1. EXPORT AND IMPORT POLICIES
1
Export and import regulations and methods to obtain
licence for export and import of pharmaceuticals as
per India , U.S and EU
Presented by
priyanka gangarapu
M. Pharmacy.
cont.

2. INTRODUCTION
2
Export is selling the drugs, pharmaceuticals, medical
devices etc. To other countries crossing the
geographical frontiers of the country.
Import is purchases drugs from other country and
brings them in to the country crossing the
geographical borders of the country.
cont.

3. General procedure for export
3
Steps of export procedures : Receipt of indent
 Receipt of license for export procurement of goods.
 Packaging and labelling appointment of forwarding agent
dispatch of goods.
 Foreign customs permit shipping order export duty and
shipment bill, Dock dues or challan loading the Mate’s
receipt.
 Bill of loading Marine insurance forwarding agent advice.
 Preparation of export invoice Payment Advice to
importer.
cont.

4. General procedure for import
4
Steps for import: Obtaining import licence foreign exchange
 Placing the indent
 Dispatch of goods by export agent
 Obtaining shipment document
 Appointment of clearing agent
 Endorsement of delivery
 Payment of import duty dock dues
 Taking delivery of goods
 Keeping goods in warehouse
 Dispatch of goods by clearing agent
 Receipt of documents
 Taking the delivery
cont.

5. Import regulation in India
5
Forms
Form 10 - import drugs excluding those specified in
schedule X.
Form 10A - import drugs specified in schedule X.
Registration certificate
Certificate issued under rule 27 a by licensing
authority in form 41 for registration of premises and
drugs manufactured by manufacturer meant for
import in to and use in India.
cont.

6. 6
Forms and application for import licence.
Application for import licence-
Form 8 (drugs excluding those specified in schedule X)
Form 8A (import drugs specified in schedule X)
 Fee
For single drug – 1000 Rs
Addition fee for each additional drug- 100 Rs
 No registration for import of invitro diagnostic kit and
reagents.
 For duplicate license (if original is damaged or lost)
250 Rs shall be paid.
cont.

7. 7
A single application be made and a single license may be
issued in respect of import of more than one drugs
manufactured by same manufacturer.
 Conditions of import licence :1. Premises where imported substance will be stocked are
equipped with proper storage.
2. The licensee shall allow any inspector authorized by
licensing authority in that behalf to enter with or without
notice .
3. Any premises where the imported substance is stocked to
inspect the means any employed can come for testing
substance and to take sample.
4. Licensee shall being informed by the licensing authority
that any part of batch of substance has been found not to
confirm with standards of strength , quality, purity.
cont.

8. 8
 Licensee shall maintain the records of all sales by him of
substances for which a license is required.
 Licensee should maintain a records of all particulars for
schedule X drugs.
 Grant of license
1. License is valid for a period of three years.
2. Prohibition of import after expiry of potency Standards of
certain imported drugs.
3. Licensing authority shall not import of any drug having less
than 60% residual shelf life period as on date of import.
4. Packaging and labelling should be in conformity with the
rules.
cont.

9. Medical Device
9
The ministry of Health and Family welfare under
Gazette notification S.O. 1468 (E) dated 6/10/05
declared the following sterile devices to be
considered as drug under Section 3 (b) (iv) of the Act
.
1. Cardiac Stents 2. Drug Eluting Stents 3. Catheters 4.
Intraocular Lenses 5. I.V. Cannula 6. Bone cements
7. Heart Valves 8. Scalp vein set 9. Orthopedic
Implant
10. internal Prosthetic replacements.
cont.

10. Import Of Medical Devices
10
Procedure for registration and import licence as
prescribed under the D&C rules shall be followed.
1. A period of 60 days would be provided for the
importers to make application for import and
registration from the date of publication of these
guidelines.
2. In case of device which have not been imported in
the country before the date of notification no import
would be permitted without the approval of the
competent authority.
cont.

11. 11
For the time being and for a period up to 6 month,
until a application is approved or rejected, the device
which is currently in use will be permitted to be
sold.
Separate committees consisting of subject expert and
representative would be setup for their expert advice
for evaluation of specific categories of devices.
Expert committees would formulate their own
procedure for evaluation and the standards to which
device should conform.
cont.

12. Export regulation of India
12
It was compulsory for every exporter to obtain an
exporter’s code number from the RESERVE BANK OF
INDIA before engaging in export.
Registration with regional authorities ( obtaining IEC
code number )
The customs authorities will not allow you to export or
import goods into or from India unless you hold a valid
IEC number.
For obtaing IEC no. you should apply to Regional
Licensing authority in duplicate.

cont.

13. 13
Before applying for IEC no. it is necessary to open
bank account in name of your company/ firm with
any commercial bank authorized to deal in foreign
exchange
The duly signed application form should be
supported by the following document :
Bank receipt ( in duplicate).
Demand draft for payment of the fee of Rs. 1000/Two copies of pasport size photographs of the
applicant duly attested by the banker to the
applicants.
cont.

14. 14
A copy of permanent account no. issued by Income Tax
Authority. If PAN has not been allotted, a copy of
application of PAN submitted to Income Tax Authority.
An IEC no. allotted to an applicant shall be valid for all
its branches/ divisions as indicated on the IEC no..
Application for grant of export license in respect of items
mentioned in schedule 2 of ITC (HS). Classification of
export and import items may be made in the form given
in appendix 18A or 18B or 18C.
cont.

15. Compulsory quality control and pre-shipment
inspection
15
 An important aspect about the goods to be exported is
compulsory quality control and pre-shipment inspection.
 Under the export act 1963 pharmaceutical product are
subject to compulsory pre-shipment inspection.
 At times , foreign buyers lay down their own standards/
Specification which may or may not be in consonance
agencies.
cont.

16. IN PROCESS QUALITY CONTROL
16
 The inspection is done at various stages of production.

 The export has to get his unit registered as “EXPORT
WORTHY” and keep record of processing and production.
 Inspection by the officers of Export Inspection Agency is
done form time to time.
 The certificate of inspection on the end-product is then
given without in-depth study at the shipment stage.
cont.

17. 17
Under this system, export is allowed on the adequacy
of in-process quality control and inspection
measures exercised by the manufactured units
themselves.
The certificates of inspection in favor of the units
approved under the scheme are issued by the Export
Inspection Agencies in the normal course.
cont.

18. Labeling, packaging, and marking goods
18
 The involves labeling, packaging, packing and
marking of export consignments.
Labeling requirement differ form country to country
and the same should be ascertained well in advance
form the buyer.
The label should indicate quality, quantity, method
of use etc.
Packaging should also be in conformity with the
instruction issued by the importer.
cont.

19. U.S. IMPORT REQUIREMENTS
19
CONTENTS
1. Import requirements.
2. Arrival of goods.
3. Entry of goods.
4. Other types of entry
5. Customs examination of goods.
6. Protest.
7. Mail shipments.
8. Restricted Merchandise
9. Foreign assets control
cont.

20. U.S. IMPORT REQUIREMENTS
20
An individual may make his own customs clearance of
goods imported for personal use or business.
All merchandise coming into the United States must
clear customs and is subjected to a customers duty unless
specifically exempted by law clearance involves a no. of
steps- Entry, Inspection, Appraisement, Classification
and liquidation.
The U.S. Customs service does not require an importer
to have license or permit.
The importer must declare the dutiable value of
merchandise.
The importer must determination the classification no. of
the merchandise imported.
cont.

21. 21
The dutiable value of merchandise is determined by
customs. Several appraisal methods are used to arrive
at this value.
The Harmonized Tariff Schedule of the United States
(HTSUS), issued by International Trade Commission,
prescribes the rates of duty and classification of
merchandise by type of product e.g., animal and
vegetable products , textile fibers and textile products.
The tariff schedule provides several rates of duty for
each item: “general” rates for most- favoured nations,
“special’ rates for special trade programs (free, or lower
than the rates currently accorded most favoured
nations) and “ column 2” rates for imports not eligible
for either general or special rates.
cont.

22. ARRIVAL OF GOODS
22
Imported goods may not be entered legally until the
shipment has arrived within the limits of the port of
entry and delivery of the merchandise has been
authorized by customs. The is normally
accomplished by filling the appropriate documents
either by importer or by importer’s agent.
Imported merchandise not entered through customs
in a timely manner (up to 30 days) is sent by
customs to a general order warehouse to be held as
unclaimed.
cont.

23. ENTRY OF GOODS
23
To make or file a customs entry, the following documents
are generally required:
1. A bill of lading, airway bill or carrier’s certificate (naming
the consignee for customs purposes) as evidence of the
consignee’s right to make entry.
2. A commercial invoice ,obtained from the seller, which
shows the value and description of the merchandise.
3. Entry manifest (Customs Form 7533) or Entry /
Immediate Delivery (Customs Form 3461).
4. Packing lists, if appropriate and other documents
necessary to determine whether the merchandise may be
admitted.
cont.

24. OTHER TYPES OF ENTRY
24
IMPORTED GOODS MAY BE SENT IN-BOND
FROM THE FIRST PORT OF ARRIVAL TO
ANOTHER CUSTOMS PORT. Arrangements for inbond shipments should be made before the goods
leave the country of export. In- bond entries
postpone final customs formalities, including
payment of duty and processing fee, until the goods
arrive at the final port.
cont.

25. CUSTOMS EXAMINATION OF GOODS
25
Examination of goods is necessary to determine:
1. The value of the goods for customs purposes and their
dutiable status.
2. Whether the goods must be marked with the country of
their origin or with special marking or labelling.
3. Whether the shipment contains prohibited articles.
4. Whether requirements of other federal agencies have
been met.
5. Whether goods excess of the invoiced quantities are
present or a shortage of goods exists.
cont.

26. PROTEST
26
With in 90 days, after the date of liquidation or other
decision, an importer or consignee may protest the
decision and receive an administrative review.
The protest is filled with the port director where
decision is being protested.
Any person whose protest has been denied may
content the denial by filing a civil action in the U.S.
Court of inter trade.
cont.

27. MAIL SHIPMENTS
27
Shipments by mail which do not exceed $2000 in
value whether commercial and non commercial
importations are entered under mail entry prepared
by a customs officer after the postal service submits.
cont.

28. EXPORT REGULATIONS
28
The Export Administration Regulations (EAR)
regulate the export and re-export of the items for
national security, non proliferation, foreign policy,
and short supply reasons. The Department of
Commerce’s Bureau of Export administration (BXA)
has taken important steps to remove unnecessary
obstacles to exporting, including completion of U.S.
Regulatory reform effort and export control
liberalization license.
cont.

29. APPLY FOR LICENSE
29
If an export license is required, you must prepare a
Form BXA- 748P, “Multipurpose Application Form”
and submit it to BXA. The form can be used for
requesting an export license, re-exports or
commodity classification.
cont.

30. MEDICAL DEVICE REGULATION OF U.S.
30
 Any medical device that is legally in the U.S. may be
exported anywhere in the world without prior FDA
notification or approval.
 The export provision under section 802 of the FD & C act
only applies to unapproved device.
 For a device legally in commercial distribution the U.S. , the
following requirement must be met1. The manufacturing facility must be registered with FDA.
2. The device must be listed with FDA.
3. Device must have cleared premarket notification 510(k) or premarket
approval.
4. Device must meet labelling requirment of 21CFR part 801 and 21 CFR
809, if applicable.
cont.

31. IMPORT MEDICAL DEVICE
31
 I n order to import medical device into U.S., the product
must meet FDA regulatory requirements.
 FDA dose not recognize regulatory approval from other
countries foreign manufacturers must meet applicable
United states medical device regulations in order to import
device into U.S. even if the product is authorized for
marketing in another country.
 These order include:
Listing of device
Manufacturing in accordance with the quality system
Medical device reporting adverse effect
Premarket notification or premarket approval entry information should
identify the product and include appropriate information to
demonstrate product compliance with FDA .
5. Product information should include product name and product code.
1.
2.
3.
4.

cont.

32. AVOIDING DELAY IN RECEIVING A LICENSE
32
In filling out a license application, re-exporters commonly make
four errors that account for most delays in processing
applications:
1. Failing to sign the application.
2. Handwriting, rather than typing the application.
3. Responding inadequately to section 22(j) of the application,
“Description of Commodity or Technical Data”, which calls for a
description of the item or items to be exported. You must be
specific, and you are encouraged to attach additional material to
explain the product fully.
4. Responding inadequately to section 21 of the application, where
the specific end use of the products or technical data is to be
described. Again you must be specific . Answering vaguely or
entering “unknown” is likely to delay the application process.
cont.

33. I and E Licence Number
33
IEC Code is a unique 10 digit code issued by DGFT-
Director General of Foreign Trade Ministry of
Commerce, Government of India to Indian companies.
To import or export IEC code is mandatory. No person or
entity shall make any import or export without IEC code
Number.
An application for grant of IEC number shall be made by
the Registered/ head office of the applicant and apply to
the nearest Regional Authority of Directorate General
Foreign Trade, the Registered office in case of company
and Head office in case of others, falls in the “Aayaat
Niryaat Form – ANF2A” and shall be accompanied by
documents prescribed therein.
cont.

34. THE APPLICATION DULY SIGNED BY THE APPLICANT SHOULD BE
SUPPORTED BY THE FOLLOWING DOCUMENTS
34
 Bank receipt (in duplicate)/ demand draft for payment of the
fee of Rs 1000. certificate from the Banker of the applicant
firm as per Annexure 1 to the form. Two copies of passport
size photograph of the applicant duly attested by the banker of
the applicant.
 A copy of Permanent Account Number issued by Income Tax
Authorities, if PAN has not been allotted a copy of the letter of
legal authority may be furnished. If there is any non resident
interest in the firm and NRI investment is to be made with
repatriable benefits, full particulars thereof along with a
photocopy of RBI’s approval. If there is NRI investment
without repatriation benefit, a simple declaration indicating
whether it is held with the general/ specific permission of the
RBI on the letter head of the firm should be finished. In case
of specific approval a copy may also be furnished.
cont.

35. 35
Declaration by the applicant that the proprietors/
partners/ directors of the applicant firm/ company the
IEC No. Is allotted with a condition that be can export
only with the prior approval of the RBI.
Profile of the exporter/ importer in a given format at
Appendix 3.11
1. The Registered office/ HO/ Branch office (duly
authorized by the HO in this behalf) should apply for
allotment of IEC No. However, only one IEC no. Is
allotted to a company and the same is valid for all its
branches/ offices/ units. The application for the grant
of IEC no. Should be made to specified in Appendix
3.111.
cont.

36. 36
The application fee shall be deposited by way of
deposit in an authorized branch of Central Bank of
India indicating the head account 1453 Foreign
Trade and Export Promotion minor head 102
import licence application fee.
2. The IEC no. Is likely to be granted within 3 days of
the receipt of the complete application and
requisite documents.
1.
cont.

37. 37
How to fill up IEC application
Application form should be made in the prescribed
from in duplicate along with the above enclosures.
1. The form should be neatly typed/ hand written in
bold capital letters only.
2. Each copy of the application from should be signed
in ink by the authorised person.
3. Items of information relevant to applicant should
only be filled and remaining items may be marked
not applicable.
cont.

38. 38
Modification of particulars of the applicant should
also be furnished on this form by filling the
relevant items.
2. However, in case an IEC holder no longer wishes to
operate under the allotted code number, the matter
should be brought under the notice of Regional
Licensing Authority to make the code number
inoperative.
1.
cont.

39. EUROPE EXPORT REGULTIONS
39
•
The MHRA on the behalf of the department of Health,
issues export certificate on request to assist exporter of
medicinal product to satisfy the import requirement of
other country.
• The certificate issued by MHRA where necessary, the
format of certificate complies with that specified by
international authorities, e.g WHO.
• The MHRA issues four different type of certificates, two
of which comply with the format establish by the WHO.
• Each type of certificate is country specific , naming one
individual country .
cont.

40. CERTIFICATE FOR PHARMACEUTICAL
PRODUCT
40
This certificate complies with the format specified by
WHO.
The certificate will provide details about a single
named medicinal product which may be licensed or
unlicensed in the U.K.
It provide details about the product:
1. The active ingredients and excipients,
2. The manufacturing and packaging sites
3. Whether or not the product is placed on the market
in U.K.
cont.

41. CERTIFICATE OF LICENSING STATUS
41
 This certificate complies with the format specified by the
WHO.
 It is intended for use by importing agents who are required
to screen bids made in response to an international tender
and can apply to licensed or unlicensed product.
 The certificate of licensing status is limited to ten product
per certificate and country specific.
 Details of the product name, dosage form, active
ingredients and amount should all be quotes in accordance
with their product license ( if applicable ) and these details
will be checked against the MHRA.
cont.

42. CERTIFICATE OF MANUFACTURING STATUS
( CMS)
42
 It dose not provide any product specified information, but
it confirms whether named sites meet Good Manufacturing
Practice requirements on a specified manufacturing license
number.
 All or any of the sites named on the manufacturing license
may be listed on the certificate.
 Certificate for the importation of a pharmaceutical
constituent ( CPC) is available for a named constituent of
medicinal product.
 The MHRA will only issue certificate for unlicensed
medicinal product that are manufactured in the U.K on a
site holding a manufacturer’s license appropriate to the
dosage form of product which the certificate applies
cont.

43. 43
It is not possible to issue a certificate for unlicensed
product manufactured outside the U.K.
THE CERTIFICATE OF A PHARMACEUTICAL
PRODUCT –
It requires the most detailed information.
All forms ask for date of application, your reference,
your name and business name and address, invoice
details if different form the applicant’s name of
importing country, standard or urgent service,
language and number of copies required.
cont.