The Drug Controller General of India (DCGI) in collaboration with World Health Organisation (WHO) is organising a two day seminar for the regulatory authorities and stakeholders of medical device industry from March 18 to 19 in Gujarat. With this seminar the DCGI aims to sensitise not only the regulatory authorities but also other stake holders about the Medical Device Regulation Bill that is expected to be passed in the Parliament.
Once the Bill on medical devices is passed by both the houses in the parliament it will be known as The Medical Device Regulation Act. This Act will focus on consolidating laws related to medical devices and to establish the medical device regulatory authority of India for establishing and maintaining a national system of controls relating to quality, safety, efficacy and availability of medical devices that are used in India.
With the enactment of the bill, the medical devices industry's long-standing demand for creating separate guidelines and definition for medical devices will be met with. H G Koshia, commissioner, FDCA informed that this seminar will focus mainly on sensitising the industry about the medical device regulation bill.
The Gujarat Food & Drugs Control Administration, (FDCA) will be co-ordinating with the DCGI and WHO to hold this event. This is the first time that the such a training seminar for medical device industry is being organised by the DCGI in the state.
Gujarat has 127 licensed medical device manufacturing units which is the largest in the country. Koshia informed that out of all the medical devices that are manufactured in the country more than 40 per cent including both new and old comes from Gujarat. Koshia points out, “Since Gujarat is considered as the hub of medical device industry it seems appropriate that this event be conducted here. This event targets at training the regulatory officials from different states and the stake holders across the country on the medical devises and the regulatory issues pertaining to it.”
He informed, that at present, medical devices is not considered as a separate entity and are treated as drugs under the Drug & Cosmetic Act with just nearly 20 notified devices regulated under this Act. Whereas there are still thousands of other devices that are outside the purview of D&C Act.
