EXPORT:-

IMPORT:-
 Introduction

 Export and import general procedures

 India export and import regulations

 U.s export and import regulations

 Europe export and import regulations

 Japan export and import regulations

 References
 Export :-
 Export is selling the drugs ,pharmaceuticals, medical devices etc. to other
countries crossing the geographical frontiers of the country.
 A good example is India selling the drugs to U.S.A and England.
 Export earns a country lot of foreign exchange and helps in tilting the
balance of payment.

 Import :-
 When a country purchases drugs from other country and brings them in to the
country crossing the geographical borders of the country it is called import.
 Indian Pharmaceutical Market ~US $ 20 bn
 Import (2008-09 ) US$ 2.7 Bn
 Export (2008-09 ) US$ 8.6 Bn
 8% global Production & 2% of World pharma Market
 Bulk Drug Production > 400 API’s
 Export of Biotech products & Biopharmaceuticals ~US $1363M
 Manufacturing Facilities 142 US FDA Approved
 Largest Number of Manufacturing Facilities outside US
 Abbreviated New Drug Approval Filing - 2nd to USA
 The export procedure includes several steps :-
1.Receipt of indent

2.Receipt of license for export

3.Procurement of goods.

4.Packing and labeling

5.Appointment of forwarding agent

6.Dispatch of goods.

7.Foreign customs permit

8.Shipping order

9.Export duty and shipment bill

10.Dock dues or challan

11.Loading the goods

12. Bill of loading
13. Marine insurance
14. Forwarding agent advice
15. Preparation of export invoice
16. Payment
1. Obtaining import licence
2. Foreign exchange
3. Placing the indent
4. Dispatch of goods by export agent
5. Obtaining shipment documents
6. Appointment of clearing agent
7. Endorsement of delivery
8. Payment of import duty dock dues
9. Taking delivery of goods
10. Keeping goods in warehouse
11. Dispatch of goods by clearing agent
12. Receipt of documents
13. Taking the delivery
 Registration

 It is compulsory for every exporter to obtain an exporters' code number from the
Reserve Bank of India before engaging in export.

 Registration with Regional Licensing: Authorities (obtaining IEC Code Number) The
Customs Authorities will not allow you to import or export goods into or from India
unless you hold a valid IEC number. (Import Export Code)

 For obtaining IEC number you should apply to Regional Licensing Authority in
duplicate . Before applying for IEC number it is necessary to open a bank account in the
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
documents:

 Bank Receipt (in duplicates)/Demand Draft for payment of the fee of Rs. 1,000/-.
 Two copies of Passport size photographs of the applicant duly attested by the
banker to the applicants.

 A copy of Permanent Account Number issued by Income Tax Authorities. If

PAN has not been allotted, a copy of application of PAN submitted to Income
Tax Authorities

 The number should normally be given within 3 days provided the application
is complete in all respects and is accompanied by the prescribed documents.

 An IEC number allotted to an applicant shall be valid for all its

branches/divisions as indicated on the IEC number
 Acquire Export License

 Exports free unless regulated: The current Export Licensing Policy of the
Government of India is contained in the new Import Export Policy and
Procedures, 1997-2002 as amended .

 It may be stated that all goods may be exported without any restriction except
to the extent such exports are regulated by the ITC (HS) Classifications of
Export and Import items
 Application for an Export License:

 An application for grant of export license in respect of items mentioned in

Schedule 2 of ITC (HS) Classifications of Export and Import items may be
made in the form given in Appendix-18A or 18B or 18C.
 
 Compulsory Quality Control & Preshipment Inspection

 An important aspect about the goods to be exported is compulsory quality

control and pre-shipment inspection. Under the Export (Quality Control and
Inspection) Act, 1963 pharmaceutical products are subject to compulsory pre-
shipment inspection.

 At times, foreign buyers lay down their own standards / specifications which
may or may not be in consonance with the Indian standards. They may also
insist upon inspection by their own nominated agencies. These issues should be
sorted out before confirmation of order.
 Particulars of the consignment intended to be exported. A crossed cheque/draft
for the amount of requisite inspection fees or an Indian Postal Order.

 Copy of the Commercial Invoice.

 Copy of letter of credit.
 Details of packing specifications.
 Copy of the export order/contract, indicating that products are strictly
according to the prescribed specifications

 The certificate is issued in the standardized form which is aligned pre-shipment

export document. (Three copies for exporter, original copy for customs use, the
second copy for the use of the foreign buyer and the third copy for the
exporter's use, fourth copy for Data Bank, Export Inspection Council, New
Delhi and the fifth copy is retained with the agency for their own office record).
 In-Process Quality Control (IPQC)
 The inspection is done at various stages of production. The exporter 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 from time to time.
The certification of inspection on the end-products is then given without in-depth
study at the shipment stage.

 Under this system, export is allowed on the basis of adequacy of in-process

quality control and inspection measures exercised by the manufacturing units
themselves. The certificates of inspection in favor of the units approved under the
scheme are issued by the Export Inspection Agencies (EIAs) in the normal course.
 Labeling, Packaging, Packing and Marking Goods

 This involves labeling, packaging, packing and marking of export

consignments. Labeling requirements differ from country to country and the
same should be ascertained well in advance from the buyer.

 The label should indicate quality, quantity, method of use etc. packaging should
also be in conformity with the instructions issued by the importer. Packing
refers to the external containers used for transportation .

 All shipping cases should be marked a number with special symbols selected
by the exporters or the importers, so that the competitors cannot find out the
details of the customers and the country of destination or supplier's country of
dispatch. Care should also be taken to ensure that the marking confirms to those
written in the invoice, insurance certificate, bill of lading and other documents.
 The export of drug, biologicals, device etc. to U.S is governed by the FDA
Export reform act 1906 under section 801 and 802 of the act.

 This act is then amended in 1986 and FDA Export reform and enhancement act
1996 which basically solves the problem for exporting of approved drugs
biologicals and devices.

 Certification for Exports:-

 Certification is the process by which a formal or official attestation is made

concerning the regulatory status of a product.
 Requests for certification have variously asked for verification that the products
being exported:

 (1) are freely marketed in the U.S.;

 (2) are in compliance with U.S. laws and regulations;
 (3) are in compliance with the importing country's requirements;
 (4) meet certain national or international standards, such as quality standards; or
 (5) do not contain specific contaminants.

 FDA has historically issued a number of different types of certificates, e.g.,

Certificates of Free Sale, Certificates for Export, Certificates to Foreign
Governments
 Under section 801(e) of the Act,

 FDA is required to issue certificates for human drugs and biologics, and devices that
meet the applicable requirements of the Act.

 If FDA issues a certificate within 20 days of receipt of a request for such a certificate,
the agency may charge a fee of up to $175.

 The following guidance has been developed to improve agency uniformity and
consistency in providing export certificates:

 Certificates for human drug products, including human biological drugs, that conform to
the World Health Organization’s certification requirements should be entitled .

 If authentication of the certificate is required, the certificate may be notarized or

certified under seal of the Department of Health and Human Services in accordance with
21 CFR 5.22, or both.
 a. Provide a written statement that:

 (1) identifies the product or products to be exported; and

 (2) demonstrates that the products to be exported--

 5. A certification issued pursuant to section 801(e) of the Act may contain the following
elements (specific examples are attached):

 a. A statement that each specific product identified is subject to FDA jurisdiction

 b. A statement indicating the compliance status of the system by which the product is
required to be manufactured for approved or licensed products
 A statement that the certificate is valid for a period of twenty-four (24) months from the
date authorized

 Examples of circumstances for which certificates would not be issued include:

 Failure of the manufacturing facilities to operate in compliance with the current Good
Manufacturing Practice regulations

 Manufacturing facility not registered or listed with FDA.

 Manufacturing facility for which FDA has no inspectional information.

 Products eligible for a certification of exportability if they meet the applicable

requirements of sections 801 and 802 of the act.
 Attachments:

   Model Certificate to Foreign Government

 
  Model Certificate of Exportability - Section 802
 
  Model Certificate of Exportability - Section 801(e)
In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug Administration (FDA)
certifies the following information concerning the product(s) to be exported listed below:
NAME OF MANUFACTURER OR DISTRIBUTER, ADDRESS
NAME OF PRODUCT(S) (GENERIC NAME IF APPLICABLE)
COUNTRY OF DESTINATION (OPTIONAL)
PREMARKET APPROVAL IDENTIFIER (IF APPLICABLE, I.E., NDA, NADA, PMA
NUMBER, 510(k) NUMBER, LICENSE NUMBER)
The product(s) described above and the plant(s) where it is produced are subject to the jurisdiction of the FDA under the Federal
Food, Drug, and Cosmetic Act.
It is certified that the above listed product(s) may be marketed in, and legally exported from, the United States of America at
this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such
inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing
practice requirements for the product(s) listed above.
_____________________________
Signature
_____________________________
Title
Food and Drug Administration
_____________________________
Date
This certificate expires on (insert - date 24 months from date notarized).
County of ________________
State of _________________
Subscribed and sworn to before me this _____ day of _________.
Notary Public ________________________
My Commission Expires __________________________________
Certificate No.
 
 The Food and Drug Administration certifies that the product(s) described below is subject to its jurisdiction under the Federal Food, Drug, and
Cosmetic Act (the Act). Such product(s), which is not approved for marketing in the United States, may be legally exported provided it meets
the requirements of Section 802 of the Act.
 Under Section 802 of the Act, a drug or device not approved for marketing in the United
 States may be exported if it is manufactured, processed, packaged, and held in substantial
 conformity with current good manufacturing practice requirements. The manufacturing
 plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time,
appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed below. The company
has certified to the Food and Drug Administration that:
 * The product(s) accords to the specifications of the foreign purchaser;
 * The product(s) is not in conflict with the laws of the country to which it is intended for export;
 * The shipping package for the product(s) is labeled on the outside that it is intended for export; and
 * The product(s) is not sold or offered for sale in the United States.
 Based on the information above, the product(s) listed below may be exported pursuant to
 Section 802 of the Act.
 NAME OF PRODUCT [NAME OF COMPANY], [ADDRESS]
 (GENERIC NAME IF APPLICABLE)
 COUNTRY OF DESTINATION (OPTIONAL)
 ______________________________
Signature
 _______________________________
Title
Food and Drug Administration
 ________________________________
Date
 This certificate expires on (insert - date 24 months from date notarized).
County of ___________________
State of ___________________
Subscribed and sworn to before me this ______ day of __________.
Notary Public ________________________
My Commission Expires _________________________
 Certificate No.
 The Food and Drug Administration certifies that the product(s) described below is subject to its jurisdiction under the Federal Food,
Drug, and Cosmetic Act (the Act). The product(s) described below may not be sold or offered for sale in the United States. The
company has certified to the Food and Drug Administration that:
 * The product(s) accords to the specifications of the foreign purchaser;
 * The product(s) is not in conflict with the laws of the country to which it is
 intended for export;
 * The shipping package for the product(s) is labeled on the outside that it is
 intended for export; and
 * The product(s) is not sold or offered for sale in the United States.
 Based on the information above, the product(s) listed below may be exported pursuant to
 Section 801(e) of the Act.
 NAME OF PRODUCT [NAME OF COMPANY], [ADDRESS]
 (GENERIC NAME IF APPLICABLE)
 COUNTRY OF DESTINATION (OPTIONAL)
  ___________________________
Signature
_____________________________
Title
Food and Drug Administration
_____________________________
Date
 This certificate expires on (insert - date 24 months from date notarized).
 County of __________________________
State of ____________________________
Subscribed and sworn to before me this ______ day of _________.
Notary Public ______________________________
My Commission ExGuidance for Industry1
FDA Export Certificates
 http://trade.gov/index.asp
 http://trade.gov/mac/index.asp
 http://www.mac.doc.gov/japan
 http://trade.gov/cs/index.asp
 http://www.buyusa.gov/japan/en/ccg.html
 http://trade.gov/mas/index.asp
 http://www.mhlw.go.jp/english
 http://www.pmda.go.jp/english/index.html
 http://www.fda.gov/cdrh/devadvice/39.html
 http://www.fda.gov/cder/guidance/pharmCert2002.pdf
 http://pharmaceuticals.gov.in/
 www.wwcf.com.au
 Vijay malik,drug and cosmetic act and rules 1940
 Mhra.gov.in
 Consumer protection act of japan .
 Sidney h.willig,GMP for pharmaceuticals,5th edition,page no.425-437.
 www.emea.europe.in
 Vidya sagar,pharmaceutical industrial management,page no. 325-335