Medical Devices Notified As Drug

  • On 11th February, 2020, the Ministry of Health and Family Welfare notified changes in the Medical Devices Rules, 2017, bringing a range of products from instruments to implants to even software intended for medical use in human beings or animals under the purview of the Drugs and Cosmetics Act,1940.
  • The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.
  • The changes made will be effective from 1st April, 2020.

Aim

  • To ensure all medical devices in the Indian market follow safety and quality standards.

Background

  • The country's highest advisory body on technical issues related to drugs and medical devices, the Drugs Technical Advisory Board (DTAB), had in April 2019 recommended that all medical devices should be notified as drugs under the Drugs and Cosmetics Act.

Need for Such Move

  • Past few years, the health sector has been at the centre of attention following revelations about faulty hip implants marketed by pharma major Johnson & Johnson. This has caused major embarrassment to the government, too, as it exposed the lack of regulatory teeth when it came to medical devices.
  • Presently, only 23 categories of medical devices are regulated under the Act.

Key Changes

Wider Coverage

  • It will cover all devices, including instruments, apparatus, appliance, implant, material or other articles -whether used alone or in combination, including software or an accessory - intended by its manufacturer to be used especially for human beings or animals.

Host of Devices

  • A list of 37 devices has been drawn up including syringes, needles, stents, catheters, intraocular lenses, intravenous cannulae, prosthetic replacements, ligatures, sutures, staplers, condoms, blood bags, nebulizers, blood pressure monitoring machines and digital thermometers.

Online Documentation & Identification

  • The manufacturer or importer will have to upload the generic name, model number, intended use, class of medical device, material of construction, dimensions, shelf life and brand name on the online portal of the Central Drugs Standard Control Organisation (CDSCO).

Timeline for Various Classes of Medical Devices

  • Further, the notification also provides timelines for medical devices that will be notified under the Act with effect from April 1 - the low to moderate risk category A and B devices from 30 months after the notification and moderate to high risk category C and D devices 42 months onwards. Upon the expiry of these time periods, all provisions of the Medical Devices Rules 2017 will apply to the respective devices.

Central Drugs Standard Control Organisation (CDSCO)

  • CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India.
  • CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
  • Functions: Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations.

Risk-Based Classifications for Medical Devices

  • CDSCO  has classified the medical devices according to the risks associated
    • Class A (Low Risk) - Absorbent cotton wools, surgical dressing, alcohol swabs
    • Class B(Low Moderate Risk) - Thermometer, BP monitoring device, disinfectants
    • Class C(Moderate High-Risk) -  Implants, hemodialysis catheter
    • Class D(High Risk) -  Angiographic guide wire, heart valve

Expected Impact

  • Ensuring Accountability and Transparency: It will make medical device companies accountable for quality and safety of their products being provided across the country. The temporary registration application for devices that are currently unregulated will  now become regulated ensuring transparency, leading to better growth of the medical device industry.

Criticism

  • According to the Association of Indian Medical Device Industry (AIMED), the move is going to impact small manufacturers as it would not be sustainable for them to hire a qualified quality management system(QMS) manager with biomedical engineering for quality check.
  • Almost all low-risk Class A category products like orthopaedic collars and pillows, spectacles and wheel-chairs and stretchers, etc, are made by MSMEs. Most small manufacturers can't comply with and have qualified regulatory staff to meet the Medical Device and Diagnostic Rules (MDR) Schedule 5.
  • However, the hi-tech diagnostic imaging sector is dominated by large players and will be the least impacted.
  • Further, under the Drugs Act, any non-conformity to guidelines can be treated as a criminal offence by any drug inspector at his discretion and hauled before a court and there is no risk proportionate penalties.
  • The Surgical Manufacturers and Traders Association, another body that represents wholesale traders and MSME device manufacturers, has also criticised the government's move, saying it may lead to the closure of thousands of small and micro units and impact consumers by way of high prices as imports will become multiple times costlier.

Way Forward

  • On the whole, the move is a positive step. However, consumer groups remained sceptical about the ability of the Central Drugs Standard Control Organisation to regulate devices under the wider scope.
  • There is need for comprehensive reforms to strengthen the regulatory mechanism in relation to patients' safety, which includes guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme.

 

Source : Civil Services Chronicle Online, February, 2020