All store owners selling thermometers, condoms, face masks, spectacles, or any other medical device will now have to get registered with the state licensing authority, with the amendment to the medical device rules coming into effect. The new regulations will allow easier traceability of medical devices, especially where a recall is initiated.

Those seeking the licence under the new regulations will have to show that they have adequate space for proper storage, have requisite temperature and lighting conditions. They are also required to purchase the devices only from a registered manufacturer or importer, besides maintaining a record of the customers, batch or lot numbers of the devices for a period of two years.

The stores will also have to provide details of ‘competent technical staff’, essentially anyone who is a graduate, or is a registered pharmacists, or has at least one-year experience of selling medical devices.

“It is good to see that most of our recommendations have been accepted in the notification. It is good that the notification states that people who have experience in selling medical devices can continue to do so,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AIMED).

He added that a fool-proof record-keeping methodology might need to be devised. “Such kind of record-keeping is definitely good, but how can we ensure a grocery store owner or paan wala selling masks and condoms keeping a record?” said Nath.

The registration, unless suspended or cancelled by the state licensing authority, will be valid “in perpetuity” as long as the retention fee of Rs 3,000 is paid every five years.

The notification also states that the licensing authority – usually the state drug controller, but a separate authority may also be established if the states want to – will have to process the application within 10 days. If the application is rejected, the authority will have to state the reason in writing. In case the registration is not granted, the applicant can approach the state government within 45 days of rejection of application.

However, the registration is not necessary for existing medical stores, stockists, and wholesalers.

“All medical stores already have a licence under Form 20, 21, 20B, or 21B under the current Act. They are not required to get registered again under the new regulations,” said Rajiv Singhal, general secretary of the All India Organisation of Chemists and Druggists (AIOCD).

There are around 9.5 lakh medicine retailers in the country.

Singhal added that other than non-medical stores selling safe medical devices such as spectacles, the big distributors of medical devices such as X-ray machines will also need to be registered under the new regulations. “So far, there was no regulation for registration of these big distributors,” said Singhal.

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Anonna DuttAnonna Dutt is a health reporter with the Indian Express. She writes o... read more