As a follow up of the notification that included 10 medical devices as drugs, the ministry of health and family welfare is to send specific instructions to all state drug control authorities as well as medical devices industry on the regulatory modalities they need to undertake now. The directive would also specify the time span that can be given to the companies to go through the regulatory requirements for all medical devices that are already in the market.
According to highly place sources, the Central Drugs Standard Control Organisation (CDSCO) has already forwarded its recommendations in this regard to the health ministry. The ministry is to decide upon the time that can be given to the companies to ensure that all medical devices that come under the notified categories are having due market clearance.
The government had, through two notifications, dated October 6 and 7, brought 10 broad categories of medical devices under the definition of "drug". The notifications had mandated central clearance prior to import, manufacture, or marketing these "drugs" in the country. The newly included 'drugs' are cardiac stents, drug eluting stents, catheters, intra ocular lenses, I V Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
Interestingly, none of these medical devices needed central clearance prior to the central notification. Due to the same reason, the markets are flooded with various brands of such medical devices. The notification has put an additional task before the state drugs control authorities as they will have to identify all the manufacturers, distributors and retailers and carry out inspections for the presence of "unapproved" medical devices. The central agency would also have to gear up to the situation as there is a sudden requirement of giving hundreds of licenses after properly evaluating the quality of these "medical devices".
Several state drug officials have expressed doubts over the capabilities of the grossly understaffed state departments to take up the new challenge. The CDSCO officials said that the entire process would be streamlined once proper regulatory guidelines are issued to the state departments / manufacturing units.
As Pharmabiz had reported earlier, notification became necessary due to an order of Mumbai High Court to notify the sterile medical devices for external or internal use in human beings as drugs with immediate effect. The HC order, which came on September 19, was directed against the Drugs Controller General of India (DCGI) and wanted the changes to be notified within three weeks.