Government to bring all medical devices under Drugs and Cosmetics Act

To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry has proposed to "notify" all such equipment used on human beings or animals as "drugs" so as to regulate them under the Drugs and Cosmetics Act. Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).

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Medical devices under the law

At present, only 23 medical devices are regulated under the law. The country's highest advisory body on technical issues related to drugs and medical devices, the Drugs Technical Advisory Board (DTAB), had in April recommended that all medical devices should be notified as drugs under the Drugs and Cosmetics Act.

"The aim is to regulate them so that they meet certain standards of quality. Besides it will also make medical device companies accountable for quality and safety of their products," a senior official said.

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Bringing medical devices under regulation has been high on the agenda of the ministry since the Modi dispensation assumed office for a second term, with some incidents of adverse reactions and impacts of medical devices coming to light in the past few years. The global pharma giant Johnson and Johnson was recently directed to pay compensation to patients who received faulty hip implants made by it.

"In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December, 2019," the draft notification read.

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As part of the draft notification, 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. Such medical devices also include those used for the purpose of supporting or sustaining life, disinfection of medical devices and control of conception. The draft notification has been put up on the ministry website. The ministry has sought suggestions and feedback from the public and stakeholders within 30 days.

CDSCO to investigate quality and safety aspects of devices

Once the notification is issued, the 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. The ministry had in February put implantable medical devices, CT scan equipment, MRI equipment, dialysis machines and X-Ray machines and a few others under the purview of the Act.

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