1 week ago
India Requires Sterilisation Licence Numbers On Device Labels
India has introduced a new labelling rule for some medical devices.
Some manufacturers send their devices to another company for sterilisation.
Sterilisation removes or reduces germs so the devices are safer to use.
The label must now show the licence number of the facility that sterilised the device.
The government says this will make it easier to trace the device and identify who performed the sterilisation.
Medical device manufacturers say the rule may make their work more difficult.
They are especially concerned that export shipments could be delayed by two to three weeks.
The industry says manufacturers already keep records that show which facility handled each batch.
India’s Ministry of Health and Family Welfare amended Rule 44 of the Medical Devices Rules, 2017.
Manufacturers outsourcing sterilisation must print the licensed facility’s licence number on device labels.
The government says the measure will strengthen traceability and accountability for sterilisation.
The Association of Indian Medical Device Industry says the rule creates an added compliance burden.
The industry group warns export shipments could be delayed by two to three weeks because switching facilities may become harder.
- Who
- The Ministry of Health and Family Welfare, medical device manufacturers, licensed sterilisation facilities, and the Association of Indian Medical Device Industry.
- What
- A gazette notification amended Rule 44 to require the licence number of an outsourced sterilisation facility on medical device labels.
- Where
- India, under the Medical Devices Rules, 2017.
- When
- The amendment was issued nearly a year after the Central Drugs Standard Control Organisation issued guidance on outsourced sterilisation licensing.
- Why
- The government aims to improve traceability and accountability, while manufacturers say the rule could increase compliance work and delay exports.
Government rationale
Industry concerns
Traceability and accountability
Government rationale
The Ministry of Health and Family Welfare says displaying the sterilisation facility’s licence number will improve traceability and identify the facility responsible for the process.
Industry concerns
The Association of Indian Medical Device Industry says manufacturers already maintain documentation and batch-level accountability under global regulatory practices.
Operational flexibility
Government rationale
The amended rule requires the licensed sterilisation site’s number to appear on the device label when sterilisation is outsourced.
Industry concerns
AiMeD says manufacturers may have less flexibility to shift work between approved facilities based on turnaround time, cobalt strength, backlogs, and available capacity.
International competitiveness
Government rationale
The government’s stated focus is stronger oversight of outsourced medical-device sterilisation.
Industry concerns
AiMeD claims other jurisdictions do not require subcontractor details on packaging and says the rule could put Indian manufacturers at a competitive disadvantage.
Key facts
- Regulation
- Rule 44 of the Medical Devices Rules, 2017 was amended through a gazette notification.
- New requirement
- Labels must include the licence number of the licensed facility performing outsourced sterilisation.
- Government objective
- Strengthen traceability and identify the facility responsible for sterilisation.
- Industry representative
- Rajiv Nath is the forum coordinator of the Association of Indian Medical Device Industry.
- Potential delay
- The industry says export shipments could be delayed by two to three weeks instead of being dispatched within a week.
- Industry concern
- Manufacturers say the requirement may limit their ability to switch between approved sterilisation facilities based on capacity and turnaround time.
- Earlier guidance
- The Central Drugs Standard Control Organisation said a loan licence may not be required when sterilisation is outsourced to a suitably licensed facility.
Quotes
Ministry of Health and Family Welfare
Government ministry that issued the gazette notification amending the medical-device labelling rules.
“In the case of a medical device manufacturer who outsourced the sterilisation activity at the site of another facility having a valid licence to carry out the sterilisation process of medical devices, the licence number of the sterilisation site should be mentioned on the label of the device.”
m.rediff.com
“Depending on cobalt strength and backlog, shipments could be delayed by two to three weeks, instead of being dispatched within a week.”
NDTV
thehansindia.com
m.rediff.com
Sources
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