Cell therapy products
Cell therapy products for therapeutic use
HSN 3002 51 00 (Cell therapy products) is not covered by a Bureau of Indian Standards Quality Control Order and carries no Partner Government Agency clearance requirement at the tariff-line level. Import follows the standard customs procedure: Importer-Exporter Code, bill of entry, commercial invoice, packing list. Related biological products under Chapter 30 — including gene therapy products, tissue-engineered products, and immunological preparations — may be classified under sibling tariff lines that carry distinct compliance requirements.
The absence of a Quality Control Order at this tariff line does not resolve the broader regulatory position of cell therapy products under Indian law; product-level authorisation requirements under drug and biologics regulations are a matter of domestic marketing and manufacturing law, not customs-tariff compliance. Re-classification by customs to a more specific biological or immunological tariff line within Chapter 30 triggers retrospective compliance and detention pending the applicable licence. Verify the precise product definition — autologous versus allogeneic, somatic versus stem cell — against the customs tariff before relying on the absence of tariff-line compliance.