Page 8 - Guidance document for import of Drugs & Pharmaceuticals from India

This stipulation is exempted only when Government of importing country has

its own barcoding/ trace & tracking system in operation. India is one of the

few countries implementing barcoding system.

Certificate of Origin

Exporter has to submit a Certificate of Origin for every consignment.

Certificates of Origin, in case of exports to countries where there are non-

preferential trade agreements exist, all Export Promotion Councils, Boards,

Chamber of Commerce as notified by DGFT, will be given. In case of countries

with Preferential Trade Agreements, Certificate of Origin will be issued by

specified Agencies

Registration with Export Promotion Councils

There are 36 Export Promotion Councils / Boards in India, which take care of

promotion of various commodities. Pharmaceuticals Export Promotion Council

of India (Pharmexcil) is set up by Government of India for promotion of export

of Drugs & Pharmaceuticals. All pharma exporters are required to register with

Pharmexcil.

Registration of products in Importing Countries

Every exporter of Drugs & Pharmaceuticals is required to register their

products with FDAs of importing countries by following the procedures as laid

down by the respective FDAs. Copy of Registration Certificate / Renewal

certificate has to be submitted along with every export consignment.