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.
Dossiers:
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.