In this article, Eshika Phadke pursuing M.A, in Business Law from NUJS, Kolkata discusses The Implications of the Medical Devices Rules, 2017 on Industry Practices.
Introduction
The Indian medical devices industry is currently valued at USD 4.9 billion[1], and forms an integral section of the healthcare industry. It is the fourth largest in Asia and one of the top twenty in the world in terms of market size[2]. However, the industry has, until now, been in a rather peculiar position. In spite of the nature of the goods produced and the significant impact that they have on the quality of human life, the industry was greatly unregulated. The part of it which was regulated – a handful of devices which had been notified[3] by the Ministry of Health and Family– was clubbed with drugs and regulated by the Drugs and Cosmetics Act, 1940. For the purpose of Foreign Direct Investment (FDI), however, the two have been recognised as separate as separate industries.
The need for a separate legislation governing medical devices has long been felt by all the stakeholders of the industry. For one, a robust legal framework would lead to a boost in the position of the Indian medical devices industry in the global market, as the devices produced in India are often not in compliance with the international standards for medical devices. Secondly, regulations would provide a more conducive environment for local manufacturers to set up industries in India. Third, it would increase the interest in India as an investment hub for foreign investors, Finally, it would lead to a higher level of satisfaction among the consumers of these devices, who in the absence of regulations may be wary of the quality of products produced by Indian manufacturers.
In a bid to cater to the demands of the stakeholders, the Ministry of Health and Family Welfare framed the Medical Devices Rules. The first draft was released in July 2016, following which a modified version was released in October 2016. The final Rules were then formulated, taking into consideration the inputs from the various stakeholders, and released in January 2017. It should be noted that these Rules are a subordinate legislation under the Drugs and Cosmetics Act, 1940. The Rules are in conformity with the Global Harmonisation Task Force – a voluntary group of that aimed at standardisation of the regulations for medical devices across the globe. Thus, the Rules would ensure that the Indian industry is boosted to a global level.
The Medical Device Rules, 2017 shall come into force on January 1, 2018. This gives the players involved in the manufacturing, testing, packaging, distribution, sale, and import of medical devices sufficient time to get familiarised with the new regulations and implement the relevant provisions to their business. In the meantime, medical devices shall continue to be governed by the current regulations – or rather the lack thereof.
Current Regulatory Scenario
Prior to the implementation of the Rules, only 15 medical devices are regulated. This includes disposable hypodermic syringes and needles; disposable perfusion sets; in-vitro diagnostics devices for HIV, HBsAg, and HCV; cardiac stents; drug eluting stents; catheters; intra ocular lenses; in-vitro cannulas; bone cement; heart valves; scalp vein sets; orthopaedic implants; and internal prosthetic replacements. Furthermore, certain products have also been classified as drugs under the Drugs and Cosmetics Act. These include blood grouping sera; ligatures, sutures and staplers; Intra Uterine Devices; condoms; tubal Rings; surgical dressings; umbilical faces; and blood and blood component bags. The list of notified devices is not exhaustive and excludes a number of devices from within the purview of the Act. This gave rise to a number of quality issues in the industry, as there were no guidelines for the manufacturers to follow and no authority to ensure that the devices met a certain standard. [4]
For the devices and products that have been classified as drugs, the Drugs and Cosmetics Act lays down the requirements and the procedure for applying for the various licenses required by the organisations involved at the various stages of production, testing, labelling, sale, and import of medical devices. Only these devices are required to be registered under the Act. The prescribed regulatory authority under the Act is the Central Drugs Standard Control Organisation (CDSCO).
One distinctive feature of the classification of medical devices as drugs is that it enables the National Pharmaceutical Pricing Authority to fix a ceiling price on the medical devices that it deems necessary to cap the price, in accordance with the Drug Price Control Orders. In February 2017, the price of coronary stents in India was brought down by 74% for the bare metal stents and by 85% for drug eluting stents. This was done in response to reports claiming that many hospitals hike the price of these stents in order to make profits, which is some cases, is up to the tune of 650%[5]; thus rendering these life saving devices unaffordable and hence inaccessible for a large section of the society. This move received mixed feedback, with most people lauding the government’s initiative, while some people questioned the long term impact that the reduction in profitability would have on the availability of these devices. Following the success of this move, the government brought knee-replacement devices under price control in August 2017 – a move which the government believes will lead to a savings of Rs. 1500 crore to patients[6]. The government has stated that it aims to bring several more medical devices under price control.
The draft National Medical Devices Policy 2015[7], which contains recommendations for the development of the industry, also deals with the issue of affordability. It recommends that medical devices be inserted as a separate list of commodities under the Essential Commodities Act, 1955, following which the government may fix a ceiling price for the devices that it deems ‘essential’ by way of a Medical Devices Price Control Order. The policy also talks about the setting up of an autonomous National Medical Devices Authority under the supervision of the Department of Pharmaceutical, which would provide a single window mechanism to the corporate bodies in the industry, as well as supervise the setting up of Medical Devices Mega Parks, educate the stakeholders and promote the industry. The Department of Pharmaceuticals is yet to release the final policy, which the government believes will give the industry a much-needed boost.
While the Drugs and Cosmetics Act does contain certain provisions specifically for medical devices, it applied exclusively to the notified devices, thereby hindering the development of the industry. The extreme leeway given to non-notified devices led to the mushrooming of substandard devices that were available in the market – leading unsuspecting consumers into believing they were of a certain quality and fulfilled safety requirements, while this was not always the case. Newer technologies were not given recognition as medical devices, which hampered the spirits of the developers and manufacturers. The industry was not reaching its full potential in terms of attracting investments in spite of 100% FDI being permitted under the automatic route in both brownfield and greenfield investments. Thus, the need for a stronger regulatory framework was felt across the industry.
Medical Devices Rules, 2017
Definition
The introduction of the Medical Devices Rules marks the beginning of a new era for the Indian medical devices industry. For the first time, they are being recognised as a separate entity from ‘drugs’. As per Rule 3(zb), a “medical device” means,
(A) Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(B) Substances including mechanical contraceptives (condoms, intrauterine devices, and tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii);
(C) Devices notified from time to time under sub-clause (IV),
of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940[8].
The Rules also define “Active Medical Device” i.e. medical devices whose operation depends on a source of energy (which may or may not be electrical energy) other than energy generated by human or animal body or gravity; “Active Diagnostic Medical Device” i.e. a medical device which is used (alone or in combination with other medical devices) to supply information for detecting, diagnosing or monitoring, or to provide support in the treatment of any physiological condition, state of health, illness or congenital deformity; and “Active Therapeutic Medical Device” i.e. used to support, modify, replace or restore biological functions or structures with a view to the treatment or alleviation of any illness, injury or handicap.
The Rules have given a rather extensive, inclusive, and progressive definition for medical devices. The devices that had been notified as drugs under the Drugs and Cosmetics Act are obviously included under these Rules; but the definition is also broad enough to include the majority of other devices in the market. In fact, even modern technologies like biosensors, fitness trackers, sleep trackers, home testing kits (which test blood, urine, saliva, and sperm), diagnostic apps, menstrual cycle tracking apps, and fitness apps have been brought within the purview of these Rules. Even mental health apps that are used to monitor moods and help ease symptoms of mental illness could potentially is included in the category of medical devices. The Rules will have a far-reaching effect on not only the medical devices industry, but also the healthcare industry at large.
Certain devices have been exempt from these Rules, to a predefined extent and subject to certain conditions. These devices have been listed under the Eighth Schedule. They include custom made devices; medicated dressings and bandages for first aid; and medical devices which have been supplied by a registered medical practitioner to his own patient, either of his own accord or at the request of another registered medical practitioner, provided that the device has been made specifically for the individual patient as per his specific requirements.
Classification and Licenses
Devices are classified into four classes. Class A devices are low risk, Class B devices are low moderate risk, Class C is moderate high risk, and Class D devices are high risk. The factors for determining the class are laid down in the First Schedule. Part I lays down the parameters for devices other than in vitro diagnostic medical devices; while Part II lays down the parameters for in vitro diagnostic medical devices. The First Schedule gives a detailed description of types of medical devices and their classification.
The basic principle for classification of devices is the intended purpose of the device. If two or more devices are to be used in conjunction, the devices would be classified separately on the basis of their independent use. Softwares that drive or influence the use of a device automatically fall under the same class as the device. Certain devices may be versatile in function, and may not intended to be used solely or principally for a specific part of the body. In such a case, the device shall be classified on the basis of the most critical specified use. If more than one rule applies to a particular device, the strictest rules resulting in the higher classification shall apply. The manufacturer is required to furnish the details of the intended use and performance of the device while applying for a license. The classification is done on the basis of these details.
Identifying the class under which a medical device falls is pertinent, as the same must be stated in an application for grant of license or loan license (i.e. license issued to a person who does not have the requisite infrastructural requirements or the equipment to manufacture the device that he is applying for a license to manufacture, and who intends to utilise the manufacturing site of the such a person who currently manufactures such medical devices, who shall be considered the other licensee) to manufacture for sale or for distribution. The form under which the application must be made differs for Classes A and B and Classes C and D. For the former, the application must be made to the State Licensing Authority; while for Classes C and D, the Central Licensing Authority is the designated body. The level of scrutiny and audit done by the Licensing Authority also varies as per the Class. Naturally, the standards to be met for a Class D device are higher than for a Class A device. The Licensing Authority may, at any time, inspect the manufacturing site to ensure that it meets the required standard.
A license or loan license, once granted, shall remain valid in perpetuity, subject to the payment of the requisite license retention fee. However, it may be cancelled or suspended, either wholly or for a particular device, by the Licensing Authority if the licensee contravenes any provision of the Drugs and Cosmetics Act or the Medical Devices Rules, and fails to rectify or justify such error. Persistent failure to pay the requisite license retention fee would also result in the license being deemed to have been cancelled.
Medical devices, like drugs, have the potential to do an unimaginable amount of harm if they are not of a certain standard. It is thus pertinent to test these devices on human subjects before they are sold in the market where millions of people will have access to them. Before the manufacturer begins, they must apply to the Central Licensing Authority for a license to manufacture a small number of devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training. The application form must be accompanied with a document containing a brief description of the medical device including the intended use, material used, the design, and an undertaking (along with details of) stating that the requirement with respect to facilities including equipment, instruments and personnel have been provided for manufacturing the device. The test license has three-year validity, but may be cancelled at an earlier time if the manufacturer violates any of the requirements. The licensee is required to maintain a record of the quantity of devices manufactured, tested and stocked and its disposition.
Imported devices form a significant portion of the Indian medical device industry. In order to sell or distribute these medical devices in the Indian market, an application must be made to the Central Licensing Authority. The applicant must be an authorised agent having a license to manufacture for sale or distribution or wholesale license for sale or distribution under the Medical Devices Rules. The Central Licensing Authority may, if it deems necessary, conduct any evaluation, test or examination on an imported medical device if the Authority has reason to believe that the quality of the device is compromised. Furthermore, the Central Licensing Authority may cause an inspection of the overseas manufacturing site, either by itself or by any person to whom the task has been delegated.
Standards
As per the Rules, the manufacturer must follow the essential principles of safety and performance of medical devices that shall be specified by the Ministry of Health and Family Welfare.
During the clinical investigation and clinical performance evaluation of a medical device, the investigator (including a Clinical Research Organisation, if the task of carrying out such investigations is delegated to such an organisation) must follow the Good Clinical Practices Guidelines that have been laid down by the Central Drugs Standards Control Organisation. An Ethics Committee must be set up as per Rule 12 DD of the Drugs and Cosmetics Rules, 1945 to safeguard the welfare of the participants. Furthermore, the testing must be in accordance with the Ethical Guidelines for Biomedical Research Involving Human Subjects that has been laid down by the Indian Council for Medical Research (ICMR).
The Rules mandate that all finished medical devices conform to the standards laid down by the Bureau of Indian Standards (BIS). In the absence of a relevant standards laid down by the BIS, the manufacturer must conform to the standards laid down by the International Organisation for Standardisation (ISO) or by the International Electrotechnical Commission (IEC), or any other pharmacopoeial standards that may apply to a product of that nature. If there are no relevant standards whatsoever, the device must comply with the validated manufacturer’s standards. The same standards applied to the notified devices under the Drugs and Cosmetics Act.
This provision ensures that all medical devices produced in India are of a certain standard. These standards serve as a quality assurance stamp, which provides a feeling of wellbeing to the consumers. It also boosts the position of the Indian medical devices industry globally, as quality was a known issue with products that are manufactured in India.
Labelling and Shelf Life
All medical devices include some kind of packaging – either a box, an outer cover, a shelf pack, or even just a simple label on the product itself. This packaging not only has significant commercial significance in terms of branding of the product, but also mandatorily must include certain statutory information.
As per the Rules, the following information must be printed on the label, the shelf pack, and the outer cover of the medical device, as well as in every outer covering in which the medical device,
- It is packed – the name of the medical device;
- Any details that are necessary for the user to the identify the device and its use;
- The name of the manufacturer and address of the manufacturing site where the device was produced;
- A true and correct statement of the net quantity in terms of weight, measure, volume or number of units;
- The month and year of manufacture (or date of sterilization, if applicable), along with either the date of expiry or the shelf life;
- If the device contains medicinal or biological substance;
- A distinctive batch number or lot number;
- Any special storage or handling conditions;
- If the device is supplied as a sterile product, its sterile state and the method of sterilization;
- Any warnings or precautions that may be necessary;
- Whether the device is intended to be a single use or multi-use;
- If a medical device is to be distributed solely to medical professionals as a free sample, the words “Physician’s Sample – Not to be sold” should be overprinted on the label of the device;
- The manufacturing license number, unless the devices are for imported;
- In case of imported devices and where such information is not already printed, a label containing the import license number, name and address of importer, address of the actual manufacturing premises and the date of manufacture.
The label may also bear the symbols that are recognised by the BIS or ISO so as to indicate vital information to users that are illiterate, or unable to comprehend the language in which the information has been printed. Devices that are produced for export purposes must contain labels on packages or containers that must be modified to meet the specific requirements of the country to which the devices are being exported. They must also contain certain essential details such as the name; batch number; date of expiry; name and address of manufacturer as well as the address of the site where the device was manufactured; license number; as well as any internationally recognised symbols if required. They are exempt from printing the rest of the information that is necessary for devices that are manufactured for use in India itself.
From January 1, 2022, in accordance with the Global Harmonisation Task Force, standards all medical devices that are approved for manufacture for sale or distribution or import, shall bear a unique device identifier which shall include a device identifier (i.e. a global trade identification number) and a production identifier (i.e. serial number, lot or batch number, software as a medical device version, manufacturing date, and expiration date). This will enable the smooth identification and tracking of medical devices at every level of distribution, export, and sale for devices that are being utilised locally, nationally and internationally.
The Medical Devices Rules have maintained the same provision with respect to shelf life as the Drugs and Cosmetic Rules. It shall be decided on the basis of technical parameters, but shall not ordinarily exceed sixty months i.e. five years from the date of manufacture. If the manufacturer can produce sufficient grounds to the Central Licensing Authority to justify extending the shelf life beyond sixty months, the same may be accepted and implemented for that device. For devices that are made up of stable materials such as stainless steel of titanium (such as surgical tools and biomedical implants) and supplied non-sterile, or in case of medical equipment, instruments or apparatus, there may not be a fixed shelf life.
Clinical Investigations
Apart from a test license to manufacture a small number of medical devices for evaluation and testing purposes, permission from the Central Licensing Authority must also be obtained to actually conduct clinical investigations. First, a pilot clinical investigation must be carried out where the investigational medical device is tested on human subjects for the very first time. Based on the data from the pilot clinical study, permission may be granted to carry out a pivotal clinical investigation.
For purely academic clinical studies on licensed medical devices the prior approval of the Central Licensing Authority is not required; it must only be duly approved by the Ethics Committee constituted by the institution. The data gathered during these studies cannot, however, be used to apply for a license to manufacture or import the investigational device. For clinical performance evaluations on new in vitro diagnostic medical devices, prior permission must be taken from the Central Licensing Authority before carrying out any testing on any specimen (including blood or any tissue) derived from the human body. An application to carry out such an investigation must be accompanied by documents and information including: approval from the Ethics Committee constituted; the source and quantity of samples; in house performance evaluation data used to establish stability, specificity, sensitivity, sensitivity, repeatability and reproducibility; clinical performance evaluation plan; list of laboratories or other institutions involved in the study. Thus, the application for a new in vitro diagnostic medical device is more detailed and comprehensive.
Like in case of drugs, the Rules have made a provision for the Central Licensing Authority to abbreviate, defer or waive the requirement of animal data or clinical data for conducting clinical investigational. This can only be done in exceptional cases where the accelerated entry of the drug into the market is paramount for the public interest. After the applicant is granted permission to conduct a clinical investigation, they must register the clinical trial with the Clinical Trial Registry of India. A clinical investigation plan must be devised, approved by the Ethics Committee, and duly followed. The investigation may be carried out in-house by the company, by a sponsor, or may be delegated to a clinical research organisation. They must submit an annual progress report to the Central Licensing Authority. In case of any unexpected serious adverse event occurring, a report of the same shall be submitted to the Authority. The clinical investigation must commence with the enrolment of the first participant within a period of one year from the date of grant of permission. In the failure of such commencement, the Authority would have to re-authorise the investigation. The Central Licensing Authority also has the power to suspend or cancel, either wholly or partly, the permission granted to the applicant for conducting a trial if there is any deficiency in the administration of the trial.
Conclusion
The introduction of the Medical Devices Rules, 2017 has been much anticipated. It lays down a number of practices which were previously unheard of in the medical devices industry. Understandably, all the businesses involved with medical devices, be it the manufacturers, exporters, importers, distributors, sellers, or clinical research organisations will require time to acquaint themselves with the Rules and implement them in their business systems. The Rules which will come into force in 2018 are expected to have a far reaching impact on the industry. The regulatory framework will give the industry a much needed boost and encourage more local manufacturers to enter this formerly unregulated playing field. Furthermore, the Rules will increase the visibility of the Indian medical devices on the global market radar and not only increase the sales of Indian devices but also attract more FDI.
References
- The Medical Devices Rules, 2017 (and the Draft Rules, 2016)
- The Drugs and Cosmetics Act, 1940
- The Drugs and Cosmetics Rules, 1945
Endnotes
[1]http://www.skpgroup.com/data/resource/skp_the_medical_device_industry_in_india_.pdf
[3]http://www.cdsco.nic.in/writereaddata/list-of-notified-medical-device(1).pdf
[4]http://www.cdsco.nic.in/writereaddata/list-of-notified-medical-device(1).pdf (ibid 3)
[6]http://www.thehindubusinessline.com/news/govt-caps-knee-implant-devices-price/article9819887.ece
[8]As per Section 3(b) of Drugs and Cosmetics Act “drug” includes-
(i) All. medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes ;
(ii) such substances (other than food) intend to affect the structure or any function of the human body or intended to be used for the destruction of 18′[vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
(iii) all substances intended for use as components of a drug including empty gelatine capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;
