New Delhi: After the Union Ministry of Health notified the draft amendment to the Medical Devices Rules, 2017 on 10 April, India’s medical device industry has pushed back against two proposed regulatory changes.
The draft has proposed, for the first time, a fixed fee structure for testing medical devices at government laboratories, along with a new requirement that manufacturers print the licence number of their sterilisation facility on product labels.
Industry players have, however, warned that fixed government testing fees could make quality checks financially unviable, and that a new sterilisation labelling rule could delay export shipments by three to four weeks.
The draft states that the government will invite public comments over 30 days, after which the feedback will be considered before the rules are finalised.
According to experts ThePrint spoke to, the supposed rationale behind the proposed amendments is to bring greater uniformity to the medical devices sector by reducing inconsistent market-driven pricing and strengthening quality control mechanisms.
The objections have been raised by the Association of Indian Medical Device Industry (AiMeD), an umbrella body representing over 1,200 manufacturers across segments, such as consumables, disposables, equipment, diagnostics and implants. The body says the proposal appears to have been drafted without adequate consultation with industry stakeholders, and could create serious operational challenges.
“Unilateral implementation without consulting NABL-accredited labs risks creating unsustainable models for quality testing,” AiMeD Forum Coordinator Rajiv Nath said.
ThePrint has reached out to the health ministry spokesperson for clarification on the rationale behind the proposal, as well as a comment on industry concerns about limited stakeholder consultation. This report will be updated when a response is received.
What the draft proposes
The draft amends the Medical Devices Rules, 2017, the primary law that governs how medical devices are made, tested, labelled and sold in India. It is administered by the Central Drugs Standard Control Organisation (CDSCO), the country’s medical device regulator under the health ministry.
The first change introduces standardised fees for testing medical devices at government laboratories. An implantation test, where a device or material is tested for safety when inserted into the body, will cost Rs 5,000. A sterility test, which checks whether a product is free of all living microorganisms, will cost Rs 2,000.
Testing surgical sutures will cost Rs 3,000, surgical dressings and syringes Rs 1,000 each, and condoms or intrauterine devices Rs 2,500.
Simpler tests, such as absorbency or specific gravity tests, will be charged between Rs 150 and Rs 250. All fees will rise automatically by 5 percent every year.
The other change concerns sterilisation.
Before a medical device reaches a hospital or clinic, it must be sterilised, meaning all bacteria, viruses, and fungal spores on or inside the product are eliminated.
This is not ordinary cleaning or disinfection. For devices that enter the body or touch internal tissue, even trace contamination can cause serious infection, so full sterilisation is mandatory.
It is typically done using steam under high pressure, ethylene oxide gas, or gamma radiation, depending on what the device is made of.
Many manufacturers outsource this step to specialised third-party facilities. Under Rule 44 of the draft, when a manufacturer does this, the outsourced facility’s manufacturing licence number must now appear on the product label, using abbreviations such as “Ster. Mfg. Lic. No.” or “S.M.L”.
The intent behind this change is traceability. If a contamination problem surfaces, regulators can trace exactly where the device was sterilised.
Why the industry is objecting
According to Nath, regulatory controls should be proportionate to risk, with stricter oversight for high-risk devices rather than rules applied uniformly across all categories. “With 6,000 plus devices in scope, controls must be risk-proportionate, rigorous for high and moderate high-risk.”
He said that the proposed testing fees for medical devices appear to have been set without adequate consultation with NABL-accredited laboratories.
These private labs, certified by the National Accreditation Board for Testing and Calibration Laboratories (NABL) to Bureau of Indian Standards (BIS)—and some to International Organisation for Standardisation (ISO) standards—currently handle a significant portion of device testing, complementing government labs that cannot manage the full volume alone.
Government laboratories, being state-funded, do not rely on fees to recover full operational costs. In contrast, NABL-accredited private labs operate on commercial models, incurring higher expenses for staff, equipment calibration, accreditation renewals and quality audits.
Industry members say that if fees are fixed at levels too low to reflect these realities, manufacturers may preferentially route testing to government labs for cost savings.
This could undermine the viability of private labs, reducing overall testing capacity and weakening the ecosystem, and may end up straining government infrastructure in the long term.
“We urge consultation with industry stakeholders, including NABL labs, to ensure fees support a sustainable ecosystem for medical devices,” Nath said.
The sterilisation labelling requirement has drawn the sharpest criticism.
When a third-party sterilisation facility that uses gamma radiation—a process that kills all bacteria and pathogens to make a device safe for use—goes into downtime for maintenance or a technical failure, manufacturers must quickly shift to an alternative one.
Under the proposed rule, every product label would have to be reprinted to show the new facility’s licence number, a process Nath said could hold up export shipments by three to four weeks.
“Mandating license numbers on product labels creates a significant barrier, delaying exports by three to four weeks during downtime at the gamma radiation subcontractor,” he said.
He added that the forum recommends limiting labelling to shipping cartons/batch records for traceability and supply chain flexibility.
Nath also raised clarity concerns regarding whether the rule would apply equally to overseas manufacturers and imports or only to Indian companies. He added that currently, no global regulator imposes such restrictions.
The draft notification, he said, is not available on the CDSCO website, limiting wider industry participation.
(Edited by Sugita Katyal)
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