Last Updated on March 13, 2021 by The Health Master
The Drugs Consultative Committee (DCC) has underlined the need to regulate sale and distribution of medical devices mandating registration of retail and distributor premises. This, according to the Committee, will bring in transparency of the sales outlets and provide credibility to the product safety.
However, the sale and distribution of regulated medical devices, coming under the definition of 3(b)(iv) of ‘drug’, will continue.
There have been several representations by the associations and stakeholders to exempt the sale license for all imported medical devices provided a registration of premises where these equipment and instruments are stocked for sale and distribution.
For Minutes of DCC meetings, click here
At its 59th meeting held early this month, DCC noted there are inherent differences between the sale and distribution of drugs and medical devices. In order to be on par with the global practices, it 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. This would enable traceability, security and integrity of supply chain of medical devices.
For this purpose, the Committee noted that CDSCO with CDAC needs to develop a portal to register the medical device traders / hospitals / firms who are involved in its sale, stock and use. The registration number generated online will help the licensing authority to have data to track and trace the movement of such medical devices.
Further, the DCC has constituted a sub-committee to examine and further frame the system. The sub-committee will be led by Dr. S. Eswara Reddy, JDC (I), CDSCO (HQ) as the chairman.
There will be four members: Dr HG Koshia, Commissioner, FDCA, Gujarat, DR Gahane, Joint Commissioner, FDA, Maharashtra, Amaresh Tumbagi, Drugs Controller, Karnataka and NK Ahooja, Drugs Controller, Haryana. Dr. Ravi Kant Sharma, DDC (I), CDSCO (HQ) is the convener of this sub-committee.
For the registration, the application for both online and offline submissions need to be notarized to validate the submission. The storage area and the qualification details of the competent personnel appointed to oversee the sale and distribution need to be submitted.
The registration certificate needs to be displayed in a prominent place in the premises. The registration holder should ensure providing proper storage, adequate space, lighting and required temperature control for the medical devices such that it does not get damaged.
He should personally supervise and ensure the competent technical staff consisting of at least one person who is a whole time employee has qualified an Intermediate Examination from a university recognized by State or Central Government and have one year experience in handling / stock / purchase / sale of medical devices.
All records of the products, purchases and the personnel details need to be maintained, such that it is made available during regulatory inspections. The audit and inspection reports are mandated for the inspectorate teams to record the observations and non-conformity.
Medical device regulation which is recent and taken up in phases, is currently sold directly to the hospitals and diagnostic centres. Very few medical devices or in-vitro diagnostics, which are directly used by consumers, are sold to the consumers and usually prescription is not involved for such purchases, said DCC.