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Nebulisers, BP monitoring devices, digital thermometers & glucometers to become 'drugs' from Jan 2020
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Arun Sreenivasan, New Delhi
December 11 , 2018
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Four more commonly used medical devices - nebulisers, blood pressure monitoring devices, digital thermometers and glucometers - will come under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics (D&C) Act 1940 from January 1, 2020.
The proposal to add these devices to the notified list was cleared by the Drug Technical Advisory Body, the country’s highest drug advisory group, at its meeting in July this year. Earlier this year, the Central Drugs Standard Control Organisation (CDSCO) had proposed to regulate medical devices such as CT and MRI scan equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator under the D&C Act to increase reliability. Once a medical device is notified, manufacturers and importers will have to get the regulatory body’s nod to sell these products in the domestic market. The devices are defined as ‘drugs’ under the D&C Act for the purpose of price and quality control and regulated using the Medical Device (MD) Rules 2017.
At present, India doesn’t have a comprehensive law to regulate the medical devices industry. Though the MD Rules came into force early this year, only 23 devices are regulated by the health ministry through its licensing authorities as of now, leaving the door open for unscrupulous firms selling products of dubious origin. Almost 95 per cent of medical devices, except the ones listed, don’t need any registration, licence or no-objection certificate for their import, manufacture, sale and distribution.
The CDSCO has been drawing flak from industry experts for getting their priorities wrong on regulating medical devices. Last week, the regulator initiated steps to add surgical gowns and drapes, relatively low-risk products, to its notified list, while critical and life-saving devices such as pacemakers, defibrillators and insulin pumps remain unregulated. Experts also pitch for policy changes to regulate devices as a group and not item by item, a major constraint under D&C Act. In the absence of sector-specific technical regulations, the BIS Act can be used to regulate all devices at one go, although a separate law for medical devices is imperative to fix accountability, they say.
“The government needs to regulate all kinds of devices at one go with a defined transition period; if the government is reluctant that it’s going to harm the industry, especially MSMEs, a calibrated approach of initially incentivising voluntary ICMED certification should be considered. Then in the next phase, pass quality control order under BIS Act to make certain provisions in the MD Rules mandatory for all manufacturers and imports,” Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry told Pharmabiz.
Instead of adhoc item-by-item addition to the notified list, the domestic manufacturers had suggested a list of 38 medical device categories to be regulated on priority basis, considering the higher proportion of risk. However, their suggestions remain largely ignored.
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