Pharmaceutical companies in India

Govt. notifies all medical equipment used on humans or animals as 'drugs'

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The Union Health Ministry has notified all medical equipment, from syringes, PET scanners to dialysis machines, as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020.

The ministry, through a gazette notification dated February 11, 2020, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.

The notification reads, "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."

Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).

All devices, including Intra Uterine Devices, Condoms, Tubal Rings, Surgical Dressings, Umbilical tapes, Blood/Blood Component Bags, Organ Preservative Solution, Nebulizer, Blood Pressure Monitoring Device, among others, will be regulated under the legislation.

Malini Aisola from the All India Drug Action Network said, “While this is a positive step, as per the timeline, it will still take a long time before many higher risk devices are regulated.”

She stated, “We are particularly wary of the CDSCOs competence, expertise and most importantly its commitment towards patient safety given its dismal track record.”

Rajiv Nath, Forum Coordinator, AiMeD said, “While we manufacturers are ok to be regulated under a Risk Proportionate Medical Devices Rules 2017 we are highly uncomfortable to be regulated under the very rigid and prescriptive Drugs Act as any non conformity can be treated as a criminal offence by any Drug Inspector at his discretion and hauled before a court and there are no risk proportionate penalties.”

He stated, “We have been seeking an assurance from Union Health Ministry that this is a temporary measure until the NITI Aayog drafted Bill to regulate Devices separately from Drugs becomes a separate Law but no meeting has been called by the government to address these apprehensions.


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