Govt eases loan licence requirement for 'outsourced' sterilisation of medical gear
Medical device makers now avoid loan licenses for outsourced sterilization services. This change simplifies business while industry leaders express concerns about new labeling rules. Printing sterilizer license numbers on device labels may hinde...
New Delhi: Makers of medical devices will no longer require a separate loan licence for outsourced sterilisation as long as the sterilisation facility holds a valid licence under the Medical Devices Rules, 2017, according to a new government provision.
The new provision has, however, triggered a pushback from the industry, because it requires the licence number of the sterilisation facility to be printed on the label of the medical device. The Association of Indian Medical Device Industry (AiMed) warned that the requirement would hurt exports.
The medical device loan licence allows a company to use its own brand name on products manufactured by another licensed manufacturer. Under the new rules notified on August 20, such a company will not require this licence for the outsourced sterilisation process.
"This change is aimed at making compliance simpler, reducing unnecessary paperwork and supporting ease of doing business for medical device industry," health ministry said. AiMed said no other country required subcontractor details to be printed on pack and that doing so would hurt export flexibility and delay shipments.
"Manufacturers will be forced to wait for sterilisation by the specific subcontractor whose licence number is printed on the packaging, removing the flexibility to choose the fastest available facility. This could delay shipments by two to three weeks instead of the current turnaround of under a week, a significant competitive disadvantage," said Rajiv Nath, forum co-ordinator, AiMed.
ADVERTISEMENT
Nath has written to the health ministry seeking suspension and a review of the new rule. His letter requests the ministry to engage with industry stakeholders to explore alternatives that ensure patient safety without undermining competitiveness and exports. The government also amended Rule 63 of the Medical Devices Rules, 2017, to include the European Union among the recognised stringent regulatory jurisdictions for waiver of clinical investigation requirements.
With EU's inclusion, medical devices approved in Europe can benefit from waiver provisions in India, facilitating faster patient access to advanced medical tech without requiring a fresh round of clinical investigations, the ministry said.
