Due to the outbreak of pandemic COVID-19 worldwide, it can be observed that usage of various medical devices has taken a hike and trading of various medical devices has increased manifold. One amongst them is ‘Infrared Thermometer’ (hereinafter referred as ‘Infrared Thermometer’ or Digital Thermometer’). Infrared Thermometer is used to measure the body temperature of a person electronically. As it is a reliable, safer and easier option for measurement of body temperature, it has proven to be very useful during this unprecedented pandemic situation. Since, people primarily rely on the data provided by such infrared thermometer and for safeguarding the interest of public at large, stipulated laws governing such devices are in place, there is a need to understand the requirements w.r.t approvals and registrations required to manufacture, import, and/or sale such Infrared Thermometer in Indian Market and check the compliances needs to be adhered.
In this article, we shall be discussing in brief on various approvals, registrations and compliances needs to be done prior to selling Infrared thermometer in Indian Market by analysing various provisions of Legal Metrology Act, 2009 (hereafter referred as ‘LM Act’), Drugs and Cosmetic Act, 1940 (DC Law) and Medical Devices Rules, 2017 (hereinafter referred as ‘MD Rules’) and will be skimming on the surfaces of various applicable provisions.
- COMPLIANCES UNDER LM ACT
- Approval of Model-
As we have discussed in the introduction part above that Infrared Thermometer is used to measure the body temperature of a person, it is to be noted that pursuant to enacted provisions of 2(w) of LM Act ‘weight and measures’ means weight and measures as defined under the Act and it includes weighing and measuring instruments of any nature in it, including Infrared Thermometer. Every such weighing and measuring instrument is termed as ‘model’ in pursuance to provisions of Rule 2(1)(b) of Legal Metrology (Approval of Models) Rules, 2011 (Model Approval Rules). Further referring to provisions of Section 22 of LM Act, any person who is intending to manufacture or import any weighing instrument including infrared thermometer, has to obtain model approval from the specified authority. Also, such approval of model is on prior basis and after that only further manufacturing and importing can be done by such manufacturer or importer. In pursuance to provisions of Rule 5 of the Model Approval Rules, every application seeking approval of model of Infrared Thermometer shall be made to Director, Legal Metrology Department, along with the prescribed fees and information, documents and sample of Infrared Thermometer. Subsequent to such submission, the concerned director shall forward such application to the laboratory for its testing who shall forward the report to such director w.r.t standards and compliance status of methodology and elements used in such Infrared Thermometer and thereafter a letter of approval of such model or measuring instrument will be issued by such Director allotting a unique Model No. for such Infrared thermometer which shall be displayed on every piece of Infrared thermometer by its manufacturer or importer.
In addition to above, in pursuance to provisions of Rule 13 of Legal Metrology (General) Rules, 2011(LM General Rules) every weighing or measuring instrument used or intended to be used in any transaction or protection shall confirm to the details mentioned under Seventh Schedule along with the physical characteristics, configuration, constructional details, materials, performances and tolerances.
- Registration as Manufacturer or Importer and Dealership License
For Importers- Pursuant to the definition of ‘import’ provided under Section 2(e) of LM Act “‘Import’ with its grammatical variations and cognate expressions, means bringing into India from a place outside India” and therefore it can be said that any person who will be doing such activity will be importer in terms of LM Act. Referring further to the provisions of Section 19 of LM Act read with Rule 15 of LM General Rules, no importer can import any weighing and measuring instrument from offshore until he gets himself registered as Importer. The application seeking registration as importer shall be made to Controller of Legal Metrology Department of the state in which the item is going to be imported and such controller shall forward the application with its report to the director, Legal Metrology Department who will approve such registration as importer. Further, it is important to understand that this importer registration is separate from obtaining Importer and Exporter Code issued by Director General of Foreign Trade (DGFT).
For Manufacturers- Pursuant to the definition of ‘Manufacturer’ provided under Section 2(i) of LM Act, Manufacturer is the person who either manufactures any weighing or measuring instrument, or manufactures any part of it and assembles the rest of the parts or assemble the complete elements of it, and claims the end product i.e. weighing or measuring instrument as manufactured by him. Further, pursuant to the provisions of Section 23 of the LM Act there is a clear embargo on the manufacturers to manufacture any weighing and measuring instrument including Infrared Thermometer until he obtains a manufacturing license from the controller of the state in which the manufacturing is to be done. It is to be noted that pursuant to provisions of Section 14 of the LM Act, the controller is appointed by the State Governments and therefore bye-laws of every state needs to be checked prior to moving an application for obtaining such a manufacturing license.
For Dealership- Pursuant to the definition of dealer provided under Section 2(b) of LM Act, to be short and clear, the dealer is the person who carries the business of buying, selling, supplying or distributing any weight or measure. It also includes in its ambit commission agents, manufacturers, importers who sells, supplies, and distributes any weight and measures to any person other than the dealer who precisely tends to cover the relation of the seller and end consumer without any intermediary dealer between it. Further, pursuant to provisions of Section 23 of the LM Act, no person (dealer) shall sell or possess for sale any weighing or measuring instruments until he obtains a dealership license from the controller of state in which the dealer is going to sale such weighing and measuring instrument. In the case of Infrared Thermometer also, this license will be important to be attained prior to selling. Further, since here the power to grant such license is again in the hand of the controller which is appointed by the state governments, state bye-laws are required to be adhered to.
- Registration as Packer and disclosure compliances
Pursuant to the provisions of Section 18 of the LM Act, no person shall manufacture, import, pack, sell or otherwise possess for sale any pre-packaged commodity until or unless all the norms and disclosures prescribed under the rules has been made or complied with. By referring to the definition of ‘Pre-packaged commodities’ prescribed under Section 2(l), it means any product which is getting packed in the absence of its purchaser will be considered as pre-packaged commodity. Further, pursuant to provisions of Rule 2(g) of Legal Metrology (Packaged Commodities) Rules, 2011 (‘Package Commodities Rules’) packer is any person who is pre-packing any product or item in any form of package irrespective of its design and is packing it in units suitable for sale in the market. Pursuant to the extant provisions of Rule 27 of Package Commodities Rules, every packer shall obtain the packer registration by making the application to the Director or Controller, as the case may be along-with the prescribed documents. Such an application must be made within 90 days of the pre-packing of any product. In addition to the said requirement every manufacturer, importer, packer or any person who intends to sell or possess for sale any product or item have to make necessary disclosures and declarations as prescribed under Package Commodities Rules which includes name and addresses of the manufacturer, importer, and packer, date of manufacturing, expiry date, if any, etc. , and the same has to be checked on the product to product basis. Unlike the case of model approval, import registration, and dealership license is restricted to weighing and measuring instruments, registration as packer and disclosures to be made in package commodities rules is applicable to every sort of product including Infrared Thermometer.
- Verification and Stamping Requirements
Pursuant to provisions of Section 24 of the LM Act, every person who is having any weighing or measuring instrument has to get every single piece of such instrument verified and stamped from the controller by paying the prescribed fees before the instrument is sold and put to use. The power to conduct such verification and stamping has been vested in the controller of the state or zone in which the person possessing such a weighing and measuring instrument is situated. The purpose behind such verification and stamping requirement is to ensure that the product meets standard quality requirements prescribed under the LM Act and necessary disclosures have been made therein.
- COMPLIANCES UNDER DRUGS AND COSMETIC ACT, 1940
The laws governing compliances required for manufacturing, importing, or selling of Infrared Thermometer in India are Drugs and Cosmetic Act, 1940 (hereinafter referred as ‘DC Law’) and Medical Devices Rules, 2017 (MD Rules) which came into effect from 01st January, 2018. If we analyze the definition of ‘Drug’ provided under Section 3(b) of DC Law, which is an inclusive definition, in its sub-clause (iv) it primarily includes all such devices intended for internal or external diagnosis of any disease in human beings or animals. Further, referring to the definition of ‘Medical Devices’ provided under Rule 3(zb) of the MD Rules, which is an exhaustive definition, in its clause (C), it refers to the instruments or devices which has been notified by the Central Government from time to time as Drug under Section 3(b)(iv) of DC Law. The Central Government vide its notification dated 03rd December, 2018 included Digital Thermometer under the definition of ‘Drugs’ under DC Law and later Drugs Controller General of India vide public notice dated 15th May, 2019 categorized such Digital Thermometers into Class-B category which basically belongs to the class of low moderate risk items. The said notification of the Central Government including Digital Thermometer into the ambit of ‘Drugs’ under DC Law was supposed to be effective from 01st January, 2020 but for now, such effective date has been extended to 01st January, 2021 vide another notification dated 27th December, 2019.
Later to such notification as mentioned above for the extension of the effective date, one more notification dated 11th February, 2020 was issued by the Central Government introducing an amendment to MD Rules by inserting a new chapter namely ‘Chapter IIIA-Registration of Certain Medical Devices’. The provision of this new chapter is presently applicable on a voluntary basis and will be mandatory in nature after 18th Months of the commencement date of this Chapter which is 01st April 2020.
Under the above chapter, the manufacturer and/or importer of any such digital thermometer shall register such device with the Central Drugs Standard Control Organisation (CDSCO) by providing the requisite information, subsequent to which, a registration number will be allocated to such manufacturer/importer which shall be mentioned on the label of such medical device.
Referring further to said notification, another introduction has been made by the Central Government by adding a new annexure to Schedule VIII of MD Rules which is precisely a list of medical devices exempted from complying with MD Rules, and it is including Digital Thermometers as of now. But such exemption is available only for a particular time period depending on the class in which the medical device is falling. For Class-B (relating to a digital thermometer) such exemption shall cease after a period of thirty months from the date of notification.
On the same date 11.02.2020, the Central Government has issued another notification which tends to include all devices, including an instrument, apparatus, appliance, implant, material or another article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used for diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder into the definition of ‘drug’ under the DC Law. The effective date of such notification is 01.04.2020, and if we refer to such inclusion made by the Central Government, it brings confusion whether it includes Digital Thermometer used for measuring the body temperature of human beings or not. Here, it is important to understand that such a digital thermometer is used just to measure the body temperature and it does not diagnose any disease or disorder. Therefore, in my view, it is not covering digital thermometer in its ambit, but some clarity must flow from the side of the Central Government over this subject matter. If any digital thermometer is having any feature to diagnose the disease or disorder type, then apparently it will fall under the definition of ‘drugs’ mentioned in the notification dated 11.02.2020.
In short, it can be said that, at present, digital thermometers not diagnosing disease or disorders are out of the purview of DC Law.
To do compliances afterward-
Post expiration of 30 months– Such Digital Thermometer will be considered as a medical device under the MD Rules and DC Law and all extant provisions needs to be complied by manufacturer/importer as the case may be, which are as follows-
Firstly, immediate action will be required to move an application for registration of Digital Thermometer to Central Licencing Authority through the identified online portal by CDSCO.
Secondly, pursuant to provisions stipulated under Rule 20 of MD Rules, for the manufacturer of Digital Thermometer which is falling in Class B, such manufacturer shall make an application to the State licensing authority for obtaining manufacturing license or loan license in Form MD-3 and 4 respectively, along with necessary documents or information mentioned therein along with the prescribed fees. It is to be noted that such a manufacturing license or loan license is required to be obtained on a prior basis. Further pursuant to Rule 34 of MD Rules, importer of Digital Thermometers is required to obtain an importer license and for the same, an application will be required to be made in Form MD-14 to the Central Licensing Authority. It is to be noted that such an application can be made only through an Authorized Agent who must have manufacturing, distributing, or wholesale license for sale or distribution under these rules.
It is to be noted that such power to grant a license is discretionary in nature and it is a one-time requirement only, though renewal fees are required to be paid on time to time basis, as prescribed. Further, the department is empowered to ask for additional information and can also conduct testing of such Digital Thermometers at its designated lab, and in case such testing happens, the manufacturing or importing license will be issued depending upon such test report.
In addition to above, under Rule 38 of MD Rules, there are certain conditions specified which needs to be complied by the License Holder. Also, the person has to comply with all the labeling requirements mentioned under Rule 44 and other compliances stipulated under MD Rules.
It is to be noted that in case the person is only performing sale or distribution of medical devices including Digital Thermometer, the license granted under Part VI of Drugs and Cosmetics Rules, 1945 will be considered valid to deal in such Digital Thermometers.
By the above discussion, we can observe that there are a lot of compliances to be done and approvals or registrations required to be obtained prior to dealing in and manufacturing Infrared Thermometers in India, as all the applicable Central and State laws are required to be complied with. But, on present-day, only LM Act is applicable incomplete manner and there are some relaxations provided under DC Laws for some period of time. Also, it has been seen that by considering the huge requirement of such Infrared Thermometers during this COVID-19 pandemic outbreak in the country and considering the issue regarding time taking the process of model approval and other formalities under LM Act, the requirement of prior approvals and registrations stipulated under LM Act has also been relaxed to some extent and with the consent of department, the practice has been followed to obtain an undertaking from the importer, as the case may be, that they will comply with such requirement by taking post-approval within the time period of three months. Since various Central and State laws are applicable in the case of Infrared Thermometers, it is very much necessary to be diligent while dealing in it as any negligence may bring huge penalties or unnecessary costs.
CS Santosh Pandey is a Company Secretary Practising in New Delhi. He can be reached at email@example.com