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EXPORT PROCESS FOLLOWED BY PHARMACEUTICAL COMPANIES

Submitted by-FAISAL ZISHANDEESHA DUTTA SUDEEP TIRKEY PRAVEER DAYAL SHISHIR KUMARExport 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.EXPORT :

Steps Involved In The Export ProcessSTEP1: Enquiry-The starting point for any Export Transaction is an enquiry.An enquiry for product should, inter alia, specify the details like Size, Drawing, Sample, Quantity, Delivery schedule etc.STEP 2: Proforma generation-After studying the enquiry in detail, the exporter - be it Manufacturer Exporter or Merchant Exporter - will provide a Proforma Invoice to the Buyer.STEP 3: Order placement-If the offer is acceptable to the Buyer in terms of price, delivery and payment terms, the Buyer will then place an order on the Exporter, giving as much data as possible.STEP 4: Order acceptance and export contract-It is advisable that the Exporter immediately acknowledges receipt of the order, giving a schedule for the delivery committed.STEP 5: Goods readiness & documentation Once the goods are ready duly packed in Export worthy cases/cartons (depending upon the mode of dispatch), the Invoice is prepared by the Exporter.If the number of packages is more than one, a packing list is a must.

STEP 6: Goods removal from works -There are different procedures for removing Export consignments to the Port, following the AR4 procedure, but it would be advisable to get the consignment sealed by the Central Excise authorities at the factory premises itself, so that open inspection by Customs authorities at the Port can be avoided.

STEP 7: Documents for C & F Agent-Forwarding Agents, who are entrusted with the task of shipping the consignments, by air or sea.InvoicePacking ListDeclaration in Form SDF (to meet the requirements as per FERA) in duplicate.AR4 - first and the second copyAny other declarations, as required by Customs

STEP 8: Customs Clearance After assessment of the shipping bill and examination of the cargo by Customs (where required), the export consignments are permitted by Customs for ultimate Export. This is what the concerned Customs officials call the LET EXPORT endorsement on the shipping bill.

STEP 9: Document Forwarding -Customs signed Export Invoice & Packing ListDuplicate of Form SDFExchange control copy of the Shipping Bill, processed electronicallyAR4 (original duplicate) duly endorsed by Customs for having effected the Export.Bill of Lading or Airway bill.

STEP 10: Bills negotiation-With these authenticated shipping documents, the Exporter will have to negotiate the relevant export bill through authorized dealers of Reserve Bank, viz., Banks.Under the Generalized System of Preference, imports from developing countries enjoy certain duty concessions, for which the exporters in the developing countries are expected to furnish the GSP Certificate of Origin to the Bankers, along with other shipping documents.

Step11: Bank to bank documents forwarding The negotiating Bank will scrutinize the shipping documents and forward them to the Banker of the importer, to enable him clear the consignment.It is expected of such authorized dealers of Reserve Bank to ensure receipt of export proceeds, which factor has to be intimated to the Reserve Bank by means of periodical Returns.

STEP 12: Customs obligation discharge :-As indicated above, Exporters are also expected to provide proof of export to the Central Excise authorities, on the basis of the Customs endorsements made on the reverse of AR4s and get their obligation, on this score, discharged.

STEP 13: Receipt of Bank certificate-Authorized dealers will issue Bank Certificates to the exporter, once the payment is received and only with the issuance of the Bank Certificate, the export transaction becomes complete.It is mandatory on the part of the Exporters to negotiate the shipping documents only through authorized dealers of Reserve Bank, as only through such a system Reserve Bank can ensure receipt of export proceeds for goods shipped out of this country.Stepwise Procedure for export of pharmaceutical productsBefore the pharmaceutical company starts actual export of their products to any country, it is very important to understand the pre-requisites like:-

Registration of the products with the respective statutory authority.Appointment of agent/representative in that country.

Registration Export regulations of IndiaIt 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 Rs. 1,000/-.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 Compulsory Quality Control & Pre-shipment Inspection 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). However, the following documents/certificate(s) are required to comply with registration requirement:-FDA license copy.Free sale certificate. C:\Users\lemovo\Desktop\FREE SALE FORM.pdfWHO-GMP certificate.C:\Users\lenovo\Desktop\The Good Manufacturing Practice.docxDetails of manufacturing facilities.Details of Quality Control Systems.Technical details about the product mentioning the following.Samples of sales pack with Q.C test report.

Sequence of activities in Pharmaceutical exportFollowing is the sequence of activities in pharmaceutical exports:-

Receive orders from overseas agent.Communicate order to the factory.Factory selects relevant batch and complies to special requirements.Documents are passed to CHA(Custom House Agent)CHA prepares shipping bill and does other documentation.CHA books air space or shipping space & communicates the same.Goods are released from factory with relevant excise.Goods are handed over to CHA to airlift or to send by ship.List of documents to be passed on to the CHA(Custom House Agent)Invoice.Packing list.GR form.Contract(if required).Letter of credit.DEPB pass book(Duty Entitlement Passbook).Certificate of origin(If required).Instruction for shipping bill.

APPLICATION FOR ISSUE OF AN EXPORT PERMITAn application accompanied by a prescribed fee for issue of an export permit shall be made on the prescribed form backed by legislation.An application for issue of an export permit shall state, for each medicine to be exported at least the following:generic name or International Non-proprietary Name (INN) strength and dosage form name and strength of each ingredient; in case of a product containing more than one ingredient trade name or proprietary name; if any pharmacopoeia specification of the medicine, where applicable total quantity to be exported name and address of the exporter name and address of the manufacturer name and address of consignee country of consignee route of dispatch license/registration number cost, insurance, freight (CIF) value expected date of dispatch The application shall be accompanied by copies of the purchase ordersImportation of drugs that lack approval and are not in line with these guidelines whether for personal use or otherwise will be considered as illegal importation and could be refused entry into any of the SADC countries or seized by customs officials.Messrs (Name of Exporter).....of (address i.e. Plot No. Street/Road, Town/City. P.O. Box).... ......Carrying on business as ......Are hereby authorised to export Pharmaceutical Products (Medicines, herbal medicines and alliedSubstances) during thecalendar year.....Name of Supervising Pharmacist ..Registration Certificate No: ..Conditions imposed by the Drug Regulatory Authority (refer to notes overleaf).This licence is valid from. to.....Registrar of medicinesDate Issued .Date stampPharmaceutical Export LicenseLicense No.Registration No.Conditions of issue / renewal for export licenseConsideration of an application for issue / renewal may take advantage to impose any new conditions or insist on any aspects that had been overlooked previously or are brought about due to new or amended legislation or policy.

Conditions for PremisesCompliance with minimum requirements Valid local authority license No adverse report since the previous issue regarding e.g. wrongful dealing in medicines, lack of proper management and control of the pharmaceutical business, etc Appropriately registered pharmacist with practicing license from Medical Council and with no recorded acts of professional misconduct over the previous year (those that may or may not warrant revocation of practicing license). Appropriate renewal forms and fees submitted well before previous license lapsed No changes to the previous conditions under which license was issued.

Conditions for Amendments

All amendments to conditions under which an export license was issued must be formally applied for and approved. A processing fee must be paid.

An applicant must not effect any changes without prior approval except for situations where e.g. a registered pharmacist leaves without notice and a locum tenens is in attendance for a period less than four weeks, changes of directorship in a company without changes in the effective supervision of the business.

Changes of ownership, effective directorship of a company, structural changes to the premises, changes in effective supervision of business, relocation to another premises require prior and written approval.Validity

Licenses are valid for one calendar year from time of issue or until formally cancelled by the issuing authority. An annual renewal must be applied for each time an applicant wishes its license to be renewed.Once a license has lapsed due to failure to renew by the licensee, there should not be a requirement for a formal notification of intent by the licensing authority to consider the license invalid.

Suspension or cancellation of licenses

A license may be cancelled under the following situations;Failure to comply with specific conditions of licensing Wrongful dealing in medicines, herbal medicines and allied substances Unauthorized change of premises Failure to comply with other legislation e.g. local authority licensing, health requirements that were part of the conditions of initial approval A formal and legislated appeal process must be conducted prior to cancellation of a license.