Do We Need a Drug License To Sell Oximeters in India?

medicine license

Medicine license:

The government has not placed oxygen concentrators under the Drugs Act, but these portable oxygen production machines can be sold under voluntary license registration until September. All wholesale and retail stores selling medical devices in the country will soon need to be registered by the drug regulatory authorities of the states they operate. The way in which DCA and MDR ensure the quality and safety of reported medical devices at all levels of the supply chain is to enforce a binding licensing requirement. The supply chain of the device in question also does not require a license simply because the importer or manufacturer of medical devices has applied for and obtained a drug license.

The scope of DCA is limited only to those medical devices that are reported by the government from time to time as “drugs” (commonly referred to as “notified medical devices”). The government initially registered all medical devices as medicines in order to maintain regulatory control over the manufacture of medical devices. The supply chain of newly notified medical devices (including marketers) must also be licensed to distribute them (i. Sanjiiiv Relhan, chairman of the Preventive Wear Manufacturers’ Association of India (PWMAI), welcomed the development and said that there was no regulation in the medical device trade more visible during the Covid-19 pandemic than anyone was allowed to store and sell medical devices such as pulse oximeters, infrared thermometers and PPE regardless of their quality.

This blog does not provide medical advice. It is intended for informational purposes only. Do not use it as a
substitute for professional medical advice, diagnosis, treatment, or disease prevention. Always seek the
advice of your physician or qualified healthcare providers for any questions you have regarding a medical
condition.

(medicine license)

The views and opinions expressed on this blog are solely those of the original authors and other
contributors. These views and opinions do not necessarily represent those of Gabriel Nieves, LAC
Healthcare Solutions, LAC.us Staff, and/or any/all contributors to this blog/site.

References:

Gabriel Nieves

After experiencing a variety of shortages, crises, and inefficiencies in the status quo of the procurement and distribution industry, I undertook the responsibility of building an interface for large organizations to abstract away uncertainty throughout their supply chain under most conditions.

We are focused on building a framework from which our teams of professionals on the ground can provide a new generation of procurement support and professional services for supply chain critical organizations around the nation.

We understand that the marketing process of critical supplies is a matter of national security and public safety. In this, we found our passion and mission: developing technologies, supplier networks, and platforms for the organizations that need it most.