India’s apex drug regulator, the Central Drugs Standards Control Organization (CDSCO), has clarified that the existing rules do not provide for granting import licenses for regenerative medical devices, leaving no stone unturned on the thorny issue of importing regenerative medical devices. It put an end to it.
“The Medical Devices Regulations 2017 do not have any special provisions regarding the regulation of regenerative medical devices. Therefore, no import permit will be issued for such devices and they cannot be imported into the country for sale and distribution.” This is stated in a letter from CDSCO to the secretariat. This was announced by the Chief Commissioner of Customs, New Delhi on January 10th.
Domestic medical device manufacturers are importing refurbished and second-hand medical devices, even though similar devices are being manufactured in India, which is against the government’s policy of promoting ‘Atma Nirbhar’. has been protesting against the import of used medical equipment for several months. Or independence.
“Suspending the import of regenerative medical devices is a genuine policy intervention that protects the domestic industry from dumping of medical devices of uncertain quality, and also supports patients in receiving appropriate medical care, thereby benefiting them and their patients. Payers, including insurance agents, that will deliver the best value for money. This is a welcome and long-awaited intervention,” says Dr Jitendra Sharma, Managing Director, Andhra Pradesh Medical Technology Zone (AMTZ), Visakhapatnam.
