In this article, Namratha Narasimha Krishnan pursuing M.A, in Business Law from NUJS, Kolkata discusses important provisions of Medical Devices Rules, 2017.

The industry manufacturing medical devices in India was governed under the stringent laws of The Drugs and Cosmetics Rules, 1945, up until recently, when the government decided to heed to the industry’s plea for a separate regulation. The defect in the prior regulation was that the medical devices listed in the Schedule C of The Drugs and Cosmetics Rules, 1945, was governed being considered same as the drug manufactures in India. This defect was considered as a major turnoff by the medical device manufacturers who believed strongly that medical devices be considered separate from the drugs.

The Medical Devices Rules aim to ease the rules regarding medical devices, including but not limited to obtaining licenses, clinical trials etc. This measure of the government seems to have received positive reaction from the industry, thus encouraging the domestic manufacturers. The following section deals with analysis of the Medical Devices Rules, 2017.

Definition of Medical Devices

The term medical device has been defined under the Rules of 2017 and includes specific devices that help in diagnosis and treatment, specific substances that affect the human body, surgical dressings, bandages, blood collection bags etc. or any other substance or device used in diagnosis or treatment of any disease or disorder of any human being or an animal. These devices and substances defined under the rules will be notified by the government from time to time.

One needs to note that the Drug and Cosmetic Act, 1940 defines ‘drug’ and this definition contains the term medical devices. Thus, the Drug and Cosmetic Rules, 1945 will continue to govern the manufacture of medical devices. Though many may consider this as a hindrance, the government seems to have thought through the possibility of conflict or overriding effect and has provided for a clarification in the Medical Rules 2017, which states that, in the event of any conflict between the Drug and Cosmetic Rule 1945 and Medical Devices Rules 2017, the Medical Devices Rules 2017, shall have effect.

Classification of Medical Devices

The Medical Devices Rules notified by the Ministry of Health and Family Welfare has been formulated to be in conformity with the Global Harmonisation Task Force framework and the international practices.

The new rules classify medical devices based on risk, as is done by the Global Harmonisation Task Force. Accordingly, the medical devices are categorised as Class A having low risk, Class B having low to moderate risk, Class C having moderate to high risk and Class D having high risk.  The regulation deals with detailed description of the method of classification in Schedule 1 of the Medical Devices Rules 2017.

The ministry in its press release regarding the Medical Devices Rules, 2017 states that, in the interest of professionalism, the rules introduce third party conformity and certification through notified bodies. These notified bodies are to be accredited to the National Accreditation Board for Certified Bodies, wherein accreditation shall be accorded based on the bodies competence of human resources and other prescribed requirements. These notified bodies are required to assess, verify quality management of the medical device manufacturers who belong to Class A and Class B of the categorisation.

License of Medical Devices Manufacturers

The Medical Devices Rules 2017 has been formulated with an aim to simplify the rules regarding medical devices in India. In light of the same aim, the rules have provided for self-assessment/ self-certification of compliance for manufacturers belonging to Class A of categories prescribed under Medical Devices Rules 2017.

The Medical Device Rules 2017 state that, all those manufacturers belonging to Class A category may be granted licence upon self-certification of compliance submitted by such a manufacturer. Upon receiving such a license, the notified bodies shall carry on an audit at the manufacturing site of such a manufacturer and certify the quality management system of the manufacturer at his manufacturing unit is up to the mark.

The Medical Devices Rules 2017, has provided that the licenses to be granted for manufacturers belonging to Class A and Class B shall be granted by the State Licensing Authorities after certification by the notified bodies regarding the quality management system. The licenses to be grated to manufacturers belonging to Class C and Class D shall be granted by the Central Licensing Authorities, which may call upon the notified bodies to assist them in the process. The Medical Rules 2017 states that the quality management system of all manufacturing units must be in conformity with ISO 13485.[1] In the event that the appropriate licensing authority figures out that the applicant manufacturer has provided any false information or details for obtaining the license, the appropriate licensing authority has been granted the power to debar such an applicant from carrying out business in India.

The Medical Devices Rules 2017, also provides for specific time period within with the licensing authorities are expected to provide their decisions with respect to the license to be granted to the applicant manufacturer. The Drug and Cosmetic Rules 1945 provided the licensing authorities, an option to extend this timeline, which has been done away with in the Medical Devices Rules 2017. The appropriate licensing authority, as the case may be, is expected to communicate its decision with respect to the license to the applicant manufacturer, within forty- five days (45 days) in case of medical device manufacturing and within sixty days (60 days) in case of import of medical devices. In the event that the appropriate licensing authority, i.e. the central licensing authority or the state licensing authority, as the case may be fails to communicate its decision to the applicant manufacturer within the stipulated time period as mentioned above, then such approval of license shall be deemed to have been granted. This provision of assumption of license grant was found to be absent in the Drug and Cosmetic Rules 1945. This change can be viewed as a welcomed decision of the government.

Rule 26 of the Medical Devices Rules 2017 states that the license granted by the appropriate licensing authority under the Medical Devices Rules 2017, is perpetual. This means to say that, any license granted to an applicant manufacturer shall remain valid, until it is cancelled. For retention of the license granted by the appropriate licensing authority, the applicant manufacturer is required to pay a retention fee, as may be specified, every five years (5 years). The Rules obligates every manufacturer to inform the appropriate licensing authority, should such a manufacturer stop manufacturing in his manufacturing unit for a period of 30 days or more.

Rule 26 also states that in the event that the manufacturer makes any minor change in the constitution of the activity for which the license is granted, the manufacturer is obligated to inform the appropriate licensing authority of such change in writing, within thirty days (30 days) from the date of such change being adopted. The Rule is specific about one aspect, i.e. no applicant manufacturer can bring in or adopt any major change in the constitution of activity for which a license has been granted to him, unless the same is authorized by the appropriate licensing authority, as the case may be.

One major defect in the Drug and Cosmetics Rule 1945 was that it failed to deal with what “constitution change” meant. The Medical Devices Rules 2017 seems to have been successful in eradicating the inherent defect of the Drug and Cosmetic Rule 1945. The Medical Devices Rules 2017 details as to what amounts to constitutional change. It goes a step ahead and details as to what change amounts to minor constitutional change and what amounts to major constitutional change. For example, any change in the address of the applicant manufacturer is considered as a major change according to the Medical Devices Rules 2017.

Product Standards to be maintained by manufacturers

Rule 7 of the Medical Devices Rules 2017 provides for the product standards to be maintained by the manufacturers. They may be categorised as follows:

1. Every manufacturer must follow a standard notified/ prescribed by the Central Government for the Medical Device specifically or which has been laid down by the Bureau of Indian Standards (“BIS”).
2. In the absence of the above, every manufacturer shall be obligated to adhere to the standards laid down or prescribed by the International Organisation for Standardisation or the International Electro Technical Commission or any other pharmacopoeial standards.
3. In the absence of the above- mentioned categories for standards, every manufacturer shall adhere to self- prescribed validated manufacturers standards.

Up until the formulation of Medical Rules 2017, the Drugs and Cosmetic Rules 1945 provided that, the manufacturers and importers of medical devices must conform with the Bureau of Indian Standards and in absence of Bureau of Indian Standards, adhere to any international or such other standards, as may be specified. The default in this was that the manufacturers were clueless about which standard to follow and adhere to in the absence of any Bureau of Indian Standards. With the formulation of the Medical Rules 2017, this confusion of the manufacturers as to which product standard to adhere to, seems to be clarified.

Risk to health and recalls

The Medical Devices Rules 2017 obligates the applicant manufacturer to recall any product that, to the knowledge of the applicant manufacturer can cause any damage to the health of the patient and is known to be dangerous or harmful and the applicant manufacturer is required to provide reasons for such recall or withdrawal of the product. This is envisaged under Rule 89 of the Medical Devices Rules 2017. The Drugs and Cosmetic Rules 1945 fails to obligate the manufacturer to withdraw the product and state reasons for such withdrawal.  While this can be considered as a dangerous and inherent defect in the regulation, the Medical Devices Rules 2017 seems to have made efforts to correct the defect present in the Drug and Cosmetic Rules 1945.

Clinical Investigations

The Medical Devices Rules 2017 has envisaged separate provisions for regulation of clinical investigations or trials of medical devices that are considered to be in par with the international practices. Similar to the clinical trials, the clinical investigations or trials of medical devices shall be governed by the Central Drug Standard Organization. The conduct of clinical investigations or trials, according to the Medical Devices Rules 2017 must be carried out with a twin objective, i.e. to protect and uplift patient welfare and safety and must be carried with an intention to invent a new medical device.

The Medical Devices Rules 2017 has also envisaged a specific time period wherein the appropriate licensing authority has to within a period of ninety days (90 days) has to communicate to the applicant manufacturer, its decision regarding the application of the manufacturer to conduct the clinical investigations or trials. The Medical Devices Rules 2017 obligates the manufacturer to get enrolled within one year of obtaining permission to conduct clinical investigations or trials. The Medical Devices Rules 2017 also introduces the concept of pilot study and pivotal study, which was absent in the Drug and Cosmetic Rules 1945.

Shelf-life of the products

The Drug and Cosmetic Rules 1945 had prescribed that any medical device intended to be imported must have a shelf life of atleast sixty percent (60%) on the date of import, unless the importer/ manufacturer has obtained express permission stating otherwise.

The Medical Devices Rules 2017 has envisaged new threshold for shelf lives of the products. The Medical Devices Rules 2017 provides that

1. If a medical device, whose shelf life is less than ninety days (90 days) may be allowed to import, if the residual shelf life of such a product is forty percent (40%) on the date of import.
2. If a medical device, whose shelf life is more than ninety days (90 days) but less than one year (1 year) may be allowed to be imported, if its residual shelf life is more than fifty percent (50%) on the date of import.
3. If a medical device, whose shelf life is more than one year (1year) may be allowed to or permitted to be imported, if the residual shelf life of such a medical device is more than sixty percent (60%) on the date of import.

Labelling of products

The Medical Devices Rules 2017 has provided for labelling of the products to be undertaken by the manufacturers. The Medical Devices Rules 2017 states that every applicant manufacturers

1. Provide a date of manufacture which may be the sterilization date for any and all sterile devices.
2. Need not provide expiry date for raw materials such as stainless steel and non sterile products.
3. Need not provide date of expiry for active medical devices that are of the nature of instruments, equipment, apparatus etc. which may be used for the purpose of diagnosis or therapy.
4. Must provide sterilisation method and sterile state, if the medical device is a sterile product.
5. Must indicate “FOR CLINICAL INVESTIGATION ONLY”, if the medical device is for investigation purpose.
6. Must indicate on outer shelf package, if the medical device is not being sold to the customer or patient directly and is only meant to be sold to the hospitals or clinical labs or diagnostic centres directly.
7. Must indicate unique device indicator containing device identifier and product identifier including serial number, batch number or lot number, manufacturing date, expiry date, software as a medical device version etc.

Conclusion

The Medical Devices Rules 2017 is to be promulgated under an Act which is required to be placed before the Parliament for its approval. In the event that the houses of the Parliament decide to bring in changes to the Medical Devices Rules 2017, then the said Rules will have effect only with those changes approved by both the houses of the Parliament.

It is pertinent to note that those manufacturers who have been granted licenses by the appropriate authority under the Drugs and Cosmetic Rules 1945, shall have validity until the date of its expiry or 31^st July 2018, whichever is later. This period of validity of existing licensed manufacturers is called the Grace Period. These license holders are required to apply for new license under the Medical Device Rules 2017, upon expiry of the old license held by them under the Drugs and Cosmetic Rules 1945.

The Medical Devices Rules 2017 does not provide for new or fresh provisions for the sale of medical devices. It is pertinent to note that the rules regarding sale of drugs under the Drugs and Cosmetic Rules 1945, has been inserted into the Medical Devices Rules 2017.

The Medical Devices Rules 2017 has also forgone the requirement of registration of foreign manufacturers and their manufacturing unit, which was provided for under the Drugs and Cosmetics Rules 1945. The Medical Devices Rules 2017 has simplified this hassle and has provided for a requirement wherein such manufacturers must appoint a local authorized agent and must apply for import of the medical devices through such an authorized agent. The Medical Devices Rules 2017 also mandates that where an authorized agent is licensed to import a particular device from a particular manufacturing site, all other medical devices manufactured by such a manufacturing site must be imported only through the authorized agent and no other agent. Thus, the Medical Devices Rules 2017 limits the authorized agent to one for every foreign manufacturer and his manufacturing unit.

Though the government has made a commendable effort in simplifying the rules and regulation governing the manufacture and import of medical devices, the very fact that the term “drugs” under the Drugs and Cosmetics Act 1940 contains the term medical devices, makes the Drugs and Cosmetics Rules 1945 still applicable to the medical devices. Though the Medical Devices Rules 2017 is given the effect to prevail, there is no stopping of confusion. One would not be completely wrong if it is said that the government could have avoided many confusions and loopholes if the government had amended the term “drugs” in the Drug and Cosmetic Act 1940, prior to promulgating the Medical Devices Rules 2017.

This action of the government leaves many players in the industry disappointed. As the implementation of the Medical Devices Rules 2017 is expected to happen in the year 2018, the industry still hopes for changes to be brought in for betterment of the industry.

The government seems to be positive about the effects of the regulation brought about by them and believe that the outcome will be positive. In the press release given by the Ministry of Health and Family Welfare, the Ministry has stated that the Medical Devices Rules 2017 aims at providing a conducive environment to help promote innovation and improve accessibility and affordability of medical devices across the globe by providing cost advantage of manufacturing in India. This shows and proves that the government through these Rules aims at promoting the government’s Make in India campaign. It is believed that the Medical Device Rules 2017 is a transparent framework that will promote and boost the investors, thus paving way for improved range of quality products in the market. It is also believed by the government, as stated in their press release that, this is likely to reduce business risks.

The government has stated in its press release that “these Rules coupled with other measures, taken by the Government in the recent past, are expected to sharpen the competitive edge and provide incentives to firms to become more efficient, innovative, and competitive. All this will support entrepreneurship, market entry and economic growth that, in turn, would produce high-paying, high-quality jobs.”[2]

As seen throughout the research and analysis of the Medical Devices Rules 2017, the government has been very positive about these Rules, but many news reports suggest that a big portion of the players in the industry still remain unsatisfied with the efforts put forward by the government and are still in the hope that some changes as suggested would be introduced when both the houses of the Parliament debate over it, before the Medical Devices Rules 2017 come into implementation. Though the draft seems to be decent, only its implementation over time can reveal the practical difficulties and confusion that come along with the Rules.

References

[1] http://pib.nic.in/newsite/PrintRelease.aspx?relid=157955

[2] http://pib.nic.in/newsite/mbErel.aspx?relid=157955