ABSTRACT
India has been recognized for its quality pharmaceuticals and is largely self-sufficient, but for medical devices it is mostly dependent on imports. Currently, there are no separate medical device (MD) regulations in India, and there is a serious mix up of drug and device regulations. The MD regulations are evolving and the direction is that the MD regulations would shape up in line with Global Harmonization Task Force (GHTF) guidelines. The Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 are currently applicable to drugs as well as medical devices. The regulatory mechanism in India consists of a two-tier system, one in the centre, the Drugs Controller General of India (DCGI), and one each in states and in union territories. The Indian Pharmacopoeial Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare, Government of India, dedicated to laying down standards for drugs, pharmaceuticals and healthcare devices/technologies besides providing reference substances and training.
