In October 2005, the Indian Ministry of Health and Family Welfare issued notifications that essentially constitute the regulation of medical devices. The notifications amended the Drugs and Cosmetics Act of 1940 by reclassifying certain medical devices as drugs in order to bring them under the purview of the Drug Controller General of India (DCGI). S.O. 1468(E) specifies ten medical devices that will now be classified as drugs, while G.S.R. 627(E) specifies that those ten drugs must be licensed for manufacture, sale, or distribution by an approved central licensing authority.
Some of the ten in vivo devices initially included in the notification are stents, heart valves, catheters, intra-ocular lenses, bone cements, and hip and knee implants. Eventually, in vitro devices will also be included. In addition, special committees will be set up to evaluate and monitor device quality and to ensure that manufacturing processes and plants are in compliance with Indian Good Manufacturing Practice.
It is likely that the regulation of medical devices will be similar to the European model, whereby the manufacturer would determine the risk classification of its own device and then submit technical data for review. Following approval, the manufacturer would be subject to periodic surveillance and assessment of product’s production process, safety, and quality.
Until now, medical devices in India have largely been an unregulated industry. The push for these notifications arose after the Maharashtra Food and Drug Administration (MFDA), a state-level agency, refused to allow drug-eluting stents to be imported for sale in Maharashtra without a drug license from the DCGI. The MFDA clamped down on imports of the device after the discovery that illegal stents had allegedly been implanted into thousands of patients. During the ban, stents approved by the U.S. FDA or with European CE certification were permitted to be imported to treat current patients. The resulting uproar from the public and the medical community over the stent scandal is one of the key factors that compelled the Ministry of Health to address the need for regulation of medical devices.