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Union Health Ministry notifies medical equipment used on humans or animals as "drugs"

"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 April 1, 2020," the notification read.

, ET Bureau|
Last Updated: Feb 11, 2020, 09.13 PM IST
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Medical
Medical equipment include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.

In a bid to ensure that all medical devices meet certain standards of quality, the Union Health Ministry on Tuesday notified medical equipment used on humans or animals as "drugs" with effect from April 1, 2020, which means that now all imported, as well as locally manufactured medical devices sold in India will be required to clear specific safety and quality standards before they are introduced in the India market.

Medical equipment include all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.

Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI). Besides it will also make medical device companies accountable for quality and safety of their products, a senior official said.


"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 April 1, 2020," the notification read.

At present, only 23 medical devices are regulated under the law.


As per the new 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.

India’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.

Consumer groups however remain skeptical about the CDSCO’s current ability to regulate devices under the wider scope. “We are particularly wary of the CDSCOs competence, expertise and most importantly its commitment towards patient safety given its dismal track record. We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety.These may include 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,” said Malini Aisola, CO-convenor, All India Drugs Action Network (AIDAN).

However, there is a caveat. According to another notification India will have to wait long enough before all its higher risk devices are regulated. The timeline for subjecting medical devices from low risk to moderate/high risk to be notified ranges from 2.5 years to 3.5 years respectively.

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