Medical devices to be treated as medicines; Approval mandatory
Kochi: All devices used as part of medical treatment are soon to be treated as medicines. The central government has issued a draft notification in this regard. All medical devices should be notified from December 1. With this move, importing and distribution of medical devices without proper examination and for unaffordable prices can be regulated. Even corporate companies are supplying such machines at very high prices.
According to the present law, levying compensation for the faults in installation of equipment is a difficult task. The Drugs Technical Advisory Board submitted the recommendation in this regard to the Ministry of Health in last April. The draft bill was published on the basis of this.
All devices for diagnosis, alleviation and monitoring will come under the purview of the new regulation. Disinfectant devices, life support devices, contraceptives and other similar equipment also will come under this. Certification of the Central Drugs Standard Control Organisation (CDSCO) has been made mandatory for the manufacturing and distribution of such devices.
Certification for the equipment that are already installed can be obtained within 18 months from December 1. Further actions will be taken after this. The feedback regarding the draft notification should be conveyed within 30 days. Only 23 key devices are included in the category of drugs at present. Some of them are included in the essential medicine list for price regulation.
At present, bypass stent, artificial knee implant devices, lens for cataract surgery, some types of syringes and contraceptives are included in the list of drugs. When the new norms are implemented, x-ray, scanning machine, colour doppler, heart-lung machine, ECG monitor, bandage, pacemaker, glucometer, thermometer, stethoscope, BP monitors, disinfectants etc. will also come under its purview.
All India Drug Action Network co-convenor Malini Aisola said that they welcome the new regulation. She added that further procedures are required to take strict action for those who are victimised to such devices.