Page 7 - Cdsco

NITI Aayog hasn't rejected offer to bring medical devices under CDSCO: Govt

It also proposes a penalty of up to Rs 1 crore on the manufacturers or importers for faulty medical devices having adverse impacts on patients.

Drug regulator making list of dual-use APIs imported from unregistered cos

The CDSCO is strictly monitoring the import of such dual-use APIs for the last few months so as to get an idea on what kind of action should be taken

CDSCO to get a new name; govt invites suggestions from stakeholders

The government has requested all stakeholders to send in their suggestions and comments on the new name and design of the new logo

Domestic drug regulator plans to inspect firms abroad, like USFDA

New Delhi, 14 AprilCentral Drugs Standard Control Organisation (CDSCO) is chalking out an international roadmap while wanting to follow the footstep of its American counterpart. The goal of CDSCO is to inspect pharma companies and their manufacturing units in other countries, especially the US, across Europe, Japan and China. ''The national drug regulator would conduct risk-based assessments of companies which supply to India,'' an official at the CDSCO told Business Standard. So far, the Indian drug controller has only conducted risk-based assessment of manufacturing units in India. Once it starts inspecting manufacturing units overseas, the Indian regulator's role would be similar to that of the United States Food & Drug Administration (USFDA). The American regulator routinely inspects pharma companies, across the world including in India, which export to the US. In fact, last year nine warning letters were issued to Indian pharma companies exporting to the US. Several plants ..

Government to consider extending shelf life of medical device after interim assessment of performance

The government has suggested a five year blanket on shelf life of all medical devices in the draft released on 19th Oct