Imports of approved & unapproved drugs under the Advance Licensing Scheme – Exemption from Registration procedure
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Exemption from registration for drug imports under Advance Licensing Scheme allows imports for valid export orders subject to conditions.
Imports of drugs under the Advance Licensing Scheme are exempt from the Registration procedure under the Drugs & Cosmetics Act for approved and unapproved drugs, provided imports are against valid export orders limited to required raw materials, licences are endorsed to the Drug Controller and State Drug Controller, random inspections are permitted, pre import conditions are met, export obligations are fulfilled within six months, and violations attract penalties under the Foreign Trade Development and Regulation Act and the Customs Act.