The Indian Medical Devices Regulatory Authority (IMDRA), proposed by the Central government, is likely to be an independent, financially self-sustaining, national certifying and regulatory agency for medical equipment and devices in India. The draft proposal on IMDRA prepared by the Society for Biomedical Technology (SBMT), which is under the active consideration of the central government, has suggested such a body that can handle administration of medical devices without creation of a big infrastructure and without transgressing on the work-area of other existing agencies like the Central Drugs Standard Control Organisation (CDSCO) and Indian Standard Institute (ISI).
The need for an independent existence was felt, as the proposed authority needs to interact with a host of government agencies that comes under several ministries and also private entrepreneurs and industry associations. The interactions of the proposed IMDRA include the government administrative machinery of the ministries of law, Industry, Finance and Health. It needs to coordinate with the technical machinery like ISI, DCGI and central excise also. The need to interact with individual manufacturers and associations like Assocham, FICCI etc has also been highlighted. The IMDRA is to interact with technical bodies vested with certification and notification responsibility, and also with the end users and hospitals. SBMT has felt that the work is too multifaceted to be catered by a ministerial department and needs the existence of an independent, if not autonomous governmental body.
The essential duties of AMDRA would be to make a registry of items and item groups from all the medical devices and equipment that are available in the market. Preparation of document based on the registry stating current standard for each item with the help of specialized institutions, certification of competent labs for QC procedure, issuance of CE, CP, and pre-market certification, surveillance and notification, enforcement, education, interaction, publicity, documentation, post-market follow-up of new products and periodic review of the procedures are all to come under the purview of the new authority.
The draft has been prepared keeping in mind the existing laws and regulations on biomedical equipment in the developed world. The SBMT has however dropped the idea of a central regulatory authority like US FDA that can encompass all the regulatory activities related to medical field stating that the model is not suitable for India.
"FDA, which regulates many things apart from medical devices, is a huge system with sweeping powers and financial backing from the government. Its rules are very stringent, and in effect, the responsibility of QC is borne by the FDA rather than the manufacturer. The manufacturer is simply responsible for maintaining QC designated individually by the FDA. In Indian scenario, the structure is nothing but another manifestation of inspector-permit-license raj occurring so frequently," the draft has noted.
According to the draft proposal, the huge financial implications, huge infrastructure requirements and element of stringent bureaucratic control (leading to corruption in the long run) of the US model is not suitable for India due to the limited number of applications and patents expected as against the thousands of applications in the USA.
The SBMT proposal calls for arming IMDRA with powers to coordinate, and collect data, authority to certify laboratories, authority to issue CO, CP, pre-market certification, to conduct surveys, including post-market research, to issue notifications, power to enforce, and to withdraw products, to form and modify QC document, to support manufacturing activities of medical equipment and devices and also act as a watch dog in the import of the devices.
The Society for Biomedical Technology (SBMT), which comes under Defence Research & Development Organisation (DRDO), has been established for utilizing defence technology spin-offs for indigenous development of medical devices, equipments and consumables.