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india’s Central drugs Standard Control Organization (Cd sco) has Published several notices since mid-march in response to the Ongoing pandemic. these address new measures to expedite access to devices intended to prevent or treat covid-19. to safeguard supply of other critical ivds, and to reduce the exposure of Cds co staff to the sars-cov-2 virus.Covid-19 |
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19 Ways The CDs co announced that it will prioritize Covid-19. Ivd test kits for expedited approval. Manufacturers who already have approval for an ivd in another market are encouraged to contact the drug's controller general of India(DC GI) to discuss fast-track approval. Additionally, manufacturers pursuing the development of new ivds may contact the dc GI directly to solicit guidance on the applicable
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the cds co issued temporary modified release procedures for other critical imported ids (e.g. hiv and hba test kits) to be followed throughout the course of the covid-19. pandemic, which has caused typical sampling and testing processes to be disrupted. port offices holding consignments of these ids may release them based on a review of documents, protocol, the manufacturer’s batch release certification, and the history of compliance. however, importers are required to retain a “sufficient quantity“ of ivds for future analysis and to make a commitment to recall products that fail future laboratory tests.
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