 "medical device")
The Central Drugs Standard Control Organisation (CDSCO) has relaxed the requirement of a loan licence for outsourcing the sterilisation of medical devices to other facilities. Manufacturers are now allowed to carry out such activities by way of a mutual third-party agreement, provided those facilities hold a valid licence to undertake the process.
Sterilisation of medical devices is the process of eliminating or reducing microbial contamination to a level that ensures they are safe for use in healthcare settings.
Previously, manufacturers without in-house sterilisation facilities were required to utilise the premises of other manufacturers through a loan licence.
Such a licence is issued by the central or state licensing authority to a person who intends to utilise another licensee’s manufacturing site for sterilising the same medical device as manufactured by the licensee at that site.
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Calling it a welcome and progressive move, Himanshu Baid, managing director, Poly Medicure, said the decision will significantly streamline the process, reducing both time and administrative burden for manufacturers.
“It will particularly benefit companies that do not have in-house sterilisation facilities, enabling faster turnaround and improving overall supply chain efficiency,” he added.
In a letter dated June 24 to all state drug controllers, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi stated that concerns had been raised from time to time by stakeholders regarding the requirement of loan licences for outsourcing the sterilisation process of medical devices to facilities with valid licences for the procedure.
Issues faced by manufacturers, especially smaller companies, included delays and complexities in the licensing process.
To address this, a subcommittee formed by the Drug Consultative Committee (DCC) recommended that the requirement for a loan licence may not be insisted upon, provided the facility where the sterilisation is conducted holds a valid licence for the same distinct medical device for which the original manufacturer is licensed.
The DCC also recommended that, since sterilisation is a critical activity, the device manufacturer must include on its label the licence number of the site where the sterilisation was outsourced.
The Drugs Technical Advisory Board (DTAB), in April this year, approved the recommendations, subject to the inclusion of an appropriate mechanism for submission of documentary evidence to the licensing authorities in support of proper sterilisation of the products.
