How to Export Pharmaceutical Medicine from India?

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, India 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.

The Indian Pharmaceutical market is dominated by generic drugs which constitute nearly 70% of the market, whereas Over-the-Counter medicines and patented drugs make up to 21% and 9% respectively.

Export of Medicine from India

• Pharmaceutical export from India stood at US $ 17.27 billion in 2017-18 and is expected to grow by 30% to reach US $ 20 billion by the year 2025.
• Exports of pharmaceutical products together stood at US $10.80 billion in April-October 2020.
• From April-October 2020, the top importers of India’s pharmaceutical products were the USA ( US $ 3.21 billion), UK (US $ 383.30 million), South Africa (US $ 367.35 million), Russia (US $ 283.33 million) and Nigeria (US $ 255.89 million).
• India is the largest supplier of generic medicines globally (20 to 22% of global export volume)
• India has one of the lowest manufacturing costs in the world. It is lower than that of the USA and almost half of 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

• 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.
• Once they have all the necessary documents, the business owners must contact individuals from importing countries and find an interested vendor or buyer.
• Next, they will have to go through the laws of the importing country and register the product in that country legally to prevent complications later.
• 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 well-being and health of consumers.
• The business owners will then have to research and finalize 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.

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• Once all these formalities are complete, the company will have to wait for the buyer or vendor to finalize 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.
• 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.

• Next, the business owners must sign a contract with the shipping or freight forwarding agency to ensure efficient order fulfillment.
• 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 out 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 statements 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. Canceled cheque
9. WHO: GMP certification
10. A 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 are 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

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