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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :IDMA advises members to seek DCGI approval for marketing all new FDCs.. 2009-10-31 18:12:40 
M.Anusha
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hi,

In view of reports that some pharma companies are introducing Fixed Dose Combination (FDC) drugs in the market without prior approval of the Drugs Controller General of India (DCGI), the Indian Drug Manufacturers Association (IDMA) has asked its members to follow all regulatory norms as stipulated and refrain from launching any such new products without prior approval from DCGI.

IDMA secretary general Daara Patel said that there have been recent reports on FDC drugs being introduced into the market by some companies without prior approval of the DCGI.

Patel said that IDMA is in constant dialogue with the DCGI on FDC issue. As all ‘new drugs’ have to be approved by the central licensing authority, i.e. the DCGI, such unethical practices must not be resorted to. “We support the DCG(I) in taking action against errant manufacturers,” he added.

Patel said that IDMA was not aware of any member actually launching such a product without approval, but as a precautionary measure, it has issued an advisory on the same. “We have requested our members to follow all regulatory norms as stipulated and refrain from launching any such new product without prior approval from DCG(I),” he said.

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