Decks have been cleared for formally implementing the comprehensive guidelines for the medical devices sector, with the Health Ministry is set to issue the notification in this regard very soon.
The minutes of the Drug Technical Advisory Board (DTAB) which was held sometime back and suggested the guidelines have been finally approved and sent to the Health Ministry for issuing notification, which may come anytime now, sources said.
Though the draft guidelines, prepared by the expert panel, were approved by the DCC and DTAB, the matter was pending due to the delay in the approval of DTAB minutes which were sent again to its members as desired by the health ministry.
The guidelines, finalised in consultation with the industry, seeks to give a regulatory framework to the largely unregulated sector by placing the medical devices as a separate category with new definition, instead of treating in line with drug definitions.
The DCGI office has already issued several notices in the recent past to streamline the sector by asking the industry to go strict on medical devices. Besides, the office also had expanded the list of medical devices, by including 19 more items to the list already in force since 2005.
"As there were not many suggestions from the DTAB members with regard to the minutes of the last meeting, we have already passed it on to the health ministry for issuing necessary notification. It can be announced very soon," sources said.
The Drug Controller General of India (DCGI) had set up a committee involving representatives of trade bodies including FICCI and CII to draft the guidelines and have gathered inputs from the industry as whole also by inviting public opinion on the same. Besides, the WHO and the United State Food and Drug Administration (US FDA) have been assisting the DCGI office to float the new guidelines and train the staff at the headquarters. The DCGI office already has a separate wing to deal with the applications, monitoring and other related tasks about medical devices.