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.
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
- Transportation and Shipment Details
- Custom Clearance
Requirements for Export of Pharmaceutical Products and Medicines from India:
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
- 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.
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
- Stability testing
- 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
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.
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