The Centre has been dragging feet over the regulation of medical devices for more than three years now. No final decision has been arrived at as to what is a medical device, its quality and the authority to monitor its manufacturing and price. The Union ministry of health and the Department of Science & Technology have been debating over the issue for several months with no conclusion as yet. Now, the latest view on medical devices has come from the Parliamentary Committee headed by Amar Singh. The Panel has suggested that a separate chapter to be added to the Drugs & Cosmetics (amendment) Bill, 2007. Its recommendation is to have a clear definition of medical devices consistent with the international standards. The panel suggested that a dedicated division as recommended by the Mashelkar Committee may be set up to deal with regulation, licensing, surveillance and monitoring of uniform implementation of laws pertaining to medical devices in the country. The panel is of the view that the current system was inadequate in regulating certification, quality assurance and post marketing surveillance of both imported and locally made medical devices. The Amar Singh Committee also objected to the ongoing clash of views between the health ministry and the DST on the issue of regulating medical devices.
Manufacturing and marketing of medical devices is one area where the Centre had failed to bring in any regulations so far despite the fact that they belong to a critical segment of healthcare sector. It is a serious deficiency of the healthcare system of the country considering the widespread use of this class of products today. The need for bringing medical devices under the regulatory umbrella was felt by the DCGI only after the Maharashtra FDA found in June 2005 that drug eluting stents used in cardiac patients had no approval from the office of DCGI. The Maharashtra FDA immediately brought a total ban on the use of the product in the state. The state FDA banned DES as it considered the product a new drug as the DES contains an unapproved drug. And DCGI had never approved DES for marketing in India as it treated DES only as a device as per the Drugs & Cosmetics Act. After the DES approval issue was raised by the Maharashtra FDA and subsequently with the intervention of Bombay High Court, the DCGI issued a notification in October 2005 identifying 10 medical devices as drugs. Thereafter a subcommittee was set up in December, 2006 to frame a set of rules for the sector. The Drugs & Cosmetics (amendment) Bill has been, thus, drafted on the basis of the recommendations of this committee. The main thrust of the Bill is to establish a Medical Devices Regulatory Authority with adequate powers to ensure standards, efficacy, safety and availability of medical devices manufactured or marketed in the country. The Authority will have a classification of devices, notify standards and guidelines from time to time, provide a mechanism for conformity assessment using direct or third party notified bodies and stipulate the procedure and guidelines for testing laboratories. Now what is required is to introduce the Bill without any further delay by incorporating what is suggested by the Amar Singh panel so that some safety and fair price can be assured to patients using these expensive medical products.