The government has come out with a document to provide guidance to port officers to take appropriate decisions for monitoring quality at the port of import based on a risk-based approach.
“The monitoring of quality of the imported drugs, cosmetics and medical devices is of paramount importance to the public health,” it said.
“This guidance document has been prepared for the Port Officer to implement a risk-based approach at various levels for monitoring the quality of the imported consignments to provide high degree of assurance for the safety of public health,” it further said.
This guideline recommends the use of a three-tiered risk-based approach for sampling which proposes that testing can occur at three levels: Desktop inspection and/or visual inspection; then through field-based tests (using the Minilab or other screening tools); and finally at the laboratory as required for complete testing.
“It is recommended that the testing shall be considered as final for taking action,” it said.According to the document in the case of information/ evidences received by Port officer of CDSCO/ custom officer about doubtful quality of the product, it has to be sampled and tested.100% samples will be sent for testing for the items like vaccines, blood products, critical diagnostic kits, condoms and re-Import case.
