News & Updates

8 February 2021

India: New Mandatory Document Requirements

On Jan 14th, 2021, India’s Central Board of Indirect Taxes and Customs published Advisory No: 02/2021 announcing a new rule requiring Customs brokers to submit certain documents to Customs when clearing merchandise for import into the country.

The new rule requires mandatory uploading of product-specific documents in the e-Sanchit Customs System by brokers and clearance agents. The document requirements are based on the imported product’s Harmonized System (HS) Tariff classification.

Most of the documentation requirements outlined in the Advisory are not unusual or new. For example, the announcement specifies that for drugs covered under HS 3004.90, a “Certificate of Analysis (CoA)” must be uploaded to the e-Sanchit System. A CoA has always been required for the import of drugs into India. In this case, the only change is that now the COA must be uploaded to e-Sanchit by the broker or clearance agent to support the import clearance.

The 249-page Advisory did create new and unexcepted document requirements for some imported products. Most notably, the notification included a new document requirement for products covered under HS 3002.90 (Human Serum/blood). These products now require uploading a “Blood Analysis Report.” This rule created confusion for importers of human specimens since, typically, there is no “Blood Analysis Report” for human clinical samples.

Fortunately, Customs has acknowledged that not all shipments of human specimen are accompanied by a “Blood Analysis Report.” Therefore, in place of the “Blood Analysis Report,” brokers may upload an Undertaking Letter (aka Intended Use Letter). The letter must state that the Serum/Blood/Plasma specimens are derived from humans, are imported for testing purposes, and do not include a blood testing report.

This new procedural rule requires the trade community to know the documentation requirements that apply to their imported products and ensure that they are available for uploading time of import. Failure to upload documents to the e-Sanchit System may result in clearance delays and or refusal of merchandise.

Marken India continues to work closely with importers, Customs authorities, and local Customs brokers to ensure compliant and swift clearance of clinical supply imports to the country.

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