To ensure that all imported as well locally made medical devices meet certain quality standards, the health ministry has proposed to regulate all such equipment used on human beings or animals. The union health ministry has come out with the draft notification, making it mandatory for all the devices to get certified by the Central Drugs Standard Control organisation (CDSCO), India’s drug regulatory authority.
According to the draft notification dated Oct 18, “In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December, 2019,” the draft notification reads.
At present, only 23 medical devices are regulated under the Drugs and Cosmetics (D&C) Act.
According to the draft notification, while certification by the regulatory authority will be on voluntary basis up to 18 months from date of notification, thereafter it will be made mandatory.
The country’s top advisory body on drugs, the Drugs Technical Advisory Board (DTAB), had in April recommended that all medical devices should be notified as drugs under the existing Drugs and Cosmetics Act.
ET had first reported about the government’s agenda to bring medical devices under regulation. The government decided to update its review process in the wake of recent case of Johnson & Johnson (J&J) hip implants which left many people permanently disabled due to the faulty device.
As part of the draft notification, “all devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others”, will be regulated under the legislation. Such medical devices also include those which are used for the purpose of supporting or sustaining life, disinfection of medical devices and control of conception.
Rajiv Nath, Forum Coordinator, AiMeD “What’s missing in covering note is assured road map to a separate medical devices law with a defined transition period and in a phased manner, in addition to the voluntary registration as a temporary measure under the current Drugs Act”.
The stakeholders have been given a month to respond to the draft notification.
The manufacturers, importers will have to upload information about their devices on the “Online System for Medical Devices” established by CDSCO for this purpose. Once the information is uploaded a registration number will be generated which the manufacturers will have to put on the label of the medical device. The manufacturers will also have to have certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of their medical device.
The importers will also have to also obtain free sale certificate from country of origin before they enter the Indian market.
Once notification comes into effect, the Central Drugs Standard Control organisation (CDSCO) will be the nodal authority to investigate quality, safety related failure, complaints and can suspend the registration based on the outcome of investigation. Currently there is no mechanism for reporting the malfunctioning of non-notified medical devices.
Once notified, there will be an effective product recall system, inspection of manufacturing sites by CDSCO.