How to Export Medicine from India

Last Updated at: Mar 19, 2021
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Import Export Code - Export Medicine

The Indian pharmaceutical industry is one of the largest in the world, helping supply generic medicines to several countries around the world. In terms of sheer volume, Indian ranks three in the world whereas in terms of value, it comes in at number thirteen. Over the years, India has established itself as a global manufacturing powerhouse and research hub. The export of pharmaceutical products from India has been growing steadily in recent years and has become a viable business opportunity. The value of generic medicine exports from India has also been on the rise, growing at a compound annual growth rate of 22.4%. Let us now look at how manufacturers can export medicine from India efficiently, without facing any legal hassles.  

Export of Medicine from India

The export of pharmaceutical products from India is heavily dominated by generic drugs. The generic medicine export from India constitutes nearly 70% of the global market. On the other hand, patented drugs and over-the-counter drugs make up only 9% and 21% of the market. In 2017, India exported medicines worth $17.27 billion and was expected to grow at 30% to hit a valuation of $20 billion by 2020. Additionally, India is the world’s largest exporter of generic medicines, making up over 22% of the total export volume. This is because India’s has much lower manufacturing costs when compared to the USA and Europe. The top import nations for medicines from India are as follows;

  1. United States of America
  2. United Kingdom
  3. South Africa 
  4. Russia 
  5. Nigeria 

get import-export license 

How to Export Medicine from India

  1. Only registered pharmaceutical companies can export medicines from India as per our Foreign Trade Policy. First and foremost, the company must register with the Director-General of Foreign Trade and apply for an Import Export Code.
  2. Once they have all the necessary documents, the business owners must contact individuals from importing countries and find an interested vendor or buyer.
  3. Next, they will have to go through the laws of the importing country and register their product in that country legally to prevent complications later. 
  4. Once they have approval from the importing country, they will have to obtain the same from the Drug Controller General of India. These are necessary as drugs or medicines are serious commodities that can impact the overall wellbeing and health of consumers.
  5. The business owners will then have to research and finalise a shipping method that will work for them. Entrepreneurs must make sure they rely only on reputed agencies to deliver their products to prevent unnecessary delays and problems. 
  6. Once all these formalities are complete, the company will have to wait for the buyer or vendor to finalise the purchase order. Similarly, along with the order confirmation, the buyer will send a proforma invoice that contains information regarding the product details, packing required and freight details.
  7. The company will then have to draft a commercial invoice against this purchase order or Letter of Credit depending on how they plan on financing the order. 
  8. Next, the business owners must sign a contract with the shipping or freight forwarding agency to ensure efficient order fulfilment. 
  9. After completing the documentation process, the last step is customs clearance which can be smoothly handled by appointing an agent. Likewise, once the products receive customs clearance, they will be shipped to the importing country and may be distributed as required. 

Applying for IEC to Export Medicines from India

  1. Individuals must visit the DGFT’s official website, navigate to the ‘Online Application’ tab and choose the ‘IEC’ option from the drop-down menu provided. 
  2. Next, click on the ‘Online IEC Application’ option to proceed.
  3. Log in to the system using your PAN and click on ‘Next.
  4. Further, navigate to the ‘File’ tab and click on the button marked ‘New IEC Application Details’. 
  5. Moreover, this will open up a new window with an application form that individuals must fill correctly.
  6. Moreover, after filing the form and double-checking all the details provided, users must click on the ‘Upload Documents’ button to proceed.
  7. Next, the users must upload all the required supporting documents and click on the ‘Branch’ button to add further details regarding their branches. 
  8. Then users must go to the ‘Director’ tab to add details regarding the directors of the company.
  9. Lastly, users should click on the ‘EFT’ button to pay the required processing fees worth INR 250 online and complete the process of the IEC application. Additionally, applicants must also send a hard-copy of their application along with the required supporting documents to the DGFT’s office within 15 days of submitting an online application. 

Documents Required for the Export of Pharmaceutical Products from India

  1. Company PAN number
  2. Incorporation Certificate
  3. Bank account statement and other financial documents
  4. Bankers Certificate and other customs documents 
  5. IEC Number 
  6. Indian Trade Classification (HS) of the product
  7. Proof of ownership of business premises or rental agreement 
  8. Cancelled cheque 
  9. WHO: GMP certification
  10. Dossier containing the following details;
  • Product details
  • Approved generic names
  • Strength per dosage 
  • Dosage form
  • Visual description 
  • Details regarding the packaging 
  • List of countries in which the product has been approved, rejected and withdrawn 
  • List of all active pharmaceutical ingredients with their properties 
  • Sites of manufacture and method of synthesis
  • Stability testing
  • Efficacy and safety

Things to Know Before Starting Generic Medicine Export from India

Manufacturers will need to look into the following matters before they start exporting generic medicines from India.

  1. Process of registering the product in a foreign country
  2. Regulatory and compliance requirements of the importing country 
  3. Additional certifications required by the importing country
  4. Method to find distributors, vendors and potential buyers in the importing country 
  5. Establishment of an efficient supply chain system in the importing country
  6. Process of customs clearance
  7. Obtaining export permission for generic medicine export from India from the Drug Controller General of India