Medical devices now under ambit of regulations, DFCO issues guidelines

Directions for the registration of medical devices, which were formerly unregulated but are now covered by rules, have been issued by the Drug and Food Control Organization (DFCO), J&K.

In this regard, the officials said that the sale/distribution of all Medical Devices, previously unregulated, including in-vitro Diagnostic Medical Devices have been brought under the ambit of regulation by the Government of India.

They said that any person not holding a license and intends to sell medical devices exclusively shall obtain a registration certificate as provided per the rules. DFCO said that in this connection, it has appointed competent authority to issue a Registration Certificate on Form MD-42 in terms of Order No. 78-DFO of 2022 dated: 20.10.2022.

“All relevant information is available on the official website of DFCO and can be reached at https://dfcojk.org. The intending applicants are directed to submit their application on Form MD-41 along with requisite documents in the shape of a hard copy in person.”

As per the amended rules, any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution.

Meanwhile, the authorities have also issued renewed directions, asking the licensing authorities to ensure that before granting the licenses, it is made sure that there are necessary arrangements done concerning the installation of CCTVs.

The officials said that the menace of drug abuse is assuming an alarming situation and instances have been reported where the pharma fraternity has been found indulging in unethical trade practices, particularly concerning the sale of intoxicating pharmaceutical preparations.

“The department has already initiated several steps to ensure that habit-forming drugs are sold by retail strictly as per legal provisions mandated under the Drugs & Cosmetics Act & Rules,” the officials said.

They said these steps are proving insufficient to check/curb the growing menace of drug abuse and it has become imperative to adopt a more stringent approach for maintaining better regulatory checks over the sale of intoxicating drugs.

The officials said that all the licensing authorities and inspecting officers have been directed to include a few more provisions in the checklist before issuing the license and going ahead with the renewals.

They said that the inspecting officers have been directed to ensure the installation of Full HD CCTV cameras with 1080p resolution and adequate data storage capacity for at least 6 months within the respective premises and all records of purchase and sale shall be maintained in a computerized manner