Clarification Regarding Import Of Diagnostic Kits Reagents For ‘Research Use Only’ For Academic Rese

 

CDSCO or Central Drugs Standard Control Organization in its recent notification has issued a clarification about the import of diagnostic kits or reagents for research use only for the purpose of academic research. Hence, clarifying the stand on the import of drugs in India.

It was clarified that all products that are meant for "Research use only" must be used in academic research institutions and should not be used for any kind of diagnostic or therapeutic purposes and they are not under the regulation of Drugs and Cosmetics Act or Medical Devices Rule.

But it is required for the applicant to submit an undertaking at the concerned port office of CDSCO stating that all imported products must be used by research institutions for the sole purpose of academic research.

It should not be used for any kind of in-vitro diagnostic or therapeutic purpose in any diagnostic labs or hospitals. The notification was issued dated 19th June 2020.

All such products must be clearly labelled as "for research use only". ICMR and DCGI have jointly framed guidelines for validating and batch testing for diagnostic kits. As per new guidelines, all US FDA approved kits along with RNA extraction kits and the viral transport medium does not require ICMR validation and the manufacturer and supplier of such kits can apply directly for getting approval from DCGI.

The firms are required to submit the batch testing certificate for the deliverance of the consignment. ICMR recognized a validation center that will undertake some of the random sample testing of kits for quality assurance.

All such requests from that manufacturer as well as a supplier must be accompanied by information such as the manufacturer and supplier name, kit name along with the batch number, first-time validation by ICMR and the difference in composition of the kit if any when compared to the first validation.