India being one of the largest markets for medical devices in the world with over 800 medical devices manufactured in India irrespective that it is still being dominated with imported products. The regulatory framework in India regarding medical devices was heavily regulated by the framework applicable to drugs i.e. Drugs and Cosmetics Act, 1940 and its rules thereof Drugs & Cosmetics Rules, 1945 which entails with only 15 types of medical devices under the head of “drugs” and rest was unregulated.

In order to regulate and promote this industry Government not only come up with 100% FDI but has also introduced “The Medical Devices Rules, 2017” which were notified under the Drugs & Cosmetics Act, 1940 on 31^st January 2017 and are proposed to come into effect from 1^st January, 2018 and are in conformity with the Global Harmonization Task Force (“GHTF”). This article aims to analyze the aspects and what changes it had brought down which might affect the concerned group of authorities in the market.

Objective

Prior to the introduction of these rules, medical devices are also being governed by the robust legislation of Drugs and Cosmetics Act, 1940 with no insight regarding the process and procedure of medical devices. Therefore, this can be the main objective and intention of legislature behind enacting such rules to distinguish medical devices from pharmaceuticals for the purpose of regulation.

These rules would not only classify the medical devices from specified drugs but these will also ease the ability to obtain a license, to conduct clinical trials. The second most objective of these rules is to provide a more conducive environment for local manufactures to set up Industries in India, so that the PM’s initiative of ‘Make in India’ can get a clear path to be fulfilled.

Thirdly, a clear set of laws and regulations would increase the interest of foreign investors to make India a hub of medical devices which would only satisfy the investors but also consumers as well, who will now be assured for the quality of these products manufactured in India.

In the press release dated Feb 2^nd 2017, the Health ministry stated 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”.

Broad Structure of Rules

This rule broadly consists of 97 Rules with 1 saving clause, 8 schedules with over 40 forms which broadly includes all the parameters, requirements, procedures, fee applicable, documents requirements for acquiring or registering for the medical device company or procuring the import/export/manufacturing license.

As discussed earlier these rules have been framed on the lines of the guidelines formulated by GHTF guidelines and in consonance with this these rules classify medical devices into 4 categories based on associated risks from Class A with low risk devices to Class D being the highest. Following given some examples of these examples associated with their risk factor:

• Class A – Cotton wool, Examination gloves, enema devices, bandages etc.
• Class B – anesthesia breathing circuits syringes and sets for infusion pumps etc.
• Class C – removable dental prosthesis, urethral stent, contact lens, harmodializers etc.
• Class D – dedicated disposable cardiovascular surgical instruments, angioplasty balloon catheters, spinal needles etc.

Single Window Clearance

All applications for import, manufacture, sale or distribution and clinical investigation, whether to be accessed by the DGCI or State licensing authority, will have to make through a single online portal of the central government. This would not only benefit the manufactures but would also be an successful initiative in the PM’s ‘Digital India’ initiative.

New thresholds for Residual shelf life

The 1945 Rules prescribes that all imported products should have a minimum residual shelf life of 60% on the data of import which became an issue for importers of short claimed shelf life. The new rules have relaxed these norms with short shelf life. Any medical device, whose total shelf life claim is:

1. Less than 90 days, will be allowed to be imported if it has more than 40 % residual shelf-life on the date of import.
2. Between 90 days and 1 year, will be allowed to be imported if it has it has more than 50 % residual shelf-life on the date of import.
3. Is more than 1 year, will be allowed to be imported by the licensing authority if it has more than 60 % residual shelf-life on the date of import.

A new Framework for Clinical Investigation

With the outset of these new rules, parliament has also introduced a new regulatory framework for clinical investigation this will guarantee the quality of these devices. Below mentioned is some of the interesting provision of this new framework:

1. A fixed timeline of ninety (90) days has been prescribed for the licensing authority to arrive at a decision on application for permission to conduct clinical trial.
2. After obtaining permission to conduct clinical trial, the first subject is required to be enrolled within one year.
3. New concepts of Pilot Study (i.e. exploratory study) and Pivotal Study (i.e. confirmatory study) have been introduced with respect to approval of investigation medical device.
4. New concept of “substantial equivalence” to predicate devices has been introduced with respect to approval of medical devices other than investigational medical devices.
5. The clinical performance evaluation of In Vitro Diagnostic Devices is now part of the regulatory framework.
6. Any institute, organization, hospital run or funded by the Central Government or the State Government is exempted from payment of fees for conduct of clinical investigation.
7. Academic clinical trials do not require prior approval of the licensing authority for its initiation if the data generated during the study will not be used for obtaining manufacturing or import license.

License & no need for renewal

The best part of these new rules which they have incorporated is that the licenses would be issued to the manufacturers and importers in perpetuity until they are surrendered or cancelled. However, there is a mandate to pay the renewal every 5 years.

The pre-requisite mentioned under the device rules to obtain the manufacturing license needs to followed and as these are regulated by both Central & state governments. The device type Class A or B application needs to be submitted to the state licensing authority whereas the device type Class C or D application needs to be submitted to the central licensing authority and all these applications will be made through a single online portal of the central government. With the new set of rules, the new system might cause a problem to the manufactures onsite but will turn out to be advantageous for long duration.

Labeling

Earlier, the only regulatory framework for the purpose of labeling was The Legal Metrology (Packaged Commodities) Rules, 2011 but now with the outset of these new sets of rules. The manufactures/sellers need to abide with both of them. The Devices Rules prescribe the contents of the label such as name of the medical device, month and year of manufacture and expiry, the manufacturing license number etc except the devices which are meant to be exported.

Major Drawback

In regard to the rule of interpretation of statutes the rules cannot be bind over the statute. Similarly, as per the Drugs & Cosmetics Act, 1940 where they have mentioned the definition of medical devices under the head of drugs would have the effect that the medical device would still be i.e. after these rules come under the effect the medical device would continue to be tied up with the definition given in the act and would be continue deemed to be drugs only until any further notification. Similarly, the repercussions of this would also be on the Drugs (price control) order,2013 which had been issued under the Essential commodity act wherein they have notified drugs under the essential commodity and drugs as per the act includes medical device. Therefore, medical device would be subjected to limited price control. The government should have separated the definition of medical devices from the definition of drug, this inadvertent tragedy can be avoided.

Conclusion

In the scenario of ‘Digital India’, ‘Make in India’, such new initiative are highly appraised. These would not regulate the whole structure holistically but also would bring more clarity in this segment which can attract more investors in one of the fastest growing medical devices markets in the world. Lastly, such important measures to encourage compliance to safety standards among stakeholders in the industry, the government may provide some more incentive schemes for this industry to adopt safety norms and a new rise in this field.