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How to Export Medicines Internationally from India

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Sumana Sarmah

Specialist - Marketing @ Shiprocket

December 15, 2022

6 min read

Introduction

In the worldwide pharmaceutical and vaccine sector, India plays a significant role as the world’s biggest supplier of generic medications. The nation supplies 20% of the world’s total supply volume and about 60% of the world’s vaccinations, where OTC drugs, generics, APIs, vaccines, biosimilars, and custom research manufacturing are prominent segments of the Indian pharmaceutical industry (CRM). 

India – The Pharmacy Of The World

India most commonly supplies vaccines like DPT, BCG, and MMR (for measles) to foreign countries. Most USFDA-approved plants outside the USA are also situated in the country. 

Did you know? India is also referred to as the “Pharmacy of the World” sometimes due to the country’s pharmaceutical industry’s low cost and good quality primary USPs. 

In 2019–20, the Indian pharmaceutical industry’s total yearly revenue was $36.7 billion, with the availability of inexpensive HIV medications among the greatest successes. Furthermore, India is also one of the biggest nations in the world that exports affordable vaccines.

Most medicines exported from India today are drug formulations and biologicals, which make up around 75% of all exports.

Why India’s Contribution Is Important To The World Pharmaceutical Landscape

India surpasses most countries of the world when it comes to contributing to the pharmaceutical industry. Here’s how. 

  • India’s export medicines are targeted to the Middle East, Asia, CIS, Latin America & the Caribbean (LAC), North America, Africa, the EU, ASEAN, and other European regions.
  • Africa, Europe, and NAFTA receive almost two-thirds of India’s export of medicines. In 2021–22, the USA, the UK, South Africa, Russia, and Nigeria were five of India’s top export markets for pharmaceutical products.
  • With shares of 29%, 3%, and 2.4%, respectively, in 2021–22, the USA, the UK, and Russia are among the top importers from India.
  • In FY21–22, India exported medicines to the following nations were to the tune of the USA ($7,101,6 million), the UK ($704,5 million), South Africa ($612,3 million), Russia ($597,8 million), and Nigeria ($588.6 million).
  • Over the past three years, the value of India’s pharmaceutical exports to the USA increased at a CAGR of 6.9%. Additionally, over the same period, it increased at a CAGR of 3.8% for the UK and 7.2% for Russia, respectively.

These statistics show why India is a key player in the pharmaceutical industry worldwide.

Registration For International Shipping Of Pharmaceuticals

The process for registering for international shipping is as follows:

  • Applicants must go to the official DGFT website, select the “Online Application” button, and select the “IEC” option from the drop-down menu. To continue, select the “Online IEC Application” option.
  • Use your PAN to log in to the system, then select “Next.”
  • Next, select the “File” tab and press the “New IEC Application Details” button.
  • A new window with an application form that people must accurately complete will be opened.
  • Users must click the “Upload Documents” option to continue after submitting the form and verifying all the information they provided.
  • Users must click the “Branch” button to enter additional information about their branches after uploading all necessary supporting documents.
  • Users must use the “Director” tab to add information on the company’s directors.
  • Finally, users should click the “EFT” option to finish the online IEC application procedure by paying the necessary processing fee of INR 250.

Please note that applicants must also provide a hard copy of their application and the necessary supporting documentation to the DGFT’s office within 15 days of submitting an online application.

List Of Documents Required For Shipping Medicines Abroad

The following documents are required for shipping pharmaceuticals from India:

  • Company PAN number
  • Incorporation Certificate
  • Bank account statements and other financial documents
  • Indian Trade Classification (HS) of the product
  • Bankers Certificate and other customs documents 
  • IEC Number 
  • Canceled cheque
  • Proof of ownership of business premises or rental agreement  
  • WHO: GMP certification

The documents outlined above should mandatorily include details: 

  • Product details
  • Approved generic names
  • Strength per dosage 
  • Dosage form
  • Details regarding the packaging
  • List of all active pharmaceutical ingredients with their properties 
  • Visual description 
  • List of countries where the product has been approved, rejected, and withdrawn 
  • Sites of manufacture and method of synthesis
  • Stability testing
  • Efficacy and safety

How To Export Pharmaceuticals From India?

If you are planning to venture into the export medicines segment, you must fulfill a few certification/documentation requirements. For instance, a medicine license number, GST identity number, registration, etc. Also, these will be the same as domestic pharmaceutical companies.

Along with these, here are a few steps to export medicines from India: 

IEC Registration

The first major requirement is the IEC (Import/Export Code) Number. All Indian importers and exporters are given this number. You must apply to the Director General of Foreign Trade at the location where your company’s office is located. No transportation of goods into or out of the nation is permitted without an IEC code.

According to our foreign trade policy, only licensed pharmaceutical businesses are permitted to export pharmaceuticals from India; thus, the company must apply for an Import Export Code and register with the Director-General of Foreign Trade.

Regulatory Compliance

To avoid issues later, businesses must review the rules of the country they are importing from and officially register their product there.

Once they receive permission from the importing nation, they must obtain the same from India’s drug controller general. This is essential as pharmaceuticals and medicines are significant goods that may hurt customers’ general well-being and health.

Market Research And Export Strategy

Once they have all the required paperwork, business owners must contact people in importing nations to locate a vendor or buyer who is interested.  Business owners should conduct research and choose a suitable shipping strategy. 

Accurate Documentation

Here, the buyer will submit a proforma invoice along with the order confirmation that includes specifics on the product, the amount of packing needed, and shipping information. Depending on how they intend to finance the order, the business must subsequently create a commercial invoice to be submitted in response to this purchase order or Letter of Credit.

Effortless And Reliable Shipping

To ensure effective order fulfillment, business owners must contract with the shipping or freight forwarding company. Exporters should only use reputable organizations to deliver their goods to avoid needless delays and issues. The final customs clearance phase occurs after the documentation procedure is complete. You can do this efficiently by engaging an agent. The same applies to shipping goods to the country of importation, where they may then be dispersed as needed after receiving customs clearance.

Summing Up

By providing affordable access to life-sustaining medications around the world, Indian pharmaceutical businesses have long been role models. In contrast to developed markets, emerging nations have recently seen a rise in pharmaceutical exports. A business exporting medicines needs a reliable and efficient shipping partner. Different medicines may require specific requirements for storage and handling, A shipping partner that understands the importance of handling instructions and can do so efficiently is the utmost requirement for the success of an export medicine venture. Check the website to understand how well we can serve your requirements.

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