systematic screening of people with diabetes and hypertension;
- older adults and other high-risk populations;
- blood-pressure detection and control;
- urine albumin testing;
- reliable eGFR reporting;
- access to ACE inhibitors/ARBs and SGLT2 inhibitors where indicated;
- reducing inappropriate NSAID and nephrotoxic-drug exposure;
- ensuring that abnormal screening results actually receive follow-up.
The committee is therefore right about the direction of travel, but questionable about the allocation strategy.
Screening without treatment capacity could create harm
A screening programme should not be judged merely by how many cases it detects. It should be judged by whether detection leads to better outcomes.
This is particularly relevant because CKD screening can generate false positives, transient Indiscriminate mass screening will generate a large number of false positives which can lead to anxiety, unnecessary repeat investigations and avoidable referrals.
The old US Preventive Services Task Force position is that evidence is insufficient to determine whether routine screening of asymptomatic adults produced more benefit than harm. It demonstrates why universal screening requires evidence about the whole pathway, not simply test performance. (USPSTF)
A better policy recommendation
Rather than rejecting the parliamentary committee’s proposal outright, UHO would redesign
it as a risk-stratified national CKD screening programme:
Universal access to CKD risk assessment should begin in early adulthood, but biochemical testing should be targeted according to age and risk, with at least annual testing for high-risk groups and progressively more intensive monitoring for people with established CKD or abnormal results.
For India, a pragmatic programme could initially prioritise diabetes, hypertension, obesity, cardiovascular disease, older age, family history of kidney disease and other recognised risk groups, while using primary-care encounters to identify lower-risk adults who need testing.
Most importantly, the government should first establish the complete chain:
identify → test → confirm → stage → treat → monitor → refer.
Without this chain, mandatory testing risks becoming a large diagnostic exercise only benefiting diagnostic laboratories, rather than an effective kidney-disease prevention programme.
“Every adult ≥20 years, every six months” is more propaganda than based on available evidence. A risk-stratified programme with strong follow-up and treatment capacity would probably deliver better value, greater equity and more measurable health benefit.
A high number of false positive will be thrown up in this young asymptomatic group leading to anxiety and a rush for treatment often from unqualified practitioners or quacks given the poor access to health services from overcrowded public hospitals in the country.
The Parliamentary Standing Committee on Health and Family Welfare has apparently not done homework on this issue.
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Universal Health Organisation (UHO) Weekly Newsletter – 07 AUGUST 2026