IGMPI India

To improve the quality of manufactured medical devices Health Ministry of India has proposed amendment to Schedule MIII of Drugs and Cosmetics Rule, 1940. Recently Health Ministry of India has set up a committee to give suggestions on proposed amendment of Schedule MIII under the D&C Rules towards enhancing good manufacturing practices (GMP) globally. Schedule MIII describes good manufacturing practices and requirements of premises, plant and equipment for medical devices and in vitro diagnostic kits & reagents. Drugs Controller General of India (DCGI) in the meeting informed the committee members that Schedule MIII was proposed to be amended to provide good manufacturing practices for Medical Devices. The requirements of premises, plant and equipment for medical devices and in-vitro diagnostic kits and reagents also need to be addressed. Committee consisting of officials from Maharashtra and Gujarat Food and Drug Administration, Pharmacy Council of India (PCI), representatives from the medical device industry and experts in the field of cardiology, orthopedic and ophthalmology. Committee will examine the issue in totality including the proposed amendment and give its recommendations.