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Business News/ Politics / Policy/  Industry wary as govt charts plan to regulate all medical devices
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Industry wary as govt charts plan to regulate all medical devices

Confusion prevails over the need for a regulation, on whether to enact separate laws and likely impact on industry
  • Any stature, policy framework or decision should ensure patient safety. People should get affordable, quality medical devices, said NITI Aayog member Vinod Paul
  • Over 10,000 medical devices are sold in the country, but only 33 categories of such devices are regulated. Photo: Madhu Kapparath/MintPremium
    Over 10,000 medical devices are sold in the country, but only 33 categories of such devices are regulated. Photo: Madhu Kapparath/Mint

    As the government continues to chart plans to regulate the production, sale and import of all medical devices, clouds of confusion hover over the need for regulation, on whether to enact separate laws and the possible impact on the medical device industry.

    The ministry of health and family welfare recently proposed to notify or include all medical devices under the Drugs and Cosmetics Act, 1940, to regulate them as per the provisions of that Act and the Medical Devices Rules, 2017. According to the draft notification, devices intended for use on human beings or animals should be treated as drugs with effect from 1 December 2019.

    “We have proposed to include all devices, including an instrument, apparatus, appliance, implant, material or other article; whether used alone or in combination, including software or an accessory," said a senior official at the Central Drugs Standard Control Organisation (CDSCO) under the ministry of health and family welfare.

    The government notification pointed out that any device that has a purpose of “diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder; diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability; investigation, replacement or modification or support of the anatomy or of a physiological process; supporting or sustaining life; disinfection of medical devices; and control of conception" will be regulated.

    Public health experts are, however, of the view that medical devices cannot be treated as drugs and the need to regulate all the devices should be seriously reviewed. The NITI Aayog, the government’s policy think tank, is also working on a proposal to classify medical devices on the basis of their usage and risk to human health. It has also proposed a separate body to regulate devices stating that authorities handling it should also have special expertise, which the CDSCO doesn’t have.

    The medical devices industry is principally import-driven, with about 80% of equipment being sourced from other countries.
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    The medical devices industry is principally import-driven, with about 80% of equipment being sourced from other countries.

    The United Progressive Alliance (UPA) government had drafted a Biomedical Device Regulation Bill in 2006, but it could not get notified into an Act. The proposed legislation was further postponed by the National Democratic Alliance (NDA) government that notified rules for medical devices regulation under existing rules. Currently, the NITI Aayog is handling the bill as the health ministry has forwarded it for polishing.

    “Regulation of medical devices is required but of only for those having bearing on health such as stents, implants etc. Regulating cotton gauges, pipes and thermometers may be revised. The CDSCO is regulating everything through some rules under clauses, in my opinion drugs and devices should be separate," said Alok Kumar, advisor health, NITI Aayog.

    “Other things may be regulated standards basis or the industry can self regulate them, keeping in mind that it won’t procure an item which is below the prescribed standards. There are thousands of categories of medical devices and further sub-categories, the government cannot just regulate everything. The final motive should be to make devices affordable, least intrusive and not mess with the industry and market."

    In keeping with the argument of monitoring medical devices and drugs separately, a task force on medical devices in 2015 recommended formulating a Medical Device Regulatory Act.

    “Medical devices should be treated distinctly from drugs and a separate chapter for medical devices should be made in the existing Drugs and Cosmetics Act. This will provide dedicated, predictable, transparent, globally harmonized and appropriate regulations for medical devices and will ensure that medical devices are only subjected to device relevant laws and not to those relevant to drugs," the report said.

    “In addition to updated definitions, the new legislation would simplify import procedures and affect change across many areas including: manufacturing, sales, distribution and clinical trial of medical devices based on international benchmarks," it added.

    The medical devices industry is principally import-driven, with about 75% of equipment being sourced from other countries. Over 10,000 medical devices are sold in the country, but only 33 categories of such devices are regulated. Experts are of the view that there is a lack of proper regulatory systems, harmonized standards, accreditation, legal requirements, proper guidance on quality and best practices in India. All this has been adversely affecting the medical devices industry.

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    Published: 29 Oct 2019, 11:03 PM IST
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