India’s medical device makers continue to point out how amendments aimed to promote Ease of Doing Business actually end up doing just the opposite.
In a letter dated August 11, 11 national associations urged the government to reconsider the Draft Drugs, Medical Devices & Cosmetics Bill, 2026. The associations seek a standalone Medical Devices Act and a risk-based, engineering-focused regulatory framework, citing concerns around criminalisation of technical lapses, compliance burden, and the absence of an independent medical devices regulator. They also urged the MoH&FW to undertake a structured stakeholder consultation before finalising the Bill.
Against this backdrop, the amendments to the Medical Devices Rules 2017, announced on August 24, brought both relief and grief. August 24’s Gazette notification to the Medical Devices Rules, 2017 (G.S.R. 743(E) Amendment to Medical Device Rules, 2017) announced the inclusion of the European Union in the list of recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements. Both Association of Indian Medical Device Industry (AiMeD) and Medical Technology Association of India (MTaI) have appreciated this move.
Another amendment has proved to be a double edged sword. On the positive side, manufacturers outsourcing product sterilisation to another facility holding a valid licence will no longer be required to obtain a separate loan licence for the outsourced sterilisation activity. This obviously reduces duplication, administrative burden, compliance costs and associated timelines, particularly for manufacturers that do not have in-house sterilisation facilities.
But it has been replaced with a mandate to mention sterilisation subcontractor details on every medical device package. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) warns that this move, “instead of resolving industry concerns, has pushed manufacturers from the frying pan into the fire.”
Pavan Choudary, Chairman, MTaI points out that removing separate licensing for outsourced sterilisation and setting uniform testing fees reflect a practical approach to reducing operational delays.
However, the MTaI statement cautions that the real impact of these changes will depend on how they are implemented on the ground. Clear guidelines are still needed on eligibility for EU-approved devices, the rationale behind specific fee structures, and the respective responsibilities of device makers and sterilisation units. Streamlining procedures must go hand in hand with strong quality checks and transparent, accountable post-market surveillance.
The AiMeD statement explains that the requirement for compulsory labelling of subcontractor details on each product is especially troubling for export shipments. It will reduce customer service flexibility, as manufacturers will be forced to wait for sterilisation by the subcontractor whose license number is printed on the packaging, rather than choosing the facility with the fastest turnaround time. Depending on cobalt strength and backlog, shipments could be delayed by 2–3 weeks, instead of being dispatched within a week.
MTaI recommends CDSCO consider a transition period, clarity on re-labelling versus batch-record disclosure, and alignment with global traceability norms, so that patient safety objectives are met without disrupting device availability or export competitiveness. Nath’s comments as part of the inauguration of the recent India Health event reflect the deep concerns of the domestic medtech sector. He touched on the need to position India as not just a low-cost assembler but a genuine global hub for medical devices, moving from pseudo-manufacturing to true value-added manufacturing — where innovation, engineering, and quality define ‘Made in India’, not just mere repackaging, relabeling, or sterilisation.
But as he points out, genuine manufacturing means component transformation, assembly, and engineering innovation that creates measurable value addition. Pseudo-manufacturing, where imports are lightly processed and passed off as “Made in India” need to be discouraged, and Nath recommended that minimum value- addition norms (e.g., 35–40 per cent) need to be in place to ensure credibility and prevent circumvention.
He also highlighted that competitiveness requires adherence to ISO, CE, and USFDA benchmarks and advocated that Indian medtech manufacturers must invest in quality systems, testing infrastructure, and certification to win global trust. He mentioned that the Indian Certification of Medical Devices (ICMED) Scheme was created to help build competencies and certify these to global ISO standards as the Bureau of Indian Standards (BIS) is not enough.
He once again made the case for a dedicated Medical Devices Act with proportionate, engineering-aligned regulation. He reasoned that India’s pharma sector is already constrained by CDSCO’s limited scientific review capacity. He also pointed out that while the government’s Biopharma Shakti programme is creating a scientific review cadre for drugs, a parallel cadre for medical devices — with biomedical engineers, clinicians, and regulatory specialists — is essential to evaluate innovation credibly.
Nath also advocated for ease of doing business reforms, aimed at simplifying approvals, reducing inspector-raj style controls, and enabling faster market entry for safe devices. This will encourage startups, attract FDI, and align India with the International Medical Device Regulators Forum (IMDRF) and global best practices and make manufacturing more attractive than trading.
However what industry deems ease of doing business adjustments to the regulatory framework will need checks and balances. And that is the regulator’s responsibility to citizens and patients.
In some cases, like the mandate to mention sterilisation subcontractor details on every medical device package, might add to the regulatory burden. But in the regulator’s view, this is a way to ensure quality and patient safety, allowing improperly sterilised products to be traced back to the erring facility.
Nath poses critical questions that remain unanswered: Will overseas manufacturers and their subcontractors also be required to obtain Indian licenses and print details on packaging? Will there be a transition period for revising packaging inventory for both Indian and overseas manufacturers? These questions hint at the competitive business environment of India’s medtech sector.
AiMeD advocates a balanced approach, “one that ensures patient safety without undermining competitiveness, exports, and the Make in India vision.” MTaI’s statement too echoes this sentiment, of working “alongside regulatory authorities to ensure these reforms build a balanced, credible system – one that advances healthcare growth, safeguards patient safety, and strengthens India’s standing as a global medtech hub.”
Balancing between these imperatives needs both sides – all sections of the medtech industry and government – to work towards a middle path.
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com