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The Ministry of Health and Family Welfare has recently notified the Medical Devices Amendment Rules, 2020 (hereinafter referred to as ‘Rules’). Under these Rules, the government has notified that medical equipment would qualify as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act, 1940. Therefore, all medical devices, which were largely unregulated till now, need to be registered with and certified by Central Drugs Standard Control Organisation. Prior to these Rules, only 37 categories of medical equipment were regulated in India. However, these Rules have substantially widened the scope of regulation by bringing all medical equipment under its ambit, thereby equating the regulation of medical equipment with that of drugs. The move had been expected after the Johnson & Johnson case which involved faulty hip implants. This Article discusses the various nuances of the Rules.
Definition – The definition adopted by the Rules defines ‘Newly Notified Medical Devices’ as follows:
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ― (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; (iii) investigation, replacement or modification or support of the anatomy or of a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception.”
The Rules have adopted a fairly wide definition of ‘drug’ so as to include all medical equipment or devices, whether used for humans or animals, under its ambit. Therefore, all medical devices manufactured, imported, sold or used in India shall be regulated by the Rules and will have to comply with the regulations, as notified.
Registration – The Rules have made it mandatory for the manufacturers or importers to register their medical devices with the Drugs Controller General of India (‘DGCI’) on or before October 1, 2021. The DGCI has proposed to use an online system for registering medical devices. The manufactures or importers will have to file certain documents, as prescribed by DGCI, to obtain the registration. It is pertinent to mention that the 37 devices which were already being regulated by DGCI will not have to register themselves. It calls for registration within a period of 18 months from April 2020 and obtaining the license within 36 months for some devices while 42 months for other, as notified.
Upon successful registration, the manufacturer or importer will obtain a registration number which it shall display on each device it is manufacturing, using, importing or selling. The registration number shall be displayed on the devices as soon as it is obtained. Further, a certificate of compliance with ISO-13485 is essential for registration of a medical device and the manufacturer has to ensure that their devices conform to the quality standards of ISO-13485.
Licensing – Every Newly Notified Medical Device will have to obtain a license under the Rules. It is not necessary to obtain registration prior to applying for a license. The government authority shall have the power to inspect the stock or premises of such manufacturer or importer to ascertain compliance with the Rules. The mandatory licensing provision has been inserted to ensure that medical devices of a certain standard/quality circulate in the Indian market, thereby restricting the sale of sub-standard devices in the market.
Penalty – If the manufacturer or importer fails to register or fails to obtain license prior to the deadline, it will have to cease manufacture or import of such devices until registration or license is obtained. However, the consequence of bringing medical devices under the Rules is that manufacture or import of devices without obtaining registration or license could result in criminal prosecution which may lead to imprisonment. Further, the stock of medical devices which are not registered after the cut-off date shall be confiscated.
Comments – The Rules have been considered as a boon for several players in the market. Considering that the Indian market is flooded with unproven designs, poor quality, defective and inconsistent equipment employed by relatively smaller medical facilities due to which several companies had been forced to import such devices from abroad, the government has taken this step to ensure maintenance of quality standards in medical equipment and forcing the manufacturers to improve the quality of their products. In addition to the betterment of quality standards of the medical equipment, it can bring economic benefits as well. Considering that most indigenous manufacturers do not possess the technology to produce quality products, it invites foreign manufacturers to invest in India in the medical equipment sector. The local manufacturers of non-compliant products will be forced to enhance quality by tying up with foreign firms who have been trying to get into the Indian market with a strategic plan to deviate from western designs which are usually over designed to meet the needs of western markets, thereby cutting down on costs. Many technical experts and organisations have applauded the move as it goes a long way to improve the medical devices industry which was largely sub-standard and unregulated.
On the other hand, several local manufacturers are expected to shut down shop as they simply cannot conform to the technical standards expected from the health industry. These businesses do not have the required investment or expertise to improve their products. Further, it is pertinent to mention that including the medical devices in the Rules instead of regulating medical devices under a separate legislation may indicate a haphazard decision. Initially, it was expected that the government will bring a separate legislation to regulate medical devices and not equate the devices with drugs, as the latter require very strict compliance and care. Further, the penalty provided under the Rules is disproportionate to the gravity of the offence. A small defective medical device which is used to measure the pulse of an individual cannot be equated with a faulty contraception pill, considering that the latter may result in severe loss including loss of life. Much clarifications are needed ahead. A separate legislation of medical devices will certainly be a welcome move.