How to Export Pharmaceutical Products from India?

Query:  

I am interested in starting an export Pharma company.
I would appreciate if i could get help from your end on the same.  

Response:

Few requirements will be same as in case of domestic pharma company like drug license number, GST identification number, registration etc. You can read requirements for both marketing company and manufacturing company by clicking at particulars.

Along with documentations mention in marketing or manufacturing company, you need few other requirements and documents for exporting medicines from India:First one is IEC number ( Import/Export Code Number). This is the number is given to all exporters and Imported of India. You have to apply for this to Director General of Foreign trade within the jurisdiction office of your firm situates. Without an IEC code, no movement of goods from/to the country to outside is allowed.

In case you are trader, not manufacturer, you have to search for a manufacturing unit which comply all norms and formalities that are required by the country’s health or drug department, you want to export medicine products e.g. USFDA approval required in case of USA.

Manufacturing unit should also have approval of that product for manufacturing from drug department. An agreement will be built between you and manufacturer regarding manufacturing of product that is exported by you. Packing is also a main part while you are exporting medicine from India. You require packing containing bar code. Most of countries only accept single molecule product, so you should collect all information about specification required by country in which you are planning for export. Your agent or importer from that country will do that work for you.

One time approval of product i.e. COPP is required from DCGI for exporting of any pharmaceutical product which is valid for one/two calendar year. After that, it has to be renewed.

Application for Issue of an Export Permit:

An 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 9
• Route of dispatch
• Licence/registration number
• Cost, insurance, freight (CIF) value
• Expected date of dispatch

Documents Required for Import Export Code (IEC) Number:

• Passport Size photograph of Proprietor/Partners/Directors
• PAN number copy of Proprietor/Partners/Directors
• Address Proof i.e. Passport/Voter ID/Driving License
• Premises ownership proof i.e. electricity/telephonic bill. Rent/lease agreement, in case premises is rented/leased.
• Partnership deed or certificate of incorporation
• Bank certificate as per ANF 2A(I) from Bank in which Firm/Company has its current account/Cancelled Cheque having pre-printed name of applicant and account number

For Pharmaceutical Products export, following procedure can be helpful to start:

• Constitution of new firm or company (Skip if you already have)
• Apply for IEC code
• Contact Foreign/Overseas Agent who is interested to import medicines in his country
• Send and finalize Prices (included or excluded of shipping cost, custom clearance and other expenses)
• Send samples
• Finalize all term and condition like term of delivery, payment term etc.
• Receive Purchase Order
• Aproval or/and NOC from DCGI (Drug Controller Genral of India) for export of every pharmaceutical products
• NOC from Wild life protection board if applicable
• Choose & finalize shipping method and Shipping agent for exporting pharmaceutical products
• Prepare Invoice (Against purchase order or Letter of Credit) and packing list
• After completing all documents, move to Custom clearance procedure. You can do it yourself or appoint any agent. (If you are new to export, hiring a custom broker or agent will be better option). Apply for shipping bill through custom online software system electronically. Obtain shipping bill.
• Pharmaceutical products then moved to shipping portion where custom officials inspect the material, documents required and other formalities , and submit examination reports for higher custom official for approval.
• After verifying all details, ‘Let Export Order’ is issued as proof of completion of export custom procedure then three shipping bills are printed. One for exporter, one as exchange control copy for submission in Reserve Bank of India through exporter’s bank and one is shipping carrier for exporting country destination.
• Pharmaceutical Products will cleared by importing party or his agent or your appointed agent in imported country.
• Products registration and any other formalities in importing country should be completed and your customer can start selling your products in his country
• Export procedure is completes

Before exporting any pharmaceutical products from India, there should be many point that you should consider. In country where you are exporting, you product should meet all requirement, manufacturing standards and quality standards. Every country has different norms of registration of a product before importing into country. Your product should be registered in exporting country before you start procedure for shipment and exporting. Registration can be done by you or your agent or distributor or marketer or party in importing country.

Along with above mention criteria, a pharmaceutical exporter should also know few below things:

HTS (HS code) of his product which he is going to be export. HTS stands for Harmonized Traffic Schedule.
ITS code stands for Indian Tariff Code. It is 8 digit level code. The first two digits give the chapter number, the heading number. The last two digits signify the subheading
Export of Pharmaceutical products is defined under Chapter 30 of schedule 2 in Indian Tariff Code (ITC). ITC is devided in two schedules. Schedule 1 define import requirement where as Schedule 2 defines export requirements.

Hope above information was useful to you….   For more suggestion and query, feel free to mail us at pharmafranchiseehelp@gmail.com