Updated: Nov 18, 2019
The Government of India issued a new draft for the amendments in the existing Drugs and Cosmetics Act passed on 10th April 1940. In order to ensure that all the medical devices meet certain quality standards, the government has proposed to include all equipment be it medical or anything used on human beings or animals under one single act.
The health ministry has come out with the draft and hence made it mandatory for all the devices to get the certification by the Central Drugs and Standard Control Organisation (CDSCO) which is India’s drug regulatory authority.
Currently, only a total of 23 devices have been registered under the Drugs and Cosmetics Act, to date. As per the draft, the certification by the Authority(CDSCO) will be on a voluntary basis up to 18 months from the date of notification, thereafter it has to be made permanent. According to the draft notification, while certification by the regulatory authority will be on a voluntary basis up to 18 months from the date of notification, thereafter it will be made mandatory.
What equipment will be covered by the amended Act?
The draft includes,” all devices, be it instruments, apparatus, appliances, and implants used in purposes like diagnosis, prevention, treatment, disease investigation, replacement or modification or support devices”. All the medical devices and equipment will be from now on included under a single framework. The act is on hold as the stakeholders have been given some time to respond to it.
What is the process to register new equipment?
The online portal by CDSCO,i.e., Online System for Medical Devices (https://cdscoonline.gov.in/CDSCO/homepage) will have the option to upload the information about the devices by the manufacturers and importers. Once the information has been uploaded, the devices will get a registration number that has to be labeled on the devices for the quality and checking purposes. The manufacturer will also have to have a Certificate of Compliance to ISO 13485 standard accredited by the National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of their medical device. As per the new governing rule, the importers have to have a Free Sale certificate from the origin before they enter the Indian market.
Who will this benefit?
Manufacturers & Distributors
Hence, now all the systems will be channelized by CDSCO making it easier for traders, manufacturers, and importers. Once, the new framework comes into action, CDSCO will be responsible for the quality check, safety compliances, any complaints or safety investigation and will act as the nodal authority. If the devices are found not adhering to the compliances, their registration is subject to cancellation by CDSCO.
Doctors & Patients
The new framework and the Act will actually help the consumers as currently there is no provision of reporting the malfunctioning pertaining to devices.
Although the new proposed framework has received criticism from all over for medical devices still being referred to as “Drugs”, the Medical Technology Association of India(MTAI) has applauded the decision made by the government of India for regulating all the medical devices under one framework. Hence, it looks like the medical industry has to wait for the final amendment and corrections proposed to happen earlier this month.
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