Import and export of drugs in India

1. NAME-AMMAR TASLEEM
Department-BSc Toxicology 5th
semester
Import and Export of drugs in India

2. All around the globe, People are in need of medicines;
some of the medicines are manufactured and available
to them locally. For the remaining percentage the drug
has to be imported from other countries.
Import and Export of drugs
in India

3.  Some facts about Indian Pharmaceutical Industry
 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 (active pharmaceutical
ingredients)
 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

4. India occupies a third largest position in the world in the field of
Pharmaceutical industry.
These industries are regulated by the Ministry of Health & Family
Welfare and Ministry of Chemical & Fertilizers .
India has a special policy for the purpose of Import and Export called as
“EXIM” policy. This policy gives way to quantitative as well as qualitative
improvements in the field of Research and Development activities .
 Exim Policy 1992 -1997
 liberalize imports and boost exports, the Government of India
for the first time introduced the Indian Exim Policy on April I,
1992. In order to bring stability and continuity, the Export
Import Policy was made for the duration of 5 years
Export-Import Bank of India (EXIM Bank) is a specialized financial
institution, wholly owned by Government of India, set up in 1982, for
financing, facilitating and promoting foreign trade of India.
Exim Policy or Foreign Trade Policy is a set of guidelines and
instructions established by the DGFT in matters related to the
import and export of goods in India. ... DGFT (Directorate General
of Foreign Trade) is the main governing body in matters related
to Exim Policy.

5. The Central Drugs Standard Control Organisation (CDSCO)
regulates the import and export of the drugs in the country, through
11 Port offices located in different parts of the country. CDSCO
regulates the manufacture, sale, import, export, and clinical research
of drugs in India by the following rules and acts 3.
Drugs and Cosmetics act, 1940 and Rules, 1945.
Pharmacy act, 1948
Drugs and Magic Remedies act, 1954.
Medicinal and Toilet Preparation act, 1956.
Narcotic and Psychotropic Substances act, 1985.
The Drugs (Prices Control) order, 1995.
The CDSCO also work through state authorities.
While, the central authorities are responsible for approval of new
drugs, clinical trials in the country; laying down the standards for the
drugs control over the quality of imported drugs coordination of the
state drug control organisations;
the state authorities regulates manufacture, sale and distribution of
drugs, licensing drug testing laboratories, approving drug
formulations for manufacture, carrying out pre and post licensing

6.  What is export of drugs ?
 Exports is selling the drugs,pharmaceuticals,medical
devices,etc.to other countries crossing the geographical
frontiers of the country

8.  Below are the 15 countries that exported the highest dollar
value worth of drugs and medicines during 2018.
 Germany: US$62.3 billion (16.8% of total drugs and
medicines exports)
 Switzerland: $45.3 billion (12.2%)
 Belgium: $27.8 billion (7.5%)
 France: $25.9 billion (7%)
 United States: $22 billion (5.9%)
 Ireland: $21.7 billion (5.8%)
 United Kingdom: $19.7 billion (5.3%)
 Italy: $19.6 billion (5.3%)
 Netherlands: $16.8 billion (4.5%)
 India: $14.8 billion (3.8%)
 Denmark: $13 billion (3.5%)
 Spain: $9 billion (2.4%)
 Canada: $6.8 billion (1.8%)
 Sweden: $6.7 billion (1.8%)
 Austria: $5.5 billion (1.5%)

9.  Export regulations of India
 Registration:
 It was compulsory for every exporter to obtain an exporters’
code number from the reserve bank of india before
engaging into export.
 Registration with Legal Liscensing:Authorities (obtaining
IEC Code Number) The Customers Authority will not allow
to import or export goods into or from India unless you hold
a valid IEC Number.
 IEC (importer Exporter Code) number is a 10 digit code
number given to an exporter or importer by the regional
office of the Director general of Foreign Trade (DGFT),
Department of Commerce, Government of India.
 For obtaining IEC Number you should apply to Regional
Licensing Authority in duplicate.Before applying for IEC

10.  .The duly signed application form should be supported by the
following documents:
 Bank receipts( in duplicates)/Demand draft for payment of the fee of
1,000 USD
 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 the 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 in 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.

11.  Compulsory Inspection Quality Control& Pre Shipment
 An important aspect about the goods to be exported is
compulsory quality control and pre-shipment inspection.Under
the Export Act, 1963 pharmaceutical products are subject to
compulsory pre shipment inspection.
 Particulars of the consignment intended to be exported.
 A crossed cheque/draft for the amount of requisite inspection
fees or an Indian Postal OrderCopy 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
specifications .
 The certificate is issued in the standardised form which is
aligned pre-shipment export document.)
 Export Act, 1963 : Act to provide for the sound development of
the export trade of India through quality control and inspection
and for matters connected therewith.

12.  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.
 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
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.

15.  IMPORT 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 .

16.  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 250 USD 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.
 Licensee shall being informed by the licensing authority that any part
of any batch of substance has been found not to confirm with

17.  Licensee shall maintain the records of all particulars
for schedule X Drugs
 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

18.  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 impart 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 .
 The top Indian importers of Medical Drug are:Ispat General
Hospital
 Fresenius Kabi India Private Ltd
 Serdia Pharmaceuticals India Pvt Ltd
 Forbes Gokak Limited
 Quintiles Research India P Ltd