How to start Export Oriented Pharmaceutical Company?

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

Response:

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.

Machinery and Area required, you can read in our article: Business Plan for Pharmaceutical Plant, machinery, area required and equipment.

  • Plant Cost owned: Depend at current rates
  • Plant Cost Rented Premises: Minimum of 35000 to 40000 per month
  • Semi Automatic capsule filling machine along with parts: Minimum of 12 lakhs
  • Tablet compression rotary: Approx. 5 lakh
  • Packaging: Alu-Alu -12 lakh /Blister- 4-6 lakh
  • Complete liquid plant: Approximately 10-11 lakh
  • Other requirements: 10-15 lakhs

You can start only one section or all sections together as per budget.
For particular certifications for export orientated manufacturing unit may be extra.

Read here: Documentations and Procedure for exporting Pharmaceutical Products/Medicines/Drugs

Hope above information was useful to you…

How to export Ayurvedic Medicines and Herbs from India?

Query:

Kindly help to under the process for getting an ayurvedic product license and the associated free sales certificate for export of the product to other countries from india.
I understand stability studies are required for product license application, please advice on the duration of study required and how many batches will be required. Is it only accelerated or long term study will also apply.

Response:

For manufacturing any Ayurvedic product in India, manufacturer’s require product’s approval from Ayush department. Product’s approval is sent in prescribed format having following requirements:

S. No. Category Ingredient(s) Indication (s) Safety Study Experience/Evidence of Effectiveness
1 2 3 4 5 6
Published Literature Proof of Effectiveness
1 Patent or Proprietary Medicine As per Text Textual Rationale Not Required of ingredients Pilot study as per relevent protocol for Ayurveda , Sidha and Unani drugs
2 Ayurveda, siddha and Unani drugswith any of the ingredients of Schedule E(1) of the Drugs and Cosmetics Act, 1940 As per text Existing Required Required Required

Note: Photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book will be attached with file.

In case of Classical Ayurvedic Products e.g. Single herbs, Chawanprash, Ristha, Ashava etc, Manufacturer need to take approval from AYUSH department just by mentioning name and prescribed book name (Along with photo copy of textual reference). Ayurvedic manufacturer can manufacturer classical products without any alteration in label and indications as described in Ayurvedic Books.

Read in detail about start Ayurvedic Manufacturing Unit and Marketing Company in India by clicking here

In case of export, Country in which we are going to export standards and requirements will also applicable. Most of country requires products registration before importing any product in country. Before proceeding to export you have to confirm all requirements and procedure for registration of your products in country in which you want to export product.

For India, Exporting Company has to apply for Free Sale Certificate for exporting Ayurvedic medicines.

“Form of Free Sale Certificate and Non-Conviction Certificate. – The State Drug Controller or Licensing Authority shall, on request by the Ayurveda, Siddha and Unani Drugs manufacturer, issue, within 15 days; from the date of application, Free Sale Certificate in Form 26 E2-I for original License holder or in Form 26 E2-II for loan license and Non Conviction Certificate for both original and loan license holder in Form 26 E3 or in the format as specified by the importing country or tenderer respectively, after fulfillment of all requisite formalities as required in the respective formats”

With above requirements, you will need IEC number ( Importer Exporter Code Number).

For exporting or importing from/to India. This is necessary for all importer or exporter to have IEC. Without IEC, no one can do export/import from/to India. IEC is alloted by Director General of Foreign trade within the jurisdiction office of your firm situates.

For Ayurvedic Products Export approval, All formulations, herbal/Ayurvedic medicines, where the label does not mention any ingredients extracted from prohibited plants shall be freely exportable without the requirement of any certification from any authorities what soever. Ref: http://dgft.gov.in/exim/2000/not/not03/not0303.htm

or

On request from processor or exporter, the competent authority shall issue certificate(s) for the export of Ayurvedic, Unani and Siddha products as per the requirement of the importing country. ref: order dated: 16-4-2008, Government of India, Ministry of commerce and Industry.

But you may have to pass one from three type of inspections or certifications:

  • Consignment wise inspection for ensuring safety with regard to contaminant such as heavy metals, pesticides, aflatoxins and microbes or
  • System approach to include end-product quality as well as implementation of good manufacturing practice (GMP’s) by the processor or
  • Safety, quality and efficacy through independent review of dossier submitted by the manufacturer.

Dossier may include following things:

  • Name of the drug
  • List of all ingredients and their strengths
  • Strength and dosage form, Indications if applicable
  • Name and strength of each ingredient; in case of a product containing more than one ingredient
  • Trade name or proprietary name; if any
  • Specification of the medicine, where applicable
  • Ayurvedic/Siddha/Unani Medicines
  • 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
  • Licence/registration number
  • Cost, insurance, freight (CIF) value
  • Expected date of dispatch

Procedure For Exporting Ayurvedic Medicines:

  • Start a Ayurvedic Company/Firm/Business
  • Apply for Importer Exporter Code and Free Sale Certificate
  • Search Foreign Customers and Agents (B2B portal may help in this regard)
  • Make a Contract with them
  • Finalize Rates (Included or excluded with shipping cost, custom clearance and other expenses)
  • Finalize payment, shipping method/agent and delivery terms
  • Receive Order
  • Prepare Invoice (Against PO or Letter of Credit(LC))
  • Clear custom procedure (By own or through agent)
  • Apply for Shipping bill electronically through Custom Online Software System and obtain shipping bill
  • Inspection will be carried out of material, documents etc. Custom officer will send examination report to higher custom officers for approval
  • “Let Export Order” will be issued and three shipping bill is generated. 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.
  • In importing country, all clearance will be handled by your customer, agent or any appointed agent.

Things to Give Attention for Exporting From India:

  • HTS (HS code) of the product which exporter is going to be export. HTS stands for Harmonized Traffic Schedule. For exporting any product, HTS code has to be mentioned of the product. These code are of international standards and accepted while clearing custom in importing country.
  • HSN code: The Harmonized Commodity Description and Coding System, also known as the Harmonized System (HS) of tariff nomenclature is an internationally standardized system of names and numbers to classify traded products.
  • ITC code stands for Indian Tariff Code. It is 8 digit level code. The first two digits give the chapter number, Four digits the heading number. The last two digits signify the subheading
  • Export of Pharmaceutical/medicines and Ayurvedic 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.
  • LC (Letter of Credit): A letter of Credit is a Bank Guarantee letter issued by Buyers Bank as a proof of payment to the seller that payment will be received on time and for correct amount.

Hope above information was useful to you….

For more suggestion and query, feel free to mail us at pharmafranchiseehelp@gmail.com

Related Articles:

How to Export Pharmaceutical Products from India?

Query:
Hi, 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 wholesale drug license number, GST identification number, company registration etc. You can read requirements for both marketing company and manufacturing company. 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. Packaging 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
  • 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
  • Approval 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