Drug export compliance requires differentiated documentation, CDSCO verification, and prior NOC-based licensing for unapproved, new or banned drugs. Manufacturer exporters of drugs other than unapproved, new or banned drugs must upload prescribed export documents through e-Sanchit. Non-manufacturer exporters must obtain an ADC/CDSCO export NOC after submission and verification of relevant documents, on which Customs ordinarily relies. For unapproved, new or banned drugs manufactured solely for export, a CDSCO Zonal Office NOC through SUGAM must precede the State Licensing Authority manufacturing licence, and shipping bill details must match the NOC. A limited interim relaxation permits post facto CDSCO NOCs until 30 September 2026 where specified approvals are valid.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
Drug export compliance requires differentiated documentation, CDSCO verification, and prior NOC-based licensing for unapproved, new or banned drugs.
Manufacturer exporters of drugs other than unapproved, new or banned drugs must upload prescribed export documents through e-Sanchit. Non-manufacturer exporters must obtain an ADC/CDSCO export NOC after submission and verification of relevant documents, on which Customs ordinarily relies. For unapproved, new or banned drugs manufactured solely for export, a CDSCO Zonal Office NOC through SUGAM must precede the State Licensing Authority manufacturing licence, and shipping bill details must match the NOC. A limited interim relaxation permits post facto CDSCO NOCs until 30 September 2026 where specified approvals are valid.
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