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Law For Medical Devices
MANUFACTURE and marketing of medical devices and equipments continue to be an area largely neglected by the regulatory authorities in many countries, despite them being is considered to be a vital segment of the healthcare industry today. The quality parameters and efficacy of these products are considered as critical as drugs as the use of substandard products could lead to serious complications or infection in patients.
The regulation of medical devices, therefore, is an increasingly important aspect of healthcare and it is growing in complexity. At a time when developed countries have already installed quality systems and quality control, only a few developing countries have functional systems to regulate imported or locally manufactured medical devices or the technical capacity to implement them. In India, surprisingly, no statutory system is in place for regulating the manufacture, import and monitoring of medical devices so far. Some state drug administrations in India are, however, issuing licenses for their manufacture but there is no practice of monitoring of their quality standards.
It was in this background, a proposal to set up Indian Medical Devices Regulatory Authority as an independent body was made by the Society for Biomedical Technology last year. The proposal was however rejected by the Mashelkar Committee and suggested to make use of the existing nationwide drug control administration for the purpose. The Committee has also called for a separate Medical Devices Division within the Central Drugs Standard Control Organization. Currently medical devices are defined as 'Drug' under section 3 of Drugs & Cosmetics Act and no rule exists for their certification, quality assurance and post marketing surveillance. This calls for inclusion of appropriate provisions in D&C Act as a first step.
Secondly, a registry of all medical devices and equipments available in the market should be prepared. There is no such list of the number and type of products with the government. A key responsibility of the new regulatory machinery should be to ensure recall of defective medical devices from the market as a large number of them are floating in the market. It should be worthwhile for the CDSCO to seek cooperation from WHO in the area of medical devices regulation. There are some developing countries implementing regulatory procedures for medical devices as per the WHO guidelines and recommendations. An association with WHO in this regard could also enhance the level of harmonization of regulations of medical devices between the countries.
(Ref : Editorial Note , PHARMABIZ, November 11, 2004)
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