Drugs Export Policy and Procedure in India

Drugs Export-Policy-and-Procedure-in-India

Drugs Export Policy and Procedure in India


Indian pharmaceutical and drugs industry is the third-largest in the world in terms of volume and thirteenth largest in term of value. India mostly manufactures generic drugs which constitute 70 per cent of the market, and 20 per cent is covered by counter medicines and nine per cent by patent drugs.

Procedure to export medicines from India

IEC Number (Importer Exporter Code Number): Every importer and exporter of drugs in India has to register at Director General of Foreign Trade Department. To apply for IEC Number, an application has to be submitted to Director General of Foreign trade's Regional Authority office. The exporter can also apply for online registration portal by visiting http://dgft.gov.in/.

The application will be scrutinized by Regional Authority of DGFT online, and a digitally signed e-IEC is issued and/or emailed to applicant within two working days if all the mandatory documents and formalities are completed. In case of rejection, a letter or email with the reason for rejection would be sent to the applicant.

Documents required:

· Premises ownership proof or rent agreement or lease proof

· Partnership deed or company association documents

· Bank Certificate or Cancelled cheque having printed details of firm/company and account number

· Or as asked by DGFT department


WHO: GMP certified Plant

Most of the countries allow pharmaceutical import from plants that are WHO: GMP approved only. Few countries like the USA have their own authority certification requirements for importing any drugs. To export to the USA you have to be approved by USFDA. 


Distributor/Agent or Registered Office in Importing Country:

Most of the micro manufacturers appoint import agent and distributor in importing country because of the expenses in marketing and sales team to handle marketing and promotion. This is the best option for the exporters who don't want to set-up their arrangement. The distributor will look at marketing and promotion, registration of product and other legal formalities in importing country.



A Dossier is very important in the registration process in importing country and permission/approval from DCGI for export. It contains complete information about the origin, nature, chemical properties and other particulars of a drug.


The format of the dossier may vary in each country as per their rules and regulations. So an in-depth study of the dossier as per country laws and regulation is necessary before registration.


Permission from DCGI:

Before exporting any drug from India, an approval/permission/NOC, i.e. COPP from DCGI is required. The Approval/Permission/NOC is one time for each product and valid for one calendar year but subject to renew further.

Indian Customs has started SWIFT (Single Window Interface for Facilitating Trade) under which exporter can acquire the required permission from different regulatory authorities like Animal quarantine, Plant Quarantine, Drug Controller, etc. online without approaching these agencies separately.


Custom Clearance: For Custom Clearance, the exporter has first to generate shipping bill through custom online Software system electronically. After the shipping bill is generated, the product will be inspected by the customs officials. The official will also check the necessary documents and other particulars and submit an examination report to higher custom officials for approval.

After all the necessary documents and inspection 'Let Export Order' will be issued. The 'Let Export Order' is the proof of completion of the export customs procedure and three shipping bill will be printed. One for the exporter, one for exchange control copy for submission in Reserve Bank of India through Exporter's Bank and one for shipping carrier for the imported country destination.