A big relief for medical devices traders in india

The new amendment in Medical Devices Rules, 2017 is a significant step by govt as it will regulate the traders of medical devices including in-vitro diagnostic devices and those that are sold in premises other than pharmacies

In a major initiative to save the medical devices traders from the uncertainty regarding licensing, the Union Health Ministry has recently introduced registration certificate for sale premises of medical devices in the country. In this regard, the Ministry has recently issued the final notification amending the Medical Devices Rules, 2017 to introduce registration certificate for sale premises of medical devices. The new amendment is a significant step by the government as it will regulate the traders of medical devices including in-vitro diagnostic devices and those that are sold in premises other than pharmacies.

As per the final notification, in Medical Devices Rules, 2017, in rule 34, which is on the procedure to apply for grant of import licence where eligibility for application is provided for an authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution, the ministry has inserted the provision for those who have registration certificate in Form MD-42 also to apply for the import license. Similarly, in the Rule 87, which deals with the provisions for sale of medical devices, a sub-rule has been inserted to mandate that any person not holding license under sub-rule (1) and intends to sell medical devices exclusively as referred to in clause (zb) of rule 3 (which include in vitro diagnostic and surgical dressing, contraceptives, among others), should obtain registration certificate as provided in these rules. Besides, in the same rule, the Ministry has also inserted provisions for issuing registration certificates to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.

Under this, the State Licensing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificates for such specific areas. Those who want to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical devices, should make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate for the same with specific certificates and documents.

The new amendment also specifies the conditions of registration certificate for sales or distribution of medical devices, which mandates that the registration certificate should be displayed at a prominent place in the premises visible to the public, the certificate holder should provide adequate space and proper storage condition for storage of the medical devices, shall maintain requisite temperature and lighting as per requirements of such medical devices, and the medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity, among others.

It has also introduced Form MD-41 to apply for registration certificate to sell or distribute devices including in vitro diagnostic devices, and Form MD-42 in which the State Licensing Authority shall grant the registration certificate or reject the application for reasons to be recorded in writing, within ten days from the date the application is made. The amendment also inserts a Form MD-43 in which the inspection book shall be maintained. The registration certificate, issued in Form MD-42 will remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Rules, before completion of the five-year period from the date of its issue.

The provision also imposes a late fee calculated at the rate of two per cent of the retention fee for every month if the certificate holder fails to pay the retention fee on or before the due date. The fee for registration certificate and the retention fee are fixed at Rs 3,000 each. If the certificate holder contravenes any provision of the Act or the Rules, the State licensing authority shall, after giving an opportunity to show cause as to why such an order should not be passed, suspend or cancel the certificate by an order for reasons to be recorded in writing.

The certificate holder, if gets such a suspension or cancellation order, can approach the State government within 45 days of the receipt of the order. The State Government has the powers to confirm, reverse or modify such order, with reasons to be recorded in writing.

Definitely, the introduction of registration certificate for sale premises of medical devices is a welcome initiative by the government. It will be a huge relief for the medical devices traders as the market place was undergoing turmoil with uncertainty and traders were being asked by state regulators to seek a wholesale drug license for which they would not qualify as in most cases they were not pharmacists. The new Rules will go a long way in providing the much needed and long awaited relief to the medical devices traders in the country.

(The author is a freelance

journalist with varied experience

in different fields)