Regulatory Focus™ > News Articles > India to Require Notification of Foreign Drug Import Alerts

India to Require Notification of Foreign Drug Import Alerts

Posted 01 July 2013 | By Ansis Helmanis

Indian pharmaceutical companies will now be required to inform the Central Drugs Standard Control Organization (CDSCO) about any drug import alert restrictions imposed on their products by foreign regulatory authorities, according to a new notice issued on 26 June 2013 by the Drugs Controlled General of India (DCGI).

The notice highlights the fact that local manufacturers whose drugs are the subject of foreign regulatory action also supply the same or similar drugs on the Indian market, and therefore local authorities need to be made aware in order "to ensure that the necessary action is taken to ensure the quality, safety and efficacy" of those drugs. 

In such cases, the information must also be brought immediately to the attention the Drugs Controller General.

DCGI Notice

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Tags: DCGI, Import, API

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