Page 6 - Guidance document for import of Drugs & Pharmaceuticals from India
P. 6
State Drug Control Administration (FDAs) issues the manufacturing upon
receiving applications and duly inspecting the manufacturing / trading
premises. If the manufacturer applies for WHO GMP certificate, the premise
will be inspected jointly by Central and State Drug inspectors before State Drug
Control Administration issues WHO GMP certificate.
Loan License
A loan licensee can also market in India, export Drugs & Pharmaceuticals by
getting them manufactured at a third party facility/premises, which is termed
as Loan License manufacturing. Under Drugs & Cosmetics Act of India, Loan
Licensee is treated at par with manufacturer having own manufacturing unit.
Trading/Sales License
A trader who wants to export Drugs & Pharmaceuticals by procuring them in
the local market has to obtain Trading License. State FDA issues such licenses
upon receiving applications and duly inspecting the premises.
Certain important licenses / Rules
Export under neutral code
An exporter can export Drugs & Pharmaceuticals by labeling a code number
allotted to him without disclosing the name and address of the manufacturer.
State FDAs issue neutral codes to the manufacturers upon application as per
normal international practice.
receiving applications and duly inspecting the manufacturing / trading
premises. If the manufacturer applies for WHO GMP certificate, the premise
will be inspected jointly by Central and State Drug inspectors before State Drug
Control Administration issues WHO GMP certificate.
Loan License
A loan licensee can also market in India, export Drugs & Pharmaceuticals by
getting them manufactured at a third party facility/premises, which is termed
as Loan License manufacturing. Under Drugs & Cosmetics Act of India, Loan
Licensee is treated at par with manufacturer having own manufacturing unit.
Trading/Sales License
A trader who wants to export Drugs & Pharmaceuticals by procuring them in
the local market has to obtain Trading License. State FDA issues such licenses
upon receiving applications and duly inspecting the premises.
Certain important licenses / Rules
Export under neutral code
An exporter can export Drugs & Pharmaceuticals by labeling a code number
allotted to him without disclosing the name and address of the manufacturer.
State FDAs issue neutral codes to the manufacturers upon application as per
normal international practice.
