Video Summary

[RSTV The Big Picture] Medical Devices Under Drugs Law

To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry on Tuesday notified medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics Act, 1940 with effect from April 1, 2020.
By IT's Video Summary Team
February 24, 2020

Contents:

  • Introduction
  • Aim
  • Medical Rules in India
  • What are the new provisions?
  • Need for the regulations
  • Significance of the move
  • Apprehensions and Concerns
  • Conclusion

Medical Devices Under Drugs Law

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Introduction:

The Union Health Ministry has notified that every medical equipment would qualify as“drugs” under Section 3 of the Drugs and Cosmetics Act, 1940 with effect from April 1, 2020.

  • The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.

Aim:

  • To regulate all medical devices so that they meet certain standards of qualityand efficacy.
  • To make medical device companies accountable for quality and safety of their products.
  • Toremove sub-standard devices from the market.

Medical Rules in India:

  • The definition of medical devices was inserted in 1982, under the definition of drug in the Drug& Cosmetic act 1940.
  • Drugs fall under concurrent list of India and at present, only 37 categories of medical devices are regulated under the law.
  • Until now only the notified devices are considered as drugs.
  • Theroadmap for the Medical Devices was deliberated for a long time and made in consultation with all stakeholders includingMinistry of Healthand Family Welfare(MoHFW), Bureau of Indian Standards (BIS), Federation of Indian Chambers of Commerce & Industry(FICCI), Confederation of Indian Industry (CII), Department of Pharmaceuticals, NITI Aayog and others for bringing all devices under drug category.
  • Medical devices Rules 2017: In order to offer the highest degree of professionalismin regulation of medical devices, the medical rules were floated. They offer clear cut regulations on how to get license, registration, manufacture and import of Medical Devices. The rules came into effect from January 1, 2018.

What are the new provisions?

  • After the law comes into effect, the manufacture, import and sale of all medical devices will now need to be certified by the Central Drugs Standard Control Organisation (CDSCO).
  • Medical equipment under this definition include implantable medical devices such as knee implants, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine etc.
  • The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.
  • All devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others, will be regulated under the legislation.
  • Compliance requirements for low risk (Class A) and low moderate risk (Class B devices) will be enforced only after 30 months& Class C and D after 42 months.

Need for the regulations:

  • With mulling the laws, the ministry hopes will ensure that the equipments follow quality standards.
  • Besides it will also make medical device companies accountable for quality and safety of their products.
  • CDSCO will be the nodal authority to investigate complaints related to the quality and safety aspects of medical devices and can suspend the registration or cancel licences of firms.

Significance of the move:

  • The new regulations will enhance the patient safety in the long run.
  • They will help Indian companies to come up to international standards of quality and integrate with global regulations.
  • This will ensure high quality production thereby enhancing exports.
  • They will help in attracting Foreign Direct Investment (FDI) in the medical industry.
  • The rules will be a win-win situation for manufacturers, sellers, importers and consumers.
  • It will also formalize the industry in much better way, enabling ease of doing business for new entrepreneurs.
  • India is still dependent on the imports of 70 % of the medical devices, in contrast to India exporting a lot of consumable drugs. Hence, the move is expected to boost production, r5educe import and promote export of medical devices.

Apprehensions and Concerns:

  • There is a need for some more clarity on regulations regarding equipments and their parts.
  • The small manufacturers with smallscale production oflow risk devicesare seeking some concessions regarding standards of manufacturing, over medium risk and high risk devices.
  • The manufacturers under regulatory ambit need sometime period for capacity and capability building.
  • They must be provided training workshops from Ministry of Health and Family Welfare and advice, guidelines and initiatives for helping them to conform to the law.
  • Medical manufacturers are demanding long term measures to regulate medical devices as devices under engineering products and not as medical drugs.

Conclusion:

The move to regulate the medical devices is a welcome and much needed stepto ensure quality, safety, performance of the medical equipments manufactured in India and also for patients’ safety. It will be beneficial for all the stakeholders involved and boost the medical devices export based economy of the country in the long run.

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