We are a new business and trying to set our foot in the export industry. We want to export generic medicines . We are not looking at manufacturing right now. There are few questions that are causing us some troubles and we are unable to find any information on them.
Would we have to take specific licenses for specific drugs or does one license covers all?
Do we have to hire a B.Pharma graduate as is the case in wholesaler’s business?
What are the few things we should look out for as newbies in this line of business?
Would you be able to help us out with this conundrum or could you point us in the right direction? Any help in this regards would be greatly appreciated.
For pharma export (other than company registration and IEC), you need wholesale drug license that you didn’t mention. If you are not manufacturer, manufacturer from which you are going to get manufactured your products should compile with cGMP certification and certifications required by importing country(to which country you will export). A dossier with complete information about molecule to be exported is to be submitted along with application form for export approval from DCGI. Read in detail about Pharma Export by clicking here
In most of case there is need to take product approval for export for every single product.
As a newbie, you need to look out for understanding proper licensing systems and rule & regulations. In pharmaceutical sector, we have to undergo in lot of paper work and documentation, that make it complex work. so there is need to understand and update about all laws related to drugs and medicines.
Hope above information is helpful to you..
For any query and suggestion, mail us at Pharmafranchiseehelp@gmail.com
I am an owner of pharma marketing company and I subcontract for manufacturing drugs with standard manufacturer. (3rd party manufacturing) and now I want to export my products. I was told that as being a marketer I am not eligible for exports because for exporting drugs you have to be manufacturer. Is it so? Am I not eligible for exports?
It is not true, you have to be manufacturer for exporting drugs. Many marketing companies also do that. But you have to comply with export country norms. Your third manufacturer should comply all requirements that are needed by exporting country like USFDA, GMP, ISO certification(which is applicable) because manufacturers plant specifications, you have to attach with your export consignment.
You need to submit dossier and other details. These can be provided by manufacturer to you on the basis of you.You can export medicines with your marketing company. Only you need to fulfill all requirements needed by exporting company. Read in detail about exporting medicines by clicking here
Hope this information will be helpful to you…
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Query:I am having good marketing experiences of formulation precisely in exports market . Now I wish to start my own manufacturing T setup on small – medium size set up export oriented.
Please give me small outlines requirements , budget , investments require to start up etc
Before going into manufacturing, we will recommend you to first start marketing set-up for exporting formulations. You can start a marketing company and start exporting medicines from your own firm name. You will require a manufacturer having all certification that are required to export to particular country. It will require less investment and time to set-up export oriented manufacturing unit. You can read documentation for starting pharma marketing company here.If you want to start-up manufacturing unit, you can read general requirements here: Documentations and licences to start pharma manufacturing unit.
Other then mentioned in above linked article, you have to take certification and fulfill compliance according to exporting country.
I am interested in starting an export Pharma company.
I would appreciate if i could get help from your end on the same.
Few requirements will be same as in case of domestic pharma company like drug license number, tax 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 is required from DCGI for exporting of any pharmaceutical product which is valid for one calendar year. After one year, 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
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
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)
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….
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