Drugs Controller General India (DCGI) has issued a notice in observance of the compliance for patient safety which seems more appealing and beneficial. DCGI notified to drug importers that they will inform or report to Indian authorities about time to time regulatory actions taken on their drugs in different countries where drugs are sold or distributed.
As per Schedule D(1) of Drugs & Cosmetics Rules, 1945 and in order to improve the regulatory compliance of drugs which are imported in the country, one of the basic scientific requirement is that the importer of such medicines shall from time to time report for any administrative action taken due to adverse reaction, viz. market withdrawal regulatory restriction, or cancellation of authorization and/or “not of standard quality report” of any drug pertaining to the Registration Certificate declared by any Regulatory Authority of any country where the drug is marketed/sold or distributed.
The despatch and marketing of the drug in such cases, shall be stopped immediately and the licensing authority shall be informed immediately. Further action in respect of stop marketing of drug shall be taken as per the directions of the licensing authority.
In such cases, action equivalent to that taken with reference to the concerned drug(s) in the country of origin or in the country of marketing will be followed in India also, in consultation with the licensing authority.
As per notice from DCGI, the licensing authority may direct any further modification to this course of action, including the withdrawal of the drug from Indian market within 48 hours time period.
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