The government plans to bring all medical devices, including implants and contraceptives, under the lens of the Central Drugs and Standard Control Organisation so as to improve their safety and quality.
In a draft notification today, the Ministry of Health and Family Welfare said it plans to define all medical devices, which were earlier not under the purview of the apex drug controller, as drugs under the Drugs and Cosmetics Act effective December 1.
While the government has sought comments from all stakeholders within 30 days before the draft notification is finalized, in the draft notification the timeline for implementation is December 1.
Once finalised, the import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI).
Apart from certain implants and contraceptives, the draft notification also plans to recategorize medical devices that are used for life support, diagnosis, treatment or alleviation of any disease or disability, and even devices that are used to disinfect other medical devices.
The increased scrutiny on medical devices comes in the aftermath of Johnson & Johnson’s faulty hip implants.
The reclassification follows a recommendation by Drugs Technical Advisory Board (DTAB), the government’s top advisory body on drugs, in its meeting earlier this year.
“Representations have been received from various stakeholders for regulating all non-notified medical devices since concerns have been raised from time to time in different fora regarding safety, quality and performance of various Medical Devices including diagnostic kits manufactured/imported in the country," minutes of a DTAB meeting on 2 April said.
The move follows the notification of other medical devices, including nebulisers, blood pressure monitors, digital thermometers and glucometers, as drugs earlier, and is part of a broader move to regularize and enhance the safety and quality of these medical devices.
In February, the government had put implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-Ray machines and bone marrow cell separators under the purview of the Drugs and Cosmetics Act.
Once these devices are classified as drugs, the Central Drugs Standards Control Organization (CDSCO) will be responsible for regulating them.
To ensure that the CDSCO will be able to cater to the extra workload, the DTAB had recommended the creation of another post of additional drugs controller, with four joint drug controllers under him, as well as hiring over 200 new officers in various other posts.
The DTAB had also recommended various other measures to boost the capacity of CDSCO to handle the extra workload, including more space at the headquarters and five new testing laboratories.
“What’s missing in covering note of under secretary is a stated policy or an assured road map to a separate Medical Devices Law with a Defined Transition period and in a phased manner , including a voluntary registration phase to regulate all devices at one go," Rajiv Nath, forum coordinator for Association of Indian Medical Device Industry said in a statement.
Nath expressed concern about the short timeframe given for implementation of the new norms, which contrary to what had been discussed by the industry and the government before. The discussions earlier gave a three to five year period for phased transition to the new norms, he said.