Import and export of drugs in india

Import and export of drugs in India

1. NAME-AMMAR TASLEEM Department-BSc Toxicology 5 th 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 inspections, for the drugs manufactured and marketed in the respective states

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

7. 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%)

8. 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 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

9. . 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 .

10. 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.

11. 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. 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 .

12. 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 .

13. 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 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.

14. 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

15. 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