The Central Government has notified 10 medical devices as drugs that require central clearance prior to import, manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.
The 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.
With the notification in place, all medical devices manufacturers will have to go by the established procedures of new drug approval through the Central Drugs Standard Control Organisation (CDSCO). The notification has also put an end to the conflicting claims made by the CDSCO and the Maharashtra FDA on the status of medical devices as a drug or not. While the Central Government was of the opinion that drug eluting stents did not come under the purview of Drugs and Cosmetics Act, the state FDA had denied marketing permission to a number of medical devices manufacturing / marketing firms on the grounds that they did not take prior permission from the central authorities.
Interestingly, a prominent section of medical professionals believe that medical devices come under the existing definition of "drug" in the Drugs and Cosmetics Act. The Act says that "drug" includes "all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; such substances (other than food) intend to affect the structure or any function of the human body or intended to be used for the destruction of 18'[vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, all substances intended for use as components of a drug including empty gelatine capsules; and such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board."
With the notification, CDSCO will now have to enhance its capabilities to scrutinize the quality of medical devices before it can be permitted for marketing in the country.