A national level study, commissioned by the Union Ministry of Health and Family Welfare has highlighted the importance of comprehensive regulation of medical devices. The study called for the preparation of an inventory of products and product groups of various medical devices and equipment that are available in the market.
The report considered the regulation of medical devices as an excellent opportunity for the Central Drugs Standard Control Organisation (CDSCO) to generate some revenue from the licensing of these products, apart from ensuring safe and quality healthcare for the general population. Noting the absence of a comprehensive set of central regulations governing the import or manufacture of medical devices, it wanted CDSCO would be to make an inventory of medical devices that are currently available in the country.
Certain medical equipments like X-ray machines, CT scan etc. are regulated by Atomic Energy Regulatory Board. Barring these, manufacture and marketing of most of the medical devices and equipment used in the country remain largely unregulated. A recent notification issued by the Health Ministry had included only certain categories of medical devices under the 'drug' list which mandates prior marketing approval from CDSCO.
Underlining the importance of proper regulatory intervention, the report called for the preparation of a detailed document of quality standards for every medical device that finds place in the inventory. Regulating import of devices through import licensing, registration etc., certification of testing laboratories for quality control, pre-market certification, surveillance and notification, enforcement and post marketing follow up (leading to even recall of products) have to be undertaken, the report suggested.
The study, carried out by A F Ferguson & Co., is yet to be approved by the Health Ministry. The task before the agency was to study on the options for financial sustainability of drug regulatory agencies. The study has been funded through the World Bank assisted Capacity Building Programme.