Exempt Licensing Requirements on Sale of Preventive Healthcare Devices to Fight Covid-19: IAMAI

In a bid to intensify the fight against the Covid-19 pandemic, the Internet and Mobile Association of India has urged the Centre to allow the sale of preventive healthcare devices – Nebulizers, BP monitoring machines, Digital Thermometer, and Glucometers, through non-licensed entrepreneurs.

At present, there are about two million drug stores in the country. Restricting the sale of these commonly used products only from a licensed pharmacy make these severely less accessible to the public. The association is of the view as the manufacturing and import of these devices are already strictly regulated by the Government of India, these medical devices are adhering to relevant ISO standards and are supplied “non-sterile”, so there’s no question on quality being compromised.

Further, neither of these devices has any specialized storage requirements, operational requirements nor possesses a date of expiry that would require special care at the point of sale. Based on the above, IAMAI believes that there is no significant requirement of having a registered pharmacist to oversee the sale of such medical devices.

“We wish to draw your kind attention to a similar situation related to the sanitisers and the applauding measures taken by the Government to exempt them from sale license that increased their accessibility to the public at large. Considering the recent surge of Covid-19 in many parts of the country, it is timely to remove any kind of sale restrictions on these devices -– Nebulizers, BP monitoring machines, Digital Thermometer, and Glucometers,” IAMAI stated.

“Limiting availability of these proactive care devices might inadvertently create a notion that these products are in short supply in the market. This also prevents the public gathering or crowding in pharmacy stores or clinics/ hospitals to purchase such devices,” the association said.

Stringent compliance requirements for these commonly used devices, equivalent to a drug, is against the ease of doing business. Any additional compliance on small-scale sellers would result in a prohibitive cost (up to ~INR 2.5 lakhs/annually) for applying for the drug license, its timely renewal, and the salary of the pharmacist. This will act as an additional liability to a majority of small-scale retailers.

The Government of India, vide Notification No 5980(e) dated 3rd Dec 2018, has brought commonly used medical devices -- nebulizers, blood pressure monitors, digital thermometers and glucometers-- at par with the drugs under the Drug and Cosmetics Act (1940) and Rules thereof, effective 1st January 2021. As an impact to the industry, all manufacturers and importers need to register their products with the Central Drugs Standard Control Organization (CDSCO) and all sellers need to obtain valid drug retail sale license for their premises to store and sell these devices.