Guidance Document on Risk Based Approach for Monitoring Quality at the Ports of Import

The Central Drugs Standard Control Organisation has issued a guidance document outlining a risk-based approach for monitoring quality at ports of import. The purpose of this document is to provide guidance to port officers on how to make informed decisions regarding the quality of imported drugs, cosmetics, and medical devices.

Importing countries are required to register their products along with manufacturing sites under Chapter III of the Drugs and Cosmetics Act 1940 and Part IV of the rules. If a drug falls under the definition of a new drug, it requires approval before registration and importation.

The risk-based approach involves three tiers: desktop inspection and/or visual inspection (Tier 1), field-based screening (Tier 2), and compendial testing (Tier 3). Desktop inspection may identify important characteristics related to product quality or issues with physical characteristics of the dosage form. Visual inspection can be used to identify falsified, unregistered, or incorrectly labeled medicines.

Field-based screening technologies can further reduce the number of samples that require compendial testing. Compendial testing provides extensive information on product quality but is also complex, expensive, and time-consuming.

The document outlines procedures for clearing Bill of Entry at port offices of CDSCO, including examination of Bill of Entry, inspection of consignments, drawing of samples, dispatch of samples, testing of samples, and release of consignments on Letter of Guarantee (L/G).

The risk-based criteria for sampling include random sampling of any one consignment in six months or sequential 10 consignments, whichever is earlier. Sampling frequency may be reduced if the product is imported from ICH countries without complaint or quality failure.

Samples are drawn in duplicate, and quantities required for testing have been specified by the Director, CDL/CRI/CDTL/NIB/NIV/NARI/NICD/IVRI, etc. Samples are drawn under the direct supervision of a technical representative of the port office, and sampling should be carried out in the presence of the importer's representative.

The document also outlines procedures for sending samples to laboratories, including the use of mini drug testing laboratories at port offices, Central Drugs Laboratories, Regional Drugs Testing Laboratories, and other approved laboratories. The release of consignments on Letter of Guarantee (L/G) is allowed pending testing reports.

If the goods are found to be of standard quality and labeled as prescribed, they may be released. If the goods are declared not of standard quality, the Customs Commissioner is informed along with two copies of the test report.

In case of grossly substandard or spurious drugs, the importers may be given an option to reship the goods to the country of origin or forfeit them for destruction.