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Indian regulator issues warning to licence or be penalised

This article was originally published in Clinica

Executive Summary

India’s medical device regulator has warned manufacturers and importers of the 10 kinds of device that fell under mandatory licensing rules in October 2005 that they will face penalties if they do not get their products licensed. Surinder Singh, the Drug Controller General of India issued a notice on the Central Drugs Standard Control Organisation (CDSCO) website last month to encourage manufacturers and importers to obtain the requisite licences from the relevant state’s licensing authority, which is then approved by the central licence approving authority. To fail to do so is to act unlawfully and will be penalised, said Dr Singh. The 10 medical device groups are: cardiac stents; drug-eluting stents; catheters; intra-ocular lenses; IV cannulae; bone cements; heart valves; scalp vein set; orthopaedic implants; and internal prosthetic replacements. Licence application forms can be obtained at www.cdsco.nic.in or email: ddci@nb.nic.in

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