CDSCO directs drug regulators to strictly monitor end-use of dual-use APIs
New Delhi: Through a recent Office Memorandum, Central Drugs Standard Control Organisation (CDSCO) has directed drug regulators to strictly monitor the end-use of dual-use Active Pharmaceutical Ingredients and apprise the apex drug regulator about the action taken in the matter.
Dual-use APIs are the ones that can be used in making special food products such as nutraceuticals apart from medicines.
Prior to this, CDSCO had issued a list of dual-use APIs and directed all Zonal, Subzonal, Port offices to strictly monitor the end-use of dual-use Active Pharmaceutical Ingredients. CDSCO has been strictly monitoring the import of such dual-use APIs for the last few months so as to get an idea of what kind of action should be taken to stop their misuse and improve quality.
In this regard, CDSCO recently received representations from various stakeholders requesting for waiving of the requirement of dual-use NOC.
Accordingly, the matter was examined and it has been decided;
"If the manufacturer himself is importing such products for their end use (other than medicinal use), one time dual use NOC may be granted for one year to such manufacturers under the intimation to this office based on the assessment of at least one year data and written undertaking by the manufacturer justifying the quantity proposed for one year."
CDSCO further added;
The period of one year may be further relaxed if the data submitted and the operations carried out by the operators indicate to prove that it is for self-consumption for further manufacturing
However, the nodal authority once again directed the drug officers to strictly monitor the end-use of dual-use Active Pharmaceutical Ingredients and action taken in this matter to be communicated to the apex drug regulator.
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