Manufacturing and marketing of medical devices is one area where there are no comprehensive regulations existing in India despite 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. Medical devices are broadly defined as instruments, apparatus, machines, appliances, implants, software or other materials for diagnosis, prevention, monitoring, treatment or alleviation of diseases in human beings. And more than 50 nations including several developing countries have stringent regulatory system for this sector. The need for bringing medical devices under the regulatory umbrella was felt by the Indian authorities 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. Now after the DES approval issue was raised by the Maharashtra FDA and subsequently with the intervention of Bombay High Court, the DCGI decided to bring medical devices under appropriate regulatory control. The first step took by the DCGI, in this regard, was to issue a notification in October 2005 identifying 10 medical devices as drugs. Thereafter a sub committee was set up in December, 2006 to frame a set of rules for the sector.

Now, a Bill has been drafted on the basis of the recommendations of this committee and is currently under circulation amongst experts in the sector. 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 proposed 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. With the formation of the Authority, the government intends to make the registration of all manufacturers of medical devices compulsory with the MRDA. The body will also have powers to inspect the devices and manufacturing facilities. An advisory committee and technical panels will also be constituted to help the Authority to carry on its tasks. Several medical devices are manufactured and marketed in the country by the medium and small scale units and are used on patients just on recommendations of physicians. Apart from these indigenous products, a number of medical devices are being imported into the country from multinational companies like Johnson & Johnson, Boston Scientific, Siemens, etc. While it is of prime importance to oversee the safety of these devices, the government has to look at the pricing of these products as most of the imported devices are very expensive and unaffordable to a large section of patients. The proposed Authority, therefore, needs to look at efficacy linked pricing of these products also while finalizing the rules.