How to export medicines from India?

If you want to export medicines from one country to another, you have to compile with both countries rules and regulations. Medicine is a sensitive product and movement of it is restricted with rules and regulations. Every country has different laws and regulations regarding importing and exporting of pharmaceutical products and medicines.

Before Start:

For exporting a product, one must have knowledge about exporting country and importing country licenses and procedures as well as other particulars.

Regarding Importing Country:

  • How to register your product in Importing country
  • Regulatory Requirements of importing country like plant specifications, certification etc
  • How to find Distributors and/or importing agent in importing country
  • How to promote, market and distribute product in importing country
  • Custom Clearance

Regarding Origin Country:

  • How to take Export Permission/approval for pharmaceutical products and medicines (In India, it is issued by DCGI (Drug Controller General of India)
  • Regulatory Requirements of origin country
  • Dossier
  • Transportation and Shipment Details
  • Custom Clearance

Requirements for Export of Pharmaceutical Products and Medicines from India:

If you are thinking to export medicines from India then we are considering, you have completed general requirements like Company Registration, set-up marketing company or manufacturing company etc.

Other requirements are as follow:

  • IEC Number (Importer Exporter Code Number)
  • WHO: GMP or Concerned Authority Certified Plant
  • Distributor/Agent or Registered Office in Importing Country
  • Dossier
  • Registration of product in importing Country
  • Export Permission from DCGI
  • Freight Forwarder Agencies/Agents
  • Indian Trade Classification (Harmonized System) ITC (HS) of Product
  • Custom Clearance

IEC Number (Importer Exporter Code):

Every Importer and Exporter requires registration at Director General of Foreign trade Department website online. After registration, Department will allot a 10-character alpha-numeric number for exporting and importing any particular from Indian and in India. This registration number is known as IEC Number (Importer Exporter Code Number).

How to apply:

For IEC Number, application is to be submitted to Director General of Foreign trade’s Regional Authority office situated within jurisdiction range of your firm/company. IEC Code is applied online by visiting http://dgft.gov.in/ website or you can hire any CA or agent for applying IEC for you.

Application that is submitted online should be digitally signed by applicant. You need to upload the documents and pay the requisite fee through net banking.  This application will be processed by Regional Authority of DGFT online and a digitally signed e-IEC is issued and/or e-mailed to applicant within 2 working days if all necessary documents and formalities are complete. Otherwise application will be rejected and rejection letter/email (with reason of rejection) would be sent to the applicant.

Application for e-IEC can also be submitted through government ebiz portal http://www.ebiz.gov.in

General Documents required (To be uploaded):

  • Passport Size Photo (Proprietor/Partners/Directors/Authorized Person)
  • PAN Copy (Proprietor/Partners/Directors/Authorized Person)
  • Address Proof Copy
  • Premises ownership proof or rent agreement or lease proof
  • Partnership deed or company association documents
  • Bank Certificate or Cancelled cheque having printed details of firm/company and account number
  • Or as asked by DGFT department

WHO: GMP certified or Concerned Authority Certified Plant:

Most of countries allow import of pharmaceutical products and medicines from plant that are approved from WHO: GMP only. Few countries has own authority certification requirements for importing any medicine in its region like for exporting to USA, a plant must be approved to USFDA. Before exporting to any country you should confirm about regulatory requirements of that country.

For marketing companies, searching for manufacturer having required regulatory requirements of concern country is crucial step at initial stage of export.

For manufacturing companies, they have to approve their plant as per required authorities.

Distributor/Agent or Registered Office in Importing Country:

Most of small and macro size companies conduct export by appointing an import agent and distributor in importing country. They can’t bear huge marketing expense and sales team to handle marketing and promotion of product in foreign country. If you don’t want to set-up own arrangement in importing country, appointing any agent or distributor will be best option.

That agent/distributor will look after all processes like product registration, marketing and promotion of product in country and other legal formalities. Agents/distributors can be searched through/by attending Pharma Expo, trade fairs, advertisement, online B2B portals etc.

In case, you want to set-up own arrangement, you can registered your company/firm as per importing company norms and regulations.

Dossiers:

Dossier is a collection of documents which contains complete information about origin, nature, chemical properties and other particulars of a product. In Pharmaceutical export dossier plays an important role in registration process in importing country and permission/approval from DCGI for export.

A dossier format and requirements may vary as per country norms and regulations. Every country may have different format and required information in any dossier. You must study importing country laws and regulation before preparation of Dossier.

General guidelines for a dossier are as follow:

Details of the product

Describe the following details:

  • Name of the product
  • Approved generic name(s)
  • Strength per unit dosage and dosage form
  • Visual description of the product
  • Visual description of the packaging

Regulatory situation in other countries

List the countries in which this product:

  • Has been granted a marketing authorization
  • Withdrawn from the market
  • Where an application for marketing has been rejected, deferred or withdrawn

Active pharmaceutical ingredient (s) (API)

  • Properties of the active pharmaceutical ingredient(s)
  • Sites of manufacture
  • Route(s) of synthesis
  • Specifications
  • Stability testing

Finished product

  • Formulation
  • Sites of manufacture
  • Manufacturing procedure
  • Specifications for excipients
  • Specifications for the finished product
  • Container/closure system(s) and other packaging
  • Stability testing
  • Container labelling
  • Product information
  • Patient information and package inserts
  • Justification for any differences to the product in the country or countries

Efficacy and safety:

  • Bio-equivalence study report
  • Any Banned Molecule in the Product
  • Summary of pharmacology, toxicology and efficacy of the product

Registration of product in importing Country:

Every country has fixed norms and regulation for pharmaceutical products and medicines to be imported, manufactured and distribute within country. Before exporting a product to any country prior registration of that product is must in importing country unless specified.

For example, if you want to export to South Africa, then you need to apply for registration of your product as per Medicines and Related Substance Act, 1965 of South Africa. Likewise in other countries, you may have to register your product as per concerning country Medicine and Drug Related Act.

Your agent/distributor or your authorized person can register your product in concern country.

Export Permission from DCGI:

Export from India is come under Free Trade but prior approval/permission/NOC is required from DCGI before exporting any pharmaceutical product and medicine form India. Approval/Permission/NOC is one time for each product and valid for one calendar year but subject to renew further.

Indian Customs has introduced SWIFT (Single Window Interface for Facilitating trade). The required permission, if any, from other regulatory agencies (such as Animal quarantine, Plant quarantine, Drug Controller, Textile Committee etc.) is obtained online without the importer/exporter having to separately approach these agencies.

If you are new to export, hiring any agency for clearing custom and permissions will be better option. Doing by own self is also not so difficult work.

General Documents Required:

  • Application at prescribed Form
  • Prescribed Fee
  • Generic Name or International Non-proprietary Name
  • Strength and Dosage Form
  • If more than one active ingredient, Name and strength of each ingredient
  • Trade Name or proprietary Name of medicine
  • Pharmacopoeia specifications of the medicines which ever applicable
  • Total quantity to be exported
  • Name, Address and registration/license number of the exporter
  • Name, Address registration/license number of the Manufacturer
  • Name and Address of Consignee
  • Country of consignee
  • Route of Dispatch
  • Cost, insurance, Freight etc
  • Expected Date of Dispatch
  • Any other documents that are asked for

Freight Forwarder Agencies/Agents:

For delivery product to imported country, you will need to selecting and finalizing cargo or freight forwarder carrier/agent. Freight Forwarder agents are person or companies who organizes shipment for companies to get goods from exporter and deliver to importer.

Indian Trade Classification (Harmonized System) ITC (HS) of Product:

ITC (HS) is a compilation of codes for all merchandise / goods for export/ import. Goods are classified based on their group or sub-group at 2/4/6/8 digits.

ITC (HS) is aligned at 6 digit level with international Harmonized System goods nomenclature maintained by World Customs Organization (http://www.wcoomd.org). However, India maintains national Harmonized System of goods at 8 digit level which may be viewed by clicking on ‘Downloads’ at http://dgft.gov.in

Custom Clearance:

Customs Clearance is required while importing and exporting any product in India or from India. You can complete this procedure by own self or can hire an authorized custom clearance agents. For custom clearance first generate shipping bill through custom online Software system electronically. After generating shipping bill product will be moved to shipping portion where custom officials will inspect product, documents and other particulars and submit an examination report to higher custom officials for approval.

Now ‘Let Export Order’ will be issued by custom department as proof of completion of export custom procedure and three shipping bill will be printed. One for exporter, one for exchange control copy for submission in Reserve Bank of India through Exporter’s Bank and one for shipping carrier for imported country destination.

Custom Clearance is also required in importing country also as per act and laws of Imported Country

Mandatory documents required for export of goods from India:

  • Bill of Lading/ Airway Bill/ Lorry Receipt/ Railway Receipt/Postal Receipt
  • Commercial Invoice cum Packing List
  • Shipping Bill/Bill of Export/ Postal Bill of Export

Bill of Lading/ Airway Bill/ Lorry Receipt/ Railway Receipt/Postal Receipt:

It is referred to any receipt of transport by which material will be exported. This is issued by freight forwarder agent or appointed freight carrier.

Commercial Invoice cum Packing List:

Commercial Invoice and Packing list could be separate or invoice can describe the packing list. Commercial Invoice is a document contains particulars about exporter, importer, invoice number, declaration of product along with rates, number of packages and detail of each package with actual value of material exported.

Shipping Bill/Bill of Export/Postal Bill of Export:

When a product passes all customs, then shipping bill/bill of export is issued by custom department.

Procedure and Business Plan for Exporting Medicines from India:

  • Make a firm/Company (Marketing/Manufacturing)
  • Take 10 digits IEC (Importer Exporter Code) Number
  • Appoint agent/distributor or register own office in importing country
  • Send quotation and finalized all particulars, and term & conditions in case of appointing agent/distributor
  • Register product in importing country
  • Take approval/permission from DCGI
  • Finalize payment term, method of shipping, cost of shipping, term of delivery etc.
  • Receive Purchase Order
  • Send Pro-forma Invoice to importer (including rates, types of packing, freight other particulars to confirm order)
  • Prepare commercial invoice (Against Purchase Order or Letter of Credit) and packing list etc
  • Tie up with freight forwarding agents for movement of product from India to importing country
  • Now dispatch product for custom clearance.
  • After Custom clearance and Let Export Order, product will be transported for imported country by mean of finalized method of transport e.g. by air, ship, rail, road etc.
  • Custom Clearance is also required in imported country as per their laws and regulations.
  • After clearance of custom clearance in imported country, export process is completed.

Hope this article will be helpful to you…

For any query and suggestion, please mail us at pharmafranchiseehelp@gmail.com

What is IEC ( Importer Exporter Code Number)?

IEC is a short form of Importer Exporter Code. Importer Exporter Code is compulsory in India if a person want to import or export any goods or service. It is ten digit code issued by DGFT- Director General of Foreign Trade , Ministry of Commerce, Government of India.
What is IEC?
An IEC is a 10-character alpha-numeric number allotted to a person
that is mandatory for undertaking any export/import activities. With a
view to maintain the unique identity of an entity (firm/company/LLP
etc.), consequent upon introduction / implementation of GST, IEC will
be equal to PAN and will be separately issued by DGFT based on an
application.

How to Apply:

Application for obtaining IEC may be filed online in ANF 2A with
applicable fees and submitted with digital signature.

When an e-IEC is approved by the competent authority, applicant is
informed through e-mail that a computer generated e-IEC is available
on the DGFT website. By clicking on “Application Status” after having
filled and submitted the requisite details in “Online IEC Application”
webpage, applicant can view and print his e-IEC.

Documents Required for Importer Exporter Code (IEC) Number:
In case of fresh e-IEC:

  • Digital Photograph (3x3cms) of the Signatory Applicant
  • Copy of PAN card
  • Bank Certificate or cancelled bearing the applicant entities name

Related Article: How to export pharmaceutical products and medicines from India?

In case of Modification of IEC:
Upload the requisite documents in digital format as detailed below:

For Proprietorship Firm

  • Digital Photograph (3x3cms) of the Proprietor.
  • Copy of PAN card of the Proprietor.
  • Copy of Passport (first & last page)/Voter’s I-Card/ Driving Licence/UID (Aadhar card) (any one of these).
  • Sale deed in case business premise is self-owned; or Rental/Lease Agreement, in case office is rented/ leased; or latest electricity /telephone bill.
  • Bank Certificate as per ANF 2A(I)/ Cancelled Cheque bearing preprinted name of applicant and A/C No.

For Partnership firm

  • Digital Photograph (3x3cms) of the Managing Partner.
  • Copy of PAN card of the applicant entity.
  • Copy of Passport (first & last page)/Voter’s I-Card /UID (Aadhar Card) /Driving Licence/PAN (any one of these) of the Managing Partner signing the application.
  • Copy of Partnership Deed.
  • Sale deed in case business premise is self-owned; or Rental/Lease Agreement, in case office is rented/ leased; or latest electricity /telephone bill.
  • Bank Certificate as per ANF 2A (I)/Cancelled Cheque bearing preprinted name of the applicant entity and A/C No.

For LLP firm/Government Undertaking/Public Limited Company/Private Limited/Company Section 25 Company

  • Digital Photograph (3x3cms) of the Designated Partner/Director of the Company signing the application.
  • Copy of PAN card of the applicant entity.
  • Copy of Passport (first & last page)/Voter’s I-Card /UID (Aadhar Card) /Driving Licence/ PAN (any one of these) of the Managing Partner/Director signing the application.
  • Certificate of incorporation as issued by the RoC
  • Sale deed in case business premise is self-owned; or Rental/Lease Agreement, in case office is rented/ leased; or latest electricity /telephone bill
  • Bank Certificate as per ANF 2 A(I)/Cancelled Cheque bearing preprinted name of the company and A/C No .

For Registered Society

  • Digital Photograph (3x3cms) of the signatory applicant/Secretary or Chief Executive.
  • Copy of PAN card of the applicant entity.
  • Copy of Passport (first & last page)/Voter’s I-Card /UID (Aadhar Card) /Driving Licence/ PAN (any one of these) of the Secretary or Chief Executive/ Managing Trustee signing the application.
  • Sale deed in case business premise is self-owned; or Rental/Lease Agreement, in case office is rented/ leased; or latest electricity /telephone bill.
  • Registration Certificate of the Society / Copy of the Trust Deed
  • Bank Certificate as per ANF 2A(I)/Cancelled Cheque bearing preprinted name of the Registered Society or Trust and A/C No. Trust

For HUF

  • Digital Photograph (3x3cms) of the Karta.
  • Copy of PAN card of the Karta.
  • Copy of Passport (first & last page)/Voter’s I-Card/ UID (Aadhar card)/ Driving Licence (any one of these) of the Karta.
  • Sale deed in case business premise is self-owned or Rental/Lease Agreement, in case office is rented/ leased or latest electricity /telephone bill.
  • Bank Certificate as per ANF 2A(I)/ Cancelled Cheque bearing preprinted name of applicant and A/C No.

Any other document considered relevant for the application .

Hope above information is helpful to you…
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com
Related Articles:

Queries Related to Ayurvedic Export

Related Query:
I want to deal in ayurvedic products like shilajit, salam, panja garlic.I want to export. Can i get registration to export these productsResponse:
For exporting Ayurvedic products, you need free trade export license. read documents and procedure for export of Ayurvedic 
You can read general requirements for exporting Ayurvedic medicine in this article. You can export your mentioned ayurvedic products after fulfilling all requirements that are required by export department of India and Import department of country to which you want to export.

Related Query 2:
I wants to start Papaya leaf extract and capsules manufacturing and export. Please advise me that what are license to be obtained and where shall I get technical know-how for manufacturing process.Response:
For manufacturing of papaya leaf extract and capsule manufacturing, you will need Ayurvedic manufacturing license. Read whole process for taking Ayurvedic License by clicking here
For export, you have to apply for IEC (import/export code) and free trade license. Read complete process of exporting ayurvedic medicines by clicking here
Technical guidance you can take from manufacturers already manufacturing papaya leaf extract.

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Four Quick Tips Regarding Pharmaceutical Export

Query:
 

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.

  1. What kind of licenses are required for pharmaceutical export, apart from company registration and IEC code?
  2. Would we have to take specific licenses for specific drugs or does one license covers all?
  3. Do we have to hire a B.Pharma graduate as is the case in wholesaler’s business?
  4. 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.
 

Response:

  1. 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
  2. In most of case there is need to take product approval for export for every single product.
  3. You can hire a B. Pharmacy or D. Pharmacy or any EP for wholesale drug license.
  4. 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

Seven Quick Tips Regarding Export from India

Query:
Please note we are a Marine Related Company from Singapore, and we are very much interested in starting our very own Export Business through the Company to Acquire and Re supply, all types of Medicines to the Ships (Owners / Management Companies, Crew etc) from our Indian Company, we however need a complete detailed list of all the necessary Licenses/Permissions, etc needed to start this business asap.
So please advice us all the details necessary, whom to contact, etc.

  • What/How many, types of Licences/Permissions are needed in India.
  • What are the documents needed in India.
  • Whom/Where do we have to approach/contact for all these procedures in India.
  • What will be the approx necessary Costs.
  • Is any approvals needed from DGCI, and for how long is it valid and how do you renew the same.
  • Do we require an IEC Code, and how is that acquired.
  • Please note this is not to sell in the Markets or to Vendor’s, this Business is only for Ships and Marine Supply.

Please view the above and advice us urgently, with all necessary information, so we can revert with our intentions.

Response:

Here we are providing a detailed response regarding your queries:
From your query, you are planning to start a Indian Pharma Company. But we are not clear whether you want to start marketing company or manufacturing company. We are assuming your are going to start manufacturing Pharma company in India.1. For manufacturing Company Set-up in India requires:Company Registration, Manufacturing License, who: gmp certification, wholesale drug license, tax identification number etc. For minimum requirement about manufacturing unit, read our article: How to start Pharma Manufacturing Unit . . Minimum area required for Manufacturing unit read by clicking here
For marketing based company, you need to take wholesale drug license, company registration, sale tax number. Minimum requirement you can read at our article: How to start pharma marketing company?. Minimum area should be 10 sq. meter for starting marketing base pharma company.
2. Documents needed can read at above mentioned links.
3. First you need to find out space for your set-up (Marketing or Manufacturing). Any property dealer or space provider can arrange space or premises for your set-up. Premises should compile the minimum basic requirements as per Drug and Cosmetic Act.
For manufacturing company, you have to meet drug control officer of concern state in which Indian state you want to start.
For marketing company, you have to meet drug inspector of District (where your office is located) of Concern State of Indian Territory.
4. Approximate cost of pharma manufacturing read in our article: Pharma Manufacturing Unit Project Report
For marketing company, read Investment required to start pharma marketing company
5. For manufacturing of new molecules permission DCGI approval is required. For other molecules approvals is required by state drug control office.
6. IEC (Import and Export Code) is necessary for all import and export from India. Read IEC by clicking at our article: How to obtain IEC requirement and exporting procedure from India can be read at our article: How to export Pharma Products?
7. For exporting medicines from India, you have to follow above mentioned requirements. For marine and Ship, there will be medical section or medicines will be purchase under tenders. For supplying medicines to ship & marine supply, you have to follow concern company law or international drug related laws.

Hope above information is helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How to Export Medicines?

Query:
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?

Response:

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…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Few reputable exporters of drugs to US and or Canada from India

Query:

I got your name from web search.
May I inquire a few recommendations of reputable exporters of drugs to US and or Canada
In particular I am looking for ED drugs.

Response:

Few reputable exporters of drugs from India are as below:

  • Sun Pharmaceutical
  • Lupin Ltd
  • Dr. Reddy’s Laboratories
  • Cipla
  • Aurobindo Pharma
  • Cadila Healthcare
  • Glenmark Pharmaceuticals
  • Divis Laboratories
  • Torrent Pharmaceuticals

Hope this information will be helpful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Export/Import Procedure and Tax Structure

Query:Kindly suggest me regarding the import and export procedures,
Customs , tax structures .

Response:

Read in detail about your queries by clicking at below links:

For import procedure click here

For Export Procedure click here

For tax structure click here

The duty that is levied for goods manufactured inside the state is called excise duty.
The duty that is levied on goods imported from a foreign country is the customs duty.
Excise duty is imposed along with VAT and sales tax at manufacturing of Goods.

For query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How To Import Medicines and Food Supplements in India?

Query:
I want to know about the import procedure for veterinary feed supplements and antibiotics, kindly help me.

Response:


You can procure all antibiotics and feed supplement in India then why do you need to import these products. You can contact third party manufacturers in India for your need. It will be less costly and easily available to you.
India is second largest supplier of medicines to USA.

If you want to import, then you have to take an Import/Export (I/E) code from Director General of Foreign Trade office in district your firm is located. Documents required for filing application for import/export code number is:

  • Passport size photo
  • Pan card
  • Address proof
  • Firm address proof
  • Firm current account detail/Cancelled Cheque

After receiving I/E code number. Contact manufacturer outside India from where you want to import feed supplements and antibiotics. You will also require whole sale drug license in case of Antibiotics and FSSAI registration in case of Food/Feed Supplements.

Other than this you need to submit application at Central Drugs Standard Control Organization (Import & Registration Division). Read all requirement by downloading pdf file related to Registration of Imported medicines by clicking here

Hope above information was useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

licenses required to export Ayurvedic Medicines

Query:Any licenses required to export like moov, tiger bam, iodex, vick vaporub, crack cream from india?

Response:

These are Ayurevedic Preparation, You need only IEC number (Importer/Exporter Code) for exporting these preparations along with free trade license for commerce industry.

Read here: How to export Ayurvedic Medicines

Hope above information is useful to you…

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com