This document discusses procedures for exporting and importing pharmaceuticals in India. It provides an overview of India's pharmaceutical industry and regulations regarding export/import licenses, quality control inspections, labeling/packaging, and medical device imports. The general export process involves obtaining necessary licenses, procuring goods, packing/labeling, shipping, and completing documentation. Import regulations specify registration requirements and conditions for licenses, standards, and record keeping for imported pharmaceuticals. Certain medical devices are also regulated as drugs under Indian law.

1. Exports and ImportsExports and Imports
ofof
PharmaceuticalsPharmaceuticals
byby
Sai dhatri ArigeSai dhatri Arige

2. TableTable ofof contentscontents
 Introduction
 Export and import general procedures
 India export and import regulations
 References

3. IntroductionIntroduction
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.

4. Indian PharmaceuticalIndian Pharmaceutical
IndustryIndustry
 Indian Pharmaceutical Market ~US $ 20 bn
 Import (2008-09 ) 254.57 USD Million
 Export (2008-09 ) 2086.32 USD Million
 10 % global Production & 2.4 % of World pharma
Market
 Bulk Drug Production > 500 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

5. Indian Pharmaceutical Industry:Indian Pharmaceutical Industry:
EXPORTSEXPORTS

6. General procedure for exportGeneral procedure for export
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.Mate’s receipt

7. 13.Bill of loading
14.Marine insurance
15.Forwarding agent advice
16.Preparation of export invoice
17.Payment
18.Advice to importer

8. Export regulations of IndiaExport regulations of India
Registration
 It was 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.
 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 1,000
USD.

9. Cont.Cont.
 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

10. Cont..Cont..
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

11. 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.

13. 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.

14.  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 standardised 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).

15. 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.

16. 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 conforms to those written in the
invoice, insurance certificate, bill of lading and other documents.

17. Indian Pharmaceutical Industry:Indian Pharmaceutical Industry:
IMPORTSIMPORTS

18. Import general procedureImport general procedure
1. Obtaining import license
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

19. IMPORT REGULATIONS IN INDIAIMPORT REGULATIONS IN INDIA
IMPORT LICENCE:
 License in form 10 is to import drugs excluding those specified in schedule X
 License in form 10-A to import drugs specified in schedule X
Registration certificate:
 means a 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.
Forms and manner of application for import license:
 An application for an import license shall be made to the licensing authority
in form 8 for drugs excluding those specified in schedule X
 Form 8-A for drugs specified in schedule X
 Fee for license:- Applicant shall make a payment of 1500 USD (or its
equivalent to Indian Currency), as registration fee for the Manufacturing
premises.
Applicant shall make an payment of 1000 USD (or its equivalent to
Indian Currency), as registration fee for a single drug and additional fee of
1000 USD for each additional drug in case the manufacturing site remains
the same.

20. CONT.CONT.
 Application for import license shall be accompanied by a copy of registration
certificate.
 Registration certificate shall not be required for import of in vitro diagnostic kits and
reagents.
 A fee of 250USD shall be paid for a duplicate copy of license issued if original is
damaged or lost.
 A single application be made and a single license may be issued in respect of import
of more than one drug or class of drugs manufactured by same manufacturer.
Conditions of import license:-
 Premises where imported substance will be stocked are equipped with proper
storage.
 The licensee shall allow any inspector authorized by licensing authority in that behalf
to enter with or without notice any premises where the imported substances is
stocked to inspect the means if any employed for testing substance and to take
sample.

21. Cont..Cont..
 Licensee shall being informed by the licensing authority that any
part of any batch of substance has been found not to confirm with
standards of strength,quality,purity.
 Licensee shall maintain the records of all sales by him of
substances for import of which a license is required.

22. CONT.CONT.
 Licensee shall maintain the records of all particulars for
schedule X drugs
 Name of the drug
 Batch number
 Name of address of manufacture
 Date of transaction
 Opening stock on business day
 Quantity of drugs received if any and the source
 Name of purchaser, his address and licence no.
 Balance quantity of drug at end of business day
 Signature of person under whose supervision drug supplied.

23. CONT..CONT..
Grant of license:-
 The licensing authority issue the license AND IS VALID FOR A PERIOD
OF THREE YEARS.
 If manufacturer fail to comply with any of the condition of import license
the licensing authority may after giving an opportunity to show the cause
why such an order should not passed by an order in writing stating
reason suspend it.
 Prohibition of import after expiry of potency
 Standards of certain imported drugs.
 Licensing authority shall not import of any drug having less than 60%
residual shelf life period as on date of import.
 Packaging and labeling should be in conformity with the rules.

24. MEDICAL DEVICEMEDICAL DEVICE
The Ministry of Health and F.W. under Gazette notification S.O. 1468
(E) dated 6/10/2005 declared the following sterile devices to be
considered as drugs under Section 3 (b) (iv) of the Act.
 Cardiac Stents.
 Drug Eluting Stents.
 Catheters.
 Intra Ocular Lenses.
 I.V. Cannula.
 Bone Cements.
 Heart Valves.
 Scalp Vein Set.
 Orthopedic Implants.
 Internal Prosthetic replacements.

25. Cont.Cont.
IMPORT OF MEDICAL DEVICES
For the purpose of import of Devices specified above, the procedure
for registration and import license as prescribed under the Drugs and
Cosmetics Rules shall be followed.
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.
In case of devices 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.

26. Cont..Cont..
 For the time being and for a period up to six months, until an
application is approved or rejected, whichever is earlier, the devices
which are currently in use will be permitted to be sold. In case of
stents or drug eluting stents the import will not be permitted if the
applicant has sold less than One thousand stents of the particular
specification prior to the date of issue of these guidelines.
 Separate committees consisting of subject experts and
representative of DCG(I) office would be setup for their expert
advice for evaluation of specific categories of devices. The expert
committees would formulate their own benchmarks and
procedures for evaluations and the standards to which such devices
should conform.