Decision is going to have a major impact on the small and marginal players, largely unorganised, in low-value high volume segment of medical devices industry

Indian medical device sector is in for a major disruption after the central government notified all medical devices — syringes to PET scanners to dialysis machines — as drugs for quality certification and monitoring purposes on February 11. The new rule will be applicable in a staggered manner, with the compliance requirements for most products kicking in on April 1, 2020.



The Ministry of Health notification said 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 will come under the purview of Drugs and Cosmetics Act for regulatory approval.



The notification clarifies that the primary intended action of the device in or on human body or animals should not be pharmacological or immunological or metabolic, but may assist in the diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder. The devices used for diagnosis, monitoring, treatment, assistance for any injury or disability, investigation, replacement or modification or support of the anatomy or of a physiological process will thus come within the scope of this definition, it said.

The products meant to support or sustain life, meant for disinfection of medical devices and control of conception will also come under this category. The decision is going to have a major impact on the small and marginal players, largely unorganised, in the low-value high volume segment of the medical devices industry.

Of the estimated size of $5.2 billion, close to 30 per cent is known to be the market for consumables and patient aids. The hi-tech diagnostic imaging sector is dominated by large players and will be the least impacted. The government has provided specific timelines for the implementation of the rule for different products.

 

While local importers or manufacturers of 24 items, including surgical dressings, bone cements, heart valves, cardiac stents, condoms, blood component bags, will see the new rule applicable from April 1, 2020, it will be effective for ultrasound equipment from November 1, 2020. Nebulizer, blood pressure monitoring device, glucometer and the digital thermometer will come under the purview of the new registration requirement from January 1, 2021.



In the last category, where compliance date is fixed from April 1, 2021, there are eight items including PET equipment, bone marrow cell separator, all implantable medical device equipment and MRI equipment. “We are okay to be regulated under a risk proportionate Medical Devices Rules 2017, we are highly uncomfortable to be regulated under the very rigid and prescriptive the 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 is no risk proportionate penalties,” Rajiv Nath, MD of Hindustan Syringes and coordinator of AiMeD, an association of Indian medical device makers say.

“We have been seeking assurance from the health ministry that this is a temporary measure until a NITI Aayog drafted a bill to regulate devices separately from drugs becomes a separate law but no meeting has been called to address these apprehensions,” he adds.

Consumer groups welcomed the move but expressed doubts over the ability of the drugs department to regulate medical devices. Incidentally, the health ministry had earlier tried to bring in four digital thermometers, nebuliser, blood pressure monitoring devices and glucometer under the ambit of the Drugs Act from January 1, 2020.

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