The Union health ministry will soon amend provisions of sale of notified medical devices as per Medical Device Rules (MDR)-2017 to effectively regulate their sale and distribution through a system of registration of premises and seller or distributor involved in it.
The move is based on the recommendations made by the Drugs Technical Advisory Board (DTAB)’s sub-committee and the 60th Drugs Consultative Committee (DCC) meet.
DTAB was apprised about the representations received from various associations / stakeholders for exemption of drugs sale license for all imported medical equipment (instruments / equipment / apparatus / appliances), provided the importer / stockist / retailer of medical devices make a registration of such premises where medical devices are stocked for sale and distributed.
The DCC in its 59th meeting held on March 2, 2021in Delhi had deliberated the matter and agreed in principle.
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Further, it was noted by the Committee that most of medical devices which are recently taken for regulation in phase wise manner are sold and distributed by distributors or retailers directly to the hospitals or doctors and in-vitro diagnostics (IVDs) and related diagnostic machinery are sold or distributed directly to the pathological laboratories.
Very few medical devices or IVDs, which are directly used by consumers, are sold to the consumers and usually prescription is not involved for such purchases by the consumers.
Accordingly, there are inherent differences between the sale and distribution of drugs and medical devices as the drugs are usually sold or distributed by wholesalers to retailers and by retailers to the patients / consumers on the basis of prescription while medical devices are sold and distributed mainly to hospitals / doctors or pathological laboratories.
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Therefore, looking at above aspects and international practices, DCC recommended to regulate the sale of medical devices in a different manner than the drugs by creating a system of registration of the premises and person involved in the business of sale or distribution of medical devices to maintain the traceability, security and integrity of supply chain of medical devices.
Committee observed that the sale and distribution of regulated medical devices, which fall under the definition of 3(b)(iv) of “drug” is as such permissible under present rule which can also be allowed to be continued in addition to maintain continuity of already existing system.
Further, DCC had also recommended constituting a sub-committee under the chairmanship of Dr S Eswara Reddy, Joint Drugs Controller (JDC), Central Drugs Standard Control Organisation (CDSCO) to examine the subject matter.
The DTAB’s sub-committee examined the matter and submitted its report in 60th (special) DCC meeting held on April 7, 2021.
60th DCC (special) deliberated the sub-committee report in detail including the proposed draft rules as prepared by the sub-committee and accepted the report of the sub-committee with the suggestion to reframe the provision with respect to appeal [proposed Rule 87(D)(2)] as under :-“A registration certificate (RC) holder whose registration has been suspended or cancelled by State Licensing Authority (SLA) under sub Rule (1) an appeal to the State Government or Authority designated by the State Government.”
DTAB examined the recommendations made by the sub-committee and the 60th DCC.
DTAB after detailed deliberations agreed to amend provisions of sale of medical devices prescribed under Rule 87 of MDR-2017 as per the recommendations made by the sub-committee and the 60th DCC.
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