Manual licence checks must for pharma imports

The Centre has mandated customs officers to manually verify licences, permissions, and registration certificates before permitting the import of various healthcare products, medical devices, cosmetics, and manufacturing inputs. This requirement, effective from September 3, extends to facilitated Bills of Entry, even for imports that have already passed through the customs risk-management system, as per a directive from the Central Board of Indirect Taxes and Customs (CBIC) to importers and field formations.

The primary reason for this directive is the current absence of full integration between the government's digital single-window system for imports, SWIFT 2.0, and the Central Drugs Standard Control Organisation (CDSCO). While this system enables importers to submit data and receive clearances from multiple government agencies through a unified electronic process, the regulatory documents of the CDSCO have not been fully incorporated into the system.

Consequently, CDSCO has sought CBIC's assistance in manually reviewing the regulatory documents, specifically the seven product-specific checklists provided by the regulator.

These checklists encompass a broad spectrum of healthcare products, including cosmetics, active pharmaceutical ingredients, and finished medicines. They also cover medicines intended for personal use, certain small-quantity imports of novel drugs, as well as medical devices, in-vitro diagnostic kits, and raw materials and components utilized in the manufacturing of medical devices.

The CDSCO's goal is to ensure that customs officers conduct a thorough examination of these documents before granting the final approval, known as out-of-charge, which permits the importer to export the goods from customs custody.