The expert group on medical devices regulation set up by the Central Drugs Standard Control Organisation (CDSCO) is to propose a system of mandatory certification like the ISI mark given by the Bureau of Indian Standards (BIS) for the entire gamut of medical devices. The CDSCO clearance for the marketing of medical devices would depend upon such certification in future. The expert group will recommend the amendments that are to be made both at the policy as well as operational level to make this possible within a month, Ashwini Kumar, Drugs Controller General of India (DCGI) informed pharmabiz.
According to him, the expert group has favoured European Union and Australian models of medical devices regulations to be adopted in the country. The regulatory agencies of these countries approve medical devices on the basis of a certification given by an independent body. Similarly, the expert group recommendation to the ministry would be to recognize private / autonomous bodies to certify the quality of medical devices before they are introduced in the market.
The CDSCO would grant marketing approval to these products on the basis of such certifications. The organization will continue to be inspection and monitoring agency for medical devices.
According to reliable sources, the health ministry may ask BIS to set up a separate committee consisting of both internal and external experts to approve each and every medical device in the country. The representatives from the central drug regulatory authority would also be part of this committee. The committee would classify the medical devices into various classes depending on the nature of the device. Some categories would be considered as safe, others would have to go through rigorous approval procedures before being cleared for marketing. As per the current plan, the Central Drugs Standard Control Organisation (CDSCO) may be the licensing and inspecting agency for the approvals given by the certifying authority. There would be a quality certification with specific class mentioned for every product.
The lack of proper regulatory control over most of the medical devices came to the limelight recently after the Maharashtra FDA banned the use of some of the drug-coated stents due to doubtful quality. The court case, which followed the Maharashta FDA action, had resulted in Mumbai HC asking the DCGI to notify 10 medical devices as drugs that requires central clearance prior to import, manufacture, or marketing in the country. The newly included 'drugs' as per the notification dated October 7, 2005 are cardiac stents, drug eluting stents, atheters, intra ocular lenses, I V Cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.