Central Drugs Standard Control Organization (CDSCO) has issued a revised Guidance Document (Version 1.0, IMP/REG/200711) on the common submission format for Import Registration Certificates (RC) and Import Licenses (IL) for bulk drugs (APIs) and finished formulations. All applications must now be submitted online through the SUGAM portal. The guidance is for public awareness only and is not legally binding.

Registration of both the drug and foreign manufacturing site is mandatory before import. Applications may be submitted by the authorized Indian agent or eligible foreign manufacturer. For new drugs under the NDCT Rules, 2019, prior new drug approval is required before applying for RC or IL.

The guidance outlines application workflows, documentation requirements (including Power of Attorney, GMP, COPP, manufacturing and wholesale licenses, Schedule D documents, stability data, QR code labeling, and prescribed fees), and classifies Post Approval Changes (PACs) as major or minor, with specified timelines and amendment fees.

It also specifies circumstances requiring a fresh RC, requirements for renewal applications, and procedures for obtaining No Objection Certificates (NOCs) under Rules 31, 36A, 37, and 104A for special import situations such as reduced shelf-life products, label overprinting, bulk packing, and charitable donations. The guidance applies to all foreign manufacturers, authorized Indian agents, and importers of APIs and finished formulations intended for human use in India.